The Integration of Motor Learning Principles to Reduce Load Asymmetry Using a Novel Robotic Device in Individuals Chronically Post-Stroke
Phase: NA
Conditions: Stroke
Sponsor: Columbia University

NCT03203291 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Official Title: Reducing Asymmetry During Gait Using the TPAD (Tethered 
Pelvic Assist Device) for Stroke Patients 
 
 
Version Date:  February 28, 2017 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PDF/A 
 
 
 
 

TITLE: The Integration of Principles of Motor Learning to Reduce Load 
Asymmetry Using a Novel Robotic Device in Individuals Chronically Post- 
Stroke 
 
 
Standard Operating Procedure - Study Protocol Manual 
 
Prepared By: Lauri Bishop, PT, DPT 
 
 
 
 
Doctoral Committee: 
Sponsor: Lori Quinn, EdD 
Committee Member: Richard Magill, PhD 
Committee Member: Sunil Agrawal, PhD 
 
Collaborating Researchers: 
Joel Stein, MD 
Moiz Khan, MS 
Adam Blanchard, MS 
Lynne Weber, MA, OTR/L 
 
 
 
*All study related procedures involving participants will take place within the Department 
of Rehabilitation & Regenerative Medicine, Columbia University Medical Center. This is 
located on the 1st Floor of the Harkness Pavilion at 180 Ft. Washington Ave. New York, NY 
10032. 
 
*Study related procedures including advisement, data analysis and manuscript preparation 
will take place at two locations. These will include Columbia University Medical Center (as 
listed above) and at Teachers College, Columbia University within the NeuroRehabilitation 
Lab. This is located on the 10th Floor of Thorndike at 525 West 120th St. New York, NY 
10025. 

Table of Contents 
 
 
 
I.         Project Summary/ Abstract……………………………………..….………  2 II.          
Research Questions……………………………………………………..….…..  3 
III. 
Study Design/ Methodology……………………….………..……..….…… 3 
IV.      Outcome Measures.…………………………………….………….……………  3 V.          
Study Population………………………………………………………..….……   4 
VI.         Procedures …………………………………………………………………...……   4 
a. Informed Consent Process……………….……….…………..……… 4 
b.  Overall Study Schema…………………………………………....……..   5 c.    
Assessments………………………………………………….……..……….   6 
i. Overground Assessments…………………………….…….   7 
1.    Gait Assessments………………………...…….……   8 
2.   Balance Assessment…………………..………….. 
15 
ii. Treadmill Assessments……………………..………….….. 
16 
d.   Intervention……………………………………………………..…….…….    18 
i.   Set up……………………………………………....…………….…. 
18 
ii. Treadmill Training…………………………………….…….. 20 
1. Visual Feedback Instructions…………….….. 21 
2. Visual Feedback Schedule………………..……. 22 
iii. Overground Training……………………………………….. 24 
 
VII. 
Participant Withdrawal……………………….……………………………. 
25 
VIII. 
Risks/Benefits…………………………………….…………………………….. 
25 
IX. 
Data Management/Storage………………….……….…………………… 
25 
X. 
Adverse Event Reporting…………………….……….…………………… 
26 
XI. 
Statistical Analysis…………………………..………………..……………… 
26 
XII. 
Dissemination of Results…………………...………………………..……. 
26 

I. Project summary / Abstract 
 
BACKGROUND: Hemiparesis, spasticity and reduced motor control are typical 
impairments after stroke and commonly contribute to motor deficits that affect gait. These 
deficits manifest as reduced velocity, decreased cadence and asymmetries in temporal, 
spatial and force parameters during ambulation. Robotic-based therapies have been used 
to increase gait velocity and reduce asymmetry in a population of individuals after stroke, 
however these therapies have demonstrated results similar to that of conventional  
training. This is possibly due to guided-assist control strategies used to deliver robotic 
training, which strategies limit participant involvement and thus constrain motor learning. 
The TPAD is a robotic device that employs actuated tethers at the user’s pelvis to 
guide the user’s pelvis along a pre-set movement trajectory. The TPAD tethers can be 
configured in an infinite array of possibilities, and most recently have been used to increase 
loading onto the paretic limb in a population of individuals after stroke. While other  
robotic devices guide the limb through the motor trajectory, and constrict the participants 
ability to participate in the motor planning and movement execution, the TPAD promotes 
weight shifting, but allows an individual to freely move the limb and to navigate 
spatiotemporal aspects of training independently. Further, if coupled with overground to 
focus on addressing a specific task goal, this device may prove useful to improve symmetry 
in individuals after stroke. 
 
