Randomized Control Trial Comparing Walking Task Specific Training With Stride Management Assist (SMA) Device vs.Functional Task Specific Training on Functional Walking Ability in Outpatient Stroke Rehabilitation
Phase: NA
Conditions: Stroke
Sponsor: Shirley Ryan AbilityLab

 
 
 
 
PROTOCOL TITLE 
Randomized Control Trial Comparing Walking Task Specific Training with Stride Management Assist 
(SMA) Device vs. Functional Task Specific training on Functional Walking Ability in Outpatient Stroke 
Rehabilitation. 
 
Principal Investigator:  
Arun Jayaraman, PT, PhD 
 
 
 
 
Department of Physical Medicine & Rehabilitation 
 
 
 
 
Northwestern University 
 
 
 
 
Rehabilitation Institute of Chicago 
 
 
 
 
345 E. Superior 
 
 
 
 
Chicago, IL 60611 
 
 
 
 
Ph: (312) 238-6875 
 
 
 
 
Fax: (312) 238-2081 
 
 
 
 
ajayaraman@northwestern.edu 
 
Sub-Investigator(s): 
 
Sangeetha Madhavan, PT, PhD 
 
 
 
 
Department of Physical Therapy 
 
 
 
 
University of Illinois at Chicago 
 
 
 
 
1919 W. Taylor (MC898),  
 
 
 
 
Chicago, IL 60612 
 
 
 
 
(312)3552517 
 
 
 
 
(312) 996-4583 
 
 
 
 
smadhava@uic.edu 
 
 
Biostatistician: 
 
Chaithanya K Mummidisetty 
 
 
 
 
Rehabilitation Institute of Chicago 
 
 
 
 
345 E. Superior 
 
 
 
 
Chicago, IL 60611 
 
 
 
 
(312) 238-1621 
 
 
 
 
(Fax) 238-2081 
 
 
 
 
Email: cmummidise@ric.org 
 
Study Drug/Study Device: 
Stride Management Assist designed and developed by Honda R&D 
Corporation 
 
 
Funding Source:  
Honda R&D Corporation and Max Nader Center Fund 
 
 
Initial version:  
 
[09/04/2013]  
Amended: 
 
 
[03/24/2014] 
 
 
 
Research Office 
Address

Study Number # STU00085161  
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TABLE OF CONTENTS 
STUDY SCHEMA ............................................................................................................................ 1 
STUDY SUMMARY ......................................................................................................................... 2 
1.0 
BACKGROUND AND RATIONALE ...................................................................................... 3 
1.1 
Disease Background ........................................................................................................ 3 
1.2 
Study Agent(s) Background and Associated Known Toxicities ....................................... 3 
1.3 
Rationale .......................................................................................................................... 4 
2.0 
STUDY OBJECTIVES ........................................................................................................... 4 
2.1 
Primary Objectives ........................................................................................................... 4 
2.2 
Secondary Objectives ...................................................................................................... 4 
2.3 
Endpoints ......................................................................................................................... 5 
3.0 
PATIENT ELIGIBILITY .......................................................................................................... 5 
3.1 
Inclusion Criteria .............................................................................................................. 5 
3.2 
Exclusion Criteria ............................................................................................................. 6 
4.0 
TREATMENT PLAN .............................................................................................................. 6 
4.1 
Treatment Dosage and Administration ............................................................................ 6 
4.2 
Duration of Therapy ......................................................................................................... 6 
4.3 
Duration of Follow Up ...................................................................................................... 7 
4.4 
Removal of Patients from Protocol Therapy .................................................................... 7 
5.0 
STUDY PROCEDURES ......................................................................................................... 7 
5.1 
Screening/Baseline Procedures ...................................................................................... 7 
5.2 
Procedures During Treatment ......................................................................................... 7 
5.3 
Time and Events Table .................................................................................................. 14 
5.4 
Removal of Subjects from Study ................................................................................... 14 
6.0 
RESPONSE CRITERIA/ OUTCOME MEASURES ............... Error! Bookmark not defined. 

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6.1 
Potential Risks ................................................................. Error! Bookmark not defined. 
 
7.0 
DRUG/DEVICE INFORMATION .......................................................................................... 15 
7.1 
Agent/Device ............................................................................................................... 155 
8.0 
STATISTICAL CONSIDERATIONS .................................................................................. 16 
8.1 
Study Design/Study Endpoints ...................................................................................... 16 
8.2 
Sample Size and Accrual .............................................................................................. 16 
8.3 
Data Analyses Plans ...................................................................................................... 16 
9.0 
STUDY MANAGEMENT .................................................................................................... 16 
9.1 
Data Management and Monitoring/Auditing .................................................................. 16 
9.2 
Record Retention ........................................................................................................... 16 
10.0 
REFERENCES ................................................................................................................... 17 

Study Number # STU00085161  
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STUDY SCHEMA 
Design 
Individuals with mild-moderate Stroke currently enrolling in out-patient physical 
therapy can participate in the study.   
 
