Comparison of Two High-intensity Gait Training Interventions on Contraversive Pushing Behaviors in Individuals Poststroke
Phase: NA
Conditions: Stroke
Sponsor: Shirley Ryan AbilityLab

STU#: 00213155 
IRB Project #: STU00213155, Medical Clearance Form (v01) 08/05/2020  
   Page 1 of 17 
Principal Investigator: Arun Jayraman, PT, PhD 
HRP-593 / v03152019 
PROTOCOL TITLE: Comparison of two high-intensity gait training interventions on 
contraversive pushing behaviors in individuals poststroke 
 
PRINCIPAL INVESTIGATOR (PI): 
Arun Jayaraman, PT, PhD 
Department of Physical Medicine and Rehabilitation 
Northwestern University 
Shirley Ryan AbilityLab 
355 East Erie Street 
Chicago, IL 60611 
Phone: (312) 238–6875 
Fax: (312) 238–2081 
ajayaraman@sralab.org 
 
VERSION DATE: 
07/17/2020 (V01) 
  
STUDY SUMMARY: 
Investigational Agent(s)  
(Drugs or Devices) 
N/A 
IND / IDE / HDE #  N/A 
Indicate 
Special Population(s) 
Children  
 Children who are wards of the state  
 Adults Unable to Consent   
 Cognitively Impaired Adults  
 Neonates of Uncertain Viability  
 Pregnant Women  
 Prisoners (or other detained/paroled individuals)  
 Students/Employees  
Sample Size 30 participants 
Funding Source Shirley Ryan AbilityLab: Brown Fellowship Grant 
Indicate the type of consent 
to be obtained 
Written  
Verbal/Waiver of Documentation of Informed Consent 
Waiver of HIPAA Authorization  
Waiver/Alteration of Consent Process   
Site 
 Lead Site ( For A Multiple Site Research Study) 
 Data Coordinating Center (DCC) 
Research Related 
Radiation Exposure 
Yes  
 No  
DSMB / DMC / IDMC 
Yes  
No 
 
OBJECTIVES 
The purpose of this study is to investigate the effect of two high-intensity gait training 
interventions on contraversive pushing behaviors (CPB) in individuals poststroke in the acute 
inpatient rehabilitation setting. We will also evaluate the effect of these interventions on 
functional mobility, strength, balance, and endurance. Furthermore, we intend to measure 
therapist burden when mobilizing individuals with CPB.  
 
 

STU#: 00213155 
IRB Project #: STU00213155, Medical Clearance Form (v01) 08/05/2020  
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Principal Investigator: Arun Jayraman, PT, PhD 
HRP-593 / v03152019 
BACKGROUND 
High-intensity gait training is strongly supported in individuals poststroke to facilitate 
neuroplastic changes in the brain in order to maximize the recovery of functional 
independence.1 In the acute inpatient rehabilitation setting, therapists utilize safety equipment, 
rehabilitation technicians, and assistive devices to implement high-intensity gait training as soon 
as possible; however, individuals with CPB exhibit significant postural control deficits, making 
this feat difficult. Contraversive pushing is characterized by three clinical features: (1) 
contralesional tilted posture with significant balance impairments, (2) tendency to push with non-
affected extremities into abduction and extension toward the hemiparetic side, and (3) 
resistance to external correction [Refer to Figure 1.A].2,3 It is hypothesized that this phenomenon 
occurs due to impaired awareness of midline where individuals perceive their body as “upright” 
when it is actually tilted up to 18 degrees towards the brain lesion [Refer to Figure 1.B].3 CPB 
has been reported in 12-18% of individuals receiving stroke rehabilitation and often leads to 
longer lengths of stay, poorer functional outcomes, and institutionalized discharge locations 
compared to individuals with stroke diagnoses without CPB.2,4,5 At times, these deficits can be 
accompanied by neglect, sensory deficits, and cognitive deficits, making ambulation overground 
at high intensities extremely difficult without heavy physical assistance.3 
 
Figure 1. A) An individual demonstrating CPB in sitting and standing.3 B) Visual representation of 
perceived midline orientation in individuals with CPB.3  
There is little research on the utilization of overground-based robotic exoskeletons like the 
EksoNR to train and ambulate individuals with acute and chronic stroke diagnoses. In addition, 
high quality evidence guiding physical therapy intervention, specifically gait training, in 
individuals with CPB is scarce. Robotic assisted gait training utilizing the Lokomat system over a 
treadmill has been effective in reducing CPB. 4,6,7  However, no studies have assessed the 
efficacy of gait training with an exoskeleton robotic suit overground as we are proposing to do. 
Traditional therapeutic interventions in individuals with CPB typically consists of progressing 
functional mobility while orienting to midline with various forms of visual and tactile feedback.4,5,8-
13 It is hypothesized that the EksoNR will be an efficacious intervention for this population 
because of its ability to position and orient an individual to midline while simultaneously working 
on gait training and decreasing the physical burden on clinicians. Unquestionably, there is a 
demand for research to support appropriate interventions, guide best physical therapy practice, 
and promote ways to safely maximize high-intensity gait training within this specific population.   
 
