Wearable Sensor Platform to Monitor Stroke Recovery During Inpatient Rehabilitation
Conditions: Stroke
Sponsor: Shirley Ryan AbilityLab

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PROTOCOL TITLE:  Wearable Sensor Platform to Monitor Stroke Recovery: A Clinical 
Exploratory Trial
PRINCIPAL INVESTIGATOR:
Arun Jayaraman, PT, PhD
Department of Physical Medicine & Rehabilitation
Northwestern University
Shirley Ryan AbilityLab
355 E. Erie St.
Chicago, IL 60611
Ph: (312) 238-6875
Fax: (312) 238-2081
Email: a-jayaraman@northwestern.edu
VERSION NUMBER: 5
VERSION DATE: 9/09/2022
 
1
OBJECTIVES:
Aim 1: Assess the feasibility of continuous long-term monitoring of patients with stroke using 
wearable sensors. 
We will obtain quantitative health data from research-grade, wireless, wearable 
sensors on individuals with subacute and chronic stroke in the clinical setting, as 
well as healthy controls. 
We will specifically check for variability in device data, as well as consistency and 
periodicity of sensor readings across the clinical study period. We will analyze 
test-retest reliability and inter-rater reliability of using the wearable sensor 
technology for clinical and monitoring applications. Furthermore, we will 
determine whether the sensors can distinguish biometric and activity 
characteristics between healthy controls and individuals with stroke.
Aim 2: Quantify upper and lower extremity movement impairments, mobility-related 
activities, speech and swallowing activities, and clinical parameters during stroke 
recovery.
We will obtain continuous biometric and movement-based sensor data for clinical 
symptoms (e.g., muscle activation, heart rate variability, talk time, gait quality, 
and balance) during the performance of validated clinical tests and during 
general clinical activities (e.g., therapy, eating, and sleeping). 
We will compare device data with clinically validated measures of movement and language 
function, such as the Modified Ashworth Scale or Western Aphasia Battery. We will describe 
variation of device data in subgroups of subjects defined by clinician assessed clinically 
validated measures (10-Meter Walk Test, Mini-Mental Status Exam, etc.). We will also assess 
the ability of the sensors to capture response to treatment, such as movement therapy, speech 
therapy, medication, and Botox by comparing sensor data before and after treatment. We will 
provide evidence about the degree to which the measured variables are intercorrelated. Lastly, 
we will evaluate and compare the state of recovery between patients at time of discharge using 
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sensor-based outcomes. Due to heterogeneity of clinical symptoms after stroke, as differing 
etiologies and degrees of recovery result in different types and levels of gait impairments, 
preliminary analyses may be performed on specific sub-datasets to determine which 
predictors, data types, and other data compositions affect algorithm performance before their 
application and evaluation on the dataset collected at the end of this study. Sub-datasets may 
be sampled based on (but not limited to) the population characteristics, the sensors used, the 
data available at the time analysis.
2
BACKGROUND:
Stroke affects more than 795,000 people per year in the United States. Stroke is a leading 
cause of long-term disability, reducing mobility and communication skills in more than half of 
survivors over age 65. Movement deficits are a hallmark of stroke, resulting from weakness or 
paralysis on one side of the body. Common outcomes of stroke are difficulty walking and 
reduced walking speed, difficulty using the affected upper arm, rigidity of the limbs, impaired 
balance, and impaired speech, language, and cognition. Improvements in these deficits are 
seen during acute recovery after stroke. Early clinical treatments, including physical 
rehabilitation and medication, aim to build on these improvements and return stroke patients to 
a certain level of function before hospital discharge. The length of stay in a hospital varies with 
severity of the stroke and the patient’s ability to function in the community. However, 
determining whether a patient has recovered sufficiently for discharge depends on measures 
that are subjective and imperfect.
Currently, the monitoring, treatment, and evaluation of stroke patients rely on infrequent clinical 
assessments, performance-based rehabilitation measures, and patient self-reports. 
Performance-based rehabilitation measures are limited by lack of sensitivity, reliability, and 
validity in identifying changes or clinical efficacy of treatment or recovery progression. The 
quality of patient-reported recovery is limited by recall and rater bias. Thus, there exists a strong 
need for objective, reliable, and continuous monitoring of stroke patients to assist clinicians and 
therapists make informed decisions about stroke treatment and recovery. 
Body-worn sensor technologies can continuously monitor individuals with stroke and allow 
clinicians and therapists to offer more customized interventions during clinical procedures. 
Specifically, a wireless sensing system enables quantitative measures of body function and 
activity, tracking biometric data and communication or mobility-related activities.
This project proposes continuous monitoring, quantification, and interpretation of recovery 
during clinical treatment of stroke using non-invasive, portable, real-time body-worn sensors. 
Clinicians and therapists would have customized access to a patient history of sensor-based 
biometric and activity data, allowing them to more fully measure recovery and assign treatment 
after stroke.
Recently, body-worn sensors (heart rate, galvanic skin response, IMUs, accelerometers, 
gyroscopes) have been used to monitor the function and activity or stroke survivors in a non-
systematic manner, either inside or outside a clinical setting. In the section below, we 
summarize the specific aspects of stroke already monitored in a limited population and present 
suggestions for other characteristics that can be monitored using continuous and advanced 
body sensors.
3
INCLUSION AND EXCLUSION CRITERIA:
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3.1
Inclusion Criteria
Patient group

Individuals diagnosed with stroke admitted to the Shirley Ryan AbilityLab 
(inpatient), or individuals in the community who had a stroke (chronic) 

Age 18 or older

Able and willing to give written consent and comply with study procedures
Healthy control group

Individuals without any known significant health problem (healthy controls)

Age 18 or older

Able and willing to give written consent and comply with study procedures
3.2
Exclusion Criteria
Patient group

Neurological degenerative pathologies as co-morbidities (such as multiple 
sclerosis, Alzheimer’s disease, Parkinson’s disease, etc.)

Pregnant or nursing

Skin allergies or irritation; open wounds

Utilizing a powered, implanted cardiac device for monitoring or supporting heart 
function (i.e. pacemaker, defibrillator, or LVAD)
Healthy control group

No known history of cerebrovascular accidents or neurological degenerative 
pathologies (such as multiple sclerosis, Alzheimer’s disease, Parkinson’s 
disease, etc.)