29 enrolled in SMA Arm  
 
 
 
 
            
 
                                       
      
 
 
 
40 enrolled in SMA Arm 
training 3 times /wk ‐ 6‐8 
weeks total (18 visits max)
45‐60 minutes sessions
Services not billed to 
insurance
Training done at RIC flagship  
& 17th floor
Assessments at visits 0,10,18 
weeks & 3 months post 
40 enrolled in IPT Arm
training 3 times /wk ‐ 6‐8 
weeks total (18 visits max)
45‐60 minutes sessions
Services not billed to 
Insurance
Training at 12th floor, 
Northbrook, Willowbrook
Assessments at visits 
0,10,18 & 3 months post
Randomize to either SMA or IPT 

Study Number # STU00085161  
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STUDY SUMMARY 
Title 
Randomized Control Trial Comparing Walking Task Specific Training with 
Stride Management Assist (SMA) Device vs. Functional Task Specific 
training on Functional Walking Ability in Outpatient Stroke Rehabilitation. 
 
Short Title 
Impairment vs. Functional Walking Training in Sub-Acute and Chronic 
Stroke (match this to title used it ClinicalTrials.gov) 
Protocol Number 
STU00085161 
Methodology 
Randomized Controlled Trial with 2 arms 
Study Duration 
1 year 
Study Center(s) 
Single site, multiple clinics within RIC’s flagship hospital and it’s 
outpatient clinics 
Objectives 
Determine if Honda Stride Management Assist vs. traditional Functional 
Gait Therapy increases Gait speed and function post stroke  
Number of Subjects 
80 
Diagnosis and Main 
Inclusion Criteria 
Cerebrovascular accident (CVA), post 30 days, Gait speed between 0.4 
m/s and 0.8 m/s, MMSE > 17, unsupported sitting >30 s, walk at least 
10m with up to max assist, follow instructions, physician clearance for 
participation 
Study Product(s), Dose, 
Route, Regimen 
Honda Stride Management Assist device in outpatient physical therapy  
Duration of administration 
18 Sessions of Outpatient Physical Therapy + 4 Sessions of  testing 
Reference therapy 
Traditional Functional Mobility Training Physical Therapy 
Statistical Methodology 
Multiple ANOVAs 
 
 
 

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1.0 
BACKGROUND AND RATIONALE 
1.1 
Disease Background 
Stroke is the leading cause of adult-onset of disability. Recent studies estimate 
that stroke affects about 795,000 people in the U.S. each year, resulting in a 
prevalence of over 6.4 million individuals1,2. A large proportion of these stroke 
survivors (up to 80%) experience considerable gait deficits, including reduced 
walking speeds and asymmetrical walking patterns, limiting their capacity for 
community ambulation3. These mobility deficits are due to a combination of 
numerous neuromuscular changes following the stroke including: reduced 
corticospinal drive and control, muscle atrophy and weakness, impaired balance 
and posture control, abnormal muscle synergies, and visuo-cognitive deficits.  
 
The goal of post-stroke rehabilitation is to reintegrate individuals back to their 
highest level of function for employment, social and community participation4. 
The return of mobility and walking is a crucial part of this return to function5. Gait 
training has been a major focus of stroke rehabilitation4, with self-selected 
walking speed considered to be one of the most important measures of stroke 
rehabilitation. It is thought to be a predictor of health status, community mobility, 
social interaction, and overall quality of life. Stroke survivors are currently 
classified based on their self-selected walking speeds as: non-ambulators 
(unable to walk), limited household ambulators (<0.4m/s), limited community 
ambulators (0.4-0.8m/s), and community ambulators (>0.8m/s)6. These walking 
speeds are however significantly lower than those exhibited by healthy controls 
(1.3-1.5 m/s)7.  
 
Physical rehabilitation has many methodological approaches to training post 
stroke. The 2 most commonly applied techniques are task specific training, in this 
case gait training and impairment based training, which is more focused on 
balance, and functional deficits. The use of unconstrained robotic exoskeletons 
may allow gait retraining to be integrated with activities of daily living. However, 
there are very few studies that looked at the impact of a robotic exoskeleton on 
walking performance in the mild-moderate-stroke population8,9. This study will 
compare task specific training using a robotic exoskeleton SMA vs. IPT 
impairment based physical therapy in the outpatient setting for individuals post-
stroke. 
 
1.2 
Study Agent(s)/Devices Background  
 
The Stride Management Assist (SMA) System is a robotic device developed by 
Honda R&D Corporation ®, Japan (http://corporate.honda.com/innovation/walk-
assist/).   

