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Multimodal monitoring setup for stroke patient
measurements and development of an easy-to-use
user interface for the data collection
University of Oulu
Information Processing Science
Master’s Thesis
Jari Paunonen
2025
2
Abstract
Stroke is a leading cause of disability in a world, and it causes huge costs to healthcare
systems. Diagnosing stroke early as possible is important, because in a brief time window,
treatment should have been started to lower the chances of brain damage and improve
rehabilitation. Early diagnostic methods that are quick and easy to use and also help
recognize stroke mimics can reduce healthcare system costs and improve recovery for
individuals who have had a cerebrovascular accident. Software integrated into these
methods, such as user-friendly graphical user interfaces (GUIs) designed for medical
devices, plays a critical role. For individuals with limited tech familiarity, GUIs should
feature large, high-contrast text, intuitive navigation, and clear visual cues to
accommodate potential visual or cognitive impairments. Voice-guided instructions and
touch-based inputs can enhance accessibility, ensuring rapid and accurate use in high-
pressure clinical settings. From a medical device regulation perspective, such software
must comply with standards like IEC 62304, ensuring traceability, usability validation
through human factors testing, and robust data security to protect patient information.
Stroke project was multidisciplinary project, with several collaborators from private
companies to universities. Data collection was done by recording data from several
different modalities in Kuopio and Oulu. My goal was to realise the multimodal
measurement setup and conduct data recordings from stroke patients for the stroke
studies. Furthermore thesis will cover the theory of designing and developing Graphical
User Interface (GUI) for a wearable medical device prototype, focusing on designing GUI
for elderly adults or nurses with a medical device regulation point of view considered
also.
Keywords
Stroke, Multimodal, NIRS, Near Infrared Spectroscopy, Usability, Accessibility, GUI
Supervisors
Minna Isomursu, Teemu Myllylä
3
Tiivistel
Aivohalvaus on johtava vammojen aiheuttaja maailmassa ja se aiheuttaa valtavia
kustannuksia terveydenhuoltojärjestelmille. Aivohalvauksen diagnosointi
mahdollisimman varhaisessa vaiheessa on tärkeää, koska aivohalvauksen
diagnosoinnissa tunnistaminen mahdollisimman aikaisessa vaiheessa on hyksi
aivovaurion mahdollisuuksien pienenmiseksi ja kuntoutuksen parantamiseksi.
Varhaiset diagnostiset menetelmät, jotka ovat nopeita ja helppokäytisiä ja auttavat
myös tunnistamaan aivohalvauksen oireiden jäljittelijöitä, voivat vähentää
terveydenhuoltojärjestelmän kustannuksia ja parantaa toipumista henkilöillä, jotka ovat
kokeneet aivoverenkiertohäiriön. Näihin menetelmiin integroitu ohjelmisto, kuten
lääkinnällisiin laitteisiin suunnitellut käyttäjäystävälliset graafiset käyttöliittymät
(GUI:t), on keskeises roolissa. Henkilöille, joilla on rajallista teknologiaosaamista,
käyttöliittymien tulisi sisältää suurikokoinen, korkean kontrastin teksti, intuitiivinen
navigointi ja selkeät visuaaliset vihjeet, jotta ne huomioivat mahdolliset näkö- tai
kognitiiviset rajoitteet. Ääniopastetut ohjeet ja kosketuspohjaiset syötteet voivat parantaa
saavutettavuutta, varmistaen nopean ja tarkan käytön korkean paineen kliinisissä
ympäristöissä. Lääkinnällisten laitteiden sääntelyn näkökulmasta tällaisen ohjelmiston on
noudatettava standardeja, kuten IEC 62304, varmistaen ljitetvyyden, käytettävyyden
validoinnin ihmistekijätestauksella sekä vahvan tietoturvan potilastietojen
suojelemiseksi.
Stroke projekti oli monitieteellinen tutkimusprojekti, jossa osallisia oli yksityisistä
yrityksis eri yliopistoihin. Tutkimusdataa kerättiin usealla eri modaliteetilla kahdessa
eri kaupungissa, Kuopiossa ja Oulussa. Minun tavoitteeni oli toteuttaa usean modaliteetin
mittausjärjestelmä ja kerätä dataa aivohalvauspotilailta, aivoverenkiertohäiriöiden
tutkimukseen.Lisäksi opinnäytetyöni kattaa teorian graafisen käyttöliittymän (GUI)
suunnittelusta ja kehittämises puettavan lääkinnällisen laitteen prototyypille, keskittyen
GUI:n suunnitteluun iäkkäille ihmisille ja hoitajille, ottaen huomioon myös lääkinllise n
laitteen säätelyn näkökulman.
Avainsanat
Aivoverenkiertohäiriö, Multimodaalinen, NIRS, Lähi-infrapunaspektroskop ia,
käytettävyys, Saavutettavuus, GUI
Ohjaajat
Minna Isomursu, Teemu Myllylä
4
Foreword
Working on Stroke project and NIRS research project was very interesting for me. I have
background on electronics, information technology and healthcare and I was able to use
all my expertise which I have gained from my previous jobs.
I have been working couple years in healthcare where I did help several customers who
were rehabilitating from stroke. This experience was very useful for me when I was
working on Stroke project with patients.
Electronics and information technology experience has also been very useful when I was
working with NIRS project. Participating in electronical development by building and
repairing NIRS devices when needed and also part of this work was finding optimized
sensors and electrodes to work with our NIRS headband. Working on Teemus wearable
NIRS device has provided me many opportunities to learn more about prototype product
development.
During the project, we have managed to develop NIRS device from large suitcase size to
wearable device which can be attached for example to arm if needed.
Headband development has been challenging work. There were many challenges to
overcome like for example, materials to use, how they are connected to skin to avoid skin
reactions and what kind of pressure on skin is needed to have a good signal quality.
Headband development was mostly done by developing new iteration of 3D models and
testing them to find out what is working and what to change for new iteration of headband.
Software development has included working with multidisciplinary environme nt,
planning and testing new features of our software and during this thesis, making a new
interface for our NIRS software.
I did participate also in electronical development by building devices and repairing our
NIRS devices when needed. Part of this work was also finding optimized sensors and
electrodes to work with our NIRS headband.
Working with NIRS development, has also provided good opportunity to get familiar with
current research on health technology with NIRS.
In summary, ongoing project had led to development of wearable biomedical device, and
we have successfully gathered substantial amount of data for development stroke
diagnostics based on multimodal data.
5
LIST OF ABBREVIATIONS AND SYMBOLS
A/D Converter Analog/Digital Converter
ABC Activities specific Balance Confidence Scale
ADHD Attention deficit/Hyperactivity disorder
AHI Apnea-Hypopnea Index
AI Artificial Intelligence
ALS Amyotropic Lateral Sclerosis
BBB Blood Brain Barrier
BCI Brain Computer Interface
BMI Brain Machine Interface
BMI Body Mass Index
BOLD Blood Oxygen Level Dependant
CBF Cerebral Blood Flow
CDSS Clinical Decision Support System
CLIS Completely Locked-In State
CNS Central Nervous System
CSF Cerebrospinal Fluid
CT Computer Tomography
DC-EEG Direct Current EEG
DSF Disease State Fingerprint
DSI Disease State Index
DSR Design Science Research
ECG Electrocardiography
EEG Electroencephalography
EMG Electromyography
EU European Union
FES Functional Electrical Stimulation
6
fMRI Functional Magnetic Resonance Imaging
fNIRS Functional Near-Infrared Spectroscopy
FUS Focused UltraSound
GUI Graphical User Interface
HbO Oxy-haemoglobin
HbR Deoxy-Haemoglobin
HbT Blood Volume
Hz Hertz
ICH Intracerebral Hemorrhage
ICU Intensive Care Unit
ID Identification Number
KYS Kuopion Yliopistollinen Sairaala
LAPSS Los Angeles Prehospital Stroke Scale
MDR Medical Device Regulation
MEG Magnetoencephalography
ML Machine Learning
MRI Magnetic Resonance Imaging
mRS Modified Ranking Scale
NIHSS National Institutes of Health Stroke Scale
NIR Near Infrared
NIRS Near-InfraRed Spectroscopy
OSA Obstructive Sleep Apnea
OYS Oulun Yliopistollinen Sairaala
PAT Positive Airway Pressure
PET Positron Emission Tomography
PREM Patient Recorded Experience Measures
PROM Patient Reported Outcome Measures
PSD Persuasive System Design
7
PTSD Post Traumatic Disorder
QMS Quality Management System
RF Radio Fregquency
rPPG Remote Photoplethysmographic
SAH Subarachnoid Haemorrhage
SDB Sleep Disorder Breathing
SPECT Single-photon Emission Computed Tomography
TBI Traumatic Brain Injury
THL Työ ja hyvinvointilaitos
TIA Transient Ischemic Attack
TUG Timed up and go
UT-NIRS Ultrasound-Tagged NIRS
VE Virtual Environments
VOT Vascular Occlusion Test
VR Virtual Reality
VTT Valtion Teknologian Tutkimuslaitos
8
Contents
Abstract ............................................................................................................................. 2
Tiivistel......................................................................................................................... 3
Foreword ........................................................................................................................... 4
LIST OF ABBREVIATIONS AND SYMBOLS ............................................................. 5
Contents............................................................................................................................. 8
1. Introduction ................................................................................................................ 10
2. Background................................................................................................................. 12
2.1 An overview of stroke........................................................................................ 12
2.2 Stroke recovery .................................................................................................. 14
2.2.1 Common practise in rehabilitation.......................................................... 14
2.2.2 Emerging rehabilitation methods............................................................ 15
3. Stroke diagnostics....................................................................................................... 20
3.1 Digital solutions in clinical practice in stroke diagnostics................................. 20
3.1.1 Differential diagnostic challenges stroke vs. migraine symptoms ...... 21
3.1.2 Cerebral circulation in individuals with stroke and sleep apnea ............ 22
3.2 Neuroimaging methods to diagnose stroke ........................................................ 22
3.2.1 PET and CT in stroke diagnostics .......................................................... 22
3.2.2 MRI in stroke diagnostics ....................................................................... 24
3.3 Emerging techniques for stroke diagnostics ...................................................... 24
3.3.1 Functional near-infrared spectroscopy (fNIRS) for stroke detection ..... 24
3.3.2 Electroencephalography for stroke detection ......................................... 27
3.3.3 Accelerometer for stroke detection? ....................................................... 28
4. Aim of the work and research questions .................................................................... 29
4.1 Research context ................................................................................................ 29
4.2 Research questions ............................................................................................. 29
4.3 Research method ................................................................................................ 30
4.4 Development goal .............................................................................................. 30
5. Design challenges in realizing easy-to-use software user interfaces.......................... 31
5.1 Generation-Oriented approach vs Aging-oriented framework .......................... 31
5.2 Generation-oriented approach............................................................................ 33
5.3 User interface for individuals with limited tech familiarity............................... 34
5.4 Dialogue and design solution ............................................................................. 34
5.5 Persuasive system designing on software development .................................... 34
5.6 EU regulations on software in medical devices ................................................. 36
6. Measurement methods ................................................................................................ 37
6.1 Fundus photography........................................................................................... 37
6.2 EEG and ECG .................................................................................................... 38
6.3 NIRS ................................................................................................................ 38
6.4 Speech and video recording ............................................................................... 39
6.5 Accelerometer .................................................................................................... 40
7. Materials and measurement protocols ........................................................................ 42
7.1 Data collection and research methods................................................................ 42
7.2 Research subjects in Stroke project ................................................................... 43
7.2.1 Inclusion criteria for research subjects ................................................... 43
7.2.2 Exclusion criteria .................................................................................... 43
7.2.3 Consent of subjects ................................................................................. 44
7.3 Sampling ............................................................................................................ 44
7.4 Recruitment ........................................................................................................ 44
7.5 Data collection protocols ................................................................................... 45
9
7.6 Balance protocol ................................................................................................ 45
7.7 Video and speech protocol ................................................................................. 46
7.8 Video speech protocol including additional measurement devices ................... 47
7.8.1 Additional measurement devices used.................................................... 47
7.8.2 Test protocol with additional measurement devices............................... 47
7.9 Fundus photography with Optomed Aurora ...................................................... 49
8. Development of the user interface for immediate measurement by NIRS................. 50
8.1 Users feedback ................................................................................................... 50
8.2 Technical description ......................................................................................... 50
8.3 The primary concept GUI .................................................................................. 50
8.4 Functions provided............................................................................................. 51
9. Results ........................................................................................................................ 54
9.1 Feasibility of the multimodal setup for stroke data collection in terms of
easy to use and measurement time ..................................................................... 54
9.2 Software interface and device development results when using NIRS
interface.............................................................................................................. 55
10. Discussion .......................................................................................................... 59
11. Conclusion ......................................................................................................... 63
12. References .......................................................................................................... 64
10
1. Introduction
Stroke is a critical health event that occurs when the blood flow to the brain tissue is
disrupted. There are two main types of strokes, ischemic stroke and haemorrhagic stroke.
An Ischemic stroke takes place when a blood clot blocks a blood vessel in the brain,
disrupting the blood supply to a part of the brain tissue. Ischemic strokes make up the
majority of stroke cases (about 79% according to the Finnish Stroke Registry 2008)
(Maretoja et al., 2011)
A haemorrhagic stroke takes place when a blood vein in the brain bursts and bleeds into
the surrounding tissue. Haemorrhagic strokes are more uncommon than ischemic strokes,
but they are generally more severe and have a higher mortality rate (Maretoja et al., 2011).
The consequences of a stroke depend on the location and the level of severity of the brain
damage, as well as the patient’s age and general well-being. Stroke can result in variety
of symptoms, including one-sided body weakness or paralysis, difficulty with speech and
understanding, visual disturbances, and problems with balance or dizziness (Maretoja et
al., 2011).
Stroke is a leading cause of death and disability in Finland. According to data from THL
(2017 Link) there are approximately 25 000 new cases of stroke in Finland each year, and
stroke is also the country’s third most frequent cause of mortality. The incidence of stroke
in Finland is higher among men than women and increases with age (Maretoja et al.,
2011)
The costs of stroke in Finland are substantial. Average costs are 25 000€ in a year after
the first stroke and on average 85 000€ across the entire remainder of lifetime after the
stroke. Expected survivability of stroke patients is rising, which will increase lifetime
costs of stroke patients in the future. This includes the costs of hospital care, medications,
and rehabilitation. Secondary costs of stroke, such as loss of productivity and the value
of informal care provided by family members, are also significant. Overall share of the
stroke patients from national healthcare spending was 7% at 2008) (Maretoja et al., 2011)
Risk factors for stroke in Finland include high blood pressure, high cholesterol, smoking,
atrial fibrillation and diabetes. Stroke prevention strategies in Finland include promoting
lifestyle changes to reduce these risk factors, as well as providing access to effective
treatments for conditions such as high blood pressure and atrial fibrillation (Maretoja et
al., 2011).
Treatment for stroke in Finland Typically involves a combination of medications and
rehabilitation. Rehabilitation after stroke may cover occupational therapy, physical
therapy and speech therapy, as well as support from social workers and other
professionals. (Maretoja et al., 2011)
It is vital to correctly identify the type of stroke a patient has experienced to provide
appropriate acute care and to predict the patients prognosis and implement preventive
measures. There are several diagnostic tests that can be used to evaluate patients with
acute ischemic stroke, and the appropriate test or combination of tests should be chosen,
based on factors such as effectiveness, potential risks to the patient, and cost. In some
cases, the availability or cost of certain diagnostic methods may pose challenges for
practitioners. (Kumar et al., 2011)
11
The development of advanced diagnostic imaging techniques and treatment options has
necessitated the optimization of diagnostic protocols while maintaining high standards of
care that are evidence-based, cost-effective and accessible. This has led to more accurate
diagnoses but has also made the process of clinical decision-making more complex.
(Kumar et al., 2011)
Stroke diagnosis has evolved significantly through software and AI, with ongoing
advancements enhancing speed, accuracy, and accessibility. Traditional software
processed CT/MRI scans using rule-based algorithms, but AI now employs deep learning
to detect strokes and differentiate mimics like seizures, often outperforming human
experts. Modern GUIs display clear visual alerts, though they often lack accessibility for
users with technologically limited skills. Future AI-driven systems will integrate
predictive analytics, multimodal data (imaging, symptoms), and personalized treatment
guidance, presented via intuitive, high-contrast GUIs with voice and touch inputs,
compliant with IEC 62304 for traceability and safety. These innovations promise reduced
healthcare costs by minimizing misdiagnosis and faster interventions, improving recovery
for stroke patients, especially when designed for usability and accessibility.
12
2. Background
This chapter covers all the background information to understanding the context, and the
theory behind the information presented in this thesis. This starts with introduction of few
different technologies which are used in hospital to monitor or taking images of brain.
Furthermore, thesis will cover the theory of designing and developing Graphical User
Interface (GUI) for a wearable medical device prototype, focusing on designing GUI for
people with limited experience using technology , with a medical device regulation point
of view considered also.
Substantial part of this thesis focuses on project work, where we were collecting
multimodal data from stroke patients in Oulun Yliopistollinen Sairaala (OYS) And at
Kuopio’s Yliopistollinen Sairaala (KYS) and from healthy test subjects.
Another major aspect on this thesis is wearable multimodal near-infrared spectroscopy
(NIRS) device project, where software is developed for nurses and home use of elderly
adults target group.