Pregnant or nursing

Skin allergies or irritation; open wounds

Utilizing a powered, implanted cardiac device for monitoring or supporting heart 
function (i.e. pacemaker, defibrillator, or LVAD)
4 STUDY-WIDE NUMBER OF PARTICIPANTS:
The exploratory phase of the study will enroll up to 100 subjects as healthy controls, assuming 
10% attrition. The study will enroll up to 400 subjects with subacute and chronic stroke for the 
clinical monitoring at the Shirley Ryan AbilityLab (SRAlab), assuming 50% attrition.
5 STUDY TIMELINES:
Inpatients with stroke will undergo up to four types of assessment (clinical, 
swallowing/speech, exercise, and sleep/rest) during inpatient stay, from the time of consent until 
discharge from the hospital or dropout from the study. Assessments will be completed a 
minimum of two times, including: (1) upon consent (surrounding admission to hospital), and 
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(2) at discharge. Assessments will be completed at additional times as schedules allow. 
Additional visits to monitor stroke recovery over time may be completed at 5 different time points 
following discharge from inpatient rehabilitation.
Individuals from the community who had a stroke and healthy controls will undergo up to three 
types of assessment (clinical, swallowing/speech, and exercise) during up to 5 laboratory 
visits (expected 2-3 hours). Additional visits may be necessary if technical issues arise or 
sensor technology changes. 
The assessments and their frequency for each cohort are as follows:
Assessment
# times 
(stroke)
# times 
(healthy)
Time required for each 
assessment
Clinical
2-10
5
1-2 hours
Swallowing/Speech
2-10
5
≤ 1 hour
Exercise
2-10
5
1 hour
Sleep and Rest
2-10
0
≤ 1 hours per day for rest, 
overnight for sleep (until wake)
Procedures for each assessment are described in Section 6.2 (individuals with stroke - 
inpatient) and 6.3 (chronic stroke and healthy controls).
6
PROCEDURES INVOLVED:
6.1 Overview and Scope
Sensors can collect the following data from healthy controls and patients with stroke:

Biometric data, including electrocardiography (ECG), electromyography (EMG), 
and sweat.

Movement data from the limbs, including signals from triaxial accelerometers 
(ACC), gyroscopes (GYR), and magnetometer (MAG).