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This robotic device assists hip flexion and extension, for each side 
independently. It is controlled through software run on a tablet. The device 
weighs 2.8 kgs, and has 2 brushless DC motors running on a rechargeable 
lithium ion battery. It comes in 3 sizes (small, medium and large). It is worn 
around like a belt with the motors near the hips and straps on the thighs. The 
SMA device allows users to increase their stride length by providing assist with 
the motors in flexion and extension. This device is 1) simple to use in the clinical 
setting; 2) easily adjustable to alter according to the requirements of each 
subject; and, 3) can quantify the amount of assistance required to facilitate 
walking patterns.  
1.3 
Rationale 
 
There is substantial evidence that post stroke recovery can last for greater than a 
year3. Due to cost pressures, various forms of therapies have been assessed for 
their effectiveness and efficiency. Task specific training post stroke has been 
found to be a very effective strategy for gait retraining10,11. Impairment based 
physical therapy is another methodology practiced in clinical settings where the 
training is based on progressive strength and balance exercise program in the 
outpatient setting12. The SMA group (task specific training) will be trained to 
simulate the demands of overground walking. The impairment based group will 
match the SMA group in intensity but will be focused on balance and other 
functional goals rather than explicitly on walking. The rationale of this study is to 
assess task specific training with SMA vs. impairment based training. To this 
end, we will use the Stride Management Assist device by Honda Corporation and 
compare it to impairment based physical therapy in outpatient sessions.  
 
The enhancement of corticospinal excitability may help account for the long-term 
plasticity and improved motor control in people with stroke. To study this, we will 
measure corticospinal excitability of the lower limb muscles using Transcranial 
Magnetic Stimulation TMS. TMS is a safe and non-invasive method that has 
been widely used to study cognition, brain-behavior relations and the 
pathophysiology of various neurologic and psychiatric disorders. 
 
 
2.0 
STUDY OBJECTIVES 
2.1 
Primary Objectives 
2.1.1 
To determine the effect on gait speed, as assessed by the 10 meter walk 
test of the SMA device vs. traditional physical therapy care in an 
outpatient setting for post stroke individuals. 

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2.2 
Secondary Objectives  
2.2.1 
To determine the effect on functional walking endurance as assessed by 
the 6 minute walk test, of task specific training with the SMA device vs 
impairment based physical therapy in an outpatient setting for post 
stroke individuals.  
2.2.2 
To determine the effect on functional balance, as assessed by the Berg 
Balance Scale, Functional Gait Assessment and Five times sit to stand 
measure as assessed by the 6 minute walk test, of task specific training 
with the SMA device vs. impairment based physical therapy in an 
outpatient setting for post stroke individuals. 
2.2.3 
To determine the effect on stroke recovery, as assessed by the step 
counter of task specific training with the SMA device vs. impairment 
based physical therapy in an outpatient setting for post stroke 
individuals. 
 
2.2.4 
To determine the effect on descending corticospinal drive to the lower 
limb muscles in training with the Stride Management Assist (SMA) device 
vs. impairment based physical therapy in an outpatient setting for post 
stroke individuals. 
 
2.3 
Endpoints 
The outcome measures will be assessed prior to the start of Outpatient Therapy, 
after 9 Outpatient PT visits , after 18 sessions and a 3 month follow up testing 
visit, which will be the endpoints of the study;  
 
3.0 
PATIENT ELIGIBILITY 
Potential subjects will be recruited from RIC’s scheduling for outpatient physical therapy. 
They will be consented and must fulfill the following criteria: 
3.1 
Inclusion Criteria 
 
≥ 30-days post stroke 
 
Age: 18-85 Years 
 
Initial gait speed of > 0.4 m/s and < 0.8 m/s 
 
Adequate cognitive function (MMSE score >17) 
 
Subject is willing to be randomized to the control group or the treatment 
group. 
 
Ability to sit unsupported for 30 seconds 
 
Ability to walk at least 10m with maximum 1 person assist, 
 
Ability to follow a three-step command 
 
Physician approval for patient participation 
 
Living in the community post-stroke with ability to travel to the intervention 
site to participate in the outpatient program and able to perform the HEP 
program in the residential facility. 
 
Willing to carry wireless body sensors through the period of the study and to 
follow-up time period, post inpatient stroke, cardiac, pulmonary, or any other 
lower extremity physical rehabilitation  

Study Number # STU00085161  
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 
≥ 90 days post major orthopedic surgery (i.e. hip, knee, and/or ankle joint 
replacement) 
 
≥ 6 months post CABG or cardiac valve procedure 
 
Able and willing to give written consent and comply with study procedures, 
including follow-up visits 
 
Willing to participate in two Transcranial Magnetic Stimulation sessions if 
they meet compatibility requirement. 
 