This study will include two interventional groups. Intervention for group one will consist of body-
weight-supported treadmill training + overground gait training. Intervention for group two will 
consist of gait training in the EksoNR exoskeleton + overground gait training. We will enroll 5-10 
participants in each intervention group with the goal of 10 participants completing the study. 

STU#: 00213155 
IRB Project #: STU00213155, Medical Clearance Form (v01) 08/05/2020  
   Page 3 of 17 
Principal Investigator: Arun Jayraman, PT, PhD 
HRP-593 / v03152019 
Since participants are inpatients on an acute rehabilitation unit, they will simultaneously be 
receiving intensive physical, occupational, and speech therapies outside of our research study 
as part of the standard of care at Shirley Ryan AbilityLab. 
 
Intervention Delivery Systems: 
Woodway PPS Medical Series + Body Weight Support LokoStation 55/70  
The commercially available Woodway + LokoStation [Refer to Figure 2.A] is intended to assist 
an individual when performing locomotor therapy under the supervision of a trained physical 
therapist. The purpose of the body weight support system is to facilitate ambulation for 
participants with walking difficulties due to cerebral, spinal, neurogenic, muscular, or osseous 
causes. See attached user manual. 
 
EksoNR Exoskeleton 
The commercially available EksoNR [Refer to Figure 2.B] is intended to assist an individual 
when performing ambulatory functions under the supervision of a physical therapist who has 
completed formalized training. It is approved by the FDA for use in individuals with stroke 
diagnoses. The EksoNR is an under-actuated lower extremity exoskeleton with actuation at the 
knee and hip joints and a passive ankle. The device enables individuals with any amount of 
lower extremity strength to stand up and walk overground with a natural, weight bearing, 
reciprocal gait pattern. The EksoNR utilizes cooperative gait rehabilitation algorithms to vary the 
amount of assistance provided to each user for an individualized therapy experience. This 
method allows the exoskeleton to work with a user's existing strength and provide only the extra 
effort required to complete a maneuver correctly and safely. Walking is achieved by shifts in the 
wearer's weight, which activate sensors in the footplate and initiate steps. See attached user 
manual. 
 
 
Figure 2. Gait intervention systems. A) Woodway Treadmill System. B) EksoNR Exoskeleton. 
 
 
 

STU#: 00213155 
IRB Project #: STU00213155, Medical Clearance Form (v01) 08/05/2020  
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Principal Investigator: Arun Jayraman, PT, PhD 
HRP-593 / v03152019 
STUDY ENDPOINTS 
Study endpoints: 
The study ends when the participant completes the intervention protocol and outcomes 
assessment and when data has been collected and analyzed. The study may also end if the 
participant discharges from the inpatient setting prior to completing the intervention protocol. 
The participant may choose to withdraw from the study at any time.  
 
Safety endpoints: 
Participant enrollment in this study will be terminated if the research or medical team determine 
that the participant is no longer medically stable to continue participation. Any adverse events 
will be documented thoroughly.    
 
PROCEDURES INVOLVED 
Screening, enrollment, and baseline procedures: 
Individuals with stroke admitted as inpatients to the Shirley Ryan AbilityLab will be asked to 
potentially enroll in the study. A thorough review of the participant’s medical history will be 
completed by licensed physical therapists, and medical clearance will be obtained from the 
individual’s medical team. The study coordinators will assess eligibility based on inclusion 
criteria, obtain informed consent, and answer any questions from the participant and/or his/her 
power of attorney (POA). If the participant is deemed unable to consent by the primary medical 
team, consent will be obtained from the individual’s power of attorney (POA). Following 
informed consent, participants will undergo a physical evaluation and screening exam by a 
licensed physical therapist. Once they are enrolled, baseline outcome measures will be 
assessed by a physical therapist [See Clinical Assessments section].  
 
If a participant is placed in the intervention group receiving gait training via the EksoNR 
exoskeleton, additional steps will be taken during baseline assessments to ensure the 
participant is appropriate for use of the EksoNR. These measures include upper and lower 
extremity range of motion, upper and lower extremity strength, spasticity, transfer status, skin 
integrity, and then three specific body measurements to assist with setting up the EksoNR 
exoskeleton. The three body measurements include hip width measured in sitting, upper leg 
lengths measured supine on a mat table, and lower leg lengths measured sitting on the edge of 
the mat table with feet supported on a step. Measurements are compared bilaterally and then 
converted to EksoNR values using a chart from Ekso Bionics (See User Manual). All 
assessments will be completed by a trained physical therapist to ensure standardization and 
safety of the participant. 
 
Procedures during treatment: 
After the baseline testing is completed, participants will complete between 9-24 training 
sessions dependent on their length of stay. These training sessions will occur in the inpatient 
Legs + Walking Lab with a licensed physical therapist and will last up to 90 minutes. Each 
session will be customized based on the participant’s functional capacity with the goal of 
maximizing stepping practice.  
 