Acoustomechanic laryngeal data to detect speech and swallowing events.
The sensors to be used will include commercial wearable devices as well as custom 
sensors designed by our collaborators, the John Rogers research group at 
Northwestern University. Both commercial and custom devices measure combinations 
of ACC, GYR, MAG, EMG, and ECG, ECG, while the custom sensors measure 
acoustomechanic laryngeal data and sweat.
Most of these sensorss have been previously validated against gold standard measures 
for healthy controls and individuals with stroke (Table 1). Thus, feasibility of inpatient 
monitoring (Aim 1) will focus on validating these sensors during common clinical tests 
and mobility-related activities for healthy controls and subjects with stroke. 
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Quantification of stroke recovery (Aim 2) will involve the development of algorithms to 
analyze sensor data for healthy and stroke cohorts.
Table 1. Validation of wearable sensors  (Commercial and custom sensors)
Sensor
Gold standard
Validation
Methods
EMG
(250-1000 Hz)
Delsys
(2000 Hz)
SRAlab: Pilot study – similar 
SNR during plantarflexion 
MVC for 1 healthy subject at 
gastrocnemius (GA). 
Qualitatively similar signal 
profile during 10MWT for 1 
healthy subject at tibialis 
anterior (TA). Temporal 
displacement of spikes 
possibly due to sensor’s non-
uniform sampling interval
SRAlab: In progress (data 
collected) – 9 healthy subjects 
and 8 with stroke
MVC, sensor 
at GA
10MWT, 
sensor at TA
ACC
(25-500 Hz)
Delsys 
(148.14 Hz)
SRAlab: Pilot study – at GA, 
good correlation with Delsys 
norms during 10MWT for 2 
subjects with stroke.
SRAlab: In progress (data 
collected) – 9 healthy subjects 
and 8 with stroke
10MWT, 
sensor at 
GA.
GYR
(25-500 Hz)
ActiLink GT3X
(100 Hz)
SRAlab: In progress (data 
collected) – 9 healthy subjects
No data for stroke (expected 
unnecessary: healthy subjects 
should be sufficient to validate 
angular velocity at same 
sampling frequency as GT3X) 
N/A
ECG
(250-1000 Hz)
Polar H7 heart 
rate monitor & 
V800 watch
(1000 Hz)
SRAlab: Pilot study – good 
agreement of pNN50 and 
RMSSD for 3 healthy subjects. 
SRAlab: In progress (data 
collected) – 9 healthy subjects 
and 8 with stroke
6MWT on 
treadmill 
(speed 
normalized 
for Fr=~0.16) 
Acoustomechanic 
Videofluoroscopic SRAlab: In progress (data 
N/A
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laryngeal sensors
measurement
collected on 5 healthy controls 
and 10 persons with aphasia)
6.2
Procedures for individuals with stroke (inpatient)
A. Enrollment, consent, test for exclusion criteria
Individuals with stroke admitted as inpatients to the Shirley Ryan AbilityLab or 
individuals who had a stroke will be asked to potentially enroll in the study. The study 
coordinator will assess eligibility based on inclusion criteria, obtain informed consent, 
and answer any questions from the participant.
Participants will complete a demographics and health intake form, by interview. This 
information will include: age, gender, race, and medical history. 
Prior to discharge, information will also be collected about the participant’s living and 
care in the community – for example, whether they will return to independent or 
assisted living, and whether they will have a full- or part-time caretaker. Because the 
anticipated support system for patients may affect readiness for discharge (e.g. 
someone with full time care would not need as much functional independence as 
someone living alone, and thus might be discharged earlier), we will be prepared to 
examine amount of recovery at discharge for subsets of the inpatient population 
related to community living and care. Participants in this group will also be offered to 
complete follow up clinical assessments at different time points following their stroke 
once they have discharged home. Up to 5 additional visit will be completed in a 
laboratory setting (sessions lasting 1-2 hours).
B. Sensor instrumentation
Participating individuals with stroke will wear different sensors for each assessment, 
including clinical, swallowing/speech, exercise, and sleep/rest. The sensor locations 
for each set are presented in the following sections.
For each sensor location, the skin will be prepped and cleaned using alcohol wipes. 
Some sensors are placed on the skin using adhesive stickers that minimize irritation. 
Medical dressing (Tegaderm, 3M) may also be used to ensure adhesion and proper 
contact with the skin. Following use, sensors will be cleaned with soap and water.
Others will be attached with Velcro straps at lower body including pelvis, thigh, shank 
and foot. Sensors and Velcro straps will be removed, cleaned, and relocated as 
needed for different activities in a given assessment.
Different commercial sensors might be used based on their commercial availability. At 
the current stage, the study will include two main technologies for motion capture, 
namely Xsens system and BionicPro system. 
Xsens Technologies B.V. (or Xsens) is a supplier of 3D motion capture products and 
inertial sensors based upon miniature MEMS inertial sensor technology. The 
company has created intellectual property in the field of multi-sensor data fusion 
algorithms, combining inertial sensors with aiding technologies such as GPS, Motion 
capture and biomechanical modeling. The Xsens MVN inertial motion capture system 
is an easy to use, cost efficient system for full-body human motion capture. MVN is 
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based on Xsens' miniature inertial sensors and wireless communication solutions 
combined with advanced sensor fusion algorithms, using assumptions of 
biomechanical models. The MVN system is a full body inertial kinematic 
measurement system, incorporating synchronized video data. Instant graphical output 
is provided, including joint angles. 
BionicPro system is a set of MEMS inertial sensors commercialized by Ottobock to 
measure and evaluate the motion of the lower limbs. The data collected by the 
sensors are elaborated by a base station and displayed on the graphical user 
interface. The sensors are placed on the pelvis, thighs, shanks and feet by means of 
clips and staps whose length can be adjusted based on the user’s anthropometries. 
BionicPro sensors measure the acceleration, the angular speed, and the magnetic 
field of the sensor, and compute information such as the pose of the limbs, the joint 
angles, the temporal parameters of the gaits.
The battery life of each sensor will depend on which signal modalities are activated 
for that sensor (e.g. ACC only: 8-35 hours, ACC+GYR: 2-4 hours, ACC+EMG: 11 
hours). We will maintain an approximate sensor charging schedule for each 
participant to facilitate assessment. Research staff and clinical staff will be recruited to 
assist with sensor charging as needed.
C. Clinical assessments
Clinical assessment will monitor patients during various clinical tests. Sensors will 
measure vital signs as well as movement and muscle activation in the upper and 
lower limbs. Sensor placement for these assessments is depicted in Figure 1:
Figure 1: Possible locations of sensor placement for patient clinical assessment
Sensor 
Type
Location
Modalities
Purpose
Clinical test
a
Left parasternal 
and mid-
ECG
Heart rate 
during/after 
All
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clavicular line, 
Left parasternal 
line, Left mid-
axillary line
test
b
Pelvis, 
Wrists, Ankles, 
Foot (bilateral) 
ACC+GYR+MAG
Movement 
detection, 
activity 
recognition
10MWT, 
6MWT, TUG, 
gait analysis, 
FIM
Muscle 
activation 
(spasticity 
detection) 
MAS
Tibialis anterior, 
Hamstring, 
Rectus femoris 
(bilateral)
EMG+ACC or 
ACC+GYR+MAG
Joint angles of 
knee during 
walking, 
postural sway 
during 
standing
10MWT, 
6MWT, TUG, 
gait analysis, 
BBS, FIM
c
Biceps brachii 
(bilateral)
EMG+ACC
Muscle 
activation
MMT, ARAT, 
FIM
d
Hip (bilateral)
ACC (Hip)
Joint angles of 
hip during 
walking
10MWT, 
6MWT, TUG, 
gait analysis, 
FIM
Participants will perform a series of common clinical tests that are used to evaluate 
functional performance after stroke. Clinical tests may include any of the following:
1.
Modified Ashworth Scale (MAS)
2.
10-Meter Walk Test (10MWT)
3.
6-Minute Walk Test with or without VO2 analysis (6MWT)
4.
Berg Balance Scale (BBS)
5.
Functional Gait Assessment (FGA)
6.
Quality Indicators (QI)
7.
Timed Up and Go (TUG)
8.
Manual Muscle Test (MMT)
9.
Action Research Arm Test (ARAT)
10. Gait analysis using GaitRite: self-selected and slow and fast walking speeds (3 
trials each)
All tests will be performed by a licensed physical therapist or occupational therapist. 
Therapist-reported outcomes for each test will be recorded separately. The participant 
will be given rest breaks as needed between tests to minimize fatigue. Therapist 
assistance and body-weight support will be provided as needed.
Research staff will be responsible for all sensor recording practices, such as 
instrumenting the sensors and marking therapy activities on a computer/tablet. 
Research staff will also keep a written log of activities as they are undertaken during 
the assessments, including notable events, amount and type of assistance, or use of 
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external devices. Logs will be consulted during analysis to compare with the 
timestamped sensor data. 
D. Swallowing/Speech assessment
Swallowing/Speech assessment will monitor patients’ swallow behavior during 
mealtimes, swallow behavior during bedside/videofluoroscopic swallow assessment, 
and speech behavior during speech and language therapy. All tests will be performed 
by a licensed speech-language pathologist, with assistance from research staff.
One to three custom acoustomechanic sensors (Rogers research group) will be 
placed as shown in Figure 2. The acoustomechanic sensors will be paired to a 
research smartphone to record all data from the devices.
Figure 2: Acoustomechanic sensor placement (bilateral to the 
hyolaryngeal complex, and/or at midline) for swallowing assessment
To measure swallowing during eating, sensors will be placed at least 15 minutes 
before scheduled mealtime. The participant will then be asked to eat their meal. 
During the meal, research staff will observe behavior and time stamp the swallowing 
events associated with eating. Additional observations will be made of coughs, 
wheezes, or gurgling noises. After the meal, research staff will observe the participant 
for at least 15 minutes afterward.
To measure swallowing during bedside or videofluoroscopic analysis, sensors will be 
placed immediately prior to the measurement. The videofluoroscopic swallow 
assessment will be performed only on those stroke patients for whom it is standard of 
care. Videofluoroscopic analysis is a radiologic examination of swallowing function 
that uses a special movie-type x-ray called fluoroscopy. The patient is observed 
swallowing various consistencies of barium-coated liquids and solid foods, in order to 
evaluate the ability to swallow safely and effectively. (Because this exam is part of the 
standard of care, a Radiation Dosimetry Form is not needed). Research staff will 
observe behavior and time stamp the swallowing events, coughs, wheezes, or 
gurgling noises for the acoustomechanic sensor throughout analysis.
To measure speech, sensors will be placed immediately prior to the patient’s 
scheduled speech and language (SL) therapy. The sensor will monitor laryngeal 
activity during common SL exercises and during testing with the Western Aphasia 
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Battery-Revised (WAB-R). The Aphasia Quotient (AQ) of the WAB-R provides an 
overall quantitative metric of aphasia severity that is based on auditory 
comprehension and oral expression skills. Tasks of the AQ include naming pictures, 
repeating words and sentences, reading words and sentences aloud, describing 
pictures, and having a conversation.
 