OBJECTIVES: The purpose of this study is to evaluate the overall feasibility in terms of 
safety, treatment tolerance and adherence as well as address preliminary efficacy of 
implementing a treatment paradigm using the TPAD with visual feedback and overground 
training to reduce load asymmetry on the treadmill and promote increased stance 
symmetry on the paretic limb during overground gait. 
 
PARTICIPANTS: To account for 20% attrition, a total of 12 individuals in the chronic (>6 
months) stages post stroke will be recruited from a voluntary stroke research registry with 
anticipation that 10 individuals will complete participation. 
 
DESIGN: A non-randomized pilot study of feasibility will be used to establish the 
preliminary efficacy of using the TPAD in combination with overground training to reduce 
load force asymmetry in this population. 
 
METHODS: Participants will undergo a series of three assessments within a one week time 
frame prior to initiating intervention. Intervention using the TPAD and overground  
training will occur the following week for five consecutive visits. On completion of the final 
training visit, participants will be re-assessed, and return for a single follow up visit the  
next week for the final assessment. Each study visit will be approximately 1-1.5 hours in 
duration, and total participation should be completed within three weeks. 
 
EXPECTED OUTCOMES: We anticipate this training paradigm will prove feasible in 
reducing both load and stance asymmetry in a population of individuals with chronic 
stroke. 

 
II. Research Questions: 
1) Is a five day gait training program using the TPAD and incorporating augmented 
visual feedback and an overground walking component feasible in terms of 
safety, treatment tolerance, and adherence in individuals with chronic stroke 
who present with gait asymmetry? 
 
2) Is this training program effective at improving load force symmetry after five 
sessions? 
 
3) Is this training program effective at improving stance time symmetry in 
overground gait? 
 
 
III. Study Design/Methodology 
This is a single arm, non-randomized pilot study of feasibility. The study population and 
details of study procedures are specified below. 
 
IV. Outcome Measures 
A. Primary Outcomes 
 
Measures of Feasibility 
o Safety 
▪ Adverse Events / Serious Adverse Events 
o Adherence 
▪ Attendance Rates of Study Visits 
o Tolerance 
▪ Ratings of Perceived Exertion (RPE) 
▪ Heart Rate (HR) 
 
Efficacy 
o Overall Load Force Symmetry (over the course of training) 
o Stance Time Symmetry 
 
B. Secondary Outcomes 
 
Daily Load Force Symmetry (intraday changes in load force) 
 
Time in Double Support 
 
Swing Time Symmetry 
 
Stride Length Symmetry 
 
Stride Velocity Symmetry 
 
Gait Velocity 
 
Balance (as per the Berg Balance Scale) 

 
 
V. Study Population 
A total of 12 adults (ages 18-75) will be recruited for participation from a voluntary stroke 
registry, anticipating 20% attrition, or that at least 10 participants will meet criteria and 
complete study participation. 
 
Inclusion Criteria: 
 
Chronic (>6 months) stages post stroke 
 
History of a single stroke event (either ischemic or hemorrhagic by origin) 
 
Minimal score of 22 or higher on the MoCA 
 
Must be independent community ambulator (with/without AFO) 
 
May use a unilateral assistive device (cane, quad cane) 
 
Must have a notable asymmetry in stance time (defined by a symmetry ratio 
of 0.90 or lower) 
 
Exclusion Criteria: 
 
History of multiple strokes 
 
History of other neurological disease (e.g. Parkinson’s Disease, Multiple 
Sclerosis) 
 
Uncontrolled medical conditions that would limit exercise tolerance (e.g. 
hypertension) 
 
Excessive spasticity in the paretic lower limb (score >3 on Modified 
Ashworth Scale) 
 
Contractures of the lower limb that prevent the ankle and knee from 
achieving a neutral position (sc 
 
 
VI. Procedures 
A. Informed Consent Process 
Written consent forms with associated HIPAA forms will be prepared, approved by the 
institutional review board, and reviewed with each participant by a member of the 
research team prior to initiating study procedures. All participants will have the 
opportunity to ask any questions they may have, and a member of the research team will 
answer any questions posed. All participants will sign written informed consent and 
HIPAA forms prior to participating in any study related procedures. Participants will be 
given a copy of these signed forms for their personal record. 
 