Body-weight-supported treadmill + overground gait training group: 
Upon arrival to the session, a Polar OH1 Optical Heart Rate Sensor and an ActiGraph GT9X 
Link will be placed on the participant. Vitals including heart rate, blood pressure, oxygen 
saturation, and rating of perceived exertion (RPE) will be assessed at the beginning, during 
walking, and at the end of the session. The physical therapist will then assist with donning a 
walking harness with padding (as needed) in sitting or standing based on the participant’s 
current functional capacity. The participant will be assisted onto the Woodway treadmill via ramp 

STU#: 00213155 
IRB Project #: STU00213155, Medical Clearance Form (v01) 08/05/2020  
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Principal Investigator: Arun Jayraman, PT, PhD 
HRP-593 / v03152019 
while seated in a wheelchair. The participant will be clipped into the body weight support 
system, assisted into standing, and provided the appropriate amount of body weight support to 
allow for successful stepping practice. During walking, the physical therapist and a rehabilitation 
technician will provide physical assistance as necessary to advance the participant’s limbs. The 
participant will be instructed to maximize the number of steps during gait training for up to 60 
minutes total with a targeted intensity of 70-85% of age-predicted heart rate maximum. The 
participant’s response to exercise will be continuously monitored via vital monitoring and the 
participant’s subjective report. The participant can request standing or seated rest breaks during 
session as needed. If, at any time, the participant’s heart rate exceeds 90% of age-predicted 
heart rate maximum, a seated rest break will be initiated by the therapist to allow the heart rate 
to return to baseline levels prior to returning to the walking protocol. The physical therapist may 
modify training parameters including: treadmill speed, incline, direction (forward, backward), and 
amount of body weight support in order to provide the appropriate amount of challenge. Upon 
completion of each session, the harness will be doffed in standing or sitting, and the 
participant’s skin will be thoroughly assessed. Some sessions may include additional 
overground gait training to assess carry-over of learning. In this case, the physical therapist will 
provide the appropriate physical assistance, assistive device, and bracing based on current 
functional level.  
 
EksoNR gait training + overground gait training group: 
Upon arrival to the session, a Polar OH1 Optical Heart Rate Sensor and an ActiGraph GT9X 
Link will be placed on the participant. Vitals including heart rate, blood pressure, oxygen 
saturation, and rating of perceived exertion (RPE) will be assessed at the beginning, during 
walking, and at the end of the session. The physical therapist will then assist with transferring 
the participant into the EksoNR exoskeleton while in sitting, adding wedges and/or padding as 
needed. Multiple straps will be applied bilaterally at the shoulders, across the abdomen, mid-
thighs, below the knees, and around the shoes. Once the participant is safely secured into the 
EksoNR exoskeleton, they will be assisted into standing to begin gait training. The physical 
therapist will encourage them to maximize the number of steps during gait training for up to 60 
minutes total with a targeted intensity of 70-85% of age-predicted heart rate maximum. The 
participant’s response to exercise will be continuously monitored via vital monitoring and the 
participant’s subjective report. Therapist will also utilize feedback from the EksoNR to guide the 
treatment session. The participant can request standing or seated rest breaks during the 
session as needed. If, at any time, the participant’s heart rate exceeds 90% of age-predicted 
heart rate maximum, a seated rest break will be initiated by the therapist to allow the heart rate 
to return to baseline levels prior to returning to the walking protocol. The physical therapist may 
modify the EksoNR programming parameters to provide the appropriate challenge. Upon 
completion of each session, the EksoNR exoskeleton will be doffed in sitting, and the 
participant’s skin will be thoroughly assessed. Some sessions may include additional 
overground gait training to assess the carry-over of learning. In this case, the physical therapist 
will provide the appropriate physical assistance, assistive device, and bracing based on current 
functional level.  
 
Clinical assessments: 
All assessments will be performed by a licensed physical therapist as per the standard of care 
at the Shirley Ryan AbilityLab. The participant will be given rest breaks as needed between 
tests to minimize fatigue. The physical therapist will provide the appropriate physical assistance, 
assistive device, and bracing based on current functional level. 
 
Clinical assessments performed at enrollment and weekly 
1. Scale for Contraversive Pushing (SCP) 

STU#: 00213155 
IRB Project #: STU00213155, Medical Clearance Form (v01) 08/05/2020  
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Principal Investigator: Arun Jayraman, PT, PhD 
HRP-593 / v03152019 
2. Burke Lateropulsion Scale (BLS) 
3. 10 Meter Walk Test (10MWT) 
4. 6 Minute Walk Test (6MWT) 
5. Berg Balance Scale (BBS) 
6. Function in Sitting Test (FIST) 
7. Functional Independence Measure (FIM) 
8. Quality Indicators (QI) 
9. Manual Muscle Test (MMT) 
10. Range of Motion (ROM) 
11. Modified Ashworth Scale (MAS) 
 
Clinical assessments performed each session 
1. Step count  
2. Time spent in 70-85% of age-predicted maximum target heart rate zone 
3. Rating of perceived exertion (RPE) 
4. Therapist heart rate 
5. Therapist RPE 
6. Therapist Numerical Rating Pain Scale 
 