Cannot not be participating in any other structured outpatient or home health 
physical therapy program 
 
3.2        Exclusion Criteria 
 
Serious cardiac conditions (hospitalization for myocardial infarction or heart 
surgery within 3 months, history of congestive heart failure, documented 
serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, 
severe aortic stenosis, angina or dyspnea at rest or during activities of daily 
living) 
 
Severe arthritis or orthopedic problems that limit passive ranges of motion of 
lower extremity (knee flexion contracture of > 10°, knee flexion ROM < 90°, 
hip flexion contracture > 25°, and ankle plantar flexion contracture > 15 
 
Serious medical conditions including myocardial infarction or heart surgery 
within 3 months, history of congestive heart failure, documented serious and 
unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic 
stenosis, angina or dyspnea at rest or during activities of daily living, Severe 
hypertension, severe weight bearing pain, life expectancy less than one year 
 
Preexisting neurological disorders such as Parkinson's disease, Amyotrophic 
Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia 
 
History of major head trauma, Lower extremity amputation,  Non-healing 
ulcers of a lower extremity, Renal dialysis or end stage liver disease, Legal 
blindness or severe visual impairment, a history of significant psychiatric 
illness 
 
Pacemakers, metal implants in the head region 
 
History 
of 
unexplained, 
recurring 
headaches, 
epilepsy/seizures/skull 
fractures or skull deficits 
 
Medications that lower seizure threshold 
 
History of concussion in last 6 months  
 
Subject is pregnant, nursing or planning a pregnancy 
 
Inability to travel 3 times per week for outpatient training programs 
 
Participating in another clinical trial that, according to the Principal 
Investigator, is likely to affect study outcome or confound results 
 
4.0 
TREATMENT PLAN 
4.1 
Treatment Sessions 
Once subjects have been consented and they meet study inclusion and exclusion criteria, 
they will be randomly placed into either the SMA group or impairment based (IPT) group. 
The Physical therapy treatment sessions will follow the guidelines below: 
 
 
IPT group 
o 
Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). 
Treatment will be divided into: 15 min balance training, 15 minutes functional 
mobility (transfers, strength or flexibility training) and 15 min high intensity gait 
training 

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 
SMA group 
o 
Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait) 
o 
Treatment consists of 30minutes high intensity gait training with device, 15 
minutes functional mobility with device (eg stairs, ramps, curbs, uneven surfaces, 
indoors, outdoors) 
4.2 
Duration of Therapy 
The Outpatient physical therapy sessions will last for a maximum of 18 visits per 
subject.  
4.3 
Duration of Follow Up 
The study will collect data at 3 points: baseline before entry into therapy session, 
midway through the therapy session after 9 visits and after 18 visits. There is to 
be no follow up after the post 18th session testing. 
4.4 
Removal of Patients from Protocol Therapy 
Patients may be removed from therapy if there is a change in medical status. The 
Principal Investigator may also decide if the patient is unable to continue for any 
extenuating circumstances to remove the subject from the study, and document 
the reason for study removal and the date the patient was removed in the Case 
Report Form.  
 
5.0 
STUDY PROCEDURES 
5.1 
Screening/Baseline Procedures 
Subjects will be randomized into 2 separate groups, either SMA or IPT. We will enroll 80 
subjects, 40 in each group, planning for a 30% attrition rate. These subjects will be 
recruited when they are referred to RIC’s stroke rehabilitation outpatient clinics at RIC’s 
flagship at 345 E. Superior St. 12th floor, or RIC Northshore in Northbrook IL or RIC 
Willowbrook in Willowbrook, IL. We will also recruit from local physicians or RIC’s Clinical 
Neuroscience Research Registry for subjects who are potential candidates for outpatient 
physical therapy. They will be directed to a physical therapist who will inform them of the 
time commitment required and questioned regarding the inclusion/exclusion criteria. 
Once subjects have agreed to participate in the study, they will come to RIC and be 
consented at one of the clinics at the Rehabilitation Institute of Chicago. Study staff will 
explain the study, a written consent form will be signed by the subject and witnessed by 
study researchers, a copy will be given to the subject and a copy will be kept in the 
subject's folder in a secure, locked cabinet in the lab's locked office.  
After consenting, subjects will undergo a physical evaluation and screening exam by a 
licensed PT. If they meet study criteria, they will be randomly placed into either the SMA 
group or the IPT group using a random number generator and they will be entered into 
the study. Once they are enrolled, baseline outcome measures will be assessed by a 
blinded research PT.  
 
In addition, subjects will have a baseline measure of their cortical excitability through 
TMS. This will be conducted at University of Illinois, Department of Physical Therapy. 
TMS sessions will last approximately 2 hours.  
 
 

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5.2 
Procedures during Treatment 
After the baseline testing is completed, subjects will begin 18 sessions of PT training in 
the outpatient clinic with a licensed RIC clinical PT. These sessions will last from 45 to 60 
minutes. Their sessions will be recorded in RIC’s electronic documentation system 
Cerner.  
A blinded research physical therapist will test the outcome measure at baseline, Mid 
Testing after Session 9 , at Post Testing after Session 18 and at 3 month follow up 
testing after Session 18.  
 