E. Exercise assessment
Exercise assessment will monitor patients during various types of scheduled therapy, 
including occupational therapy (OT), gait therapy (i.e. treadmill training and 
overground walking), and other prevalent exercises undertaken during therapy. 
Sensors will measure vital signs as well as movement and muscle activity in the 
upper and lower limbs. Sensor placement for this assessment, depending on the 
therapy type, is depicted in Figure 3.
Figure 3: Possible locations of sensor placement for patient exercise assessment
Sensor 
Type
Location
Modalities
Purpose
Therapy Type
a
Left 
parasternal 
and mid-
clavicular line, 
Left 
parasternal 
line, Left mid-
axillary line
ECG
Heart rate 
during/after 
exercise, % 
time in target 
HR range 
during therapy 
(from Tanaka 
formula)
All
b
Pelvis, 
Wrists, Ankles, 
Foot (bilateral) 
ACC+GYR+MAG
Movement 
detection, 
activity 
recognition
All 
c
Tibialis 
anterior, 
EMG+ACC or 
ACC+GYR+MAG
Muscle 
activation 
Gait Therapy, 
Other
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(spasticity 
detection) 
Hamstring, 
Rectus 
femoris 
(bilateral)
Joint angles of 
knee during 
walking, 
postural sway 
during standing
Gait Therapy, 
Other
Biceps brachii 
(bilateral)
EMG+ACC
Muscle 
activation
Occupational 
Therapy, Other
d
Hip (bilateral)
ACC (Hip)
Joint angles of 
hip during 
walking
Gait Therapy, 
Other
Sweat
Forehead 
(bilateral)
Sweat 
microfluidics
Sweat rate, pH, 
concentrations 
of chloride, 
glucose, lactate
Gait Therapy
All exercises will be supervised by a clinician or therapist and will be recorded as they 
occur during a regular therapy session. Types of exercises recorded during each type 
of therapy may include, but are not limited to:

Occupational Therapy: Box and Blocks, 9-Hole Peg Test

Gait Therapy: Treadmill Training, overground walking, and balance. Patients’ 
Ratings of Perceived Exertion will be recorded immediately after each 
exercise.Gait analysis provides a quantitative means of assessing walking 
function based on spatiotemporal parameters of gait. Subjects walk at a 
comfortable and fast pace on the GaitRite® system, an electronic walkway 
with integrated sensors. Data from GaitRite® is considered reliable and valid 
for evaluating walking characteristics and will provide a gold standard for 
validating gait parameters obtained from the wearable sensors. For gait 
analysis, we will focus on 5 parameters: stride time, swing time, stance time, 
step length, and cadence. 

Other Exercises: such as stair climbing or upper/lower limb cycling. Relevant 
sensors will be used from Fig. 3C.
We will also record 10 minutes of quiet rest before exercise and 10 minutes of rest 
after exercise, as permitted by the structure of the therapy session. Pilot testing with 
the physiological sensors has shown that 10 minutes is sufficient to capture recovery 
(i.e. return to resting heart rate) following exercise for individuals with stroke.
Research staff will be responsible for all sensor recording practices, such as 
instrumenting the sensors and marking therapy activities on a computer. Research 
staff will also keep a written log of activities as they are undertaken during the 
assessments, including notable events, amount and type of assistance, or use of 
external devices. Logs will be consulted during analysis to compare with the 
timestamped sensor data. 
F. Sleep and Rest assessment
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Sleep and rest assessment will monitor patients during overnight sleep and during 
wakeful rest in their rooms. Sensors will measure vital signs and movement in the 
upper and lower limbs. Sensor placement for this assessment is depicted in Figure 4. 
Figure 4: Possible locations of sensor placement for inpatient sleep and rest 
assessment
Sensor 
Type
Location
Modalities
Purpose
Assessment
a
Left parasternal 
and mid-
clavicular line, 
Left parasternal 
line, Left mid-
axillary line
ECG
Heart rate (and 
variability), 
abnormalities (i.e. 
ectopy rate)
Sleep,
Rest
Movement detection, 
light exposure to 
evaluate sleep 
events and quality
Sleep
b
Wrists 
(bilateral)
ACC+GYR, 
Actigraphy
Movement detection, 
activity recognition
Rest
c
Hands, feet 
(bilateral)
Forehead, 
thigh, 
intraclavicular 
region, 
stomach
Skin 
temperature
Skin temperature to 
evaluate sleep 
events and quality
Sleep
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Research staff may record continuous sensor data for various rest-related activities, 
such as sitting or moving in a wheelchair, for use in activity recognition models.
Clinicians will log sleep and movement events as noticed during their usual patient 
rounds. After assessment, they will also ask the patient for information about bedtime, 
wake-up time, total sleep time, sleep latency, wake after sleep onset, naps, any 
unusual events during the day or night, and rating of overall sleep quality, recording 
as much information as is communicable by the patient. Logs will be consulted during 
analysis to compare with the timestamped sensor data.
6.3 Procedures for Individuals from the community who had a stroke (chronic) and 
healthy controls 
A. Enrollment, consent, test for exclusion criteria 
Potential subjects will visit the Shirley Ryan AbilityLab. The study coordinator will 
assess eligibility based on inclusion criteria, obtain informed consent, and answer any 
questions from the subject.
Participants will complete a demographics and health intake form, by interview or self-
report. This information will include: age, gender, race, and medical history.
B. Sensor instrumentation
Sensors will be used for clinical and exercise assessments. These sensors will be 
placed after obtaining informed consent, at the locations depicted in Figure 5. 
Additional sensors may be placed for swallowing assessment, as depicted in Figure 2 
and described in 6.2.D.
 