Description of clinical assessments: 
1. Scale for Contraversive Pushing (SCP): The SCP is a three-item test used to measure 
lateropulsion, scored on a three point ordinal scale. It rates a participant’s action/reaction of 
maintaining or changing a position in both sitting and standing. A score >0 indicates the 
presence of CPB.   
2. Burke Lateropulsion Scale (BLS): The BLS is a five-item test used to measure lateropulsion, 
scored on a four to five point ordinal scale. It rates a participant’s action/reaction of keeping 
or changing a position in sitting, standing, rolling in supine, transfers, and walking.  
3. 10 Meter Walk Test (10MWT): The 10MWT is a common clinical measure of gait speed. 
Participants will be directed to walk at their comfortable, self-selected speed. Participants 
will be positioned at the start line and instructed to walk the entire 10 meter distance while 
the therapist times the middle six meters. The distance before and after the timed 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: 2.46 sec). The test 
will be performed two times at self-selected speed with adequate rest in between. The 
average of the two times should be recorded. The test will then be repeated with the 
participants directed to walk at their fast but safe speed. Appropriate assistive devices, 
bracing, and the minimal amount of physical assistance from the physical therapist will be 
applied. 
4. 6 Minute Walk Test (6MWT): The 6MWT measures the distance a participant can walk 
indoors on a flat, hard surface in a period of six minutes. 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 test is self-paced. Participants are allowed to stop and rest 
during the test; however, the timer does not stop. If a participant is unable to complete the 
time, the time stopped is noted and reason for stopping prematurely is recorded. 
Appropriate assistive devices, bracing, and the minimal amount of physical assistance from 
the physical therapist will be applied. 
5. Berg Balance Scale (BBS): The BBS is a 14-item test, scored on a five point ordinal scale. It 
measures 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 participants must maintain their balance.  

STU#: 00213155 
IRB Project #: STU00213155, Medical Clearance Form (v01) 08/05/2020  
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Principal Investigator: Arun Jayraman, PT, PhD 
HRP-593 / v03152019 
6. Function in Sitting Test (FIST): The FIST is a 14-item test of sitting balance, scored on a five 
point ordinal scale. It measures sensory, motor, proactive, reactive, and steady state 
balance factors.  
7. Functional Independence Measure (FIM): The FIM is an 18-item test (13 motor tasks, 5 
cognitive tasks) for evaluating level of disability and how much assistance is needed for a 
participant to perform certain activities of daily living. Each item is scored on a seven point 
ordinal scale, ranging from total assistance to total independence. Items include eating, 
grooming, bathing, dressing, toileting, bladder/bowel management, transfers, locomotion, 
stairs, comprehension, expression, social interaction, problem solving, and memory.  
8. Quality Indicators (QI): This is a standardized, evidence-based measure of health 
care quality used to track clinical performance and outcomes in post-acute care. Items are 
scored on a six point ordinal scale, ranging from independent to dependent. Items can also 
be coded as participant refuses, not applicable, environmental limitations, not attempted due 
to medical condition or safety concerns, or unplanned discharge.  
9. 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 
participant 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 participant’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 participants may be tested while lying prone 
(gravity eliminated). 
10. Passive Range of Motion (ROM): The purpose of this test is to evaluate a participant’s 
passive range of motion in the joints of the hips, knees, and ankles. 
11. 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. 
12. Step count: The number of steps taken during each session will be measured using 
ActiGraph GT9X Link activity monitors. These devices are small accelerometers that can be 
worn on a belt and/or on the ankle to record steps and Kcals during an activity. The therapist 
leading the intervention session will apply the ActiGraph at the beginning of each 
intervention session and remove it upon completion. 
13. Age-predicted maximum heart rate zone: The target range of 70-85% of age-predicted 
maximum heart rate will be calculated for each participant utilizing HRmax = 208 − [0.7 × 
age] as developed by Tanka et al in 2001.14 It is recommended that clinicians should apply 
moderate to high-intensity walking training to improve walking speed and endurance 
individuals poststroke.1,15 We will record the amount of time participants spend in their pre-
calculated target zone during each gait training session utilizing the Polar OH1 Optical Heart 
Rate Sensor.  
14. Borg Rating of Perceived Exertion (RPE): The Borg RPE is a tool to measure the subjective 
report of effort, exertion, and fatigue during physical work. It consists of a 15-point scale 
from 6-20, in which 6=no exertion and 20=absolute maximum exertion. It is presented to the 
participant in written format with descriptors to standardize the report of perceived exertion 
across tasks.   
15. Numerical Rating Pain Scale (NPRS): The NPRS is used to measure the subjective report of 
pain intensity. It consists of an 11-point scale, 0-10, in which zero indicates no pain and ten 
indicates the most intense pain imaginable. In this study, therapists will be provided a written 
format of the NPRS to report their perceived pain following delivery of each intervention 
session. 