 
IPT 
group 
Baseli
ne 
TMS 
Baseline 
testing  
(blinded 
PT) 
Session
s 
1-9  
3 x wk  
Mid 
Testing 
(blinded 
PT) 
Session
s 10-18  
3 x wk 
Post 
testing 
TMS 
Post 
testing 
(blind
ed 
PT) 
Follow up 
testing 
(blinded 
PT) 3 
months 
post 
SMA 
group 
Baseli
ne 
TMS 
Baseline 
testing  
(blinded 
PT) 
Session
s 
1-9  
3 x wk  
Mid 
Testing 
(blinded 
PT) 
Session
s 10-18  
3 x wk 
Post 
testing 
TMS 
Post 
testing 
(blind
ed 
PT) 
Follow up 
testing 
(blinded 
PT) 3 
months 
post 
 
The TMS protocol 
We will test descending corticospinal drive to the rectus femoris, vastus lateralis, 
lateral hamstrings, tibialis anterior, and medial gastrocnemius muscles. These 
muscles have the biggest representation in the motor cortex and are most 
involved during the gait cycle. 
 
Maximum Voluntary Isometric Contractions (MVIC): Before beginning the TMS 
protocol, an estimate of MVIC will be obtained for each muscle with the subject 
positioned in sitting on a chair, with the knee joint at 90 degrees of flexion and 
ankle in neutral position. Manual resistance will be provided by one of the 
investigators as the subject tries to extend or flex the knee, dorsiflex  or 
plantarflex the ankle. Subjects will then be seated with the feet constrained by 
flexible 4.0 kg weights placed over the dorsum of each foot. The subject will be 
given real time feedback of muscle activity to match a target contraction 
corresponding to 10% MVIC for individual muscles during TMS measurements 
(details below).  
 
Transcranial Magnetic Stimulation (TMS):  TMS is a safe, non-invasive, painless 
method of brain stimulation that has been widely used to study the physiology of 
the representations of muscles in the motor cortex in healthy and neurologically 
disordered individuals13. Very short duration (< 1 ms) magnetic pulses are 
applied via an insulated wire coil placed on the intact scalp overlaying the motor 
cortical area projecting to a target muscle. Each pulse induces a motor evoked 
potential (MEP) in a target muscle that can be readily monitored by recording 
Electromyogram EMG from that muscle. A figure-of-eight or double cone coil is 
typically used to deliver focal magnetic pulses to a number of scalp sites over the 
cortical area representing a muscle of interest.  
 
Self-adhesive disposable electrodes (Delsys) with an inter-electrode distance of 
2 cm will be applied over the muscle bellies of the quadriceps, hamstrings, ankle 
dorsiflexors and ankle plantarflexors in the lower extremity.  A ground electrode 
will be applied over the patella. Standard skin preparation techniques (light 

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abrasion and cleansing with alcohol) will be completed prior to application of the 
electrodes. EMG recordings will be amplified (Delys, Bagnoli EMG), band-pass 
filtered (10-1000 Hz), and sampled at 5000 Hz. Electromyographic (EMG) activity 
will be collected from the all the muscles bilaterally. Magnetic stimuli will be 
delivered via a double cone coil/figure of eight connected to a Magstim 200 unit 
(Magstim Company, Boston MA). The resting and active threshold for TMS will 
be determined for each subject. TMS measurements will involve generating 
motor evoked potentials (MEP) for each muscle from two different coil positions – 
2cm on either side of the vertex. Motor evoked potentials (MEPs) at intensities 
ranging from 70 – 140% active threshold will be generated for each muscle from 
each coil position. A figure-of-eight or double cone coil will be used to deliver 
focal magnetic pulses. Resting motor threshold for the muscle of interest in will 
be defined as the stimulator output intensity that can elicit motor evoked 
potentials (MEPs) with peak-to-peak amplitude more than 50 µV in four out of 
eight trials. It will be determined by increasing stimulus intensity in steps of 1% 
stimulator output.  Active thresholds will be determined with the same protocol, 
however with the subject contracting the muscle of interest to about 10% of 
maximum voluntary contraction. Subjects will receive approximately 100 – 150 
pulses of stimulation. These measures will assist the investigator and co-
investigators in generating recruitment curves which will help assess the 
corticospinal excitability of the ipsilateral and contralateral motor cortex to each 
lower limb muscle. 
 
 
 
 
 

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The sessions of physical therapy will be customized for each individual based on the group they 
are placed. 
 
For the IPT group: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Balance IPT OG 15 
min 
Sitting balance 
 
Reaching 
 
Perturbations 
Progress to standing 
Change stance: 
 
Static 
 
Dynamic 
 
Double limb stance 
 
Romberg 
 
Tandem 
 
Semi-tandem 
 
Unilateral Single limb 
stance 
Change surface: 
 
Balance board 
 
Foam cushions, half 
foam roll  
 
Bosu ball 
 
Balance beam 
 
With/without AFO 
Dual Tasking: 
 
Ball catch 
 
Cognitive tasks 
 
Reading, visual 
attention  
 
Perturbations  
 
Dynamic Gait OG IPT 
15 min  
Change surface/stance: 
 
Level surfaces 
 
Over obstacles 
 
Over compliant 
surfaces 
 
Tandem walk 
(forwards/backwards) 
 