2.1 An overview of stroke
Stroke refers to a neurological disorder caused by the blockage of blood vessels, resulting
in brain clots that obstruct normal blood flow. This blockage can cause arteries to clog
and burst, resulting in bleeding. When arteries supplying the brain rupture during a stroke,
brain cells rapidly die from oxygen deprivation. Beyond physical symptoms, stroke may
also lead to depression and cognitive decline such as dementia. Stroke is also one of the
primary causes of death and leading factor in long-term disability across the world.
Developing countries have the highest incidence of stroke, with ischemic stroke
representing the majority of cases. Our knowledge of stroke pathophysiology has grown
considerably, revealing increasingly complex insights into its mechanisms and the
essential processes that cause ischemic injury. The main objectives of stroke treatment
are to re-establish blood circulation within the brain and address neurological harm
caused by stroke. As a result of inadequate outcomes in latest clinical studies, animal
models have been implemented in stroke research. While there have been notable
improvements in managing stroke, post-stroke care remains major challenge, impacting
not only families but also healthcare infrastructure and the broader economy. Advancing
both clinical and pre-clinical approaches is likely key to enhancing treatment success and
long-term recovery (Kuriakose & Xiao., 2020)
When a stroke occurs, it is due to insufficient blood flow to the brain through the blood
vessels. A comprehensive understanding of neurovascular anatomy. Including the
anterior cerebral artery and the two posterior vertebral arteries, is crucial. Ischemic
strokes occur when blood and oxygen are unable to reach the brain tissue, while
haemorrhagic strokes are the result of blood vessel rupture or leakage (Kuriakose, 2020)
Ischemic occlusion can cause intracerebral bleeding, potentially leading to thrombotic
and embolic conditions in the brain. Thrombosis happens when atherosclerosis causes
blood vessels to narrow, obstructing the flow of blood. The build-up of plaque in the
vascular chamber can eventually cause clots, resulting in a thrombotic stroke. An embolic
stroke, however, occurs when an embolism reduces blood flow to a specific brain region,
causing substantial stress and premature necrosis (cell death). As a consequence, the
13
plasma membrane is disrupted, organelles swell, leakage of cellular material into the
extracellular space leads to the disruption of neuronal activity. Vital factors like
excitotoxicity, leukocyte infiltration, blood-brain barrier dysfunction, free radical
toxicity, inflammation, glial cell activation, complement activation, disrupted
homeostasis, energy deficiency, oxidative stress, cytokine-driven cell damage, elevated
intracellular calcium, and acidosis are central to stroke pathology. (Kuriakose, 2020)
Haemorrhagic stroke, comprising 1015% of strokes, carries a high mortality rate. Brain
tissue stress or internal injuries cause blood vessels to rupture, leading to this condition,
which damages the vascular system and causes infarction. It includes intracerebra l
haemorrhage (ICH) and subarachnoid haemorrhage (SAH). ICH results from vessel
rupture, with blood buildup in the brain. Key causes include elevated blood pressure,
heavy anticoagulant use, vascular irregularities, and thrombolytic agents. Subarachnoid
haemorrhage, on the other hand, features blood pooling in the brain’s subarachnoid space,
usually from a cerebral aneurysm or head injury. (Kuriakose, 2020)
Recognizing the abrupt onset of focal neurological deficits of waking up with them is
crucial in diagnosing ischemic stroke. The commonly experienced symptoms that occur
with transient ischemic attack (TIA) are speech problems and loss of strength affecting
one side of the body. However, stroke can be mimicked by other conditions such as
seizures, migraine with aura and/or headaches, conversion disorder and hypoglycaemia.
Obtaining a patient’s medical history and conducting diagnostics tests can usually help to
rule out stroke mimics. To differentiate between TIA and intracerebral haemorrhage, in
addition to identify non-stroke conditions, neuroimaging is vital. Neuroimaging selection
is based on accessibility, thrombolysis eligibility, and contraindications. Subarachnoid
haemorrhage (SAH), typically indicated by a sudden, severe headache, is optimally
diagnosed with a noncontrast head computer tomography (CT) (Yew, K.S., Cheng, E.M.
2015)
The symptoms of acute stroke are often confusing and can be misunderstood by both
patients and clinicians. It is the responsibility of family physicians to identify and treat
acute cerebrovascular diseases promptly. Family physicians are not available in every
healthcare system, so then responsibility to identify stroke is on the physician treating the
patient. A prompt and precise evaluation of individuals exhibiting stroke symptoms can
minimize disability and reduce the chances of recurrences. Stroke can be categorized
based on the pathological mechanism and the affected vascular distribution.
Understanding the underlying pathological mechanism is crucial for determining
appropriate treatment decisions such as antithrombic therapy, thrombolysis, and
predicting prognosis. Mortality rate is greater for haemorrhagic stroke when compared to
ischemic stroke. According to Yew et al, of all strokes in the U.S., 87% are ischemic,
caused by large-artery atherosclerosis, small vessel occlusion, cardio embolism, or other
unspecified reasons. The other 13% are haemorrhagic, located in subarachnoid or
intracerebral regions. (Yew, 2015)
Clinicians typically diagnose stroke with moderate to good reliability, but those with less
experience or lower confidence show reduced diagnostic accuracy. Ischemic stroke
commonly presents with sudden onset of awakening with symptoms where unilate ral
weakness and speech disturbances are the most frequently observed physical findings.
While determining the time of onset does not aid in diagnosing stroke, but this
information is critical, as it establishes whether a patient qualifies for the 34.5-hour
thrombolysis eligibility window in ischemic stroke cases, guiding precise treatment
decisions. Physicians who are responsible for treating acute stroke patients must develop
knowledge of National Institutes of Health Stroke Scale (NIHSS). This scale
14
compromises 15 items and can be completed in approximately five minutes. While it can
aid in distinguishing stroke from other conditions that mimic stroke, its primary purpose
is to accurately assess the severity of a stroke, thereby enabling physicians to determine
whether administering tissue plasminogen activator is suitable. (Yew, 2015)
2.2 Stroke recovery
For many years, it was widely thought that the brain was rigid, unchanging structure and
that once an even such as a stroke occurred, brain structures and functions were
permanently lost. Recently our knowledge about motor learning, brain plasticity and
functional recovery following brain injury has greatly improved. Breakthroughs in basic
neuroscience have spurred further research in motor rehabilitation. The brain has a
remarkable ability to adapt and change its neural circuits, a phenomenon known as
plasticity, which can result in spontaneous recovery. Rehabilitative training can enhance
this process and enhance the brain’s plasticity. The restructuring of the remaining
components of the central nervous system helps with behavioural recovery. This can
occur through changes in interhemispheric lateralization, increased activity in the
association cortices connected to the injured area, and the reorganization of cortical
mapping. According to Hara, animal studies in animal models indicate that both motor
learning and cortical stimulation could modify intracortical inhibitory circuits, promoting
long-term potential and remodelling of the cortex. Specifically, the use of
Electromyography (EMG) controlled electrical muscle stimulation has been shown to
enhance the motor function of the hemiparetic hand and arm. According to Hara, NIRS
research indicates that, during non-invasive measurement of brain haemoglobin levels in
functional tasks, the greatest cerebral blood flow in the damaged sensory-motor cortex is
observed during an EMG-controlled functional electrical stimulation session. (Hara,
2015)
According to Hara, in 2015 there were no studies of brain activity during a therapeutic
Functional Electrical Stimulation (FES) intervention, due to the electrical stimulation
obstructing assessment methods such as fMRI, Single-photon emission computed
tomography (SPECT) and PET. These functional neuroimaging techniques cannot be
used during a typical FES intervention. NIRS has been recently developed as a
neuroimaging method that is not affected by electrical stimulation, making it possible to
assess brain activity during FES interventions in rehabilitation setting. NIRS offers
several advantages, including non-invasiveness, high sensitivity, a natural environment,
low operating costs and portability. It measures changes in concentration of deoxygenated
and oxygenated haemoglobin, which have been linked to regional cerebral blood flow
(CBF) and are considered a reflection of cortical activation. (Hara, 2015)
2.2.1 Common practise in rehabilitation
According to Finnish käypähoito (Duodecim, Käy Hoito, 2024), the usual
rehabilitation path for stroke patient begins with a rehabilitation assessment made for him
with a week or as the overall condition allows. The assessment is based on the patients
need for physical and cognitive rehabilitation. The assessment requires an evaluatio n
made by a multidisciplinary expert team, about who benefits from rehabilitation.
The need for rehabilitation and individual goals are recorded in a rehabilitation plan,
which is prepared in cooperation with the unit responsible for care, the patient and his
relatives, and a multidisciplinary team. Healthcare professionals act as liaisons with
15
hospital districts and primary healthcare. They have a central role in the early stages of
the rehabilitation path and in monitoring the implementation of the rehabilitation plan. If
necessary, cooperation is also carried out with occupational healthcare, insurance
institutions, and Kela.
The mortality of those treated in a multidisciplinary rehabilitation unit and the risk of
remaining in permanent institutional care, are smaller than for rehabilitators treated in a
ward. The effectiveness of the treatment is reflected in shortened treatment times, reduced
disability, and improved quality of life. The multidisciplinary rehabilitation team includes
doctor, physiotherapist, nurse, social worker, occupational therapist, speech therapist,
neuropsychologist, liaison officer, and later a rehabilitation counsellor.
The most typical forms of therapy are, for example, physiotherapy, occupational therapy,
speech therapy, and neuropsychological rehabilitation. Physiotherapy can include various
walking exercises to promote walking ability and upper limb function enhancement with
different exercise methods. Increasing the intensity of physiotherapy improves mobility
rehabilitation, and the decisive factors are an early start and the practice of the desired
feature of skill.
In supportive therapy, the aim is to promote opportunities to act independently in various
everyday tasks or at work. The methods in the exercises can be various task-focused
repetition exercises, enhanced hand rehabilitation, mental image training, strength
training, or training in virtual reality (VR).
In speech therapy, communication skills and functional capacity as well as swallowing
functions are rehabilitated. The goals of speech therapy can be related to the
rehabilitators interaction ability. For example, communication guidance give to an
aphasic person can support the activity of the person being treated.
In neuropsychological rehabilitation, where cognitive disorder rehabilitation has been
deemed appropriate based on a neuropsychological examination, it is carried out using
neuropsychological methods. Rehabilitation is targeted at cognitive disorders and
behavioural changes as well as symptom awareness.
2.2.2 Emerging rehabilitation methods
Virtual Reality and Virtual Environments
Neuropsychological rehabilitation treatment options have undergone advancements in
recent times with the integration of technology like VR. Virtual environments (VE) offer
not only advanced diagnostic tools and additionally enable healthcare providers to create
highly targeted rehabilitation programs. Limited VR programs have been created to help
individuals undergoing neurological rehabilitation improve their ability to perform daily
activities. (Ansado et all., 2021)
Over the past 10 years, VR has been combined with both conventional and state-of-the-
art neuroimaging methods, resulting in two potential outcomes: 1. Charting neural
networks pre- and post-VR training, and 2. Live monitoring of brain activity while
performing VR tasks. Common neuroimaging methods utilized include
electroencephalography (EEG), Functional magnetic resonance imaging (fMRI) and
functional near-infrared spectroscopy (fNIRS) are critical for studying brain function in
stroke diagnostics. The integration of VR with these neuroimaging techniques is
16
increasingly researched, providing neuropsychologists with promising tools to enhance
stroke rehabilitation and differentiate stroke mimics. Participants in various clinical
studies have benefited from monitoring their cerebral activity during VR immersion. This
approach, often using fNIRS or fMRI, supports neuropsychologists in developing
targeted treatments, particularly for stroke rehabilitation and cognitive recovery. While
the emphasis is primarily on enhancing motor abilities and balance in conditions like
cerebral palsy and Parkinson’s, as well as utilizing exposure therapy to treat anxiety and
post traumatic disorder (PTSD), the current literature review focuses on exploring how
fNIRS, EEG, and fMRI integrated with VR can improve the rehabilitation of cognitive
functions, such as memory and attention, by allowing clinicians to identify biomarkers
that predict therapeutic success. This approach holds significant potential for stroke
recovery and personalized treatment planning. Particularly, the current examination
focuses on the rehabilitation of stroke, attention deficit disorder (ADHD), , traumatic
brain injury (TBI), and with or without hyperactivity as they are among the strongest
examples of recent advancements in VR applications and the potential benefits of
simultaneous neuroimaging. Ansado et al claims that by combining multimodal
neuroimaging with VR, a neurorehabilitation program can be tailored to an individuals
unique brain activity pattern as affected by their specific traumatic event. Multimodal
neuroimaging can bring significant benefits to the developing field of VR-based
neurorehabilitation. (Ansado et al., 2021)
Neuroimaging is a technique used to determine which areas of the brain respond to
training or stimulation and evaluate the level of activation. Advanced brain imaging
techniques used in clinics help scientists understand how cognitive training influences
neuroplasticity. These methods track brain volume, activity, and connectivity by
observing blood flow in fine detail. Another tool, EEG, records brain waves using
electrodes on the scalp, offering a clear picture of brain activity over time. The data is
then analysed for unusual patterns or important signals. Lastly, fNIRS uses near-infrared
light to visualize changes in blood flow and haemoglobin levels, making real-time
imaging of brain activity possible. (Ansado et al., 2021)
In fMRI studies, participants are typically required to keep their head and body still while
lying in the scanner. To perform task, they often move a hand or a finger in a VR world
displayed through and head mounted device (HMD) or built into MRI scanner. An
alternative approach involves conducting neuroimaging scans on participants at multiple
stages during, after, and before treatment, to assess cerebral changes and enhance stroke
rehabilitation strategies. Unlike fMRI, EEG equipment is portable and can be used while
participants are sitting or walking within a restricted area, depending on the experiments
requirements. fNIRS offers balance between portability and temporal resolution like
fMRI, offering the best of both worlds. The choice between of which imaging technology
to use in VR training depends on the desired outcome, as each of the three techniques
provides unique information (Ansado et al., 2021).
EEG Typically provides sufficient temporal information for neurofeedback or simple
brain activity monitoring during performance. Advanced neuroimaging techniques, such
as fMRI and fNIRS, facilitate precise mapping of active brain regions and detailed
analysis of activation changes over time, particularly during, after, and before VR-based
training. In stroke rehabilitation, however, therapists encounter challenges with VR
applications, primarily due to their initial design for general audiences rather than
therapeutic purposes, necessitating specialized adaptations. However, developers have
made advancements in this area by incorporating features that are relevant to therapy,
such as adjustable intensity levels based on patients progress, tasks that can be controlled
by the therapists, and the ability to track and records movements to provide clear picture
17
of the patients progress and recovery. The features mentioned are also among the key
benefits of using VR in rehabilitation, particularly when combined with neuroimaging.
According to findings from a meta-analysis, this technology is generally associated with
beneficial results and is not linked to adverse outcomes. (Ansado et al., 2021)
Brain-Computer Interfaces
Brain-Computer Interfaces (BCIs) are technologies that enable control of computers or
other devices through brain activity, circumventing the peripheral nervous system. They
provide a vital communication pathway for those with significant motor impairments or
in vegetative states. (Naseer & Hong, 2015)
BCIs utilize brain activity to capture a users intended actions. The initial phase of
creating an fNIRS-BCI system involves gathering relevant brain signals, typically from
the primary motor cortex and prefrontal cortex. Signals from the motor cortex relate to
motor execution and imagery, while those from the prefrontal cortex stem from activities
like mental arithmetic, counting, musical imagery, or visualizing landscapes. Different
emitter-detector arrangements are used in these regions, but the distance between emitters
and detectors is kept within a specific range due to its significance in fNIRS
measurements. For example, a wider emitter-detector gap allows deeper brain imaging.
Naseer et al. suggested a 3 cm separation to effectively measure hemodynamic signals
from cortical regions. A gap less than 1 cm could mainly detect skin-layer signals, while
a separation exceeding 5 cm could result in weak, inconsistent signals. (Naseer et al.,
2015)
The prefrontal cortex activities are a favourable option for fNIRS-BCI as they generate
fewer motion artifacts and signals that are not as impacted by hair movement.