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IRB Project #: STU00213155, Medical Clearance Form (v01) 08/05/2020  
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Principal Investigator: Arun Jayraman, PT, PhD 
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DATA COLLECTION AND ANALYSIS 
Data from participants will be collected during their hospital stay, including clinical and functional 
outcomes. The complete medical history of the participants, including physical findings, 
radiological reports such lesion size, location, type, medications, intervention training 
parameters and therapist-assessed clinical outcomes may also be collected (See Clinical 
Assessments section). Participants’ records and data will be kept confidential and in compliance 
with HIPAA 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. Analysis will be 
completed to compare the two intervention groups and draw conclusions on the efficacies of 
both interventions.  
 
Photographs, audio, and video recordings: 
We may photograph, audio, or video record the participants during the study to be used for 
scientific publications and scholarly presentations only. The photographs will be de-identified, 
meaning that the face of the participants will not be shown. Participants will be given the choice 
to accept or decline this optional aspect during the informed consent process. Their choice will 
not impact their participation in the study.  
 
STUDY TIMELINES 
We anticipate it will take each participant up to eight weeks to complete the study protocol. 
Clinical assessments will be performed at baseline and once weekly for up to eight assessment 
sessions or until the participant is discharged. The intervention will be delivered three times 
weekly up to 24 sessions or until the participant is discharged. In total, each individual will 
participate in 13-34 sessions [Refer to Figure 3]. We anticipate a 12-month period to enroll all 
inpatient participants. 
 
Type of Session 
# of Sessions 
Time Required for Each Session 
Enrollment/ 
Baseline Clinical Assessment/ 
Baseline Measurements 
1-2 
60-120 minutes 
Weekly Clinical Assessments 
3-8 
60-90 minutes 
Training Protocol 
9-24 
60-90 minutes 
Figure 3. Summary of sessions. 
 
INCLUSION AND EXCLUSION CRITERIA 
Inclusion Criteria: 
 
Age 18-80 years old 
 
Unilateral, supratentorial ischemic or hemorrhagic stroke within the past six months 
 
Medical clearance from primary medical team (signed Medical Clearance form) 
 
CPB as determined by a score of >0 on the Scale for Contraversive Pushing 
 
Adequate cognitive function as determined by the NIH scale: score ≤1 on question 1b 
and score =0 on question 1c 
 
Informed consent provided by participant or POA 
 
English speaking 
 
 

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Principal Investigator: Arun Jayraman, PT, PhD 
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Exclusion Criteria: 
 
Severe aphasia limiting ability to express needs or discomfort verbally or nonverbally 
 
Severe behavioral neglect as determined by a score of ≥ 21 on Catherine Bergego Scale 
(CBS) via the Kessler Foundation-Neglect Assessment Process (KF-NAP)16 
 
History of prior stroke  
 
Concurrent neurologic condition (i.e PD, TBI, MS, etc.) 
 
History of peripheral nerve injury  
 
Joint contracture or significant spasticity in the lower limbs (Modified Ashworth Scale ≥3) 
 
Severe knee, hip, or ankle osteoarthritis 
 
Severe osteoporosis as indicated by physician medical clearance 
 
Open wounds on surfaces in contact with exoskeleton or harness 
 
Unstable spine or unhealed fractures 
 
Weight bearing precautions 
 
Unresolved deep vein thrombosis (DVT) 
 
Concurrent participation in other lower limb research studies that according to the PI is 
likely to affect study outcome or confound results 
 
Pregnancy 
 
EksoNR Exclusion Criteria17: 
 
Weight >220 lbs (100 kg) 
 
Height below 60 inches or above 76 inches 
 
Standing hip width of approximately 18 inches or more 
 
Joint contractures or range of motion deficits that limit normal range of motion during 
ambulation 
 
Knee flexion contracture greater than 12° 
 
Hip flexion contracture greater than 17° 
 
Inability to achieve 0° neutral ankle dorsiflexion with knee flexion up to 12° 
 
Bilateral hip flexion less than 110° 
 
Leg length discrepancy 
 
Greater than 0.5 in. (1.27 cm) for upper legs 
 
Greater than 0.75 in. (1.91 cm) for lower legs 
 
Active heterotopic ossification 
 
Significant spasticity in the lower limbs (Modified Ashworth Scale ≥3) 
 
High anxiety or claustrophobia  
 
Clostridium difficile or other gastrointestinal isolation precautions 
 
Colostomy 
 
Uncontrolled autonomic dysreflexia 
 
Lower limb prosthesis 
 
VULNERABLE POPULATIONS 
We will recruit participants with communication deficits (i.e. aphasia) as a result of their stroke 
who are deemed safe to consent by their supervising medical and therapy team. For these 
participants, we will provide the necessary supported communication strategies to ensure the 
proper understanding of the experimental protocol and consent process prior to obtaining 
consent. 
 
For those deemed unable to consent by their supervising medical and therapy team as a result 
of their stroke, we will obtain informed consent from their POA. We will ensure the POA 
understands the purpose of the study, the procedures, risks and benefits, and the participant’s 
rights before providing informed consent on behalf of the participant. 
 

