Clinical Algorithm for Post-Stroke Gait Training With C-Brace
Phase: NA
Conditions: Hemiparesis Due to Stroke, Hemiplegia Due to Stroke
Sponsor: The University of Texas Health Science Center, Houston

IRB NUMBER: HSC-MS-16-0031 
IRB APPROVAL DATE: 03/16/2017 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical Algorithm for Post-Stroke Gait Training with C-Brace 
 
NCT02892760 
 
Version Date: 03/16/2017 
 
 

IRB NUMBER: HSC-MS-16-0031 
IRB APPROVAL DATE: 03/16/2017 
 
Protocol Title: 
Clinical Algorithm for Post-Stroke Gait Training with C-Brace 
Principal Investigator: 
Gerard Francisco, MD 
Co-Investigators: 
Shuo-Hsiu (James) Chang, PT, PhD 
Study Coordinator: 
Marcie Kern, PT, MS 
Population: 
Human subjects (male and female), age 18 years or older, who have a 
diagnosis of hemiparesis or hemiplegia due to stroke, in the Houston 
metropolitan area. 
Number of Sites: 
1. TIRR Memorial Hermann 
Study Duration: 
2 years 
Subject Duration: 
8-10 weeks 
 
 
 
 
 
GENERAL INFORMATION 
Inability to walk is one of the significant challenges that affect quality of life in 
individuals with chronic hemiparesis. Not only is gait an important activity of daily living, it can 
also help minimize many of the secondary complications seen as a result of decreased mobility 
resulting from neurological injury, such as cardiovascular deconditioning and loss of bone mass. 
Assistive devices and orthoses are utilized to assist individuals with hemiparesis to regain the 
ability to walk, however, efficiency of walking using these devices (assisted walking) is often 
overlooked. Introducing an orthotic device alters the gait kinematics. The inefficiency of 
assisted walking could be the result of abnormal gait kinematics and kinetic patterns which are 
associated with outdated product design and inadequate users’ ability. With advanced 
technology, a novel microprocessor-controlled leg orthosis system (C-Brace, Ottobock Health 
Care LP) has been developed to promote assisted walking with near-to-normal gait 
biomechanical parameters. This device, therefore, could also improve the efficiency of assisted 
walking. 
With the advanced technology, however, little is known about which patients would 
receive maximal therapeutic benefits in physiology, physical function and quality of life. 
Therefore, the purpose of this study is to develop a clinical algorithmic-based evaluation and 
treatment approach for C-Brace for use by persons with hemiparesis or hemiplegia. We are 
mostly interested in measuring the physiological effects, specifically neuromuscular and 
cardiovascular parameters, and gait characteristics during walking with C-brace. We plan to 
identity the strongest predictors and outcome measures of walking in persons with hemiparesis 
or hemiplegia using the C-brace, then develop an algorithm for reliable prognosis and early 
subgrouping. 

IRB NUMBER: HSC-MS-16-0031 
IRB APPROVAL DATE: 03/16/2017 
 
BACKGROUND INFORMATION 
The impaired ability to walk independently is a significant consequence after 
neuromuscular injuries resulting in substantial limitation in mobility and performance of daily 
activities, thus restricting full participation and home and community re-integration [1]. 
Regaining the ability to walk is one of the priorities in rehabilitation in this population, however, 
walking efficiency and energy cost is often overlooked. The consequence of additional 
metabolic demand contributes to fatigue, which promotes a sedentary life style that 
predisposes an individual to secondary health deterioration and compromised quality of life. 
 
Energy expenditure in walking is increased in persons with hemiparesis and hemiplegia 
[2]. Studies have indicated that energy cost in walking is affected by many factors such as ankle 
plantarflexors [3], quadriceps activity[4] and center of mass motion [5]. Therefore, walking 
with orthoses whose design is to compensate or correct an abnormality, could reduce energy 
expenditure [6] while different orthoses designs could also affect energy expenditures [7-9]. 
 