▪ Prior to initiating study procedures, participants will also complete a demographic 
form (Case Report Form (CRF_TPAD_Form_01)– See attached) and will be asked 
about use of an Ankle Foot Orthosis (AFO) – specifically if s/he typically ambulates 
inside the home with or without an AFO. 
➢ IF the participant typically DOES NOT wear the AFO for household 
ambulation, then the AFO WILL NOT be worn during the study procedures. 
➢ IF the participant typically DOES wear the AFO during household 
ambulation, then the AFO WILL be worn during the study procedures. 

B. Overall Study Schema 
 
vergrou 
Re
D
d
®
M 
D 
P A 
s a e 
M 
t 
Week 2 
APDM® 
ures 
Gai 
Gait Measures 
 
 
 
Overground 
Pre-Test 1 
(1-1.5 hours) 
 
 
 
 
Week 1 
O 
nd 
Pre-Test 2 
(1-1.5 hours) 
 
 
 
 
 
 
 
 
Baseline 
(5 Min) 
Overground 
Pre-Test 3 
(1-1.5 hours) 
 
 
TPAD Tethered 
Training 
(40 Min) 
 
Visual Feedback 
Faded over 5-days 
 
Overground 
Post-Test 
(1-1.5 hours) 
 
 
 
 
 
Post 
Training 
(10 Min) 
 
 
 
 
 
Overground 
Training 
(5-10 Min) 
 
 
 
 
peat 
aily 
x 5 
ays 
 
 
 
Week 3 
Overground 
1-week Follow Up 
(1-1.5 hours) 
 
 
End of Study 
 
 
 
 
 
 
Week 1 – PRE TEST 
(3 visits) 
Week 2 - TRAINING 
(Daily visits) 
Week 3 – FOLLOW UP 
(1 visit) 
Consent **Day 1 only 
10MWT with APDM® 
before and after training 
daily 
10MWT with APDM® 
Info Sheets **Day 1 only 
Treadmill (TM) Training 
with Feedback 
BBS 
MoCA **Day 1 only 
Overground Training 
SIS 
Stroke Impact Scale (SIS) 
**Day 1 only 
Treadmill Assessments 
(Force Measures in tandem 
with baseline and post 
training gait on TM) 
10MWT with APDM® 
BBS **Day 5 only 
Berg Balance Scale (BBS) 
SIS **Day 5 only 

C. Assessments 
 
 
 
Overground 
Pre-Test 1 
(1-1.5 hours) 
 
 
 
 
Overground 
Pre-Test 2 
(1-1.5 hours) 
 
 
 
 
Overground 
Pre-Test 3 
(1-1.5 hours) 
 
 
 
 
 
 
 
Overground 
Post-Test 
(1-1.5 hours) 
5 Day Training with 
pre/post 10MWT 
**Post Test occurs on 
completion of Day 5. 
 
 
 
Overground 
1-week Follow Up 
(1-1.5 hours) 

 
i. 
Overground Assessments 
Overgound assessments will include: 
 
Gait Assessments 
o 10MWT as measured with APDM® sensors 
 
Balance Assessments 
o Berg Balance Scale (BBS) 
 
Self Assessments 
o Stroke Impact Scale (SIS) 
 
Overground assessments will be taken during week one (Pre Testing), week two (Gait 
Assessments before/after Intervention and Post Testing on Day 5) and week three 
(Follow Up) of study procedures. 
 
The Overground Assessment will occur as per the following schedule: 
 
Week 1: (Pre Test) Participant sessions will include gait 
assessments, balance assessments and self-assessment (Day 1 
only) for each of three visits during the first week of study 
participation. 
 
Week 2: (Intervention) Participants will repeat gait assessments 
before and after each daily intervention session. On day 5 after study 
intervention, participants will be given a 10-15 minute seated rest 
break, and all (gait, balance, and self assessment) assessments will be 
repeated. These will be recorded as Post Test. 
 
Week 3: (Follow Up) Participants will complete all (gait, balance and 
self assessment) assessments. 
 
** Denotes primary outcome measure. 
 
➢ Participant will complete the ‘Informed Consent’ process prior to initiating any 
assessment or study related procedures. 
 
➢ A physical therapist and at least one other member of the research team will be 
present to perform all assessment procedures. 
 