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PARTICIPANT POPULATION(S) 
Accrual 
Number: 
Category/Group: 
(Adults/Children 
Special/Vulnerable 
Populations) 
Consented: 
Maximum Number to be 
Consented or 
Reviewed/Collected/Screened 
Enrolled: 
Number to Complete 
the Study or Needed 
to Address the 
Research Question 
Local 
Adults with stroke + 
CPB 
45 
30 
 
 
 
Study-wide 
 
 
 
 
 
 
Total: 
 
45 
30 
 
RECRUITMENT METHODS 
This study will involve recruitment of individuals with stroke from the inpatient units at the Shirley 
Ryan AbilityLab. Clinicians at this location will be informed of the inclusion and exclusion criteria 
for this study in order to refer appropriate participants to the study coordinators. Information 
regarding this study will be posted on the Shirley Ryan AbilityLab webpage detailing available 
research studies. Authorized research personnel will identify and screen potential research 
participants based on inclusion and exclusion criteria using the Cerner application. After 
identification of participants based on inclusion and exclusion criteria, a verbal permission from 
the participant will be obtained to request medical clearance from their physician.  
 
COMPENSATION FOR PARTICIPATION IN RESEARCH ACTIVITIES 
Participants will not receive compensation for participation in this study. 
 
WITHDRAWAL OF PARTICIPANTS 
Participants may be withdrawn from the study without their consent if there are any safety 
concerns for continued participation. This may be due to a change in medical status or inability 
to follow the outlined study protocol at any point during the study. 
 
Participants may withdraw from the research study voluntarily at any time. Once the participant 
has revoked consent, he/she cannot continue to participate in the study. Data collected until 
point of withdrawal will be maintained. The research team may request reason for withdrawal to 
monitor study participant attrition.   
 
To revoke consent, the participant must do so in writing to the PI, Dr. Arun Jayaraman. 
Participants can call the PI at (312)238-6875 if assistance is needed in this process. 
 
RISKS TO PARTICIPANTS 
Risk minimization: 
Procedures are in place to minimize risk to the human participants. There are minimal risks or 
side effects associated with using exoskeletons or standard physical therapy care. We will be 
following hospital/facility safety precautions throughout the study. All clinical assessment and 
intervention sessions will be under the supervision of a trained researcher and/or physical 
therapist. Manual assistance or cueing will be provided as necessary for safety and balance. All 
participants will be permitted to stop physical activity or rest at any time during the study.  

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EksoNR exoskeleton:  
The EksoNR exoskeleton used in this study is commercially available and approved for use by 
the FDA in this population. The physical therapists operating this device completed formalized 
training to ensure the proper safety measures are taken to minimize any risk to the participants. 
Safety procedures include setting range of motion values in the controller, ensuring proper 
setup within the exoskeleton, monitoring skin tolerance pre/during/post treatment, and 
knowledge of the emergency protocol when using the EksoNR. Additionally, the EksoNR is 
equipped with an emergency stop feature to protect the participant during use. The therapists 
will closely monitor device function throughout the research study.  
 
Muscle soreness or joint pain:  
There is a possibility of muscle and/ or joint discomfort as a result of exercise and utilization of 
the exoskeleton or safety harness. This risk will be minimized through close monitoring of 
participant feedback by licensed physical therapists throughout all training sessions. In addition, 
adjustments to the sizing, placement of protective padding, and the amount of therapist 
assistance can be modified during exoskeleton or harness use. The physical therapists guiding 
the testing and intervention sessions are trained in how to safely progress the participant to 
more dynamic and complex activities. Adequate rest periods will be provided per participant 
request or based on physical therapist judgement.  
 
Fall risk:  
Individuals with stroke may be at increased risk for falls when performing functional tasks due to 
impaired strength, sensation, and balance. It is anticipated that fall risk will not be significantly 
increased when performing functional tasks in this study. The most appropriate assistive 
devices and/or bracing will be used to minimize fall risk. In addition, functional tasks will be 
performed in a harness or with a gait belt with licensed physical therapists closely assisting at all 
times. 
 
Skin and soft tissue injury:  
There may be a risk for skin abrasion, bruising, or discomfort from use of the exoskeleton or 
safety harness. This risk may be increased for individuals with neurologic conditions due to 
impaired sensation. Trained personnel will apply and remove the exoskeleton and safety 
harness to ensure proper alignment. Personnel will also perform skin checks at all areas of 
contact following each use of the exoskeleton, harness, or standard of care lower extremity 
bracing (i.e ankle foot orthosis). Participants will be educated to notify personnel immediately of 
any discomfort during tasks; the tasks will be discontinued and personnel will evaluate the 
source of discomfort. 
 
Vitals: 
Participants in this study are in the inpatient setting following acute stroke diagnoses. As a 
result, participants may be at risk of fluctuations in cardiovascular response to exercise. We will 
be checking vital signs including blood pressure, heart rate, and oxygen saturation level 
throughout each session. If heart rate surpasses 90% of age-predicted heat rate maximum , 
and/or blood pressure levels surpass 170 systolic and 100 diastolic, a seated rest break will be 
initiated. If these levels continue to be elevated, the session will be discontinued, and the on-site 
attending physician will be immediately contacted. Physical therapists administering the 
intervention protocol have access to nursing and medical staff at all times.  
 