The knee-ankle foot orthosis (KAFO) is one of the most often prescribed to facilitate 
walking for patients with weakness of the muscles which control the knee and protect against 
loss of structural integrity of knee joint. Two most commonly utilized KAFOs are conventional 
KAFO and stance-control orthosis (SCO). The difference between these 2 orthoses is the knee 
control mechanism during walking: conventional KAFOs prevent knee flexion during stance and 
swing phase, while SCO prevent knee flexion during stance phase while allowing knee flexion 
during swing phase. The advantage of the SCO is it reduces the commonly observed gait 
compensatory strategies observed with use of conventional KAFO during swing phase to create 
sufficient toe clearance such as hip hiking, vaulting and circumduction and promotes improved 
gait kinematics[10-13]. As noted in the literature these gait compensations tend to increase 
energy expenditures [14-16]. Due to a reduction in gait deviations and compensations, walking 
with a SCO could lead to improved walking energy efficiency. 
 
Although SCO allow users to have a more nature gait pattern, functional limitations 
remain. The most important limitation is the lack of dampened knee flexion in the weight 
bearing condition required to descend ramps and stairs and when transitioning from standing 
to sitting. Additionally the absence of knee flexion dampening in swing phase of the SCO 
orthosis results in an absence of stumble recovery, permitting a sudden loss of control and a 
fall. These limitations significantly affect the ability to perform daily activities not only at home 
but within the community as well. Recently a novel microprocessor-controlled leg orthosis 
system (C-Brace) has been developed to engage dampened knee flexion in the weight bearing 
condition to overcome the limitation from SCO[10]. Therefore, C-Brace could also promote 
assisted walking with near-to-normal gait biomechanical parameters and lead to a reduction of 
energy cost and improved quality of life. 
 
To enhance the feasibility and success rate of interventional trials in gait training with C- 
brace, early identification of subgroups based on outcome predictors should be investigated. 
These outcome predictors could serve as inclusion and exclusion criteria for identifying 
subgroups of patients who may receive maximal therapeutic effects from using C-brace. 

IRB NUMBER: HSC-MS-16-0031 
IRB APPROVAL DATE: 03/16/2017 
 
Therefore, the purpose of this study is to develop a clinical algorithmic-based evaluation and 
treatment approach for C-Brace for use by persons with hemiparesis or hemiplegia. We are 
mostly interested in measuring the physiological effects, specifically neuromuscular and 
cardiovascular parameters, and gait characteristics during walking with C-brace. We plan to 
identity the strongest predictors and outcome measures of walking in persons with hemiparesis 
or hemiplegia using the C-brace, then develop an algorithm for reliable prognosis and early 
subgrouping. 
 
OBJECTIVES 
Specific Aim 1: To quantify and compare the neuromuscular, cardiopulmonary 
responses and gait kinematics during walking with and without C-brace in individuals with 
hemiparesis or hemiplegia. We plan to recruit patients with hemiparesis or hemiplegia 
following stroke and include a wide range of gait impairments. It is expected that subjects will 
demonstrate various degree of difference in energy expenditures, neuromuscular responses, 
functional status and gait characteristics between walking with and without C-brace, depending 
on their current walking ability. We hypothesize that the changes in cardiopulmonary 
responses, neuromuscular responses of major lower muscle groups and gait characteristics 
would be greater in persons with lower functional status and severe gait impairment. 
 
Specific Aim 2: To investigate the association between gait improvement (i.e. gait 
kinematics, speed and walking distance) in walking with C-Brace and baseline neuromuscular, 
cardiopulmonary characteristics that affect gait performance, cognition and physical function in 
individuals with hemiparesis or hemiplegia. We also aim to develop an algorithm to 
characterize and subgroup the patients who receive gait training with C-Brace. We hypothesize 
that the improvements observed in walking with C-Brace are related to muscle strength, range 
of motion, severity of spasticity and the functional status, and the degree of relations may be 
varied. We will then identify the key parameters and measures based on association to develop 
an algorithm to characterize the patients who may receive the maximal benefit of using C-Brace 
for walking. 
 
STUDY DESIGN 
Subjects 
15 individuals with diagnosis of stroke and residual hemiparesis or hemiplegia will be 
grouped into one of three categories based on their walking speed at baseline. Subjects will 
receive 4 weeks of gait training utilizing C-Brace, 3 times per week for a total of 12 sessions. 
We will utilize the 10 Meter Walk Test to assess gait speed for all groups at baseline (week 0). 
Once training sessions are complete and subject is considered an independent experienced 
user (week 5) we will assess the neuromuscular and cardiopulmonary responses and gait 
kinematics during walking with and without C-Brace. Subjects will then continue with use of C- 
Brace in their daily routine in their home and community environments for 4-6 weeks. Subjects 
will then return for a follow up visit (week 8-10) and reassessment of neuromuscular and 
cardiopulmonary responses and gait kinematics during walking with and without C-Brace. 