Figure 5: Possible locations of sensor placement for clinical and exercise assessment 
in healthy controls
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Sensor 
Type
Location
Modalities
Purpose
Assessment
a
Left 
parasternal 
and mid-
clavicular line, 
Left 
parasternal 
line, Left mid-
axillary line
ECG
Heart rate 
during/after 
exercise
Exercise
b
Pelvis, 
Wrists, Ankles, 
Foot (bilateral)
ACC+GYR+MAG
Movement 
detection, 
activity 
recognition, 
stride time, 
swing time, 
stance time, 
cadence, step 
count
Clinical 
(10MWT, 
6MWT, TUG, 
gait analysis), 
Exercise 
Muscle 
activation 
(spasticity 
detection) 
Clinical (MAS), 
Exercise, FMA
Tibialis 
anterior, 
Hamstring, 
Rectus femoris 
(bilateral)
EMG+ACC or 
ACC+GYR+MAG
Joint angles of 
knee during 
walking, 
postural sway 
during standing
Clinical 
(10MWT, 
6MWT, TUG, 
gait analysis, 
BBS), Exercise, 
FMA
c
Biceps brachii 
(bilateral)
EMG+ACC
Muscle 
activation
Clinical (MMT), 
Exercise, FMA
d
Hip (bilateral)
ACC (Hip)
Joint angles of 
hip during 
walking
Clinical 
(10MWT, 
6MWT, TUG, 
gait analysis), 
Exercise
Sweat
Forehead 
(bilateral)
Sweat 
microfluidics
Sweat rate, pH, 
concentrations 
of chloride, 
glucose, lactate
Exercise
For each sensor location, the skin will be prepped and cleaned using alcohol wipes. 
Some sensors are placed on the skin using adhesive stickers that minimize irritation. 
Medical dressing (Tegaderm, 3M) may also be used to ensure adhesion and proper 
contact with the skin. Following use, sensors will be cleaned with soap and water.
Others will be attached with Velcro straps at lower body including pelvis, thigh, shank 
and foot. Sensors and Velcro straps will be removed, cleaned, and relocated as 
needed for different activities in a given assessment.
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Different commercial sensors might be used based on their commercial availability. At 
the current stage, the study will include two main technologies for motion capture, 
namely Xsens system and BionicPro system. 
Xsens Technologies B.V. (or Xsens) is a supplier of 3D motion capture products and 
inertial sensors based upon miniature MEMS inertial sensor technology. The 
company has created intellectual property in the field of multi-sensor data fusion 
algorithms, combining inertial sensors with aiding technologies such as GPS, Motion 
capture and biomechanical modeling. The Xsens MVN inertial motion capture system 
is an easy to use, cost efficient system for full-body human motion capture. MVN is 
based on Xsens' miniature inertial sensors and wireless communication solutions 
combined with advanced sensor fusion algorithms, using assumptions of 
biomechanical models. The MVN system is a full body inertial kinematic 
measurement system, incorporating synchronized video data. Instant graphical output 
is provided, including joint angles. 
BionicPro system is a set of MEMS inertial sensors commercialized by Ottobock to 
measure and evaluate the motion of the lower limbs. The data collected by the 
sensors are elaborated by a base station and displayed on the graphical user 
interface. The sensors are placed on the pelvis, thighs, shanks and feet by means of 
clips and staps whose length can be adjusted based on the user’s anthropometries. 
BionicPro sensors measure the acceleration, the angular speed, and the magnetic 
field of the sensor, and compute information such as the pose of the limbs, the joint 
angles, the temporal parameters of the gaits.
The battery life of each sensor will depend on which signal modalities are activated 
for that sensor (e.g. ACC only: 8-35 hours, ACC+GYR: 2-4 hours, ACC+EMG: 11 
hours). We will maintain an approximate sensor charging schedule for each 
participant to facilitate assessment. Research staff and clinical staff will be recruited to 
assist with sensor charging as needed.
C. Clinical assessments
Once instrumented, the participant will complete a battery of clinical tests, which may 
include any of the following:
1.
Modified Ashworth Scale (MAS)
2.
10-Meter Walk Test (10MWT)
3.
6-Minute Walk Test with VO2 analysis (6MWT)
4.
Berg Balance Scale (BBS)
5.
Functional Gait Assessment (FGA)
6.
Quality Indicators (QI)
7.
Timed Up and Go (TUG)
8.
Manual Muscle Test (MMT)
9.
Action Research Arm Test (ARAT)
10. Gait analysis using GaitRite: self-selected and slow and fast walking 
speeds (3 trials each)
All other procedures for this assessment are the same as that for inpatients, 
described in section 6.2.C. 
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D. Swallowing/Speech assessment
Swallowing may be assessed in this laboratory visit, during a break from physical 
activities. Participants will be asked to complete oral facial movements and swallow a 
variety of food consistencies and a beverage. Participants may also be engaged in a 
brief (5-minute) conversation about an established topic to provide a representative 
sample of their typical language. Procedures for sensor use during this assessment 
are the same as that for inpatients, described in section 6.2.D.
E. Exercise assessment
Healthy participants and chronic stroke will perform physical exercises during this 
laboratory visit to measure heart rate during comfortable exercise and during 
recovery. We will continuously record sensor data for each of the following exercises:
1.
Walking on a treadmill (up to 45 minutes)
2.
Overground walking (up to 20 minutes)
3.
Balance (up to 10 minutes)
4.
Walking up and down stairs (up to 10 minutes)
5.
Cycling (lower limbs, up to 10 minutes
We will also record 10 minutes of quiet rest before the exercise and 10 minutes of rest 
after the exercise. For each exercise, participants will be asked to move at a 
comfortable pace. All other procedures for this assessment are the same as that for 
inpatients, described in section 6.2.E. 
6.4
Description of clinical assessments