POTENTIAL BENEFITS TO PARTICIPANTS 
Research has shown that gait training interventions may lead to significant improvements in 
mobility and function.1,15 There is the potential for participants in this study to experience the 

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same benefits. These outcomes have implications that outweigh the minimal risks (See Risks to 
Participants section) that are associated with participation.  
 
DATA MANAGEMENT AND CONFIDENTIALITY 
All personal information (names, addresses, email, phone numbers, etc.) gathered for this study 
that can identify participants will be kept secure to protect their privacy and will never be shared 
with any person or entity at any time. 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 in a secure location. 
 
PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFEY OF PARTICIPANTS 
Keeping the confidentiality of all data collected through this study is paramount. As a result, we 
have devised numerous procedures to ensure the privacy of the participants. Data will be de-
identified so information cannot be linked to the participants. Behavioral and functional data 
collection will take place at the Shirley Ryan AbilityLab. There will be no recordings conducted 
outside of this institution. 
 
Data storage:  
All research data is recorded with a participant code that does not contain personally identifiable 
information. All personally identifiable information is stored in a locked cabinet within the 
laboratory and only authorized personnel listed on this IRB will have access to them. There will 
be no collection of criminal behavior or other potentially sensitive information. Information on the 
computer will be encrypted and password protected. After the study has been completed, we 
will preserve all study information on a secure and encrypted computer for possible further 
testing and comparison with future studies. There is no scheduled date on which participant 
data will be destroyed. 
 
Length of data storage:  
De-identified data may be stored indefinitely. Records with identifiable data will be destroyed at 
the end of the study. Video tapes for educational purposes with the consent of the participant 
may be kept indefinitely. 
 
Data access:  
Only authorized personnel listed on this IRB will have access to the data. 
 
Process for releasing data:  
During and after the study, all study records will be assigned a code to protect the confidentiality 
of the participant’s personal information. The information will be labeled with an unidentifiable 
code to reduce the risks to participant privacy.  
 
Once research information has been collected, we may share some of it. Any research 
information shared with people outside of Shirley Ryan AbilityLab/Northwestern (NU) will not 
contain the participant’s name, address, telephone, or social security number, or any other 
direct personal identifier unless disclosure of the direct identifier is required by law [except that 
such information may be viewed by the Study sponsor and its partners or contractors at the 
Principal Investigator's office]. Research information may be shared with:  
 
Authorized members of NU and the Shirley Ryan AbilityLab workforce, who may need to 
see participant information, such as administrative staff members from the Office of 
Research, and members of the Institutional Review Board (a committee which is 
responsible for the ethical oversight of the study) 

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 
Other University research centers and University contractors who are also working on 
the study 
 
Study monitors and auditors who make sure that the study is being done properly,  
 
Government agencies and public health authorities, such as the Food and Drug 
Administration (FDA) and the Department of Health and Human Services (DHHS) 
 
PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF PARTICIPANTS 
Steps taken to protect privacy of participants: 
The participants will only provide personal information to the study personnel listed on the IRB. 
All data is obtained specifically and solely for research purposes. The data is made 
unidentifiable by using anonymous participant codes to minimize the risk to the participants’ 
privacy. Behavioral and functional data will be the only form of research material obtained from 
individually identifiable living human participants. Human participant personal information 
(name, contact information) and medical information necessary to the study (age, sex, possible 
diagnoses, medications) will be taken during recruitment. All recordings are kept in a secure 
computer, non-accessible to other investigators other than the ones listed on the protocol. All 
information regarding experimental participants, including consent forms, will be kept in a locked 
file cabinet. There will not be any type of collection of sensitive data, such as sexual, criminal, or 
illegal behavior. 
 
Steps taken to ensure participant comfort:  
To ensure that participants feel at ease, the purpose of the study in addition to the procedures 
will be clearly described. At the beginning of each session, the relevant procedures are 
reviewed with the participant. Throughout the study, there will be open communication between 
the participant and the research staff, and the study will be stopped should the participant feel 
uncomfortable with any of the questions or procedures that are part of the protocol. 
 
Research staff permissions:  
All study staff are CITI certified and all information and records are in compliance with HIPAA 
rules.  
 
COMPENSATION FOR RESEARCH-RELATED INJURY 
If the participant gets an injury or illness as a result of study, the participant is required to 
promptly notify the PI or research personnel 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 participant from seeking to be paid back for 
care required because of a bad outcome. 
 
ECONOMIC BURDEN TO PARTICIPANTS 
There is no anticipated economic burden to the participants since they will be inpatients and the 
study will occur in the same building. Participants will not receive compensation for their 
participation in this study. 
 
CONSENT PROCESS 
Prior to enrollment into the study, the participant will be provided an explanation of the study 
and the opportunity to review the consent form. Once this is complete and research personnel 
ensures the participant understands the implications of participating in this study, informed 
consent will be obtained from the participant with their signature on the IRB-approved consent 
form. In order to participate in the study, the consent form must be signed and dated by the 

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participant and the research personnel who completed the consenting discussion. If any 
changes to the protocol are made, participants will be consented with an updated consent form.  
 