With/without AFO 
Multidirectional walking: 
 
Backwards 
 
Sidestepping 
 
Tandem 
Dual tasking: 
 
Ball catch 
 
Ball bounce 
 
Cognitive tasks 
Other: 
 
Increased speed 
 
Pivot turn 
 
Balance beam 
 
Perturbations  
 
Increase distance 
 
Assistive device 
progression 
 
Reduction in physical 
assist progression 
 
Functional Mobility 
– IPT OG 15 min 
 
Sit to stand transition 
 
Functional up right 
postures 
 
Reaching 
 
Step up and step 
down 
 
Stairs 
 
Ramps, curbs  
 
Weights/Theraband 
 
Stretches 
 
 
To customize the 
program, the 
therapist may adjust 
the time between the 
Balance, Dynamic 
Gait & Functional 
Mobility needs of the 
patient.  

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For the SMA group: 
 
 
 
 
 
 
Dynamic Functional Gait 
– SMA OG 45 min  
 
 
Change surface/stance: 
 
Level surfaces 
 
Over obstacles 
 
Over compliant surfaces 
 
Tandem walk 
(forwards/backwards) 
 
With/without AFO 
Multidirectional walking: 
 
Backwards 
 
Tandem 
Dual tasking with gait: 
 
Ball catch 
 
Ball bounce 
 
Cognitive tasks 
Other Gait challenges: 
 
Increased speed, stopping 
and starting  
 
Pivot turns 
 
Balance beam 
 
Perturbations 
 
Obstacles 
 
Increased distance 
 
Assistive device 
progression 
 
Reduction in physical 
assist progression 
Functional up right 
postures 
 
Stairs 
 
Ramps, curbs 
 
Outdoors/community 
ALL training  for both 
groups will be High 
Intensity Training  
 
 
 
Intensity: RPE minimum 
12 up to 16 on 6-20 RPE 
scale 
 
 Or HR up to 75% of Age 
predicted max (220-age) 
 
PT will consider Beta 
blockers and Ca channel 
clockers for HR 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Home Exercise 
Program 
 
 
 
 
Will be customized 
based on same 
parameters for both 
groups: on high 
intensity gait 
training 
 
Intensity 12-16 
RPE or HR 70% 
APMHR 
 
Frequency & 
Duration– initially 
determined by PT 
according to pt’s 
functional ability 
 
To work towards 45 
min/once a day/at 
12-15RPE at d/c 

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Response Criteria / Outcome Measures:  
 
The following outcome measures will be evaluated for both the groups at testing points at 
baseline, mid-testing , post-testing and follow-up testing. 
 
Clinical Performance Outcome Measures: 
 
1. 6 Minute Walk Test: 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 distance for people with sub-acute stroke is 60.98 meters.14   
 
2. 10 Meter Walk Test: The 10mWT assesses walking speed in meters per second 
over a short duration. Changes in gait speed that result in a transition to a higher 
category of ambulation classification resulted in better function and quality of life15. In 
the 10mWT, subjects are directed to walk at their self-selected and maximum safe 
speed with the effects of acceleration and deceleration minimized (by adding 1 meter 
at the beginning and at the end of the course to isolate the subject’s steady state 
speed). Any assistive device and orthotic should be kept consistent and documented. 
It should also be documented whether the gait is tested at “preferred walking speed” 
or “fastest walking speed”. The 10mWT has been validated for the stroke population 
and is accepted as a responsive, functional measurement of the patient’s ability to 
ambulate over short distances such as those typical to a household setting.  A small 
meaningful change for people with stroke is 0.06 meters/second; a substantial 
meaningful change is 0.14 meters/second14. A speed of <0.4 and >.08 m/s is an 
exclusion in the study.  
 
3. Berg Balance Scale (BBS): The BBS is a 14-item objective measure designed to 
assess static balance and fall risk in adult populations and is a well-accepted 
measure in the stroke literature. The functional activities that are assessed include 
sitting and standing balance during transfers, altered base of support, reaching, 
turning, eyes open and closed. Each item is scored from 0 to 4 points. The maximum 
score is 56 points. A score from 0 to 20 represents balance impairment, 21 to 40 
represents acceptable balance, and 41-56 represents good balance. The minimal 
detectable change score for individuals with acute stroke is 6.9 points16 and 4.66 
points in chronic stroke17. 
 
4. 5 Times Sit to Stand Test (5xSST): The 5xSST is used to measure functional lower 
extremity strength during the transitional movement of sit to stand. The individual is 
timed in moving from the start position of sitting, arms across chest, in a standard 
chair without armrests to fully standing five times. The minimal detectable change in 
individuals with chronic stroke is 3.6 seconds.18 
 
5. Gait Analysis: A quantitative means of assessing gait function in adults post-stroke 
based on spatiotemporal parameters of gait. The GaitRite® system is an electronic 
walkway with integrated sensors and is considered a reliable and valid means of 
assessing gait changes poststroke. 
 