Additionally, they tend to be more effective for individuals with motor-related
disabilities. Given these benefits, most research has focused on prefrontal activities,
yielding encouraging outcomes. Some of the frequently employed prefrontal activities in
fNIRS-BCI include mental arithmetic, musical visualization, mental counting, and
landscape visualization. (Naseer et al., 2015)
Recent advances in fNIRS-BCI research have been notable, but applications remain
largely confined to training and demonstration. Two key limitations hinder real-world
use, slow information transfer rates and high error rates. Moreover, most evaluations
occur under controlled lab conditions, which do not reflect the difficulty of maintaining
focused mental effort in real-world environments. (Naseer et al., 2015)
BCI technology can aid in restoring lost motor and cognitive functions in individ uals
affected by stroke or spinal cord injury. This is made possible through the ability of BCI
feedback to activate self-regulation of brain activity. According to Naseer, previous
neurofeedback studies, EEG has been extensively used due to its high temporal
resolution. However, EEG has limitations such as imprecise localization and difficulty
accessing subcortical regions, making fMRI, which measures hemodynamic activity, a
more suitable option for neurofeedback studies to overcome these challenges. (Naseer et
al., 2015)
FNIRS is an appealing option compared to fMRI for accessing subcortical brain signals
due to its affordability, ease of use and portability. Because it can be worn on the head or
body, fNIRS is easy to useeven in an ambulance and it tracks brain activity faster than
18
many fMRI machines. Since it isnt easily affected by movement, it holds strong promise
for use in neurofeedback studies. (Naseer et al., 2015)
Brain-Machine Interfaces
Brain-Machine interfaces (BMI) allow paralyzed patients to interact with their
environment by using their brain activity to control external devices. For example,
possible target groups can be patients with amyotrophic lateral sclerosis (ALS) or
restoration of motor impairment of people after severe stroke incident. (Chaudhary,
Birbaumer & Curado, 2015)
BMI offer promising solution for communicating with paralyzed ALS patients, as they
do not require muscle involment. Different methods have been explored to control BMI’s
for communication, including EEG and NIRS. According to Chaudhary et al, Previous
research indicates that EEG-BMI supports communication in ALS patients who still have
limited eye control, but it is ineffective for those with total paralysis. However, the recent
introduction of fNIRS-BMI has opened new avenues for communication with completely
locked-in state (ALS) patients who have completely lost the ability to move any muscle,
even in cases of complete locked-in syndrome. (Chaudhary et al., 2015)
Aside from assisted communication, BMIs are also being thoroughly studied for their
potential in promoting motor recovery after a stroke. This BMI method associates brain
signals related to a patient’s intent to move an impaired limb with sensory feedback from
that movement, aided by rehabilitation aids. Most studies use magnetoencephalography
(MEG) or EEG systems for their strong temporal resolution, supporting real-time
synchronization of movement intent and sensory feedback. A recent controlled study by
Chaudhary et al. found that EEG-BMI training significantly enhances motor function in
stroke patients with severe weakness. (Chaudhary et al., 2015)
While the conditions of locked-in state have motivated research in this area, there are still
only few systems which have been successfully used on this population. Three successful
technologies used are EEG-BMI, fMRI-BMI and fNIRS-BMI. In comparison to fMRI, a
NIRS based BMI’s can be conveniently used to assist bedridden and immobile patients
who desperately require communication. (Chaudhary et al., 2015)
According to Chaudhary et al., the first controlled assessment of a NIRS-BMI achieved
an 89% accuracy rate in differentiating right- and left-hand imagery with a 20-channel
NIRS system over the sensorimotor cortex, using a hidden Markov model classifier and
no prior training. Recently, NIRS was employed successfully to analyse functional
cortical responses in a complete locked-in syndrome (CLIS) patient to auditory stimuli,
such as true or false statements and open-ended questions. Hemodynamic changes in the
motor cortex were tracked over multiple sessions for more than a year to train a classifier
that accurately predicted yes” or no” responses at a rate of 71.76%. This was a
significant improvement, as earlier EEG-BMI systems had not yielded successful
outcomes. (Chaudhary et al., 2015)
Stroke is a major contributor to acquired disabilities among adults worldwide. Repetitive
motor task has been effective in restoring motor function in patients with incomplete hand
paralysis, but people with serious hand weakness often cannot benefit from regular
rehabilitation because they cannot do the exercises. But BMI training a system that uses
brain signals could help them regain movement. It works by helping the person repeatedly
19
try movements with their weak limb, while a device gives them visual and physical
feedback to support the process. (Chaudhary et al., 2015)
20
3. Stroke diagnostics
This chapter describes different challenges, methods and technologies on related to stroke
diagnoses.
3.1 Digital solutions in clinical practice in stroke diagnostics
Diagnosing posterior circulation strokes can be difficult. Dizziness is a common
complaint among patients but is rarely a sign of stroke. Research on adults aged 44 or
older who sought emergency care or were directly hospitalized with dizziness as their
primary symptom found that only 0.7% of those with isolated dizziness received a
diagnosis of stroke or TIA. However, in 44% of cases, the initial examiner failed to
identify their stroke, highlighting the need for precise diagnostic tools. (Yew & Cheng,
2015)
Among the patients who exhibit acute vestibular syndrome characterized by continuous
vertigo or dizziness lasting for at least one hour, combined with gaze-evoked or
spontaneous nystagmus, vomiting or nausea, intolerance to head motion and newly
developed gait unsteadiness, at least one-quarter may have a posterior circulation stroke.
Notably, up to two-thirds of patients with stroke-related acute vestibular syndrome may
lack obvious neurological symptoms. (Yew et al., 2015)
Neuroimaging is the only reliable method for accurately distinguishing between
haemorrhagic and ischemic stroke. While patients experiencing haemorrhagic stroke may
exhibit symptoms such as vomiting, headache, meningismus, diastolic blood pressure
exceeding 110 mm Hg or coma, these individual or combined findings are not conclusive
enough to make a definitive diagnosis. (Yew et al., 2015)
Subarachnoid haemorrhage (SAH) manifests differently compared to intracerebral
haemorrhage or ischemic stroke. In cases of aneurysmal SAH, approximately 80% of
patients experience a sudden, extremely severe headache. Another crucial historical
discovery is the presence of a prior sentinel headache occurring between two to eight
weeks before rupture of a cerebral aneurysm, which is found in up to 40% of SAH
patients. Accompanying the headache can be symptoms such as photophobia, vomiting,
seizures, neurological signs, meningismus and a reduced level of consciousness.
Funduscopy is essential, as intraocular haemorrhage is present in one in seven patients
with aneurysmal SAH. With bleeding occurring outside the brain, SAH patients may lack
focal neurological signs. (Yew et al., 2015)
When examining a patient with suspected stroke, healthcare providers should consider a
wide range of potential diagnoses. Conversion or somatoform disorder, seizures,
hypoglycaemia and migraine headaches are some of the most common conditions that
can mimic stroke. To determine if a patient is eligible for intravenous thrombolysis,
healthcare providers use checklists that explicitly require the detection of
hyperglycaemia, hypoglycaemia and recent seizures. The percentage of stroke
misdiagnosis in studies involving consecutive patients who did not undergo thrombolysis
ranges from 25% to 31%. On the other hand, among patients who received thrombolysis,
the proportion of individuals diagnoses with a stroke mimic ranges from 1.4% to 16.7%.
(Yew et al., 2015)
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All patients with suspected stroke symptoms should undergo immediate neuroima ging
via MRI or noncontrast computed tomography (CT). The primary goal in suspected
ischemic stroke cases is to rule out non-ischemic central nervous system lesions and
distinguish ischemic from haemorrhagic strokes. Noncontrast CT effectively identifies
mass lesions, such as brain tumours or abscesses, and acute haemorrhage, but its
sensitivity for detecting strokes within three hours post-infarction is limited, with fewer
than two-thirds of cases identified. Furthermore, it exhibits reduced sensitivity for small
or posterior fossa strokes, necessitating advanced imaging for comprehensive diagnostics.
(Yew et al., 2015)
Multimodal MRI sequences, especially those involving diffusion weighted images,
provide superior resolution compared to noncontrast CT scans. Consequently, they
exhibit higher sensitivity in identifying acute ischemic stroke. The sensitivity of MRI
sequences in detecting intracerebral haemorrhagic stroke is comparable to that of
noncontrast CT scans. Although MRI offers superior resolution than noncontrast CT, the
latter is more widely available, faster and less expensive imaging modality. Additionally,
noncontrast CT can be safely performed in individuals with implanted devices or
claustrophobia. When a patient is eligible for intravenous thrombolytic therapy within a
specific time windows, guidelines recommend using noncontrast CT or MRI to exclude
intracerebral haemorrhage and assess for ischemic changes. Compared to noncontrast CT,
MRI has a lower misdiagnosis rate in individuals under 55 years of age who present with
stroke-like symptoms. This is attributed to the lower occurrence of vascular risk factors
and higher incidence of central nervous system stroke mimics in this age group. (Yew et
al., 2015)
3.1.1 Differential diagnostic challenges stroke vs. migraine
symptoms
Most of neurological diagnostics is based on local neurological symptom identifying and
analysing. Most common symptom is migraine aura which is important to identify from
temporary transient ischemic attack (TIA). Migraine aura is mostly visual disorder which
includes positive (vibrations, stars) and negative (partial loss of sight) symptoms and it
increases and fades away in 5-60min. TIA is more suddenly happening and lasting shorter
time. TIA is usually having negative symptoms like partial loss of something like sight,
speech, able to swallow, eye movement and muscle strength without mentioned migraine
symptoms. Migraine aura also usually has headache while TIA does not. Clinically is
known cases where stroke has happened with in connection of long-lasting migraine aura.
Less than 1.5% stroke cases are counted as migraine strokes.
In practice it can be hard to decide when a local symptom can be monitored as migraine
aura and when patient should be sent to more tests because of TIA or stroke suspicion.
Early correct diagnose will affect on treatment and leads coming tests to correct way.
Migraine aura without complications does not need efficient treatments. TIA on other
hand is warning sign of threatening brain catastrophe, and it will need quick action for
starting treatments. Early differentials diagnose of TIA and migraine is mostly done from
discussing with patient because usually patient’s condition is normal when he comes for
doctor. Especially patients own precise description of symptoms is vital for diagnosing
TIA or migraine aura and it will speed up for treatment decisions (Kallela et al. 2012,
Duodecim). In Stroke project we are using fNIRS/DC-EEG device, which is developed
in University of Oulu and it should help on developing differential diagnose between TIA
and migraine aura.
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3.1.2 Cerebral circulation in individuals with stroke and sleep apnea
Sleep-disorder breathing (SDB) is more common individuals who have experienced a
stroke compared to those without a stroke history. SDB is a separate risk factor for stroke
and can harm cerebral circulation through various mechanism, potentially contributing to
wake-up strokes. Ultrasound-tagged NIRS (UT-NIRS) is an innovative technology that
can non-invasively and in real-time detect cerebral blood flow and present it as the
cerebral flow index (CFI). The most effective treatment for SDB is positive airway
pressure (PAP). (Jurik M. et al., 2021)
In recent times, the prevalence of sleep-disordered breathing (SDB) has surged,
predominantly due to escalating obesity rates. The primary subtype, obstructive sleep
apnea (OSA), is identified when the apnea-hypopnea index (AHI) is 5 or more events per
hour, impacting roughly 24% of men and 9% of women globally. Strikingly, among
individuals with a prior stroke or TIA, SDB prevalence reaches as high as 72% after
adjusting for age. As a confirmed independent risk factor for ischemic stroke, OSA
exacerbates cerebrovascular pathology. Over time, OSA leads to elevated blood pressure,
imbalanced autonomic function with heightened sympathetic activity, impaired
endothelial function, metabolic changes, and a pro-inflammatory state. PAP is the top
choice for treatment and the most successful method for managing SDB. (Jurik et al.,
2021)
Alzheimer Disease (AD) has also been connected to SDB, with occurrence of over 50%.
Individuals who have SDB often encounter cognitive problems, such as deficiencies in
memory and attention, which are connected to changes in neuroanatomy and loss of grey
matter. It is worth noting that SDB can also exacerbate cognitive decline in the elderly,
and OSA is associated with neurophysiological indicators of multiple brain functions.
The frontal cortex, which is closely linked to memory, attention, and higher cognitive
abilities, as seen in AD patients, was the brain region where the hemodynamic response
was assessed. Findings of Ferdinando et al seems to support correlation between SDB
and AD. (Ferdinando et al., 2022)
According to Jurik et al., multiple studies have employed NIRS to assess cerebral blood
flow (CBF), demonstrating reduced cerebral oxygenation during OSA episodes,
particularly in severe cases. Despite NIRS’s advantages, including non-invasiveness,
continuous monitoring, and high temporal resolution, it is limited to measuring tissue
oxygenation rather than cerebral perfusion. A novel technology, ultrasound-tagged NIRS
(UT-NIRS), integrates NIRS’s strengths with ultrasounds capability to track blood cell
movement, enhancing perfusion assessment. (Jurik M. et al, 2021)
3.2 Neuroimaging methods to diagnose stroke
3.2.1 PET and CT in stroke diagnostics
Positron Emission Tomography (PET) scans, in conjunction with Computed Tomography
(CT), offer a comprehensive approach to diagnosing strokes, leveraging the strengths of
both modalities for enhanced accuracy and precision. While PET imaging provides
functional information about tissue metabolism, CT imaging offers detailed anatomical
images of the brain’s structure.
23
PET scans represent a pivotal advancement in medical imaging technology,
revolutionizing the diagnosis and treatment of numerous diseases. At the heart of PET
scanning lies innovative fusion of nuclear medicine and computerized imaging
techniques. (Orhii et al., 2023 )
PET scans utilize radiopharmaceutical tracer, typical a molecule tagged with radioactive
isotope, administered into patient’s bloodstream. As the tracer circulates, it accumulates
in tissue with high metabolic activity, such as tumors or areas of inflammation. Crucially,
this process allows PET scans to visualize not just anatomical structures but also
functional processes within the body. (Orhii et al., 2023 )
In Hospitals, PET scans are indispensable tools in oncology for detecting, staging, and
monitoring cancer. By pinpointing areas of heightened metabolic activity, PET scans aid
in precisely locating tumours, assessing their aggressiveness, and evaluating treatment
response. Moreover, PET imaging extends beyond oncology, playing a vital role in
diagnosing neurological disorders like Alzheimer’s disease, cardiovascular conditions
such as coronary artery disease and various other ailments. (Thientunyakit et al., 2022)
In the context of stroke diagnosis, the combination of PET and CT, known as PET-CT
imaging, provides a powerful tool for clinicians. CT scans are often performed first to
identify any acute bleeding or structural abnormalities in the brain, such as haemorrhages
or ischemic damage. Once acute bleeding has been ruled out, PET scans can be used to
assess tissue viability and metabolic activity in the affected areas.
PET-CT scans in stroke diagnosis allow clinicians to precisely delineate regions of
ischemic injury and differentiate viable tissue from irreversible damaged tissue. This
information is crucial for determining the potential benefits of reperfusion therapies, such
as thrombolytic therapy or mechanical thrombectomy, which aim to restore blood flow to
the affected areas and salvage viable brain tissue.
By integrating the anatomical and functional information provided by CT and PET scans,
respectively, clinicians can make more informed decisions regarding stroke management,
including the selection of appropriate treatment strategies and the prediction of patient
outcomes.
In summary, the synergy between PET and CT imaging technologies in stroke diagnosis
exemplifies the power of multimodal imaging approaches in modern medicine. By
combining anatomical and functional imaging data, PET-CT scans enable comprehensive
assessment of stroke pathology and facilitate personalized treatment planning, ultimate ly
improving patient outcomes and quality of care. PET scans represent pivotal advancement
in medical imaging technology, revolutionizing the diagnosis and treatment of numerous
diseases.
The integration of PET scanning into hospital workflows has significantly enhanced
patient care by allowing earlier and more accurate diagnoses, custom treatment plans, and
ongoing therapeutic monitoring. As technology continues to advance, PET imaging
continues to evolve, promising even greater insights into inner workings of the human
body and further transforming the landscape of modern medicine. (Minoshima et al.,
2016)
24
3.2.2 MRI in stroke diagnostics
Magnetic Resonance Imaging (MRI) has evolved significantly over the past decades,
transforming from a promising technique with limited applications to a primary
diagnostics tool for various medical conditions. Initially MRI was mainly used to examine
the brain and spinal cord, but it is now used to examine all parts of the body. As our
understanding of MRI has grown, we have gained a better appreciation of how to use it
effectively, either on its own or in combination with other techniques, to achieve the
highest level of diagnostic accuracy. (Katti et al., 2011)
MRI is non-invasive way to visualize the internal structure and certain functions of the
body. It uses non-ionizing electromagnetic radiation and has no known harmful effects.
The procedure involves placing the patient inside a strong magnetic field and using radio
frequency (RF) radiation to produce detailed cross-sectional images of the body. This is
done by aligning the nuclei of certain atoms, such as hydrogen with the magnetic field
and then applying RF signal, which causes energy to be released from the body. The
resulting energy is detected and used by computer to create an MRI image. (Katti et al.,
2011)
Functional magnetic resonance imaging (fMRI) is widely used, non-invasive method for
detecting changes in brain activity during preclinical and clinical studies. The fMRI
leverages the magnetic properties of oxygenated and deoxygenated haemoglobin to
measure blood flow changes linked to neuronal activity, known as the blood oxygen-
level-dependent (BOLD) response. During periods of neuronal activity, blood flow to the
region increases to provide oxygen to the active neurons through a process called
neurovascular coupling. fMRI allows researchers to identify and quantify brain activity
in response to a task or stimulus by using blood oxygen level dependant (BOLD) response
as indicator of neuronal activity. It is safe and non-invasive method, making it particularly
useful for studying neurovascular conditions like stroke. However, fMRI has some
limitations in preclinical research, including the need to use anaesthesia with animals,
which can affect the results of the study. (Crofts et al., 2020)
The earliest MRI sign of an acute cerebral infarction is the loss of signal drop-out from
arterial flow, which may create asymmetry in large infarcts. In contrast-enhanced
imaging, reduced arterial flow enhances affected arteries. Within hours, swelling causes
cortical thickening, sulcal narrowing, and increased T2 signal, with contrast scans
showing intravascular enhancement. Even after 24 hours, ~20% of infarcts remain
undetectable on T2-weighted images. MRI is less sensitive for acute infarcts, making CT
equally reliable for diagnosis, except in posterior fossa infarcts and suspected basilar
artery thrombosis, where MRI is superior (Duodecim, n.d.)