➢ Participants’ height and weight will be measured and recorded on 
CRF_TPAD_Form_03a (See attached). 
 
➢ Any incidents with patient safety** during assessment sessions will be reported 
on CRF_TPAD_Form_03/03a/03b. 
 
➢ Any missing visits** of the assessment sessions will also be noted on 
CRF_TPAD_Form_03/03a/03b. 

 
1. Gait Assessments 
 
Gait variables recorded include: 
 
Percentage of time in Stance phase of gait cycle (for each limb individually)** 
 
Percentage of time in Swing phase of gait cycle (for each limb individually) 
 
Percentage of time in Double Support phase of gait (net for both limbs) 
 
Stride Length (for each limb individually) 
 
Stride Velocity (for each limb individually) 
 
 
 
A 14-meter course will be measured along a quiet hallway. The middle 10- 
meter segment of this course will be marked. Gait measures will be recorded 
during a series of three, 10 meter walk tests (10MWT) using the APDM® inertial 
based sensors. 
A. Set up: 
a. Turn on MacBook Pro (Mid 2015, Apple®, Inc.) laptop and login with 
the User Name “NRR_Lab” and Password “anngentile1”. 
b. Secure the Access Point in the accompanying stand, and attach to the 
MacBook Pro laptop via the (18 inch) Micro USB cable provided. 
c. Attach Opal Sensors (Sensor Numbers: 1251, 1253, 1254) to the 
Docking Station using 3 of the (6 inch) Micro USB cables provided. 
d. Attach the Docking Station to the MacBook Pro laptop with the attached 
USB cable. 
 
 

e.   Initiate Mobility Lab© 2015 (Version 2.0, APDM, Inc.) software. 
 
 
 
 
f. 
Ensure that Project Group “TPAD” is selected. 
 
 

g.    From tabs (at top of page), select “Hardware Configuration”. 
 
 
 
 
 
h. Ensure and/or assign sensors by dragging ‘Available Sensor’ to 
associated position at figure. Sensor assignment is: 
 
XI-001254: Lumbar 
 
XI-001251:  Left Foot 
 
XI-001253:  Right Foot 
 
 
 
 

i. 
Select “Apply Configuration”. 
 
 
 
 
 
 
 
j. 
From tabs (at top of page), select “Subjects”. 
 
 
 
 

 
 
1. For New participants (DAY 1 Pre Test ONLY): 
a. Select “+ New Subject” (at top right of screen). 
b. Add First Name = “TPAD_D” (for ALL participants). 
c. Add Last Name = Enter Participant’s Study ID number. 
d. Enter participant height. 
e. Select ‘gender’. 
f. Enter year of birth. 
 
 
 
 

 
 
2. For Returning participants: 
a. Select participant from list by clicking on “Last Name” / 
Participant Study ID number. 
 
 
 
 
 
k. From tabs (below Project Group), select “New Test”. 
 
 
l. 
At Pop Up Test Selection prompt, select ‘Open Ended’ from the ‘Walk’ 
parameter (top of list). 

 
 
m. Select the “ + “ button 3 times to add a total of 3 walks to the participant 
profile. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
n. Select ‘Next’. 
 
 
o. Ensure participant is seated for sensor placement. 
 
 
p. Remove Opal sensors from Docking Station and place on participant at 
L2, and at the dorsal surface of bilateral feet as shown. (Port faces down 
for lumbar sensor and towards the toes for feet sensors.) 
 
 
 
 

 
q. Participant is asked to stand and is assisted (if needed) to one end of the 
14-meter walkway. 
r. Turn on Sony 6300 camera. 
 
 
B. Procedures:  Conducting the Assessment 
a. Instruct the participant to walk from their current position to the 
opposing end of the 14-meter path at a ‘comfortable pace’ on your “GO” 
signal. 
b. Activate Opal sensors by selecting “Start Recording”. 
c. At the sound of the tone, instruct the participant to begin walking. 
d. A stopwatch will be used to capture the 10MWT portion of the pathway. 
e. Times will be recorded on CRF_TPAD_Form 03/03a/03b (See attached). 
f. 
A member of the study team will walk alongside the participant to 
ensure safety. 
g. A second member of the study team will video record the participant’s 
gait during performance of the walk using the Sony 6300 camera. 
h. Repeat procedures for all 3 walk trials. 
i. 
On completion of all 3 trials, the participant will be seated, Opal sensors 
removed and reattached to the Docking Station. 
j. 
From tabs (at top of page) select “Power Off Sensors”. 
k. Remove sensors from docking station after ‘Power Off’ sequence is 
complete. 
l. 
Ensure Opal sensors go blank. 
m. Detach Docking Station and Access Point from MacBook Pro laptop and 
replace into APDM® suitcase. 
n. Close Mobility Lab software and shutdown MacBook Pro laptop. 
 