Modified Ashworth Scale (MAS): The MAS is a 6-point ordinal scale used to grade 
the amount of hypertonicity in individuals with neurological diagnoses. A score of 0 
on the scale indicates no increase in tone while a score of 4 indicates rigidity. Tone 
is scored by passively moving the individual’s limb and assessing the amount of 
resistance to movement felt by the examiner.

10-Meter Walk Test (10MWT): The 10MWT is a common clinical measure of gait 
speed. Subjects will be directed to walk at their preferred maximum but safe 
speed. Subjects will be positioned 1 meter before the start line and instructed to 
walk the entire 10-meter distance and past the end line approximately 1 meter. 
The distance before and after the course are meant to minimize the effect of 
acceleration and deceleration. Time will be recorded using a stopwatch and 
recorded to the one hundredth of a second (ex: 2.15 sec). The test will be 
recorded 3 times, with adequate rest in between. The average of the 3 times 
should be recorded.

6-Minute Walk Test with VO2 analysis (6MWT): The 6MWT measures the 
distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, 
using assistive devices, as necessary. The test is a reliable and valid evaluation of 
functional exercise capacity and is used as a sub-maximal test of aerobic capacity 
and endurance. The minimal detectable change in distance for people with sub-
acute stroke is 60.98 meters. The test is self-paced and assesses the level of 
functional capacity. Subjects are allowed to stop and rest during the test, however, 
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the timer does not stop. If the subject is unable to complete the time, the time 
stopped is noted and reason for stopping prematurely is recorded. This test may be 
administered while wearing a mask to measure oxygen consumption. 

Berg Balance Scale (BBS): The BBS is a 14-item test, scored on a 5-level ordinal 
scale. It is used to measure functional balance in a clinical setting and includes 
static and dynamic tasks (such as sitting, standing, transitioning from sitting to 
standing, standing on one foot, retrieving an object from the floor), during which 
subjects must maintain their balance. 

Functional Gait Assessment (FGA): The FGA is a 10-item test for assessing 
postural stability during various walking tasks. It includes 7 of the 8 items from the 
original Dynamic Gait Index, and 3 new items, including “gait with narrow base of 
support,” “ambulating backwards,” and “gait with eyes closed.” The FGA 
demonstrates excellent concurrent validity with the Berg Balance Scale for 
individuals with strokei. The maximum score is 30 points; minimal detectable 
change for chronic stroke is 4.2 pointsii.

Timed Up and Go (TUG): The TUG assesses mobility by measuring the time that 
a person takes to rise from a chair, walk three meters, turn around, walk back to the 
chair, and sit down. During the test, the subject is expected to wear their regular 
footwear and use any mobility aids that they would normally require.

Quality Indicator (QI) :QI will be done on admission, and weekly until discharge 
(mean stay 23 days for stroke patients). The QI evaluates level of disability, and 
how much assistance is needed for a subject to perform certain activities of daily 
living.iii,iv Each item is scored ranging from total assistance to total independence. 
Items include eating, grooming, bathing, dressing, toileting, bladder/bowel 
management, transfers, locomotion and stairs, comprehension, etc.

Manual Muscle Test (MMT): The MMT is a procedure for evaluating the strength 
of 16 individual muscles relative to gravity and manual resistance. Instructions are 
provided to the subject before testing each muscle. A muscle is isolated, and 
gradual external force is applied at a right angle to the muscle’s long axis. Each 
muscle is scored on a graded scale of “weak” to “strong” based on the subject’s 
ability to resist the external force. The test is first completed for muscles on the 
unimpaired side to determine normal strength before being repeated on the 
impaired side. Weaker subjects may be tested while lying prone (gravity 
eliminated).

Action Research Arm Test (ARAT): The ARAT is a 19-item test, scored on a 4-
point ordinal scale. It is used to assess upper limb function and is divided into four 
subtests: grasp, grip, pinch, and gross movement. The subject picks up various 
items (wooden block, ball, stone, tube, marble, ball bearing) and is scored on ability 
to do so.

Fugl-Meyer Assessment (FMA): The FMA is a performance-based impairment 
index designed to assess motor functioning, balance, sensation and joint 
functioning in hemiplegia stroke patients. These domains are assessed on a 3-
point ordinal scale from 0-2. “0” is equal to “cannot perform”, “1” is equal to 
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“performs partially”, and “2” is equal to “performs fully.” The domains for upper 
extremity and lower extremity motor function will be used.