3.3 Emerging techniques for stroke diagnostics
3.3.1 Functional near-infrared spectroscopy (fNIRS) for stroke
detection
Functional near-infrared spectroscopy (fNIRS) is a non-invasive optical neuroimaging
technique that uses near-infrared light to measure cortical hemodynamic responses
associated with brain activity. (Myllylä et al 2020) Near-infrared (NIR) light is emitted
into the skull, where it undergoes random scattering and absorption processes within
tissues, enabling fNIRS to measure cortical hemodynamic responses. Some fraction of
25
photons creates banana shaped path back to the skull surface and finally there, it is
detected by sensitive photodetector as shown in figure 1 (OpenNIRS, 2022)
Figure 1. Banana Shape and principle of NIRS. Adapted from OpenNIRS.org
Most parts of tissue consist of water and are relatively transparent in NIR range to the
light. NIR light can penetrate the cranium and reach sufficient depth on brain tissue. This
optical range is approximately 650-950nm and in this range, tissue is relatively
transparent to the light. This is often referred as Optical Window (figure 2). Absorption
and scattering on tissue do remain fairly constant, deoxy-haemoglobin (HbR) and oxy-
haemoglobin (HbO) strongly absorb the NIR light while their concentration is changing
with blood flow and metabolism (OpenNIRS, n.d.).
Figure 2. Optical Window of NIRS. Source OpenNIRS.org
To accurately measure the concentrations of different chromophores, it is necessary to
select at least one wavelength on each side of the isosbestic point of interest. Isosbestic
26
point is specific wavelength at which the absorption coefficients of two of more molecules
that absorb light are equal. This means that at this specific wavelength, the absorption of
light by the molecules is the same, regardless of their concentration. This property can be
used in analytical chemistry and medical imaging to monitor changes in concentration of
molecules in a sample or tissue.
Isosbestic point for HbO and Hb is approximately at 800 nm and for water and HbO at
approximately at 950 nm. Absorbance peak for water is located approximately at 980 nm.
The device used for stroke data collection employs a frequency-domain technique to
modulate the intensity of illuminating light and measure both the phase and attenuation
of backscattered light. When selecting specific wavelengths for measurement, both
absorption and scattering properties must be considered, as scattering affects the depth of
light penetration.
For non-invasive measurements, it is essential that a sufficient number of photons scatter
back to detector. However, at a source-detector distance of 30 mm, the detected signal is
highly attenuated. Variability at larger source-detector separations may result from
individual differences in brain and skull structure. Measurements and simulations beyond
30 mm are increasingly affected by noise, making result interpretation more challenging.
Conversely, at distances shorter that 10 mm, the detected optical radiation does not reach
the cerebrospinal fluid (CSF) layer. (Myllylä et al., 2020).
NIRS technology has been increasingly used in studies of cerebrovascular incidents. One
of the most serious conditions in this category is intracranial hemorrhage (ICH), which
can result in high mortality if not diagnosed and treated quickly. The potential of NIRS
for early detection of ICH in patients presenting with headaches in the emergency
department has been investigated in a recent study.
This study included 378 patients, categorized into four groups based on their final
diagnosis: migraine, tension-cluster headache, ICH, and a control group. NIRS
measurements of cerebral regional oxygen saturation (rSO2) were taken from both the
right and left sides of the forehead at the initial medical contact. The study found that
patients with ICH had significantly lower rSO2 values on both sides of the brain
compared to those in other groups. Additionally, there was a significantly greater
difference between the right and left rSO2 values in patients with ICH. (Çınarlu et al.,
2024)
Gato et al. (2023) conducted a study to measure cerebral oxygen saturation and the
relative concentrations of oxygen and deoxyhemoglobin in the right and left frontal lobes.
They developed an automated classification framework to distinguish between patients
with ischemic stroke, hemorrhagic stroke, and those who are healthy. The framework
shows promising accuracy, which could potentially reduce the time needed for diagnosing
stroke. (Gato et al., 2023)
Li Y. et al. studied the use of NIRS technology to assess systemic low-frequenc y
oscillations (sLFOs) as potential biomarkers for vascular integrity in ischemic stroke
patients. NIRS was utilized to measure oxyhemoglobin fluctuations at various peripheral
sites, such as the toes, fingertips, and earlobes. The findings indicated that NIRS could
detect asymmetries in sLFO transmission caused by embolization, suggesting more
extensive circulatory dysfunction. The study emphasizes NIRS as a valuable tool for
monitoring vascular health in stroke patients, with the earlobes identified as particularly
informative sites for these measurements (Li et al., 2020).
27
In the context of neuroimaging techniques for diagnosing and managing ICH, several
novel approaches have emerged for rapid pre- and in-hospital diagnosis. NIRS is
highlighted alongside other advanced technologies like dual-energy CT, rapid MRI
techniques, and automated ICH detection methods. NIRS technology shows promise in
enhancing the speed and accuracy of ICH diagnosis, which is crucial for effective patient
management (Rindler, 2020).
NIRS technology has also been utilized for post-stroke depression (PSD), the most
common mental health condition affecting mood, following a stroke and a major factor
limiting patient rehabilitation and recovery. Koyanagi et al. investigated the application
of NIRS in diagnosing and evaluating PSD. Their study emphasizes that measuring oxy-
HB with NIRS is an effective method for diagnosing PSD in post-stroke patients
(Koyanagi et al., 2021).
NIRS has also showed promising preliminary results on detecting patients who had
neurovascular surgery, where NIRS detected reduced perfusion by observing decreased
oxygenation from patients who had ischemic stroke during the operation. Similar
monitoring has been used in aortic and cardiovascular surgery. (Guo et al., 2023), NIRS
is also an emerging bedside tool with advantages of being portable, easy and non-invasive
(Atais et al., 2024) for monitoring cerebrovascular physiology from the patients with
acute brain injury or from those who have high risk of developing cerebrovascular injury.
(Thomas, 2023)
NIRS technology has also been demonstrated in individuals with mild problems with
memory or thinking, who are at high risk of developing dementia. The study found that
groups with lower Mini-Mental State Examination (MMSE) scores exhibited a greater
increase in deoxygenated hemoglobin. In the stroke group, the increase in oxygenated
hemoglobin concentration was smaller compared to the control group, likely due to
reduced cerebrovascular reactivity. (Huang, 2023)
3.3.2 Electroencephalography for stroke detection
Electroencephalography (EEG) is a technique for observing brain electrical signals as
they appear on the scalp. An EEG, the recorded output, reflects alternating electrical
activity captured through scalp-placed electrodes and conductive agent. (Teplan, 2002).
(Olejniczak, 2006) defines EEG as graphical representation of the difference in voltage
between two different cerebral locations plotted over time”. The EEG when measured
with using depth probes is called Electrogram and when measured from directly from the
cortical surface, it is called Electrocorticogram. I will refer EEG to only measured from
the head surface in this paper.
EEG measurement is a non-invasive procedure that can be safely used on adults, children,
and patient’s multiple times with minimal risk or limitations.
When brain cells are activated by different processes, they create local current flows. EEG
measures most of the cases current flows during synaptic excitations in the cerebral
cortex. Electrical potential differences arise in pyramidal cells, forming electrical dipoles
between the neuron’s body and neural branch. Brain electrical currents are mainly
produced by Cl-, K+, Na+ and Ca++ ions moving in a direction set by the membrane
potential. This is rough description, and more detailed microscopic picture is lot more
sophisticated. (Teplan, 2002).
28
It takes only large population of neurons to generate enough recordable electrical activity
on surface of the head. Weak signals detected by electrodes on the scalp are amplified
massively and then stored to computer memory or hard drive or printed on paper. (Teplan,
2002).
Encephalographic measurement recording system consists of electrodes, amplifiers with
filters, recording device and A/D converter (Analog/Digital converter). Electrodes are
reading signals from the surface of the head, converters change signal from Analog to
Digital, amplifiers will bring microvolt signals in to range where they can be accurately
digitalized and computer or other device stores and displays the gathered data. Minimal
configuration for single channel EEG consists only one electrode and multichannel can
go up to 128 or 256 electrodes. There are many types of electrodes with different
characteristics, which can be listed as disposable electrodes, reusable disc electrodes,
needle electrodes, saline-based electrodes and headbands and electrode caps. For
multichannel measurements, electrode caps are preferred. (Teplan, 2002).
Skin surface is generally cleaned from sebum (oil) and scrubbing dried parts away is
recommended. With disc and disposable electrodes, abrasive paste is used. When used
needle connections, right hygiene and safety protocols are important. EEG measured by
mounted cap for same electrode points will have threat of pain and bleeding for a subject,
because needles can penetrate the skin. (Teplan, 2002).
Brain waves have been categorized into four mostly used frequency bands. These are
Delta (0.5-4Hz), Theta (4-8Hz), Alpha (8-13Hz) and Beta (>13Hz). (Teplan, 2002). There
are also Gamma band which is at 30 and up (HZ. Files, 2011). There is also inconsiste nc y
between different frequency bands between Teplan and HZ Files. Delta frequency starts
at 1Hz and Alpha ends at 12 HZ by Hz.Files.
While EEG is not primary diagnostic tool like CT or MRI, it offers valuable
supplementary information in specific clinical scenarios, particularly in assessing brain
activity changes, monitoring recovery, and detecting post-stroke complications.
3.3.3 Accelerometer for stroke detection?
Primary objective of Wilkinsons study was to investigate the effectiveness of a low-
priced, transportable EEG system among individuals who recently suffered stroke in
differentiating between patients who had an ischemic stroke and a control group
compromising individuals who displayed suspected stroke symptoms, the stroke mimics.
Using the Muse device, participant movement was analysed by collecting data from the
gyroscope and accelerometer. The research determined that individuals with stroke
displayed greater accelerometer variability in the X-axis and lesser variability in the Z-
axis, suggesting more tilting head movements and less shaking head movements. These
differences may reflect impairments in the motor system or attentional deficits due to
contralateral neglect. It is worth noting that since the data was collected with eyes closed,
impaired motor function, including postural support, may have contributed to the
observed differences. The absence of significant differences in the gyroscope’s rotational
data highlights the accelerometer’s potential as a more sensitive instrument for detecting
movement disparities between controls and stroke patients. This finding suggests that
overall movement patterns may provide greater diagnostic value than rotational metrics.
(Wilkinson et al. 2020).
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4. Aim of the work and research questions
This chapter’s main focus is on describing the goals of the Stroke Project, the research
questions and the methods used.
4.1 Research context
Stroke data project was a two-year Business Finland project which goal is to develop
solutions for early Cerebrovascular accident recognition, prevention and rehabilitatio n.
Solutions are developed for patients and healthcare professionals. Especially goal is to
develop data-based Decision support solutions for physicians and other healthcare
professionals and solutions based on Artificial Intelligence (AI) and machine learning
(ML) methods to support cerebrovascular accident diagnostics, also for example video
and speech analysis techniques. Also, project aims to develop new sensors for measuring
patients with near infrared spectroscopy and low frequency brainwave measuring devices.
Project aims to develop automatic evaluation system which uses audio visual and bio
signals to support stroke diagnosis. Project also is going to develop iteratively business
model ecosystem for helping developed solutions getting on domestic and foreign
markets.
4.2 Research questions
The following are the research questions (RQ) for this thesis work.
RQ 1: How feasible is a multimodal brain monitoring setup for stroke data collection in
terms of ease of use and measurement duration?
RQ 2: What are the possibilities to develop wearable NIRS brain monitoring technology
that could enable easily and immediately to start brain monitoring of patient with possible
stroke?
My work on the project began with learning to use various devices for data collection.
Next, we tested the measurement protocols to evaluate their feasibility. It quickly became
evident that the planned protocol was not suitable for actual patients, as stroke conditions
vary significantly among individuals. Consequently, we made adjustments to the protocol
and identified a suitable location within the hospital for conducting all measurements.
One of my tasks during the project included training research nurses at Kuopio University
Hospital. I travelled there twice to conduct training sessions and a few additional times to
deliver spare parts and participate in measurements. This allowed me to assist with data
collection and monitor how the measurements were conducted.
During the development of NIRS device, I did participate on several different task, for
example building a new electronic board for NIRS device, repairing device when needed,
developing, designing and testing new headband and NIRS device, software development
and designing GUI and also doing user testing on the NIRS software.
30
4.3 Research method
In my work, I have chosen the Design Science Research method. In Alan R Hevner’s A
Three Cycle View of Design Science Research presents a structured approach to
understanding Design Science Research (DSR) by introducing three interconnected
cycles, the Relevance Cycle, the Rigor Cycle, and the Design Cycle. The Relevance cycle
connects with real-world problems by gathering requirements from the application
domain, which consists of people, organizations, and technical systems. It ensures that
research remains applicable by introducing the developed artifacts into practical field
testing, allowing for validation and iterative improvement based on real-world feedback.
The Rigor cycle provides the theoretical foundation for research, drawing from scientific
theories, established methodologies and domain expertise to ensure that design efforts
grounded in prior knowledge. This cycle also contributes back to the knowledge base by
expanding existing theories, refining methodologies, and documenting research insights.
At the core of the process, the Design Cycle operates as an iterative loop where artifacts
are created, evaluated and refined. This cycle is essential for ensuring that the designed
solutions are both effective and scientifically rigorous.
Hevner emphasizes that these three cycles must be present in any high-quality SR project,
as they ensure a balance between practical relevance and scientific rigor. Unlike
traditional natural sciences, which focus on understanding phenomena, Design Science is
inherently problem solving oriented, aiming to create artifacts, such as models, systems,
or methodologies, that address real-world challenges. The research methodology
integrates systematic design, empirical evaluation, and theoretical contributions, making
it an essential paradigm in fields like Information Systems, Engineering and Architecture.
By recognizing DSR as a pragmatic science, its dual contribution is highlighted as
improving real-world systems while simultaneously advancing theoretical understanding
(Hevner, 2007).
In my work, the Relevance Cycle involved data collection from patients using one version
of an fNIRS device. We identified issues with conducting measurements and recognized
development goals that needed improvement. The Design Cycle involved developing
iterative prototypes, such as a new headband, based on insights from the Rigor Cycle.
Ultimately, this process led us to develop a smaller, digital wearable device that caused
less discomfort for test subjects.
4.4 Development goal
The development goals focus on advancing the NIRS device into a wearable form while
enhancing the head unit connection for improved usability. The objective is to facilitate
quicker and easier attachment to the forehead while ensuring accurate measurement
distances. Additionally, the device and its user interface is designed to be more user-
friendly, accommodating a diverse range of user groups. Another key goal in headband
and device development is the integration of additional EEG, ECG and accelerometer
measurement capabilities to make NIRS device wearable multimodal measureme nt
device.
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5. Design challenges in realizing easy-to-use
software user interfaces
This chapter will go through some theoretical background on designing User Interfaces
and introduce a few methods which can be used to design easy-to-use interfaces for
different user groups typically with limited experience of using software interfaces for
medical monitoring purposes.
Nurses represent the primary user group and encompass a highly diverse population. This
diversity is reflected in significant age differences and varying levels of computer
proficiency. Younger nurses generally exhibit greater familiarity with computer
applications than their older counterparts. However, many nurses’ express apprehension
about adopting new applications or using technical devices. Among the numerous
challenges, this thesis focuses solely on developing intuitive and user-friendly
applications to address specific concerns and facilitate adoption.
5.1 Generation-Oriented approach vs Aging-oriented framework
According to Liu.S, Generation-oriented approach and the aging-oriented approach vary
in the following ways.
Overview of variations between age groups. Elderly people typically have more
challenges on using today’s interfaces of present-day technology compared to younger
people. The Generation-oriented approach examined the relationship between the
generation-based information and experience of elderly people and the demands of the
current user interface to understand their difficulties with the latter. The Aging oriented
approach is focusing on genetic and biological features and their gradual loss because of
the process of aging.
32
Figure 3. Generation oriented and Aging oriented approach Framework. Adapted from
Liu.S. 2012.
Declining and maintaining. While aging-oriented approach focus on the gradual loss in
abilities that come with age and suggest design approaches to compensate for those
deficits, the generation-oriented approached focuses on the abilities and knowledge that
remain and provides design recommendations to make use of them.
Historical context. The aging-oriented approach tends to be isolated from historical
context and external influences, whereas the generation-oriented approach recognizes the
importance of context and considers each generation to be shaped by its historical
circumstances. This makes the generation-oriented approach dynamic, as it requires
ongoing updates to our understanding of the knowledge and experience of older adults as
new generations enter that age range.
To summarize, the aging-oriented design approach has had moderate success in crafting
user interfaces for elderly users, but it faces certain shortcomings. On the other hand, the
generation-oriented approach holds promise for refining and advancing the aging-
oriented technique. Therefore, a framework that integrates these both approaches in a
systematic way is highly desirable for achieving the conclusive design solutions. (Liu,
2012)
If the target users capabilities are not properly understood in interface design, it can lead
to frustration, accidents, or even exclusion. When the requirements of specific interface
33
features surpass users abilities, design exclusion occurs, as the capability-demand
relationship suggests. For developing an interface that is easy to operate and approachable
for older people, it’s crucial to consider all the main characteristics and capabilities of this
user group in the design process.
Designing user interface for older people is commercially popular so there is gap in
literature for designing and evaluating design concepts. To address the gap in current
research, emphasize the need for a deeper understanding of what it means to be an older
adult, and offer a more nuanced approach for developing interfaces tailored to older
people. In Lius article, they are proposing a framework that combines the generation-
oriented and aging-oriented approach.