6. 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 stroke.19 The maximum score is 30 points; minimal detectable change for 
chronic stroke is 4.2 points.20 

Study Number # STU00085161  
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13 
7. Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA): The purpose of 
the FMA is to evaluate and measure recovery in post-stroke hemiplegic patients. 
There are five domains assessed on a 3 point ordinal scale from 0-2. “0” is equal to 
“cannot perform”, “1” is equal to “performs partially”, and “2” is equal to “performs 
fully. The domain for lower extremity motor function will be used. It has been found to 
be reliable and valid in assessing individuals with stroke with a minimal clinically 
important difference of 10 points for the lower extremity motor scores.21 
             Self-Reported Measures: 
 
8. Modified Falls Efficacy Scale (mFES): The mFES is a 14 item self-report survey 
that assesses an individual’s perception of balance and stability during indoor and 
outdoor activities of daily living. The mFES is a 10 point numerical rating scale with 
higher scores indicating higher confidence in the performance of the activity.  
 
9. Activities- specific and Balance Confidence Scale (ABC): The ABC is a 16-item 
self-report questionnaire that measures confidence in performing various ambulatory 
activities without falling. Items are rated on a scale ranging from 0-100, with zero 
representing no confidence and 100 representing complete confidence. It has good 
to excellent reliability and adequate construct validity, correlating with the BBS and 
10mWT.22 
 
10. Stoke Impact Scale (SIS): The SIS is a validated measure of the impact of stroke on 
overall physical and cognitive function. This 59-item patient-based questionnaire 
assesses eight domains of stroke recovery: strength, mobility, communication, 
emotion, memory and thinking, participation, activities of daily living/instrumental 
activities of daily living (ADL/IADL) and hand function. An additional question requires 
the patient to rate their stroke recovery on a scale from 0 to 100. This measure 
instructs subjects to answer the question based on the period of time two-four weeks 
prior to the questionnaire. 
 
11. Community Participation Indicators (CPI): The CPI is an eighty-item self-report 
questionnaire that assesses the individual’s satisfaction with their community 
participation. 
 
12. Visual Analog Scale or Numeric Pain Rating Scale: The 0-10 rating scale for pain 
is used to gain a subjective report of the intensity of a person’s pain. Zero represents 
“no pain” and ten represents “the most intense pain imaginable”. A meaningful 
change would be plus or minus 3 points. 
 
13. Patient Health Questionnaire-9 (PHQ-9): The PHQ-9 is a 9-item self-report 
screening assessment for depression. It is the depression module of the Diagnostic 
and Statistical Manual (4th edition). Each item is scored from 0-3; total scores may be 
0-27, with higher scores representing increased severity of depression. 
 
14. Stroke Specific Quality of Life (SSQoL): The SSQoL is a self-report questionnaire 
that is accepted as a reliable and valid way to assess health-related quality of life 
specific to stroke survivors. Subjects respond to 49 questions in 12 domains: mobility, 
energy, upper extremity function, work/productivity, mood, self-care, social roles, 
family roles, vision, language, thinking, and personality. Each item is rated on a 5-
point Likert scale, with higher scores indicating better functioning. Domains scores 
(un-weighted average of item scores) and a summary score (un-weighted average of 
all 12 domain scores) are computed. 
 

Study Number # STU00085161  
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14 
15. TMS: will assist researchers in generating recruitment curves which will help assess 
the corticospinal excitability of the ipsilateral and contralateral motor cortex to each 
lower limb muscle. 
16.  
5.3 
Time and Events Table 
 
 
 
Consent, 
Baseline 
Sessions  
1-9 
Mid 
Testing 
Sessions 
10-18  
Post 
Testing
Follow 
up 
Inclusion Exclusion  
X 
 
 
 
 
 
Informed Consent 
X 
 
 
 
 
 
History and PE 
X 
 
 
 
 
 
SMA 
protocol 
or 
IPT protocol 
 
X 
 
X 
 
 
Clinical 
performance 
measures 
X 
 
X 
 
X 
X 
Self-Reported 
Measures 
X 
 
 
 
X 
X 
TMS 
X 
 
 
 
X 
X 
5.4 
Removal of Subjects from Study 
5.4.1 
Patient voluntarily withdraws from treatment  
5.4.2 
Patient withdraws consent (termination of treatment and follow-up); 
5.4.3 
Patient is unable to comply with protocol requirements 
5.4.4 
Patient demonstrates change in medical condition 
5.4.5 
Patient experiences adverse event that makes continuation in the 
protocol unsafe; 
5.4.6 
PI judges continuation in the study would not be appropriate; 
5.4.7 
Patient becomes pregnant  
6.0 
ADVERSE EVENTS 
6.1 
Potential risks 
6.1.1 
The risk of falling: This could be caused by loss of control of the training 
activity by the participant or therapist as well as malfunction of the SMA 
device itself. The risk of falling will be minimized by having RIC licensed 
PT personnel conduct the participant training sessions with manual 
assistance, gait belt, assistive devices such as cane or a walker as 
needed. This risk is similar to that during any clinical outpatient physical 
therapy session. 
6.1.2 
Discomfort, skin pressure/friction, bruising, pain, or unusual swelling 
caused by the exoskeleton which has the potential to lead to skin 
breakdown or abrasions. This risk will be minimized by a thorough skin 
check performed by RIC’s experienced licensed physical therapy 
personnel at each session. Adjustments to the sizing and placement of 