 
 
 This will complete the gait assessment portion. 
 
2. Balance Assessments 
 
A standardized Berg Balance Scale is performed with each of the participants 
(CRF_TPAD_Form_04 – See attached). 
 
Assessments will be video recorded, and independent reviewers will score 
each item of the assessment. 
 
Total scores will be recorded on CRF_TPAD_Form_03/03a/03b (See 
attached). 

 
3. Self Assessment 
 
 
A Stroke Impact Scale (SIS) will be given to participants to complete on Pre 
Testing, Day 1, on Post Testing, and on Follow up. Total scores of these 
assessments will be recorded. 
 
 
 
 This will complete the overground assessment portion. 
 
 
 
 
ii. Treadmill Assessments 
 
 
 
 
 
 
 
 
Force Measures Taken 
during Baseline and 
Post Training 
 
 
 
 
Force Assessments will be recorded on the treadmill in an effort to calculate 
force symmetry between the affected/less affected limb. 
 
Treadmill assessments will occur simultaneously within the interventional sessions. 
These assessments will be completed daily during week two of study participation. As 
they will occur within the intervention, no additional time is needed for data collection 
during these procedures. 
 
An engineer trained in the use of the TPAD will be present and record data while the 
physical therapist is supervising the participant during the treadmill portion of the 
intervention. 
 
Data collected from baseline (Intervention Day 1) and post training (Intervention Day 
5) will be used as a primary outcome of vertical Ground Reaction Force (GRF)**. Daily 
measures (Baseline to Post Training within day) will be used as secondary measures of 
GRF over the course of training. 

 
Procedures are as follows: 
 
➢ Reflective markers, safety harness, pelvic belt and arm sling will be placed as 
described in ‘Intervention’ section above. 
 
➢ The participant will be assisted onto the dual belt treadmill and confirmed gait 
speed established as described in ‘Intervention’ section above. 
 
➢ Force plates embedded under the dual belts of the treadmill will be activated for 
data recording of Forces in the vertical direction (Fz) as a measure of GRF.  
These recordings will occur during minute 1, 3 and 5 during ‘Baseline’ gait 
procedures as described in the ‘Intervention’ section above. 
 
➢ RPE** and HR** will be recorded before (at resting) and after ‘Baseline’ gait, at 
10-minute intervals during TPAD force intervention, on completion of ‘Post 
Training’ gait, and lastly on completion of overground gait.  These measures will 
be recorded on CRF_TPAD_Form_02. 
 
➢ Force plates will also be activated for data collection of Fz as a measure of GRF 
during minutes 1, 3, 5, 7, 9 of of ‘Post Training’ gait procedures as outlined in the 
‘Intervention’ section above. 
 
➢ These procedures will be repeated during daily intervention sessions. 
 
 This will complete the Treadmill Assessment portion. 

 
D. Intervention 
 
 
 
Treadmill Training 
 
 
Baseline 
(5 Min) 
 
TPAD Tethered 
Training (40 Min) 
Post 
Training 
(10 Min) 
Overground 
Training 
(5-10 Min) 
 
 
Visual Feedback 
Faded 
 
 
Tethers ON 
Tethers OFF 
 
All interventional procedures are to be performed during week two of study participation. 
These sessions will occur daily for five consecutive days. The duration of each 
interventional session will be approximately one and one half hours (90 minutes). 
 
Participants will be asked to wear gym shorts and comfortable walking shoes for each 
training session. If participants wear other clothing to the session (e.g. in winter months), 
they will be given the opportunity to change clothes prior to initiating any study 
procedures. 
 
A licensed physical therapist will supervise all training sessions. Engineers experienced in 
operating the TPAD will be primarily responsible for the operating and running of the 
TPAD and treadmill during the training session. 
 