The suggested framework in the article, could act as a theoretical framework that
illustrates the design process and reasoning pathway. To Begin the process of designing
the user interface, it is important to thoroughly understand the characteristics of the target
user group, which in this case are older adults. The designers will follow two paths in the
framework diagram: the aging-oriented and the generation-oriented approaches.
To gain extensive understanding of the characteristics of older adult user, the designers
should follow both paths outlined in the framework. This involves applying both the
aging-oriented and the generation-oriented approach. After completing this process, early
design solutions based by each approach can be generated. It’s worth noting that these
preliminary design solutions may differ from one another. To arrive at a final design
solution, a dialogue comparing the two preliminary products is necessary. This design
solution informed by the comparison dialogue will be created at the end of the process.
(Liu, 2012)
5.2 Generation-oriented approach
On the opposite side of the diagram of figure 13, the focus is on developing design
solutions through a generation-oriented approach. This strategy centres on gaining insight
into older adults by exploring the unique experiences and knowledge shaped by their
generational background.
The first in this generation-oriented approach framework is innate knowledge, followed
by sensorimotor knowledge, then knowledge specific to an individual’s culture and
finally expertise. Additionally, there is a level of tool knowledge that encompasses the
sensorimotor, cultural and expertise levels of knowledge (Liu.S 2012).
Within the suggested framework, knowledge is divided into three categories, the
sensorimotor, cultural, and tools level. The sensorimotor level includes concepts such as
population stereotypes, image schemas and affordance. Knowledge can differ
significantly between cultures, including differences in population stereotypes, colour,
values, and language. At the tool level, there is knowledge about specific product features
such as operation, appearance, location and but also mental models and symbols (Liu.S
2012).
In the proposed framework, experience is divided into three categories. Expertise with a
wide variety of products spanning multiple types and domains, familiarity with other
products of the same type or domain, and specific experience with the product being
evaluated. All three categories of experience are included in the framework.
34
In the proposed framework, historical context is considered an important factor in the
generation-oriented approach. This is because each generation is shaped by the unique
historical context in which they grow up and live, which includes social, cultural,
environmental and technological characteristics. Studying how user interfaces have
developed over time, as well as the objects and interactions that senior adults have
experienced during key developmental periods, is important for understanding their
behaviours and preferences. In particular, the formative period (ages 10-25) is a critical
time for the acquisition of norms, values, and skills that shape future of behaviours and
preferences (Liu.S 2012).
5.3 User interface for individuals with limited tech familiarity
When designing GUIs for people with limited tech familiarity, it is important to consider
their specific needs and abilities. User may have visual, cognitive, or even physical
limitations that can affect their ability to use the interface. For example, they may have
difficulty reading small text or distinguishing between similar colours. They may also
have slower processing speed or memory deficits that can impact their ability to learn and
use the interface (Liu, 2012).
To address these challenges, it is important to consider the principles of universal design,
which aim to make products and environments accessible to all users, including those
with disabilities. Some strategies for designing GUIs for users with limited tech
familiarity, include using larger text and high contrast colours, providing clear and simple
instructions, and allowing for customization of the interface to meet the needs of the
individual user.
Designers can use simulation kits, helping designers gain insight into varying levels of
physical and sensory functions. On the other hand, currently there are lack of proper tools
for simulating elderly users’ prior knowledge and experience (Liu, 2012).
5.4 Dialogue and design solution
The final product of this framework will be successful if we have a dialogue comparing
the solutions produced using the aging-oriented and the generation-oriented approach. To
reach a final design solution using the framework, it is important to encourage and
conduct a dialogue that includes careful analysis, evaluation and discussion of the specific
goals and needs, as well as the specific design challenges and situations (Liu, 2012).
5.5 Persuasive system designing on software development
According to Oinas-Kukkonen, Interactive information technology that seeks to change
people’s behaviour or attitudes is called persuasive technology. Historically, persuasion
has referred to communication designed to impact other’s actions and decisions. The
Internet, smartphones, and related technologies open possibilities for persuasive
communication through their ability to reach users effortlessly. In addition, the Web-
based systems are particularly suitable for persuasive interaction, since they consolidate
the benefits of personal and broad audience communication. Persuasive technology may
prove especially valuable in fields like healthcare software applications that motivate
people to adopt healthy habits, potentially preventing or delaying medical issues and
easing the burden on public healthcare systems. (Oinas-Kukkonen & Harjumaa 2009)
35
As in Oinas-Kukkonen article persuasive systems are defined as “Computerized software
or information systems designed to reinforce, change or shape attitudes or behaviours or
both without using coercion or deception. This definition comes with three potential
effects for persuasive system. The shaping or change of attitudes, the voluntary
reinforcement and/or behaviours. A reinforcing effect refers to the strengthening of
existing attitudes or behaviours, making them harder to change. A changing effect refers
to the modification of a person’s response to a particular issue. A shaping effect refers to
the creation of a new pattern for situation that did not previously exists. In many cases,
communication that results in a shaping effect may be more effective that communication
that targets for a changing effect. (Oinas-Kukkonen, 2009)
Oinas-Kukkonen introduces in their article for the Persuasive System Design (PSD)
model with seven postulates behind Persuasive System, which is based on other research,
conceptual analysis, and their empirical work. (Oinas-Kukkonen, 2009)
First postulate is that Information technology is never neutral, but rather constantly
influencing people’s attitudes and behaviours. This is like how teachers persuade students
in school, and it is not inherently negative. Persuasion can be viewed as a process rather
than single event. Persuading a user is a multifaceted and complex task that may change
over time based on factors such as the user’s goals. (Oinas-Kukkonen, 2009)
The second postulate maintains that people like their views about the world to be
organized and consistent. This is bases in theories of commitment and cognitive
consistency. Systems that foster commitment can enhance persuasive outcomes. The idea
of commitment propose that persuasive systems could offer the option for individuals to
make private or public commitments to engage in the desired behaviour. One way to
implement this is by providing a convenient way to send a text message or email to one’s
family, friends, or colleagues. (Oinas-Kukkonen, 2009)
The third postulate states that direct and indirect routes are key persuasion strategies.
Someone who thoughtfully analyses the persuasive communication is likely to be
persuaded through the straightforward path, in contrast, a person demonstrating
diminished evaluative ability and uses simple cues or stereotypes may be swayed by the
indirect route. Both direct and indirect processes may operate at the same time and be
supported by various features of the software system. Direct persuasion has been more
effective in the long run, but in today’s age of information overload, people are often
forced to rely on indirect cues more frequently due to the overwhelming amount of
information they must process. (Oinas-Kukkonen, 2009)
The fourth postulate states that Persuasion is often incremental. It is more effective to
gradually introduce new actions to someone through a series of progressive
recommendations, rather than trying to persuade them to adopt a new behaviour all at
once. A persuasive system should therefore aim to guide people towards a desired
behaviour by encouraging them to take small, incremental steps. For example, a healthy
eating app might first encourage users to include some vegetables in their meals, and then
later suggests filling half of their plate with vegetables. It is important to consider ethical
implications of incremental persuasion and ensure that the ultimate goal is transparent
and clear at every step. (Oinas-Kukkonen, 2009)
The fifth postulate states Persuasion through persuasive systems should always be
open. It is important to openly acknowledge the designer’s bias in a persuasive system.
For example, simulations can be powerful tools for persuasion, but if the designers bias
is not clearly stated, they may lose credibility or even mislead users. Additionally, it is
36
essential to make sure that the content of the persuasive system is based on accurate and
truthful information, as the overall goal is to encourage voluntary changes in attitudes or
behaviors. (Oinas-Kukkonen, 2009)
The sixth postulate is Persuasive systems should aim at unobtrusiveness”. In order to
meet user expectations, it is important that persuasive systems do not disrupt or divert
users attention while they are engaged in their primary tasks with the system. The
fundamental idea of unobtrusiveness also requires careful consideration of when it is
appropriate to present persuasive features. Using persuasive features at inappropriate
times, such as suggesting exercise to someone who is sick or reminding someone to take
pharmacy products for high blood pressure during a demonstration at the lecture, can lead
to negative outcomes. (Oinas-Kukkonen, 2009)
The seventh postulate states that Persuasive systems should aim at being both useful and
easy to use”. In example, at really helping the users needs. To be effective, a persuasive
system must process a range of characteristics that contribute to a positive user
experience. These include ease of access, responsiveness, error free operation,
convenience, and high-quality information, along with attractiveness and user loyalty. It
is important to note that these are general qualities that all software should strive for and
are not unique to persuasive systems. If a system is difficult to use or provide not value
to user, it is unlikely to be persuasive. (Oinas-Kukkonen, 2009)
5.6 EU regulations on software in medical devices
When developing software for medical device in EU, manufacturer must consider several
requirements from the standards and from Medical Device Regulation (MDR). Main
standards for medical device software are IEC 62304, which is for medical device
software and software’s life cycle process and IEC 82304-1, which is mainly for Health
software and general requirements for product safety. Also, there are other standards like
as ISO 13485 which is standard for Quality Management Systems (QMS) and ISO 14971
standard for risk management. These standards need to be considered also, in a software
development process. Even though standards have been written much of a waterfall model
in mind, they still do allow agile methodologies and development sprints, but require
approvals, documentation and reviews. These standards are not usually freely distributed,
and developers and medical device manufacturers are required to buy them.
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6. Measurement methods
This section describes the various technologies used to collect data for the stroke project.
6.1 Fundus photography
The eye can be said to be structural extension of the brain and spinal cord. In addition, it
has structural properties that are characteristics of the central nervous system. The retina
or fundus is anatomically and developmentally an extension of the central nervous
system. It is made of retinal ganglion cells whose axons form the optic nerve. The optic
nerve fibres in turn, are in fact axons of the central nervous system. So, it is not wrong to
say as London et al says, eyes are the mirror of soul- or if not a mirror, then at least
window to the brain. Several well-recognized neurodegenerative conditions that affect
spinal cord and brain are also noticeable in the eye, especially in the fundus. In fact, ocular
symptoms are in some cases the first signs of central nervous system disorders and can
therefore be used as a prophylactic aid in early-stage diagnosis (London, Benhar &
Schwartz, 2013)
Figure 4. Optomed Aurora Camera.
Photo from Personal picture gallery
Figure 5. Research nurse using Camera.
Photo by Riitta Laitela
In cerebrovascular disorders, changes occur in the small blood vessels of the retina that
are imaginable. However, it is typical that the changes are not seen at an early stage, but
only when the blood-brain barrier has been damaged and the brain suffered permanent
damage, for example because of oedema (Cheung et al. 2013). It is therefore reasonable
to assume that early detection of small vascular changes could justify initiating
prophylactic treatment for Cerebrovascular disorder.
Tools based on AI are already being used in various areas of healthcare. In the context of
Retinal imaging, Artificial intelligence-based algorithms are used to identify changes
associated with, for example diabetic retinopathy. However, it is known that algorithms
38
can detect much more of the retina than is detectable to the human eye. For example,
Poplin and colleagues developed algorithm that identified several factors influencing risk
of cardiovascular disease from digital retinal photography, like age, sex, and diastolic and
systolic blood pressure (Poplin et al, 2018)
In a recent review article, Esteva and colleagues speculated that retinal will be
increasingly provide information on non-ocular diseases, but in particular cardiovascular
and central nervous system diseases or systemic diseases (Esteva et al, 2021)
In this Stroke Project, the retina of cerebrovascular disorder patients, in other words
fundus is imaged with Optomed Aurora digital fundus camera, manufacture by Optomed.
The images show changes in retinal vasculature as a function of time, as well as possible
other changes. The aim of the observed changes is to develop an algorithm that utilizes
artificial intelligence, which could be used on the one hand to monitor recovery but
possibly also to detect early changes that anticipate cerebrovascular disorder.
6.2 EEG and ECG
EEG provides information on the electrical activity of nerve cells (neurons) in the cortex
on brain. The electrical activity of the brain manifests itself as variations in the voltage
and frequency of the waves. Rhythmic voltage fluctuations are thought to be due to the
rhythmic oscillation of neural networks. The measured signals are in the microvolt range
and frequencies are usually between the 0.5 and 100 Hz. The brains electrical activity is
broadly divided into four main frequency bands, Delta (0-3 Hz), Theta (4-7 Hz), Alpha
(8-13 Hz) and Beta waves (14-30 Hz). Each frequency range has its own characteristics
and their changes in cerebrovascular disorders are studied.
In general, with EEG measurements, slow frequencies <0.5 Hz are filtered out because
they are thought to be caused something non-neural activity. In Stroke project in
particular, low frequency direct current DC-EEG voltage fluctuations <0.5 Hz are also
interest because they reflect the strongest mechanism of cerebral glia circulation that
deliver changes in permeability across the blood-brain barrier affecting the previously
mentioned faster neural rhythm (Kiviniemi et al. 2017). In cerebrovascular disorder, these
low frequency functions can be radically altered when vascular function fails. The
measurements are done with Bittium’s commercial NeurOne DC-EEG measuring device,
which can also be used to measure Electrocardiography (ECG) signal which is reflecting
electrical activity of the heart.
6.3 NIRS
The NIRS device was developed at the University of Oulu and it enables continuo us
measurement of cerebral blood flow, in particular synchronous measurement of the
concentrations of deoxy haemoglobin (Hb) and oxygen haemoglobin (HbO),
cerebrospinal fluid (CSF) concentrations (Myllylä et al., 2018).
39
Figure 6. NIRS setup testing. Photo
Personal picture gallery
Figure 7. Bittium NeurOne. Photo
Personal picture gallery
6.4 Speech and video recording
Research aim is to find early anomaly symptom patterns and incidents, for example
aphasia, face nerve paralysis and motorized problems from video image of the patient and
recorded speech. Algorithm based on video image monitors facial muscle asymmetry and
changes in blood flow by distinguishing remote photoplethysmography (rPPG) signals
from several areas from face.
There is little literature material about detecting stroke from video image and most of
material is concentrated on detecting muscle paralysis from video image, like for example
(Thevenot 2017). Paralysis symptoms can be caused by several different factors like for
example, infection, trauma, tumours, stroke and different syndromes like Guillan-Barre
and Moebius. Differential diagnosis between these is not easy or obvious. Different
methods have been developed to identify asymmetries between the sides of the face in
facial stroke. In these tests, the test subject is usually asked to perform different
expressions like smiling. Image processing can also be used to measure the distances of
anatomical points, facial features and to compare facial aspects. In addition, facial
movement can be measured to assess facial muscle activation.
Video based studies have used House-Brackman method as a reference, which allows
physicians to assess the severity of stroke at six different levels (I-VI) from normal
symmetrical movement (Level I) to complete paralysis (Level VI). House-Brackman is
the most used point scale for measuring facial nerve function (Niziol et al., 2015).
However, the method has been criticized for not being able to accurately measure facial
mobility. The method is used to evaluate the face generally as whole and not the different
parts of the face like example forehead, nose, eyes and mouth separately. In addition,
there is little consensus among different physicians. Banks et al. Have developed the
Electronic Facial Paralysis Assessment” tool, which has been validated using several
different measurement scales, but can only be used to detect facial paralysis. (Banks et
al., 2015).
Recently has been published a study that used video first time to assess stroke. The video
was recorded in the hospital emergency room. The study achieved 93% sensitivity for
classification as stroke / non-stroke and 79% accuracy from the video which was less than
four minutes. The method used in the study, utilized a combination of visual and audio
data (Yu et al., 2020).
40
Stroke project aims at better accuracy compared to Yu et als research, by using among
other things like more advanced methods of artificial intelligence and machine learning,
as well as a new kind of data combination. Unlike previous studies, in addition to video
and audio signals, Stroke project utilizes photoplethysmography signals and examines the
added value of pooled data in classifying stroke patients.
Figure 8. Video and speech measurement.
Photo by Riitta Laitela
6.5 Accelerometer
According to recommendations of Toimia database (Terveysportti 2022) the balance of a
stroke patient can be assessed by the following indicators, ABC survey (The Activities-
Specific Balance Confidence Scale) (Powell, Myers 1995), posture swing on power plate,
the Berg’s balance test (Berg et al. 1989), and the Timed up and go test (TUG) (Podsiadlo
& Richardson 1991). The ABC query is based on only questions, which means it does not
require special facilities or equipment. Measuring postural oscillation on power plate, on
the other hand requires a separate power plate, computer, and software to perform the test
and it is usually done by a physiotherapist. The Berg Balance test as well as the TUG tests
also require professional to do the tests and the Berg test takes about 15 minutes and the
TUG a little less than that.
VTT has developed an Accelerometer based method for assessing the risk of falling based
on a person’s walking style. In developing this method VTT has used Berg’s balance test
as reference meter (Similä et al. 2017). However, this method has not yet been tested with
stroke patients. Acceleration based balance assessment provides an opportunity to speed
up balance assessment at the outpatient clinic and on the other hand, it also provides a
cost-effective opportunity to monitor rehabilitation of a stroke patient, especially with
regard to walking rehabilitation.
Stroke project investigates the applicability of accelerometer-based balance assessment
in the balance of stroke patients based on their walking style traits. Project utilizes on
their study an application which is previously developed by VTT and uses it to collect
41
acceleration sensor data from stroke patients about their walking style. Stroke project uses
on its research clinical measures as reference measures. The result of this method is
compared to for example, with the results of the ABC survey (Powell & Myers, 1995)
and the results of mRS meter (Van Swieten et al., 1988). Stroke project is going to refine
the index composed of features suggesting imbalances which is more suitable for patients
with cerebrovascular disorders.