Study Number # STU00085161  
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15 
additional padding will be assessed to decrease the risk of skin 
breakdown as well. 
6.1.3 
The device itself could malfunction. The device delivers 6-8 Nm (Newton-
meter) of torque, which give a gentle assist to movement. In the event of 
device malfunction, this force will be absent and the subject will be given 
with physical assistance if required, and the patient will be able to safely 
transfer out of the device, if required. Research engineers will ensure 
that the device has been maintained according to specifications and the 
software is always in working order. 
6.1.4 
Muscle soreness from exercises during therapy sessions. All subjects 
will work with RIC’s licensed physical therapy personnel and will be 
initiated with testing and therapy sessions with simple activities, 
progressing on to more dynamic, complex activities when it is clear that 
they are safe and acclimated to the protocol being used. To manage this, 
subject will be provided with adequate rest periods and subjects will be 
monitored by questions regarding discomfort. 
6.1.5 
Risks associated with TMS:  
There are certain populations who have a risk of seizures following 
TMS. Individuals will be screened using the TMS safety checklist. Single 
pulse TMS has been deemed to "carry little risk beyond occasionally 
causing local discomfort" in healthy adult populations (Anand and Hotson 
2002). Our stimulation procedures follow published safety guidelines. 
Seizure activation is extremely unlikely with the single pulse low numbers 
of stimulation proposed in the current investigation. 
A small number of people find TMS uncomfortable, particularly at high 
intensities of stimulation. If subjects report feelings of discomfort 
stimulation intensity will be reduced or, if not feasible, testing will be 
terminated. The "clicking" noise associated with stimulation may also be 
uncomfortable for some individuals. All subjects will be provided with 
protective ear-plugs during stimulation. 
There is a possibility that a subject could develop muscle soreness or 
fatigue from holding a tonic contraction. If shoulder, wrist or leg pain 
occurs as a result of the experiment, we will withdraw the subject from 
the study. During testing, there is also a possibility that a subject may 
experience irritation due to the nerve stimulation or EMG electrodes or 
electrode gel. 
7.0 
DEVICE INFORMATION 
7.1 
Device  
 
Other names for the device: Walking Assist Device with Stride Management 
System 
 
 
Classification - type of device: Walking Assist Device 
 
 
Mode of action: This device is a light weight design with 2 DC motors can 
generate torque up to 6 Nm, worn around hips and thighs to provide 
assistance during walking.  

Study Number # STU00085161  
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16 
 
 
Storage and stability: Weighs 2.8 kgs and easy to store in a cabinet 
 
 
Protocol dose: 45-60 min sessions ,3x/week for 6-8 weeks 
 
 
Preparation: Belt like device to be worn around hips and thighs 
 
 
Availability: Provided by Sponsor (free of Charge) 
 
 
8.0 
STATISTICAL CONSIDERATIONS 
8.1 
Study Design/Study Endpoints 
This proposed study is a randomized control trial to compare Task Specific 
Training with SMA and Impairment based Physical Therapy on Functional 
Walking Ability in Outpatient Stroke Rehabilitation setting. 
8.2 
Sample Size and Accrual 
A total enrollment of 80 subjects is estimated for this study. Each enrolled subject 
is randomly assigned to either one of the groups (SMA or IPT; 40 participants per 
group). A detailed description of study procedures and study endpoints are 
provided in section of 5.0   
8.3 
Data Analyses Plans 
The outcome measures for each subject (listed in Section 5.2) are recorded 
during 0th, 10th and 18th session of the training cycle and at 3 month follow up 
visit. Photographs and video without individual subject’s faces will be recorded as 
this device is not commercially available yet and dissemination of accurate 
information will be assisted by showing how the device operates when donned 
and used by subjects Outcome measures are compared with in the subject and 
across the subject pools for statistical significant differences using Multiple 
ANOVAs. All the statistics will be performed at 90% confidence level. 
9.0 
STUDY MANAGEMENT 
9.1 
Data Management and Monitoring/Auditing 
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.  
 
9.2 
Record Retention 
Study documentation will be collected and kept confidential and compliant with 
HIPPAA requirements. Photographs and video without recording individual 
subject’s faces will be recorded as this device is not commercially available yet 
and dissemination of accurate information will be assisted by showing how the 
operates when donned and used by subjects. Data will be held for 3 years after 
the study is completed and published.  
 

Study Number # STU00085161  
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17 
10.0 
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