Gait analysis: Subjects walk at a comfortable and fast pace on the GaitRite® 
system, an electronic walkway with integrated sensors. Data from GaitRite® is 
considered reliable and valid for evaluating walking characteristics and will provide 
a gold standard for validating gait parameters obtained from the wearable 
sensors. For gait analysis, we will focus on 5 parameters: stride time, swing time, 
stance time, step length, and cadence.
7
DATA COLLECTION AND ANALYSIS
Healthy controls and individuals with stroke will be instrumented with wireless sensors. Data 
from participants will be collected to validate sensor signals and clinical outcomes. Data from 
inpatients will be collected during hospital stay, including clinical, swallowing, exercise, and 
sleep/rest assessments. For all subjects, biometric information will be derived using sensor-
based electrocardiography, electromyography, and accelerometry. Movement of the upper and 
lower limbs will be detected as changes in the acceleration, gyroscope, and magnetometer 
values in three axes. Speech and swallowing activities will be detected as changes in the 
acoustical waveform obtained from the laryngeal sensor. Clinical scores and therapist 
evaluations will be incorporated to further validate sensor-based outcomes and map these 
outcomes onto traditional measures of stroke recovery.
The complete medical history of the inpatients, including physical findings, radiological reports 
such lesion size, location, type, medications and therapist-assessed clinical outcomes may be 
used to associate with biometric and movement obtained from the wearable sensors.
Subjects’ records will be kept completely confidential. Data will be collected and kept 
confidential and compliant with HIPPAA requirements. Research data will be de-identified and 
stored in locked cabinets in the lab with access only to research staff. Electronic data will be de-
identified and kept on secure, password protected files and password protected computers (see 
Sec. 7 for details).
We will use kinematic models to estimate gait-based parameters (such as step duration or joint 
angles) and physiological models to estimate cardiac parameters (such as MET intensities or 
time in target heart rate zone). We will use machine learning techniques for activity recognition, 
classifying different mobility-related activities (such as walking or stair use). We will also use 
traditional multiple correlation and regression analysis to identify associations of clinical 
outcomes with measures of body structure and function, activity limitations and demographic 
characteristics. Analysis will be performed in subsets of the stroke cohort and also in 
comparison with the healthy controls. This will guide us the ability to create clinical predictors for 
recovery following stroke and measure the state of recovery prior to hospital discharge.
8
DATA STORAGE
Keeping the confidentiality of all data collected through this study is paramount and we will 
devise numerous procedures to ensure the privacy of the participants.
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Data will be de-identified and cannot be linked to subjects. Upon completion of data collection 
phase of the study, all data will be transferred to internal servers and only accessible to 
research staff.
Data from additional sensors, such as sweat sensors and acoustomechanical sensors to assess 
swallowing/speech, will also be de-identified and stored on internal servers only. This data will 
also be accessible to the John Rogers research group.
Access to data on internal servers is highly restricted by the following measures:

Firewalls and other digital security measures

Written protocols and permission systems that require those who can have access to 
understand how they can use the data, where they can use it, and training in the 
procedures for handling such data

Identifiers will be used as keys allowing researchers to link information on an as-needed 
basis
 
The database server used for long-term storage will only be visible to the SRAlab network.
9
DATA AND SPECIMEN MANAGEMENT:
We will use kinematic models to estimate gait-based parameters (such as step duration or joint 
angles) and physiological models to estimate cardiac parameters (such as MET intensities or 
time in target heart rate zone). We will use machine learning techniques for activity recognition, 
classifying different mobility-related activities (such as walking or stair use) and 
swallowing/speech events. We will also use traditional multiple correlation and regression 
analysis to identify associations of clinical outcomes with measures of body structure and 
function, activity limitations and demographic characteristics. Analysis will be performed in 
subsets of the stroke cohort and also in comparison with the healthy controls. This will guide us 
the ability to create clinical predictors for recovery following stroke and measure the state of 
recovery prior to hospital discharge.
10 WITHDRAWAL OF PARTICIPANTS:
Subjects will be withdrawn from the study in the event of a medical event or complication that 
may alter the inclusion/exclusion criteria or which limits the patient from safely completing the 
remainder of the study, or at the discretion of the PI.  
Subjects can voluntarily discontinue the study at any time. The participant will then be 
requested to notify the Principal Investigator, Dr. Arun Jayaraman, in writing or call at 312-
238-6875, if assistance is needed in this process. Information collected prior to the study 
discontinuation by a participant may still be used by the research team.  
The researchers reserve the right to discontinue study participation for any individual or for 
the study as a whole at their discretion.
11 RISKS TO PARTICIPANTS:
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All testing and training sessions will be under supervision of a trained researcher.  Manual 
assistance or cueing will be provided as necessary for safety and balance.  Vital signs will be 
monitored before and after physical exertion and during activities, as needed.  All subjects will 
be permitted to stop physical activity or rest at any time during the study. 

There is a risk of muscle soreness due to increased physical activity during 
testing sessions. All subjects will work with trained therapists and researchers. 
Adequate rest will be given and subjects will be monitored by the therapist for 
verbal or visual signs of fatigue or discomfort.

There is a risk of falling during testing. The risk of falling will be reduced by 
having each participant supervised during training and testing by a trained 
researcher proficient in all testing procedures. During testing, the participant will 
use a gait belt for safety. The risk is similar to that during any clinical inpatient 
outpatient therapy session.

There is a risk of irritation to the skin from device wear. This risk will be reduced 
by minimized by excluding people who have a known allergy and discontinued 
use if skin irritation occurs. 