Figure 9. MoveSense Balance Sensor. Photo
from personal picture gallery
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7. Materials and measurement protocols
In this part is described the data collection protocols and measurement methods that were
used.
7.1 Data collection and research methods
Data collection is carried out as a national multicentre study in two university hospitals
in Finland. At Oulu university hospital (Oulun Yliopistollinen Sairaala , OYS) and
Kuopio’s university hospital ( Kuopion Yliopistollinen Sairaala, KYS ). The research is
based on direct observations in which the aim is to monitor the conditions of subjects and
the effects of changes in the subjects. The Stroke Project is not an intervention study that
actively seeks to change the conditions of the subjects, but an hybrid study. Main research
methods are quantitative and qualitative. In my thesis from Stroke project data, only
quantitative data collection from bioelectrical sensors method is used. This is prospective
patient series study that aims to gather data for the development of new technologies and
analytical methods, as well as to determine the accuracy of the methods compared to
existing clinical methods. In addition, control data is collected as a reference point, which
can be examined by separate invitation example at OYS’s premises. The control data and
the data collected for differential diagnosis cover three different groups, which can be
examined by separate invitation, example at OYS’s premises. Subject groups are listed in
Table 1.
Table 1. List of test subjects
Planned amount of test subjects
50
50
25
100
The data collection is preceded by a month-long testing of the measurement protocol, in
which the functionality of the protocol is verified in practice and modified if necessary.
At this stage, the research nurses will be trained by researchers to make the measurement
protocol and the staff of the department involved in the data collection will be informed
about the forthcoming research and its purpose. Patients are recruited for 6 months in the
hospital’s cerebrovascular disorder department and the follow-up period is three months.
The data collection protocol is evaluated and if necessary, updated after three months of
recruitment to ensure sufficient and correct data.
The purpose of the study is to extract from the hospital systems the information that
cerebrovascular disorder patients currently that is collected during their treatment, as well
as to collect data with the surveys, sensors and devices which are developed in the project.
The collection of data has no effect on the treatment received by the patient or on the
43
treatment decisions made for him or her. The study nurse or research assistant will take
the following measurements on the patient.
Video and speech recording by mobile application which has been developed for
this purpose
Balance measurement with a wearable motion sensor and mobile applicatio n
which has been developed for this purpose.
Measurement of the electroencephalogram (DC-EEG) and optical brain imaging
with Near Infrared Spectroscopy (NIRS) with head mounted measuring device
Cardiac electrocardiogram (ECG) measurement with a chest electrode.
Fundus photography with Optomed Aurora camera.
Questionaries on background factors, cerebrovascular disorder risk factors,
assurance of functional balance and patient experience related to their health
(Patient Reported Outcome Measure, PROM)
Patients at risk for cerebral infarction (ABCD2) and severity of injury from
cerebrovascular disorder (Modified Ranking Scale, mRS)
Patients medical condition will be considered, and measurements shall be performed only
if the patient’s condition permits. The opinion of the Ethics Committee of the Northern
Ostrobothnia Hospital District is sought for the study, and it is submitted to the Ethics
committee of the Northern Savonia Hospital District for information. In addition, the
equipment used in the study, will be reported to Fimea. Following the favourable opinion
of the Ethics committee, registry research permits are also applied for from OYS and
KYS for the collection for registry material.
7.2 Research subjects in Stroke project
7.2.1 Inclusion criteria for research subjects
Participants were included in the study if they were over 18 years old and had a suspicion
of transient ischemic attack (TIA) or stroke, classified under ICD-10 codes I60-69 and
G45, as well as ICD-8 and ICD-9 codes 430-438. In addition to the main study group, the
University of Oulu and Oulu University Hospital (OYS) collected data for both a control
group and differential diagnostics group. Control group participants were required to be
healthy individuals over 18 years old without any chronic diseases or regular medication.
The differential diagnostics group included subjects with either severe migraine or
vascular dementia. Migraine patients had to be over 18 years old and experience at least
15 migraine days per month, while dementia patients had to be over 18 years old with a
diagnosis of vascular dementia.
7.2.2 Exclusion criteria
Individuals in the exclusion criteria group included prisoners, forensic psychiatric
patients, minors, individuals with disabilities, and pregnant or breastfeeding women, in
accordance with the Medical Research Act (488/1999). Additionally, healthy control
participants were required to have no regular medication, smoking habits, or other
addictions, however, the use of blood pressure and cholesterol medication was permitted.
44
7.2.3 Consent of subjects
The written, informed voluntary consent of the subjects is requested at the time of
recruitment. Subjects shall be provided with a written explanation of their rights, the
purpose, nature and methods the study, as well as any risks and inconveniences (Medical
research Act 488/1999). Participants have the right at any stage of the study to suspend
their participation without giving any reason affecting their treatment or services. Consent
forms will be signed in duplicate, one of which will remain with the patient and the other
will be kept by the study nurse in a prearranged locker on hospital premises.
The ability of memory-impaired patients to be recruited for differential diagnosis to give
informed consent, may be impaired. If the patient is under guardianship, consent to
participate in the study will be asked from the guardian. If the patient is not subject to
guardianship, the patients physician will assess the patients ability to consent to
participate in the study. If the treating physician considers that the patient’s conscious
ability to consent is impaired, consent will be asked from the relative. Relatives are asked
to assess whether the patient would have given their consent before the memory illness
and to decide on behalf of the patient. If the treating physician considers that the patients
ability to give informed consent has not been impaired, consent will be asked from the
patient himself.
7.3 Sampling
KYS’s cerebrovascular disorder ward has an estimated 500-600 patients annually and
their average length of hospital stay is 4 days. Correspondingly the cerebrovascular
disorder ward at OYS has 600-700 annually and average length of hospital stay is 3.5
days. Patients are actively treated in both hospitals, as well as patients referred for
rehabilitation, will come for a follow-up visit after 3 months. Follow-up checking can
also be done by phone call. The number of these patients in both hospitals is estimated at
150-200 per year.
The sample consists of all patients who meet the admission criteria coming to
cerebrovascular ward during the recruitment period, so that it is estimated that the
research nurses will be able to recruit and perform the planned measurements for one
patient per day within working hours while not disturbing the daily treatments of the
patients. During the estimated 6-month recruitment period, it is possible for patients with
TIA or Stroke suspicion to reach N=50-100 per hospital, for a total N= 100-200 patients.
The number of patients that can be reached will be specified during protocol testing. In
addition, the University of Oulu and OYS measure control and differential diagnosis data,
N=100 -125, which are called on by email-lists, like for example Oulu.fi and ppshp.fi and
based on research invitations to local newspapers.
7.4 Recruitment
When a patient who meets the admission criteria arrives at the cerebrovascular disorder
ward, the ward physician will present the research in the context of the doctor’s round
and provide the patient with a paper version of the subjects bulletin and consent form.
The study nurse will later inquire about the patient’s willingness to participate in the
research. If recruitment is not done at doctor’s round, the study nurse will go recruit new
patients from the ward by him or herself and ask from ward’s nurses for suitable patients
and check that they meet the recruitment criteria. Then research nurse will go present the
45
research for patient and if patient is willing to participate for the research, he/she gives
the subjects bulletin for the patients and consent form. The patient is asked for voluntary,
individualized, informed, and unambiguous written consent prior to the measurements.
During the recruitment process, all patients invited to the study and reasons for their
refusals are recorded to assess the generalizability of the results.
In the control group, healthy controls are collected either from patients’ relatives of from
mailing lists using attached separate invitation. Patients with severe migraine are recruited
from the neurology department for those patients whose diagnosis has not been fully
confirmed and or whose symptoms have required departmental care. In addition, migraine
patients can be recruited from the emergency department if necessary. Patients with
vascular dementia are recruited from the Department of Neurology Memory Clinic
7.5 Data collection protocols
If the patient agrees to the study, the study nurse will perform the following measureme nts
on the patient once while they are in a Stroke ward as soon as possible after they have
entered the ward. The study nurse with the help of the ward staff, will evaluate when the
patient has appropriate time to participate in the measurements, in which case he or she
will not have any procedures or examinations related to normal care. Measurement
protocols are described in following sub chapters.
1. Balance measurement using a wearable motion sensor at the waist and mobile
application developed by VTT for this purpose. The measurement is performed
on those patients who can walk independently for distance of at least 10 meters.
2. Video and speech recording with a mobile application developed by VTT for this
purpose.
3. Combined measurement in which DC-EEG, NIRS, ECG and Accelerometer
signals are measured in addition to video and speech.
4. Fundus photography by using Optomed Aurora camera.
5. Questionnaires either as a paper form filled in by the patient him or herself or by
interviewer.
6. Meters made by a study nurse.
a. TIA patients stroke risk (ABCD2)
b. Severity of disability caused by stroke with Modified Ranking Scale
(mRS)
7.6 Balance protocol
Patients dynamic balance is assessed using a walk test. The walk test is performed on
patients who can walk about 10 meters independently. For the walk test, a 3D acceleration
sensor is attached to the patient’s waist and the measurement data is transferred wirelessly
to the mobile device. Mobile device has an easy-to-use mobile application which has been
developed for this purpose by VTT, where measurement is started and stopped. Mobile
application does not store any personal information of patients.
1. Study nurse evaluates patients ability to walk independently about 10 meter
distance. If patient is able to perform walking test, study nurse will explain the
course and purpose of the measurement.
46
2. Study nurses attach accelerometer sensor (Movesense, size 36,6mm x 10,6mm,
weight 10g) around patients waist with fastening belt that comes with a sensor.
3. Study nurse will type patients previously determined patient code into application.
4. Study nurse follows instructions from the application, which gives guidelines to
study nurse for checking there is 10-meter space for walking, like for example
hallway. When patient is ready, study nurse starts the measurement from the
application by pressing Aloita button and stops measurement by pressing
Stop button. Measurement can be do again if needed.
Balance measurement takes about 5 minutes. Only study nurse will use mobile applicatio n
for measuring balance and patient does not get any feedback from the balance test.
7.7 Video and speech protocol
Video and speech recording is done by consent of patient. Any other persons, like for
example hospital staff, other patients, relatives and so on, are not visible on video
recording.
1. Research nurse presents test protocol for a patient.
2. Research nurse inputs predefined patient identification number to a mobile
application developed for this purpose.
3. Research nurse follows instructions given by an application and starts the
recording.
4. Patient is asked to perform following tasks.
a. Patient is asked to smile, show teeth, and raise eyebrows a few times.
b. Patient is asked to extend the other hand first to 90-degree angle and keep
eyes closed and keep hand extended 10 seconds and then perform same
tasks with other hand and then extend both hands to 90-degree angle with
eyes closed for 10 seconds.
c. Patient is asked to read aloud sentences which are presented to him in
paper.
d. Patient is asked to explain in aloud what is happening on a paper which is
showed to patient.
e. Patient is asked to follow with his eyes only an object which is moved to
left and right.
f. Patient is asked to lie down and asked to raise first other leg to 30-degree
angle and keep it erected for 5 seconds and repeat the same task with other
leg.
g. If Patient is able, he is asked to stand still for 30 seconds.
In part C and D showed sentences and pictures are shown in figure 10. Tasks are chosen
by following meters used in clinical work. National Institutes of Health Stroke Scale
(NIHSS), FPSS, CPSS, Los Angeles Prehospital Stroke Scale (LAPSS), and FAST/BE-
FAST.
1. When tasks are finished, recording is stopped from mobile application.
Video and speech recording is used only by research nurse and collected videos can only
view through mobile application. Mobile Application requires personal access code.
Estimated time for video on speech protocol is 5 minutes.
47
Figure 10, Picture From Stroke tutkimussuunnitelma
7.8 Video speech protocol including additional measurement
devices
7.8.1 Additional measurement devices used
In this protocol, DC-EEG, NIRS, Accelerometer, ECG and video is collected
simultaneously. Protocol is using following equipment’s and sensors.
Bittium NeurOne and DC-EEG cap, which has also followed sensors attached to
it.
o NIRS
o 3x Accelerometer
o ECG sensors
Video and speech recording with mobile application
7.8.2 Test protocol with additional measurement devices
1. Research nurse introduce test protocol to patient.
48
2. Research nurse enters predetermined patient identification on application
developed for measurement on laptop and in mobile application which has been
developed for recording video and speech.
3. Research nurse dress headcap for patient which includes DC-EEG, NIRS, and
Accelerometers.
4. Research nurse dress ECG sensors to patient’s chest.
5. Research nurse starts DC-EEG, NIRS, Accelerometer and ECG sensor recording
on computers and on mobile application by instructions from mobile application.
6. Patient is first asked to sit 5 minutes, then next lie down for 5 minutes and then sit
down 5 minutes again.
7. Patient is asked for breath and hold breath for a moment for CBF reserves
(Cerebral Blood Flow) calibration. Patient is asked to breath normally first 30
seconds and then hold breath for 30 seconds.
8. Patient is requested to perform following task.
a. Patient is asked to smile, show teeth, and raise eyebrows a few times.
b. Patient is asked to extend the other hand first to 90-degree angle and keep
eyes closed and keep hand extended 10 seconds and then perform same
tasks with other hand and then extend both hands to 90-degree angle with
eyes closed for 10 seconds.
c. Patient is asked to read aloud sentences which are presented to him in
paper.
d. Patient is asked to explain in aloud what is happening on a paper which is
showed to patient.
e. Patient is asked to follow with his eyes only an object which is moved to
left and right.
f. Patient is asked to lie down and asked to raise first other leg to 30-degree
angle and keep it erected for 5 seconds and repeat the same task with other
leg.
g. If Patient is able, he/she is asked to stand still for 30 seconds.
In part C and D showed sentences and pictures are shown in figure 10. Tasks are chosen
by following meters used in clinical work. National Institutes of Health Stroke Scale
(NIHHS), FPSS, CPSS, Los Angeles Prehospital Stroke Scale (LAPSS), and FAST/BE-
FAST.
1. When task is finished, recording is stopped from laptop and mobile application.
2. Research nurse removes sensors from a patient.
3. Research nurse disposes ECG sensors and cleans and disinfects headcap.
Patient part of protocol is estimated to take 1 hour, consisting of ten steps as follows:
Steps 1-4: 30 minutes
Steps 5-9: 15 minutes
Step 10: 20 minutes
An additional step, which does not apply to the patient and consists of cleaning the
equipment, is estimated to take 20-30 minutes.
49
7.9 Fundus photography with Optomed Aurora
Photographs of the patients retina, in other words fundus are taken with Optomed Aurora
camera. The images are fist saved to cameras memory card, from where they are
transferred to the laptops hard drive and then transferred to secure network drive for the
study for later use. The photograph does not require for example the use of pupil dilators
or other prior preparations. The photographing event corresponds to normal
photographing with a digital camera. The inconvenience to the patient is limited to the
use of the flash.
1. Research nurse presents the test protocol to patient.
2. Research nurse creates in camera the folder named study and enter there the
patients pre-determined unique identification number ( ID ).
3. Research nurse takes photograph by following instructions.
4. At the end of the measurement, research nurse will move the images from camera
to separately specified storage space.
Estimated time for measurement protocol is 5 minutes. In addition, cleaning the camera
will take from research nurse approximately 1 minute. This step does not apply to the
patient time.
50
8. Development of the user interface for
immediate measurement by NIRS
Presently, the process of conducting measurements with NIRS device is challenging,
compounded by software that primarily caters to researchers. Consequently, the software
encompasses numerous functions irrelevant to nurses or lay users, rendering it
challenging to utilize effectively without requisite expertise.
Purpose of new interface in prototype software was to create easy to use user interface
for people who does not have knowledge or skills to use current interface efficiently.
8.1 Users feedback
Some of the requirements came from feedback of foreign researchers who are using our
NIRS device and our software. They were also in need of interface, which would be easy
to use and do not have anything extra information, which could confuse users. Currently
GUI has been developed mainly for researchers, and because of that, it can be challenging
to use efficiently without proper knowledge. One target group for future users from the
feedback, is for example research nurses.
8.2 Technical description
Hardware software has been developed with C and main GUI has been developed by QT
software and logic and functionality is done with python version 3.9. Main libraries used
in Python are, Pyqt5, Scipy, Pyqtgraph, Matplotlib, Numpy. Python programming has
been done with Visual studio Code and later with Pycharm Community Edition. Version
control has been done with a GIT. The GUI Window was created using QT Designer,
PyCharm and Python version 3.13.
8.3 The primary concept GUI
The primary concept behind the interface design was involved implementing a single
button to streamline most functions, allowing users to initiate measurements with just one
press. This guideline does follow persuasive design seventh postulate of easy to use. The
default time of 5 minutes was selected as it aligns with the typical duration used as a
baseline in measurements with NIRS devices. To enhance user’s clarity, a countdown
timer was integrated to distinctly display the remaining measurement time. This
deliberate choice aims to ensure that for example elderly home users can easily follow
and comprehend the remaining time for the measurement, reducing the likelihood of
prematurely stopping the process.
Layout design adhered to the principles of the Golden Cut, strategically placing more
significant GUI functions towards centre and middle of the interface. This approach
enhanced the visual appeal for the users. The pivotal functions, such as the START button
and timer indicator, command a more prominent presence through larger sizes and fonts.
This helps users who have challenges on hand motoric skills to press start button easily.
Additional information-providing functions are predominantly situated in the corners of
the interface. One of the design ideas is based on generation-oriented approach, as the
51
GUI uses the same principles as those found in blood pressure medical device interfaces,
which are widely used. This makes GUI very familiar and easy to understand and user-
friendly.