1. Set up 
Prior to initiating the training, a member of the research team will complete the Treatment 
Checklist, including: 
 
a. Participants will stand while reflective markers are placed bilaterally at: 
 
R/L Medial & Lateral 
metatarsal heads 
 
Superior surface of first 
distal toe 
 
R/L Med & Lateral malleoli 
 
R/L Heel 
 
R/L Tibial Plateau 
 
R/L Fibula Head 
 
R/L Med & Lateral distal 
Femur 
 
R/L anterior shaft of the 
Femur (at midpoint) 
 
R/L lateral shaft of the 
Femur (at midpoint) 
 
Anterior Superior Iliac Spine 
(ASIS) 
 
Superior (on abdomen) to 
ASIS for ASIS Recreation 
 
L3 

 
 
 
 
 
 
b. Patient clothing will be taped in place to ensure marker visibility throughout 
treatment. 
 
c. Participants will then don: 
 
A safety harness that will connect to an overhead metal brace/beam 
during gait tasks on the treadmill. 
 
A sling to support the paretic arm during gait. This is done to prevent the 
blocking of reflective markers during gait that are needed for the 
application of forces. 
 
A pelvic belt that has been altered to allow the attachment of force 
tethers. 
 
d. Heart Rate (HR) monitor and Borg Scale will be in place to allow recordings 
throughout treatment session. 

 
e. Participants will then be assisted onto the dual belt treadmill. 
 
f. A still image will be recorded using a Vicon® infrared recording system and 
evaluated to ensure all markers are in place and are visible. 
 
g. During the still image, recordings will be made of vertical forces (Fz) during quiet 
stance for both the paretic and non-paretic limb. 
 
h. Measures of resting heart rate (HR) and Ratings of Perceived Exertion (RPE) will be 
taken and recorded on CRF_TPAD_Form_02 (See attached). 
 
2. Treadmill Training 
 
 
a. The treadmill will be initiated and speed gradually increased by 0.1 m/s intervals. 
The participant will be asked when s/he feels this will be a challenging, yet tolerable 
speed to sustain for one hour (60 minutes). A supervising Physical Therapist will 
confirm the speed and this will be recorded on CRF_TPAD_Form_02 (See attached). 
The confirmed speed will be used for all subsequent treatment sessions. *This will 
occur during Day 1 treatment ONLY. 
 
b. The participant will continue walking at the self-selected gait speed for five minutes. 
 
c. During this time the participant will gain familiarity with treadmill walking 
(Baseline), and vertical force measures (Fz) will be recorded. This is explained in 
detail in the ‘Assessments’ section. 
 
d. Video recordings will be taken from a posterior view during minutes 3-4 of baseline 
gait. 
 
e. On completion of the five minutes of baseline gait, the supervising therapist will 
verbally tell the patient to hold on to the side hand rails, and the treadmill will be 
stopped. 
 
f. HR and RPE will be recorded on CRF_TPAD_Form_02 (See attached). 
 
g. Tethers will be attached to the pelvic belt. 
 
h. Participants will be offered a seated rest break. Time of rest break will be recorded. 
 
i. Reflective markers will be placed on the tethers at the point of attachment to the 
pelvic belt and at the level of the pulley/frame. 

 
 
j. A force of resting magnitude will be applied during static standing (enough force to 
keep tethers taut during gait, but this resting magnitude will be evenly distributed 
among the four force tethers along a horizontal plane at left/right anterior/posterior 
positions). 
 
k. A still image will be taken to ensure tethers are appropriately in place, and markers 
attached to tether attachment points will be removed. 
 
l. Once forces tethers are taut, the visual feedback monor will be turned on and the 
supervising therapist will explain the role of feedback during the training. 
 
 
Verbiage to be used: 
“Do you see the 2 bars in front of you?  The right/left (side of the paretic 
limb) represents your weaker leg. This bar moves depending on how 
much weight you put into your leg. Go ahead and lift your leg so you can 
see the bar move.” [Participant lifts leg and bar representing paretic limb 
lessens]. 
“Do you see the other bar? It is your target.  On each step, I want you to 
try and get your right/left (paretic) bar up to the top of that target and 
keep it there as long as possible while you are walking. Do you have any 
questions?” [Participant is given an opportunity to ask questions for which a 
member of the research team will respond appropriately.] 
“There will be points during training where this screen isn’t on.  I still 
want you to think about the screen and put as much weight on your 
weaker leg and keep it there as long as possible – even when you do not 
see the screen.  Do you understand?” 
 
m. The treadmill will be re-initiated at the self-selected speed, and a force of 10% of the 
participants’ body weight will be applied along the horizontal plan in the 
anterolateral direction, ramping up/down in a trapezoidal fashion on the side of the 
paretic limb. This will occur at the point of heel strike and be completed by mid- 
stance during each step. This will be sustained for 40 minutes. 
 
n. At the midpoint of training participants will be offered a seated rest break, after 
which training will immediately be re-initiated. 
 