Risks associated with swallowing and speech activities are the same as those 
associated with routine standard of care. Participants may experience difficulties 
swallowing or choking during mealtimes. There may also be frustration if speech 
tasks are deemed too difficult. Trained therapists will be present for all 
swallow/speech tasks, and participants will be given frequent rest breaks as 
needed.  
12 POTENTIAL BENEFITS TO PARTICIPANTS:
There will likely be no direct benefit by participating in this research study. The participants 
might get some information on the state of their clinical symptoms over an extended time 
period. The long-term goal of this research is to improve the ability to quantify symptoms 
of stroke and look at the impact of novel therapeutic interventions during the in/outpatient 
stay. This benefit could lead to better treatments in the future. 
13 SETTING:
Location: The study will occur at the Shirley Ryan AbilityLab, 355 E. Erie Street, Chicago IL 
60611 in room 11-1401 or in the Ability Labs on inpatient units.
14 RESOURCES AVAILABLE:
Experienced and trained therapists will be leading all training sessions and providing 
assistance as needed for safety. Each staff member involved in the study will be trained on the 
protocol and procedures by the study coordinator. 
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All staff assisting with training are employees or interns of the Shirley Ryan AbilityLab therefore 
are familiar with the study site and are experienced with the study population.
The Shirley Ryan AbilityLab is an acute inpatient rehabilitation hospital. The 24th floor is one of 
the floors within the rehabilitation hospital in which patients with a diagnosis of a stroke are 
likely to be admitted. This unit has 27 beds. Of those beds, on average approximately 25-40% 
can meet the inclusion criteria at a given time. The study will occur in the Ability Labs on the 
floor in which they are staying or in room 11-1402.
There will be medical resources including a resident on call and nursing staff available 24 
hours a day if needed in case of an emergency. 
15 RECRUITMENT METHODS:
This study will involve recruitment of individuals with CVA from the in/outpatient units and the 
Clinical Research Registry (CRR) at the Shirley Ryan AbilityLab (SRAlab). CRR is a non-public 
database which will be used for recruitment purposes. Clinicians at this location will be informed 
of the inclusion and exclusion criteria for this study in order to refer appropriate subjects. 
Information regarding this study will be posted on SRAlab’s available research studies 
webpage. Potential research subjects will be referred to, and evaluated by, authorized research 
personnel. Potential research subjects will be identified based on inclusion and exclusion criteria 
using the Cerner application. After identification of subject based on inclusion and exclusion 
criteria, a verbal permission from the patient will be obtained to request medical clearance from 
their physician. 
16 NUMBER OF LOCAL PARTICIPANTS:
The exploratory phase of the study will enroll up to 100 subjects as healthy controls, assuming 
10% attrition. The study will enroll up to 300 subjects with subacute and chronic stroke for the 
inpatient monitoring at the Shirley Ryan AbilityLab, assuming 50% attrition.
17 CONFIDENTIALITY:
All personal information (names, addresses, email or phone numbers, etc.) gathered for this 
study that can identify participants will be kept secure to protect their privacy and will never be 
shared at any time with any person or entity. Data collected during the study and shared with 
others will reference participants only by an alphanumeric code. The “master list” linking 
personal information to the alphanumeric code will not be shared, and will be kept by the study 
PI in a secure location. All personal information linking participants to their data will be 
destroyed after 7 years following the completion of the study.
18 PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF PARTICIPANTS:
Every possible precaution will be taken to protect the privacy interests of subjects. To begin 
with, participation in this study is completely voluntary. Trained research personnel will explain 
the purpose of the study and intended use of subject’s personal health information and 
precautions taken to keep the study information and data confidential.
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19 COMPENSATION FOR RESEARCH-RELATED INJURY:
If the subject gets an injury or illness as a result of study, the subject is required to promptly 
notify the PI of the study about the illness or injury. The hospital [Researchers, Shirley Ryan 
AbilityLab, Northwestern University and all affiliated clinical sites] will not pay for medical care 
required because of a bad outcome resulting from participation in this research study. However, 
this does not keep subject from seeking to be paid back for care required because of a bad 
outcome.
20 ECONOMIC BURDEN TO PARTICIPANTS:
The subjects will receive compensation for their participation in this study. Inpatients will be paid 
$50 for completing initial assessments (i.e., surrounding hospital admission) and an additional 
$50 for completing assessments at discharge. Individuals in the chronic stroke and healthy 
control groups will be paid $40 for each visit. 
21 CONSENT PROCESS:
Before recruitment and enrollment onto this study, the patient will be given a full explanation of 
the study and will be given the opportunity to review the consent form. Each consent form must 
include all the relevant elements as approved by the Northwestern University Institutional 
Review Board. Once this essential information has been provided to the patient and the 
investigator is assured that the patient understands the implications of participating in the study, 
the patient will be asked to give consent to participate in the study by signing an IRB-approved 
consent form. Subjects will be consented with a new consent form if changes are made to the 
protocol. 
Prior to a patient’s participation in the trial, the written informed consent form must be signed 
and personally dated by the patient and by the person who conducted the informed consent 
discussion. The consent process will take place at the Shirley Ryan AbilityLab in Room 11-1401 
or on the inpatient floor. 
Non-English Speaking Subjects
Non-English speaking subjects will be permissible for recruitment and enrollment in the 
study. 
If subjects who do not speak English are recruited, all study written and oral communication 
will be conducted in subjects’ native language with the use of an interpreter.
22 PROCESS TO DOCUMENT CONSENT IN WRITING:
Informed consent will take place at Shirley Ryan AbilityLab in 11-1402 or on the inpatient floor 
with authorized study personnel. 
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Trained research personnel will guide the subject through consenting process. Subject will be 
given detailed explanation of the purpose, time line, commitment, procedures, data handling 
and privacy and confidentiality of information pertaining to the study.
23 DRUGS OR DEVICES:
The purpose of the study is NOT to evaluate the safety and effectiveness of devices or to seek 
premarket approval of the devices. The devices will be used only as a means of collecting bio-
physiological data. 
For example, the acoustomechanic laryngeal sensors measure laryngeal movement data during 
swallowing and speaking, which are converted into an acoustical waveform that can provide an 
estimate of swallow function or how much a person is talking. Previous versions of this device 
have been used for bio-physiological data collection in other medical conditions, and have 
confirmed that there is minimal risk to participants. Similarly, the sweat sensors collect sweat 
loss during exercise and detect the pH of sweat, as well as concentrations of chloride, glucose, 
and lactate. This device has previously been used for bio-physiological data collection during 
exercise, and confirmed that there is minimal risk to participants. 
We are merely collecting these data using non-significant risk devices, without manipulation of 
any variables. These devices are therefore exempt from any IDE requirements.
i Thieme H, Ritschel C, Zange C. Reliability and validity of the functional gait assessment (German version) in 
subacute stroke patients. Arch Phys Med Rehabil. 2009;90(9):1565-1570.
ii ii Lin JH, Hsu MJ, Hsu HW, Wu HC, Hsieh CL. Psychometric comparisons of 3 functional ambulation measures for 
patients with stroke. Stroke. 2010;41(9):2021-2025.
iii Dodds TA, Martin DP, Stolov WC, Deyo RA.  A validation of the functional independence 
measurement and its performance among rehabilitation inpatients.  Arch Phys Med Rehabil. 
1993 May;74(5):531-6.
iv Rayegani SM, Raeissadat SA, Alikhani E, Bayat M, Bahrami MH, Karimzadeh A.  Evaluation 
of complete functional status of patients with stroke by Functional Independence Measure scale 
on admission, discharge, and six months poststroke. Iran J Neurol. 2016 Oct 7;15(4):202-208. 
PMCID: PMC5392193
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