Colour scheme primarily employs black, white and gray to ensure the visibility of main
functions for potential users with colour blindness. The only instance of colour use is in
indicating signal quality, which colours ranging from red to yellow to green.
8.4 Functions provided
Following functions were already created for the original version of the GUI, and I chose
to use these functions in my GUI.
Hr monitoring
HRV monitoring
Signal quality
Measurement recording
Controlled timer
Figure 11 shows the GUI, where HR and HRV were incorporated to provide nurses with
additional insights into the physiological conditions of test subjects. HR is valuable for
detecting potential health issues in test subjects, offering a means to identify other
underlying health conditions and for normal users, it gives also interesting information of
users HR.
Signal quality indicators were incorporated as per the request to provide additional
insights into the signal’s quality. This enhancement aids users in identifying whether there
is a necessity to adjust the position of the head unit.
Start button will handle Data recording, by using default filename with timestamp.
Pressing it again will stop data recording before timer goes to zero.
Configure timer button was added, so GUI can be used for different test protocols where
time would be different.
52
Figure 11. Screenshot of GUI Window
Software developed for a medical device, or intended to function as a medical device(e.g.,
operating a device, providing a user interface, or standalone software), is subject to strict
regulation under the European Union’s MDR. Such software is typically classified as a
Class IIa medical device under the MDR. If software or device is considered as wellness
product, then MDR regulation does not effect on it. In my thesis, I will be considering my
software as a wellness product in this thesis, because getting called a medical device,
software needs to have audited by notified body and pass all the regulations of the MDR,
so I won’t be taken in consideration most of the requirements which goes under MDR. I
introduced shortly some of the requirements in chapter 5.6, but I won’t go too deeply on
them, because that can be topic to whole new thesis.
Developing graphical user interface (GUI) can be challenging task, as it requires
balancing the needs and goals of the user with the constraints and capabilities of the
system. To create effective and user-friendly GUIs, it is important to follow best practices
and guidelines for design and evaluation article (Nielsen, Molich 1990).
Nielsen and Molich’s article (Nielsen, Molich 1990) introduces a method called heuristic
evaluation, which involves reviewing the interface against set of usability heuristics.
These heuristics, such as visibility of system status and consistency and standards,
provide a set of criteria for assessing the quality of the interface. Using heuristic
evaluation as a part of the design process can help identify problems and areas for
improvement in the interface. According to the article, most people probably perform
heuristic evaluation based on their own common sense and with their intuition.
Another important consideration in GUI design is the use of appropriate input and output
methods, like predict how much time is required for a user to move their pointer to a
target on the screen. This can be useful in designing efficient and effective input methods,
such as selection buttons and menu items article (Nielsen, Molich 1990).
In addition to usability and input/output methods, it is also important to consider the
overall appearance and layout of the interface. Some guidelines for designing user
interface software can include the use of good visual design principles, such as hierarchy
53
and balance and the use of appropriate widgets and layout techniques article (Nielsen,
Molich 1990).
It can be also helpful to use tools and resources to assist in the GUI design process. Like
for example various user interface design tools and their features, including prototyping,
simulation, and usability testing capabilities. Using such tools can help enhance the
design process and ensure that finished product is of high-quality (Nielsen, Molich 1990).
54
9. Results
In this section, I present results related to RQ1 in chapter 9.1 and RQ2 in chapter 9.2.
9.1 Feasibility of the multimodal setup for stroke data collection in
terms of easy to use and measurement time
The following table is based on my experience with making measurements using the
presented methods during Stroke project. The times provided are mostly estimations
based on my experience of how long it took us to complete the measurements
Table 2. Timetable for measurements used in stroke project
Method
Min
Time/min
Max
Time/min
Other information
Fundus camera
5
30+
We stopped trying to capture a
successful picture after 30 minutes of
unsuccessful attempts.
MoveSense
3
10
Software did cause sometimes
problems. Could not connect to sensor
successfully always.
EEG
20
45
2-3 people were working together
always at the same time to prepare EEG.
fNIRS
10
25
We were using MRI compatible version
of NIRS device with optical fibers and
LabView software which made using
the device slower
Fundus camera was quite small and lightweight. Learning to use it was also quite easy,
but taking good pictures did take some time and practice. It was not always easy to get
good pictures, because, for example, different problems people had in their eyes. The
older the test subject was, the more problematic it was to get good pictures. We
encountered a few test subjects, from we did not get any good pictures, and we had to
skip that part of the test.
MoveSense was very small in size and very easy to use. The only problem with it was
that we had challenges getting connected to mobile applications. Sometimes we needed
to remove the battery and try with better luck with a full power battery.
NeurOne EEG device did take a long time to prepare for measurements. Sometimes it
was bit uncomfortable for test subjects, so when test subjects were not in good shape and
were getting already too tired, we sometimes divided measurements to two days and did
easier measurements during the first day and at second day we did EEG measureme nts.
Couple time test subjects commented about preparing EEG headcap as “head massage”.
55
While preparing headcap with elderly subjects, we needed to be more careful, because
the skin is no longer that durable as compared with younger test subjects. NeurOne also
required quite a lot space and was not easy to move between the hospital and University
side of the building.
The NIRS device was housed in a large metal box, which was quite heavy. Due to the
long fibers, it was not easy to operate. The holders were not connected to each other,
making it difficult to maintain an exact 3 cm distance between them. We had to measure
the distance manually using a ruler, and holders moved quite easily during position
changes from sitting to supine.
Software required some experience to operate effectively and to recognize signal quality
issues. At times, the fibers pressed a bit too hard on the test subjects foreheads, and we
received a few comments indicating that the holders felt uncomfortable.
With our newly developed wearable multimodal fNIRS device, we can significantly
reduce preparation time and minimize the stress associated with using multiple
measurement devices for stroke patients. This innovation will enable faster (as shown in
Table 3) and more reliable stroke diagnosis in future, as doctors will have access to
multimodal data to help differentiate stroke from symptoms caused by other medical
conditions.
9.2 Software interface and device development results when using
NIRS interface
Quickly diagnosing a stroke is crucial, as it directly impacts recovery and rehabilitatio n
outcomes. In the ambulance, a simple FAST test is typically used to assess stroke, and it
is a reliable method for rapid diagnosis. However, when symptoms overlap with
conditions like migraine or vascular dementia, additional tools may be needed to
distinguish a stroke from less acute conditions. The 4-hour windows has been established
as a key benchmark for determining when stroke treatment should begin from the start of
the symptoms, as initiating treatment within this timeframe can significantly improve
recovery and rehabilitation outcomes for stroke patients.
If emergency medical personnel in the ambulance can diagnose a stroke early, they can
initiate treatment right away, if feasible, and notify the hospital in advance. This allows
the hospital to prepare for the patient's arrival and begin treatment quickly as possible.
On emergency situations, time is of the essence. There may be instances where patients
are unconscious or unable to respond to verbal cues. In such cases, a NIRS device could
be invaluable, as it can be quickly deployed to assess whether the patient is experiencing
a stroke, or at the very least, help rule out one potential cause from the diagnosis.
The software interface (figure 11.) is now easier and faster to operate than our regular UI.
Starting the measurement is quicker and does not require high technical skills to configure
settings. Also, software has been developed from LabView program to Python, which
makes it easier to use on different computers and GUI has been improved also to show
more important data for researchers. The name of GUI could be changed in future,
because users could be also other than nurses or elderly home users.
Devices have been developed to be smaller, which makes it possible to use as a wearable
device. Connectors are reduced to a minimum, which makes it easier to operate. Head
56
unit needs now only one connector which makes using the device easier and lowers the
mistakes on connecting head unit sensors.
Figure 12 shows multimodal test measurement done together with our wearable NIRS
device with ACM sensors and EEG data from clinically approved medical device
NeurOne. Data has manually synchronized, which can be seen on the picture figure 12
by three artefacts. Manual synchronization was done by tapping different sensors three
time at the same time.
Figure 12. Multimodal measurement with NIRS, ACM and EEG
signals with manual synchronization artefact.
Overall, I conducted over 100+ measurements in this project using different versions of
our software. I made tests on myself to measure how long it would take to start program
and until recording is started. With four tests, I got an average time of 54 seconds with
my GUI. With our current version of software, it would take about 30-60 seconds longer
time. This time would be probably bit longer if users don’t have much experience on
using the device and software, which I did have quite a lot. In my tests, I had all cables
disconnected. Having them already connected to the device, or replacing them with
wireless solutions, would significantly reduce startup time, making the device easier to
operate, especially in ambulances.
I made short tests with six subjects from our research group. The test was the same as I
did myself. I gave verbal instructions to test subjects who had lower experience on
conducting measurement, on how to use devices. All the cables were disconnected, and
test subjects used my head to install headband. The test started when program was clicked
to start and ended when the start button was pressed on the interface. Results are shown
in Table 3.
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Table 3. Speed test for starting measurement with new GUI and wearable NIRS device
Test Subject
Level of
experience
Starting the
measurement
time (s)
Measurement
time (s)
Estimation
of time for
removing
the device
from test
subjects
head (s)
1
High
54
300
2
2
Low
124
300
3
3
Low
144
300
4
4
Low
70
300
3
5
Low
95
300
3
6
Low
89
300
3
Average
96
300
3
Standard deviation
30,49044
0
0,534522
The test result did show clear differences between experienced users and less experienced
users. Two users tried the test a second time and they managed to decrease their time by
30 seconds and the other by 59 seconds. For my opinion, this indicates that our device
and software is easy to learn so operating time can be lowered significantly with very
little practice. Compared to MRI compatible NIRS devices operating time, with our
wearable device, shows significant results on operating time. On the test we run 5-minute
standard test and then the removing device part consisted of removing the headband from
the head. Compared to Stroke project measurements with NIRS and EEG where it could
take sometimes even 1 hour to prepare time for starting measurements, we have made
significant improvements on how quickly we can start measurements.
In the future, one goal is to reduce preparation time to under one minute. This can be
achieved by improving how the head unit is connected to the test subject’s forehead,
making the device wireless, and simplifying the user interface.
Succes rate on measurements with proto3 version is quite good. For experienced users
the acceptable collected data is about 75%. When the protocol is calm, the possibility of
getting good signal is high.
For example, from one measurement, where 30 subjects were measured. There were 3
protocols used, which were supine to stand, sit to stand and breath hold protocols. In
supine to stand protocol, 22-25 out of 30 were at least acceptable, with few of them having
differences between left and right channel. In Sit to stand protocol, 22-25 out of 30 were
at least acceptable, with few of them having differences between left and right channel.
58
In Breath hold protocol, 21-29 out of 30 were at least acceptable, with few of them having
differences between left and right channel.
Compared to different techniques used in the Stroke project, our wearable solution is
significantly faster. For example, with NeurOne, preparing time was usually about 20
minutes when three people were working with a patient. With the Fundus camera, there
was much more variability because taking pictures of older patients was more difficult
compared to younger people. The quickest attempt took about 5 minutes, but sometimes
we had to stop trying because we couldn’t get good quality pictures. After about 20
minutes, we usually stopped and moved on to the next measurement.
The Movesense sensor has its limitations because patients are not always able to walk
due to paralysis. Video recording is also not practical in ambulances or emergency care,
as it requires more space and is currently a bit slow to use. However, it may have good
potential in the future with more efficient AI software.
Our developed fNIRS device is capable of quickly and easily starting brain monitoring
and recording for stroke patients.
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10. Discussion
Every sixth Finnish people will have once in their lifetime a cerebrovascular accident,
also known as a stroke. Stroke is third expensive disease group, which yearly costs is
estimated to be 1.6 billion euros. Stroke kills in every year about 4500 people in Finland,
which makes it third most common cause of death. It is also notable that stroke can cause
permanent disadvantage to half of survivors. Permanent disadvantage causes great danger
for disability for work and because of that, it has big impact on social costs. For stroke
treatment, fast diagnose and starting of treatment is essential.
There are different kinds of stroke, like TIA which usually is only temporary and last
usually under one hour and mostly 2-15 min, and ICH and SAV. About 10-20% of TIA
patients will get stroke under 90 days if correct treatment is not given. If patient needs
dissolution treatment, time window is about four hours from starting of symptoms. Also,
doctors need comprehensive information of starting symptoms, previous diagnoses,
medication and other risk factors. This critical pathway needs new technologies which
helps faster treatment for stroke patients.
Estimation is that 8/10 of strokes could be prevented with early intervention on risk
factors like obesity, high blood pressure, diabetes, alcohol usage, mid-body obesity,
smoking, heart-based diseases, stress, bad diet, lack of exercise and high blood fat values.
Risk factors are known well, but more research information is needed for how to monitor
different risk factors and how background factors can effect on patients’ recovery. Stroke
risk factors identification and anticipation could help on reducing following health and
economy costs considerably.
New research is showing that stroke and glymphatic system disturbance are closely
related. It is also found that glymphatic system can be disturbed by migraine and
dementia. Differential diagnostics can be challenging, and these different diseases should
be separate from different blood circulatory diseases. One of the goals in Stroke project
is to develop new methods to separate blood circulatory and glymphatic system
disturbances.
The Stroke project was quite a big project with several different collaborators from two
different University hospitals and several different companies from the private sector.
Also, during the project, we had two big things that did an effect on the project, and the
biggest was a global pandemic, which influenced project planning, how the work needed
to be done and how we were needed to communicate with each other. We did not meet
face to face, so communication was done remotely when possible and planning that was
its own work. There was also a strike with nurses, and this did influence collecting the
data.
In KYS research room which were planned for project, did change because reorganization
of wards in KYS. Also, in OYS we had to find new space for doing measurements during
the project. In Oulu our room was not big enough for our needs, so we did have small
problems placing all the measuring devices well enough in the room, especially when
patients had to change positions. We had all three (two research nurses and me) helping
during these position changes. Everyone had some cables to handle or devices to carry
during movement or taking care of moving other objects away or correct position, for
example examination bed to correct position. Few times the electrodes did move also, and
we had to correct sensor positions back to correct place and optical fiber cables got also
some damage during the project while patient was changing position, even though we
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tried to be very careful when handling optical fibers, they still got slightly damaged and
we had to replace them once during the project. Also, our NIRS device needed LED
replacements once and we had some smaller problems with other devices which did affect
how we could do measurements.
The data collection model changed during the project planning period. Originally the plan
was to use one research nurse, but when we tested protocols before starting actual
measurements with a project leader and with research nurse, we quickly found out that it
would be very difficult to do all the measurements alone. Handling all the different
devices and taking care of a patient’s safety at the same time would have been too much
for one person. Taking care of patients’ safety was a priority one for us and because
conditions with stroke patients could change from walking on their own to moving in bed,
it did bring own challenges when working with patients. Sometimes we could not do all
the measurements because of the condition of the test subject.
There were challenges on recruiting patients and different recruiting methods between
KYS and OYS. In KYS physicians at ward did present the project to suitable patients and
asked their interest to join as a test subject for research, and in OYS we recruited patients
with research nurses from the ward by asking from nurse’s possible patients which were
suitable for being our test subjects and then we went discussing with patients and tried to
recruit them. In Oulu we could only get patients for our measurements in the late
afternoon when normal daily routines in the ward have ended. Luckily most of the people
we were asking to participate were interested in joining in our research.
They’re existed variations in patient recruitment between OYS and KYS. While KYS had
a limited number of TIA patients, OYS predominantly enrolled TIA patients. TIA patients
posed less complexity as test subjects since they typically exhibited normal mobility.
Later in Oulu we recruited control group subjects by sending emails to hospitals mailing
lists. Challenge recruiting control group test subjects were requirements, which were at
start preferably over 60 years old, healthy and with no medication. This was then changed
so that some medicines were allowed, like for example blood pressure medicines which
did help recruit test subjects.
The plan on the project was also to recruit test subjects with severe migraine and people
with dementia. On this goal we failed, and we managed to measure only one test subject
with migraine. There were challenges in the recruitment process for both groups and also,
we were running out of time on the project, and because of that, priority was stroke
patients and control group.
Obtaining a new server for data analysis presented significant hurdles, particularly in
navigating legal considerations. Eventually, we identified suitable servers provided by
CSC. Since the project plan lacked an allocated budget for ICT service expenses, this
posed a major challenge in determining how researchers could gain access to the data
collected. The lengthy duration of this process prevented researchers from assessing the
data’s quality during collection. Access to the data was granted only after our data
collection had concluded, leaving us unaware of its suitability for research purposes. All
these caused that project to apply for more time.
Data recording needs precise naming for files. Even though we designed to use codes on
naming the files, there were still too many differences on naming files. Even that we
practiced the test protocols with KYS and OYS side research nurses, there were still some
differences, like for example NeurOne had different sampling rate. Luckily this was not
61
a problem. Also, i noticed afterwards that I should have been more active with KYS
research nurses to ask if they need help with using devices and I should have visited there
more often to practice test protocols more with them. When I asked for comments from
them after we finished collecting data, they told us that they were not confident on using
our NIRS device. More training would have increased their confidence in using our
device.
The need for new interface did arise from the user feedback and from the future plans to
use devices in different user groups outside of researchers, like home users and nurses for
example. Main idea was to create user interface which is very easy to use and still have
main functions of the main program. The concept of a single-button interface draws
inspiration from devices such as blood pressure monitors, where the user interface
operates seamlessly with just one button.