 
If participants decline rest at midpoint (20 minutes), they will be offered 
another rest break at minute 30 of training. 
 
Duration of rest break(s) will be recorded. 

 
 
o. Visual feedback will be given as indicated by Table 1: 
 
 
 
Table 1: Visual Feedback Schedule per Training Day Visit 
Day 1 
Day 2 
Day 3 
Day 4 
Day 5 
Minute 1-
10 
9 minutes on/ 
1 minute off 
7 minutes on/ 
3 minutes off 
5 minutes on/ 
5 minutes off 
3 minutes on/ 
7 minutes off 
1 minute on/ 
9 minutes off 
Minute 
11-20 
9 minutes on/ 
1 minute off 
7 minutes on/ 
3 minutes off 
5 minutes on/ 
5 minutes off 
3 minutes on/ 
7 minutes off 
1 minute on/ 
9 minutes off 
Minute 
21-30 
9 minutes on/ 
1 minute off 
7 minutes on/ 
3 minutes off 
5 minutes on/ 
5 minutes off 
3 minutes on/ 
7 minutes off 
1 minute on/ 
9 minutes off 
Minute 
31-40 
9 minutes on/ 
1 minute off 
7 minutes on/ 
3 minutes off 
5 minutes on/ 
5 minutes off 
3 minutes on/ 
7 minutes off 
1 minute on/ 
9 minutes off 
Total 
90% on (36 
min)/ 10% off (4 
min) 
70% on (28 
min)/ 30% off 
(12 min) 
50% on (20 
min)/ 50% off 
(20 min) 
30% on (12 
min)/ 70% off 
(28 min) 
10% on (4 
min)/ 90% off 
(36 min) 
 
****** Video Recordings using a posterior view will be made during minutes 5, 15, 
25, and 35 of training. 
 
p. On completion of the 40 minute training with the force tethers and visual feedback, 
the participant will be cautioned to hold onto the hand rails and the treadmill will be 
stopped. 
 
q. HR and RPE will be taken and recorded at every 10 minute interval (at minute 10, 20, 
30 & on completion) throughout the treatment session using CRF_TPAD_Form_02 
(See attached). 
 
r. Participants will be offered a seated rest break and water at completion of training. 
 
s. Immediately on completion of the rest break, participants will stand, and continue to 
walk for an additional 10 minutes on the treadmill with no force tethers attached 
(Post Training).  This will allow the participant to ‘cool down’ from the training. 

 
During this time vertical forces (Fz) will be taken for each the paretic and non paretic 
limb. 
 
t. Video recordings will be made from a posterior view during minutes 5 of post 
training. 
 
u. On completion of post training, participants will be assisted off of the treadmill and 
reflective markers, safety harness, pelvic belt and arm sling will be removed. 
 
v.   HR and RPE will be taken and recorded on CRF_TPAD_Form_02 (See attached). 

 
3. Overground Training 
 
 
 
 
Overground 
Training 
(5-10 Min) 
 
 
 
a. Participants will then initiate overground training for which they will ambulate in a 
quiet corridor and will receive verbal and gentle tactile cues to reinforce TPAD 
training. Overground training will be between 5-10 minutes. Duration of 
overground training period will be recorded. 
 
 
Verbal cues will include: 
o “Remember to walk and put as much weight on your right/left 
(paretic) limb as possible and keep it there as long as possible.” 
o “Can you put more weight on your right/left (paretic) side?” 
o “A little more” 
o “More weight over here” 
o “Keep it/your weight there a little longer with each step.” 
 
Tactile cues will include: 
o Gentle tapping at right/left (paretic) side. 
o Gentle tapping at right/left (paretic) quadriceps. 
o Light hand hold around pelvis with gentle weight shift onto paretic 
side. 
 
b. On completion of overground training, HR and RPE will be taken and recorded one 
additional time on CRF_TPAD_Form_02 (See attached). 
 
c. CRF_TPAD_Form_02 will be completed daily for each intervention session. 
 
d. Any incidents with patient safety during interventional procedures will be 
reported on CRF_TPAD_Form_02. 
 
e. Any missing visits** occurring during intervention will also be noted on 
CRF_TPAD_Form_02. 
 
f. This will conclude the training portion of the session. 