Adults able to consent: 
For participants with stroke, informed consent will be obtained by the PI or any trained licensed 
physical therapist prior to completion of study protocol. We will ensure the participant 
understands the purpose of the study, the procedures, risks and benefits, and rights as a 
research participant, and he/she can provide informed consent. Participants able to make their 
own decisions regarding research participation will be allowed to discuss with other appropriate 
parties prior to giving informed consent. Participants will not be openly encouraged to participate 
in the research or told that there is any expected benefit from the experimental interventions 
during participation. Participants will have access to research staff to assist with any questions 
or concerns until understanding is achieved to the judgment of the individual asking the 
question. If a participant refuses participation, no further contact will be made. 
 
Adults able to consent who have communication deficits: 
For participants who demonstrate communication deficits (i.e. aphasia) but who are deemed 
safe to consent by their supervising medical and therapy team, we will provide necessary 
supportive communication strategies to ensure proper understanding of the consent process 
prior to obtaining consent. 
 
Adults unable to consent: 
For those deemed unable to consent by their supervising medical and therapy team as a result 
of their stroke, we will obtain informed consent from their POA. We will ensure the POA 
understands the purpose of the study, the procedures, risks and benefits, and the participant’s 
rights before providing informed consent on behalf of the participant. 
 
Process to document consent in writing: 
Informed consent will take place at Shirley Ryan AbilityLab on the inpatient floors with 
authorized study personnel.  
 
Trained research personnel will guide the participant through consenting process. The 
participant will be given detailed explanation of the purpose, timeline, commitment, procedures, 
data handling, privacy, and confidentiality of information pertaining to the study. 
 
For all participants, we will obtain written consent as usual. The signed consent form will be 
stored in a locked cabinet for the duration of the study. Our consent document has been 
uploaded to the eIRB folder.  
 
NON-ENGLISH SPEAKING PARTICIPANTS 
The study will only recruit participants who are fluent in English because all tests and 
instructions are administered in English.   
 
PROTECTED HEALTH INFORMATION (PHI AND HIPAA) 
Participant records will be kept completely confidential. Every possible precaution will be taken 
to protect the privacy interests of participants. Participation in this study is completely voluntary. 
Trained research personnel will explain the purpose of the study, the intended use of a 
participant’s medical information, and the precautions taken to keep the study information and 
data confidential. Data will be collected and kept confidential and compliant with HIPAA 
standards.  
 

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Participants will be assigned an alphabetical or numerical study identification number. 
Identifying data will be kept in locked cabinets and password protected servers completely 
separate from de-identified data. Research data will be de-identified and stored in locked 
cabinets in the lab accessible only to authorized research personnel. Electronic data will be de-
identified and kept on secure, password protected servers at the Shirley Ryan AbilityLab. Only 
authorized research staff will be able to access any of the formerly mentioned data. De-
identified data will be kept indefinitely.  
 
Study documentation will be collected and stored and kept confidential and compliant with 
HIPAA requirements.  
 
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 with any person or entity at any time. 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 in a secure 
location. 
  
QUALIFICATIONS TO CONDUCT RESEARCH AND RESOURCES AVAILABLE 
Describe other resources available to conduct the research: 
The Shirley Ryan AbilityLab services the stroke poption at a rate of approximately 300 
new patients per year. The Shirley Ryan AbilityLab is a research hospital that maintains 
a research registry (greater than 750 participants). We will recruit inpatients to meet our 
enrollment goal and perform all research on site at the flagship hospital. The study team 
members are all employees of the Shirley Ryan AbilityLab. They are familiar with the 
study site and are experienced with the study population. 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. 
All study team members will be trained on the study protocol and procedures and have 
already been trained on how to safely administer all functional outcomes using 
standardized methods. The research staff consists of clinical researchers and licensed 
physical therapists trained in the safe use of therapeutic equipment, including the 
harness system used for locomotor training in the overground gait track and over all 
treadmills, gait belt use for assessments, and emergency management of the EksoNR 
exoskeleton. In addition, three therapists within the Legs + Walking team have 
completed both Part 1 and Part 2 of the EksoNR standardized training program. 
Experienced physical therapists will lead the assessment and treatment sessions. 
Finally, all research and therapy staff members have been CITI-certified and have Basic 
Life Support (BLS) training. 
 
The PI of this study, Arun Jayaraman, PT, PhD, is Director of the Max Nader Center for 
Rehabilitation Technologies and Outcomes (RT&O Lab), within the Center for Bionic Medicine. 
Adequate dedicated office space is available for private meetings with potential participants, 
performing physical evaluations, explaining the study protocol, obtaining study consent, 
performing data analysis, and writing manuscripts.  
 
Feasibility of recruiting the required number of suitable participants within the agreed 
recruitment period:  
The planned number of participants is relatively small. Therefore, recruitment is not a concern.  

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11. Fujino Y, Amimoto K, Sugimoto S, et al. Prone positioning reduces severe pushing behavior: 
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15. Hornby, TG, Reisman, DS, Ward IG, et al. Clinical practice guideline to improve locomotor 
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