Techniques used in stroke project are not at the moment very reliable for detecting
strokes. Stroke symptoms can be detected from the subjects face, but confirmation still
needs other tests, like for example, MRI. That is where AI can be useful in future to detect
strokes from video recording, when it can be used easily with, for example, by mobile
phones.
Eye camera technics have a problem with a different eye. From my experience, taking
good pictures can be challenging, because the patient cant stay still, they can’t keep their
eyes open enough or they have some other problems with their eyes which make taking
good pictures really challenging. It is more suitable for use in a controlled environment
and with subjects who don’t have, for example, cataracts.
Detecting stroke from balance is a novel technique, but it has some limitations. Where
biggest one is that subjects need to able to walk by themselves without assistance and
results could give wrong diagnoses if the subject already had problems in walking by
some other reasons like for example injury in leg or hip which effects on walking. For my
opinion, this technique won’t be very reliable in near future.
NIRS technique looks most promising from techniques used in stroke projects. NIRS
device has been developed to be wearable and easy to use, so it can fit easily in
ambulances or use in emergency care. Preliminary results from NIRS data analysis are
promising, however, this analysis work was not part of this thesis but will be later
published in a journal.
Tests in our research group show that our device can be utilized quickly with a little
training. Our test group had big variation on how skilled users were doing measurements.
Actual device was known to all, but only one of the test subjects had done actual
measurements with our device and others had mostly experience of being test subject.
One of the test subjects was developing our device software and had mostly experience
on testing software changes with the device.
Development of NIRS devices to be wearable and developments on software and head
unit made measurements easier and faster. This also helps to lower the stress on patients
because the time needed for making measurements is shorter and head unit feels more
comfortable.
We can increase the starting time in future with, for example, making the new GUI start
as a only interface for users. This would increase the starting time considerably. I have
also tested with our newer prototype version, but for this thesis, I did not include our latest
62
prototype version, and it already shows that it is quicker and easier to use. We are also
planning in future to develop devices to be wireless and using Android applications.
These changes can make device to more quicker to use. Also connecting device to
forehead is having improvements, which would help in future use in emergency
situations, making installment of device to patient faster and safer, which would help
using the device for example in ambulances or emergency care in hospitals.
For my opinion, NIRS technology does have bright future as a medical device and also
as a wellbeing device in consumer markets.
63
11. Conclusion
The development of the NIRS device from desktop version to wearable format has
expanded its potential applications across various settings. This advancement enables its
use not only in hospital environments but also in consumer markets. Additionally, as the
device becomes more compact and the software more user-friendly, ne clinical
applications within hospital settings continue to emerge.
With a smaller size, lighter weight, and improved holder connections to the forehead, the
NIRS device has become more practical for use in various hospital wards, including
emergency care. Additionally, a simplified GUI allows even people with limited
technological familiarity to operate the device with minimal training.
In the future, wearable NIRS technology could serve as a rapid diagnostic tool for stroke
detection, particularly in ambulances, where first responders can quickly differentiate
stroke from migraine or vascular dementia symptoms. This early diagnosis would enable
faster treatment initiation, improving patient outcomes and aiding stroke rehabilitation.
Additionally, quicker intervention and enhanced recovery could contribute to reducing
the overall burden on healthcare costs.
For future research applications, further development of the NIRS device is needed,
particularly in the holder design, to enable quicker and easier attachment to the forehead
without requiring an additional headband for stability. While the device is already
wearable, future iterations will be smaller and lighter, enhancing usability and comfort
for extended measurements, such as in sleep research.
Development is also underway to make the NIRS device wireless and operable via mobile
software, further enhancing its usability. Future software improvements will focus on
increasing user-friendliness, reducing the need for extensive training, and making the
device more accessible for a wider range of users. Signal analysis could also be developed
to function in the cloud, enabling automated processing and rapid result delivery to users
mobile software. This would allow users to quickly access metrics such as the clearance
of the glymphatic system during sleep.
In my opinion, wearable NIRS technology has a promising future in healthcare and may
also have potential applications in consumer markets too.
64
12. References
At, İ., Ersunan, G., Blỉr, Ö., Yavaşỉ, Ö., Altunt, M., & Karakulluu, S. (2024). The
utility of NIRS in follow-up of patients with acute ischaemic stroke treated with IV
thrombolysis and mechanical thrombectomy in the emergency department. Journal of
Thrombosis and Thrombolysis, 57(3), 466-472.
Atula, S. (2019). Vaskulaarinen dementia (verenkiertopeinen muistisairaus).
Lääkärikirja Duodecim.
Ansado, J., Chasen, C., Bouchard, S., & Northoff, G. (2021). How brain imaging provides
predictive biomarkers for therapeutic success in the context of virtual reality cognitive
training. Neuroscience & Biobehavioral Reviews, 120, 583-594.
Banks CA, Bhama PK, Park J, Hadlock CR, Hadlock TA. Clinician-Graded Electronic
Facial Paralysis Assessment: The eFACE. Plast Reconstr Surg. 2015 Aug;136(2):223e-
230e. doi: 10.1097/PRS.0000000000001447. PMID: 26218397.
Berg, K. O., Wood-Dauphinee, S. L., Williams, J. I., & Gayton, D. (1989). Measuring
balance in the elderly: preliminary development of an instrument. Physiotherapy Canada,
41(6), 303311.
Biedrzycka, A., & Lango, R. (2016). Tissue oximetry in anaesthesia and intensive care.
Anaesthesiol Intensive Ther, 48(1), 41-8.
Chaudhary, U., Birbaumer, N., & Curado, M. R. (2015). Brain-machine interface (BMI)
in paralysis. Annals of physical and rehabilitation medicine, 58(1), 9-13.
Cheung, C. Y. L., Tay, W. T., Ikram, M. K., Ong, Y. T., De Silva, D. A., Chow, K. Y.,
& Wong, T. Y. (2013). Retinal microvascular changes and risk of stroke: the Singapore
Malay Eye Study. Stroke, 44(9), 2402-2408.
Çınarlu, O. S., Bora, E. S., Acar, H., Akan, C., Küçük, M., & Kık, S. (2024). Is near-
infrared spectroscopy a promising predictor for early intracranial hemorrhage diagnosis
in the Emergency Department?. Brazilian Journal of Medical and Biological Research,
57, e13155.
Crofts, A., Kelly, M. E., & Gibson, C. L. (2020). Imaging functional recovery following
ischemic stroke: clinical and preclinical fMRI studies. Journal of Neuroimaging, 30(1),
5-14.
DuoDecim. (n.d.). Akuutin aivoinfarktin kuvantaminen.
https://www.duodecimlehti.fi/duo92542
DuoDecim, Käypä Hoito. (2024). https://www.kaypahoito.fi/hoi50051#s18
Esteva, A., Chou, K., Yeung, S., Naik, N., Madani, A., Mottaghi, A., Liu, Y., Topol, E.
(2021) Deep learning-enabled medical computer vision. Npj Digital Medicine, 4(1):5.
Ferdinando, H., Moradi, S., Korhonen, V., Helakari, H., Kiviniemi, V., & Myllylä, T.
(2022). Spectral entropy provides separation between Alzheimers disease patients and
controls: a study of fNIRS. The European Physical Journal Special Topics, 1-8.
65
Files, B. (2011). An introduction to EEG. Perception
Gao, T., Liu, S., Wang, X., Liu, J., Li, Y., Tang, X., ... & Fan, Y. (2023). Stroke analysis
and recognition in functional near-infrared spectroscopy signals using machine learning
methods. Biomedical Optics Express, 14(8), 4246-4260.
Guo, X., & Dye, J. (2023). Modern Prehospital Screening Technology for Emergent
Neurovascular Disorders. Advanced Biology, 7(10), 2300174.
Hara, Y. (2015). Brain plasticity and rehabilitation in stroke patients. Journal of Nippon
Medical School, 82(1), 4-13.
Hevner, A. R. (2007). A three cycle view of design science research. Scandinavian
journal of information systems, 19(2), 4.
Huang, Y. H., Chen, W. Y., Liu, Y. H., Li, T. Y., Lin, C. P., Cheong, P. L., ... & Wu, C.
C. (2024). Mild cognitive impairment estimation based on functional nearinfrared
spectroscopy. Journal of Biophotonics, 17(1), e202300251.
Johnston, S. C., Rothwell, P. M., Nguyen-Huynh, M. N., Giles, M. F., Elkins, J. S.,
Bernstein, A. L., & Sidney, S. (2007). Validation and refinement of scores to predict very
early stroke risk after transient ischaemic attack. The Lancet, 369(9558), 283-292.
Juk, M., Siarnik, P., Valovičová, K., Karapin, P., Klobucnikova, K., Turčáni, E., &
Kollar, B. (2021). Cerebral blood flow in stroke patients with sleep apnea: any role of
single-night positive airway pressure therapy?. Neuroendocrinology Letters, 42(7).
Kallela, M., & Lindsberg, P. J. (2012). Miten erotan migreeniauran TIA-kohtauksesta?.
Duodecim, 128(9), 971-977.
Kato, K., Miyata, S., Ando, M., Matsuoka, H., Yasuma, F., Iwamoto, K., ... & Noda, A.
(2017). Influence of sleep duration on cortical oxygenation in elderly individuals.
Psychiatry and Clinical Neurosciences, 71(1), 44-51.
Katti, G., Ara, S. A., & Shireen, A. (2011). Magnetic resonance imaging (MRI)A
review. International journal of dental clinics, 3(1), 65-70.
Kiviniemi, V., Korhonen, V., Kortelainen, J., Rytky, S., Keinänen, T., Tuovinen, T., ... &
Alahuhta, S. (2017). Real-time monitoring of human blood-brain barrier disruption. PLoS
One, 12(3), e0174072.
Koyanagi, M., Yamada, M., Higashi, T., Mitsunaga, W., Moriuchi, T., & Tsujihata, M.
(2021). The usefulness of functional near-infrared spectroscopy for the assessment of
post-stroke depression. Frontiers in Human Neuroscience, 15, 680847.
Kumar, M. A., Vangala, H., Tong, D. C., Campbell, D. M., Balgude, A., Eyngorn, I., ...
& Albers, G. W. (2011). MRI guides diagnostic approach for ischaemic stroke. Journal
of Neurology, Neurosurgery & Psychiatry, 82(11), 1201-1205.
Kuriakose, D., & Xiao, Z. (2020). Pathophysiology and treatment of stroke: present status
and future perspectives. International journal of molecular sciences, 21(20), 7609.
66
Liedes H, Mattila J, Lingsma H, et al. Prediction of outcome after traumatic brain injury:
Comparison of disease state index and IMPACT calculator. In: Studies in Health
Technology and Informatics. Vol 224. IOS Press; 2016:175-180.
Li, Y., Ma, Y., Ma, S., Liang, Z., Xu, F., Tong, Y., ... & Li, X. (2020). Asymmetry of
peripheral vascular biomarkers in ischemic stroke patients, assessed using NIRS. Journal
of Biomedical Optics, 25(6), 065001-065001.
Liu, S., & Joines, S. (2012, September). Developing a framework of guiding interface
design for older adults. In Proceedings of the Human Factors and Ergonomics Society
Annual Meeting (Vol. 56, No. 1, pp. 1967-1971). Sage CA: Los Angeles, CA: SAGE
Publications.
London, A., Benhar, I., Schwarz, M. (2013) The retina as a window to the brain from
eye research to CNS disorders. Nat. Rev. Neurol, 9: 44-53.
Mattila, J., Koikkalainen, J., Virkki, A., Simonsen, A., van Gils, M., Waldemar, G.,
Lötjönen, J. (2011). A Disease State Fingerprint for Evaluation of Alzheimers Disease.
Journal of Alzheimer’s Disease, 27(1), 163176.
Meretoja, A., Kaste, M., Roine, R. O., Juntunen, M., Linna, M., Hillbom, M., ... &
Häkkinen, U. (2011). Direct costs of patients with stroke can be continuously monitored
on a national level: performance, effectiveness, and Costs of Treatment episodes in Stroke
(PERFECT Stroke) Database in Finland. Stroke, 42(7), 2007-2012.
Minoshima, S., Drzezga, A. E., Barthel, H., Bohnen, N., Djekidel, M., Lewis, D. H., ... &
Van Laere, K. (2016). SNMMI procedure standard/EANM practice guideline for amyloid
PET imaging of the brain 1.0. Journal of Nuclear Medicine, 57(8), 1316-1322.
Musen, M. A., Middleton, B., & Greenes, R. A. (2014). Clinical Decision-Support
Systems. In Biomedical Informatics (pp. 643674). London: Springer London.
Muehlschlegel, S., Selb, J., Patel, M., Diamond, S. G., Franceschini, M. A., Sorensen, A.
G., ... & Schwamm, L. H. (2009). Feasibility of NIRS in the neurointensive care unit: a
pilot study in stroke using physiological oscillations. Neurocritical care, 11(2), 288.
Myllylä, T., Harju, M., Korhonen, V., Bykov, A., Kiviniemi, V., & Meglinski, I. 2018.
Assessment of the dynamics of human glymphatic system by near‐infrared
spectroscopy.” Journal of biophotonics 11 (8).
Myllylä, T., Kaakinen, M., Vihriälä, E., Jukkola, J., Zhao, Z., Ferdinando, H., ... &
Eklund, L. (2020, May). Functional NIRS study of blood brain barrier disruption when
induced by focused ultrasound and intra-arterial mannitol infusion. In Tissue Optics and
Photonics (Vol. 11363, pp. 74-79). SPIE.
Naseer, N., & Hong, K. S. (2015). fNIRS-based brain-computer interfaces: a review.
Frontiers in human neuroscience, 9, 3.
Nielsen, J. (2005). Ten usability heuristics.
Nielsen, J., & Molich, R. (1990, March). Heuristic evaluation of user interfaces. In
Proceedings of the SIGCHI conference on Human factors in computing systems (pp. 249-
256).
67
Niziol R, Henry FP, Leckenby JI, Grobbelaar AO. 2015. Is there an ideal outcome scoring
system for facial reanimation surgery? A review of current methods and suggestions for
future publications. J Plast Reconstr Aesthet Surg. 2015 Apr;68(4):447-56. doi:
10.1016/j.bjps.2014.12.015. Epub 2014 Dec 24. PMID: 25589458.
Oinas-Kukkonen, H., & Harjumaa, M. (2009). Persuasive systems design: Key issues,
process model, and system features. Communications of the association for Information
Systems, 24(1), 28.
Olejniczak, P. (2006). Neurophysiologic basis of EEG. Journal of clinical
neurophysiology, 23(3), 186-189.
OpenNIRS Documentation (n.d.) OpenNIRS.org Modular open hardware for Near
InfraRed Spectroscopy. http://www.opennirs.org/documentation/
Orhii, P. D., Haque, M. E., Fujita, M., & Selvaraj, S. (2023). Advances in PET imaging
of ischemic stroke. Frontiers in Stroke, 1, 1093386.
Poplin, R., Varadarajan, A. V., Blumer, K., Liu, Y., McConnell, M. V., Corrado, G. S.,
Peng, L., Webster, D. R. (2018) Prediction of cardiovascular risk factors from retinal
fundus photographs via deep learning. Nat Biomed Eng. 2: 158-164.
Podsiadlo, D., & Richardson, S. (1991). The timed Up & Go”: a test of basic functional
mobility for frail elderly persons. Journal of the American Geriatrics Society, 39(2), 142
148
Rindler, R. S., Allen, J. W., Barrow, J. W., Pradilla, G., & Barrow, D. L. (2020).
Neuroimaging of intracerebral hemorrhage. Neurosurgery, 86(5), E414-E423.
Shneiderman, B., Plaisant, C., Cohen, M. S., Jacobs, S., Elmqvist, N., & Diakopoulos, N.
(2016). Designing the user interface: strategies for effective human-computer interaction.
Pearson.
Similä, Heidi, Milla Immonen, ja Miikka Ermes. 2017. Accelerometry-based
Assessment and Detection of Early Signs of Balance Deficits. Computers in Biology and
Medicine 85: 25-32.
Teplan, M. (2002). Fundamentals of EEG measurement. Measurement science review,
2(2), 1-11.
Thevenot J., Bordallo López M., Hadid A., (2017) A Survey on Computer Vision for
Assistive Medical Diagnosis from Faces, IEEE Journal of Biomedical and Health
Informatics
Thientunyakit, T., Shiratori, S., Ishii, K., & Gelovani, J. G. (2022). Molecular PET
imaging in Alzheimers disease. Journal of Medical and Biological Engineering, 42(3),
301-317.
Thomas, R., Shin, S. S., & Balu, R. (2023). Applications of near-infrared spectroscopy in
neurocritical care. Neurophotonics, 10(2), 023522-023522.
van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J. 1988 Interobserver
agreement for the assessment of handicap in stroke patients. Stroke. May;19(5):604-7.
68
Wilkinson, C. M., Burrell, J. I., Kuziek, J. W., Thirunavukkarasu, S., Buck, B. H., &
Mathewson, K. E. (2020). Predicting stroke severity with a 3-min recording from the
Muse portable EEG system for rapid diagnosis of stroke. Scientific Reports, 10(1), 18465.
Yew, K. S., & Cheng, E. M. (2015). Diagnosis of acute stroke. American family
physician, 91(8), 528-536.
Yu, M., Cai, T.,Huang, X., Wong, K., Volpi, J., Wang, J.Z., and Wong, S.T.C., 2020.
Toward Rapid Stroke Diagnosis with Multimodal Deep Learning, MICCAI 2020, LNCS
12263, pp. 616626.