 
VII. Participant Withdrawal 
Participation in this study is voluntary. Participants will be allowed to withdraw from the 
study at any point. Withdrawal of participation from this study will not preclude 
individuals from participating in any future studies relating to stroke or for which the 
individual would be a potential candidate. 
 
The participant may be withdrawn by a member of the research team if: 
 
The participant does not complete all Pre-Test Assessments. 
 
The participant completes < 4/5 training visits 
 
The participant does not complete Post-Test Assessment 
 
The participant sustains an injury while participating that would prevent s/he from 
completing study procedures 
 
VIII. Risk / Benefit 
No invasive interventional procedures will be used during these study procedures. Thus, 
this is a low risk study. General risks of exercise are expected during study participation, 
including but not limited to muscle fatigue, muscle stiffness, and muscle soreness.  In an 
effort to minimize risk to participants, a licensed physical therapist will be present for all 
study related activities. Additionally, a MD will be available in the event of an injury or the 
occurrence of an adverse event. Any medical injuries sustained during participation in this 
study will be recorded (CRF_TPAD_Form_02), and the Principle Investigator and the 
Institutional Review Board will be notified within 24 hours of event. The study participant 
will be responsible for any incurred cost from a study related injury. 
 
We anticipate that participants who complete study procedures may receive improvement 
in gait symmetry by participating in this trial. However, we cannot guarantee physical 
benefit from study participation. Additionally, it is likely that any benefit in gait 
performance seen from participating in this trial will be temporary and not long-lasting 
due to the short duration (one week) of the intervention. 
 
 
IX. Data Management/ Storage 
Hard copies of CRF and study documents will be stored in files coded by patient 
identification numbers assigned at the onset of study participation. These files will be 
stored in a locked file cabinet in the office of a member of the study team. Only team 
members will have access to these files. 
 
Electronic data will also be coded using the same patient identification numbers. A code 
key will be located in the hard copy files. All electronic data will be stored either in a 
REDCap Database (feasibility results of safety, adherence, treatment tolerance, gait velocity 
and balance scores) or on a CUMC encrypted end point device (gait data from embedded 
force plates and APDM inertial sensors) that is backed up regularly. Patient data sheets  
will be input into the REDCap database and each member of the study team will have  
access via an individualized login/password combination. Coded copies of electronic data 
will be shared between members of the research team via Columbia University email 

 
system. To ensure data security, all electronic data will be coded, and the code key will not 
be included with data files. 
 
 
 
X. Adverse Event Reporting 
Adverse events include study related injuries including, but not limited to: 
 
Falls 
 
Ankle sprains/strains 
 
Fractures 
 
Orthopedic related injuries 
 
Dizziness 
 
Severe fatigue that requires a ceasing of study procedures 
 
In the case of an adverse event (AE), the participant will be evaluated immediately by the 
physical therapist present for all study procedures. If the AE persists, study procedures 
will be stopped, and the study MD notified to evaluate the participant. In such cases where 
applicable (e.g. fracture, ankle injury) the participant will be referred and assisted to the 
Emergency Room for immediate attention. 
 
All AEs will be recorded and reported to the PI and IRB within 24 hours. 
 
 
XI. Statistical Analysis 
Please see attached Statistical Analysis Plan. 
 
XII. Dissemination of Results and Publications 
Results of this work will be analyzed and a manuscript prepared for publication. Full 
details of this work including prior work using the TPAD, background, study procedures, 
statistical analysis procedures and detailed results will be written and stored on file as a 
part of the final dissertation report. 
 
Lauri Bishop, PT, DPT will serve as primary author on the dissertation with Lori Quinn,  
EdD providing sponsorship. Ms. Bishop will also serve as a primary author for manuscripts 
prepared discussing the feasibility and preliminary efficacy of the TPAD to reduce 
asymmetry in a population of individuals after stroke. Moiz Khan, MS will serve as primary 
author for any manuscripts detailing technical specifics of implementing TPAD treatment  
in a population of individuals after stroke. Other participating members of the research 
team will be recognized in authorship in all manuscripts submitted for publication.