IRB NUMBER: HSC-MS-16-0031 
IRB APPROVAL DATE: 03/16/2017 
 
Study Population 
15 individuals with hemiparesis or hemiplegia after stroke in the Houston metropolitan area. 
Inclusion and exclusion criteria are listed in Table 1. Participants will be screened and evaluated 
by study investigators and certified physical therapists. We plan to recruit individuals with a 
wide range of walking abilities. The walking ability will be determined by gait speed from 10 
meter walk test: severe gait impairment (gait velocity <0.4 m/s, moderate gait impairment (gait 
speed 0.4-0.8 m/s) and mild impairment (gait speed >0.8 m/s)[17]. 
 
Table 1: 
Inclusion Criteria 
Exclusion Criteria 
15 subjects (5 subjects 
in each group) 
 Mild 
 Moderate 
 Severe 
 Age 18 - 65 years 
 Diagnosis of hemiparesis 
or hemiplegia following 
stroke 
 Presence of abnormal 
walking pattern 
 Poor knee control during 
stance phase 
 Cognitive ability to (or 
care provider) manage 
daily charging of battery 
 Cognitive ability to 
follow commands 
 Hip flexor muscle 
strength grade 3 or 
greater or the ability to 
perform reciprocal gait 
using compensatory 
patterns 
 Able to operate C-brace 
 Weight > 275 lbs. (Includes 
body weight and weight of 
heaviest object carried) 
 Less than 2° of ankle motion 
 Severe spasticity of the 
quadriceps (MAS >3) and/or 
uncontrolled spasticity of the 
quadriceps 
 Severe spasticity of other lower 
limb muscles (MAS >3) 
 Fixed genuvalgum exceeding 
10° beyond anatomic neutral 
valgum 
 Any fixed genuvarum exceeding 
anatomic neutral varum. 
 Hip or knee flexion contractures 
greater than 10° 
 Presence of COPD 
 Chronic heart failure – NYHA 
stages 3 and 4 
 
STUDY PROCEDURES 
Fitting and Training Protocols: 
Qualified participants will be fitted with the C-Brace by a certified orthotist specialist. Subjects 
will participate in a baseline assessment after which they will participate in training sessions for 
gait training from certified physical therapist(s). The length of training is 4 weeks with a total of 
12 sessions (3 times per week for 4 weeks). The goal of training sessions is to progress subject’s 
ability to walk with C-Brace over progressively more challenging environments. They will learn 
how to safely and independently walk with the C-Brace in the following conditions: overground 
walking, reciprocal slope, descending ramps and stairs and negotiation of uneven terrain. 
Adjustments will be made to C-Brace according to subjects ability and performance to progress 
them toward independence. Once subject has reached the independent/experienced user 

IRB NUMBER: HSC-MS-16-0031 
IRB APPROVAL DATE: 03/16/2017 
 
level, they will continue to utilize the C-Brace in their home environment. Subjects will be 
considered as independent/experienced users when they are able to safely walk with C-Brace 
without a loss of balance for at least 10 meters and when they can complete this task without 
requiring aide from an additional assistive device or physical assistance from the therapist. 
Subjects will be checked off on their ability to safely ambulate in the overground environment 
as well as in the various conditions of slopes, ramps, steps and uneven terrain. 
Once subjects are declared independent users, they will participate in a post training 
assessment. After training sessions have been completed, subjects will be provided with the C- 
Brace to use in their everyday routine for 4-6 weeks. During the home use period, subjects will 
continue to wear the C-Brace as they return to their normal daily activities. During this period 
subjects can return to see the therapist for any adjustment or re-training as needed. The daily 
activity will be recorded in an activity log. Subjects will return for a follow up assessment a the 
end of the home use training. Follow-up assessments will be scheduled at the 4 week mark, 
with a 2 week window allotted to allow for accommodating subject and staff schedules. 
The training and assessment sessions will be conducted at UT Health Motor Recovery 
Laboratory at the NeuroRecovery Research Center at TIRR Memorial Hermann. 
 
Specific Aim 1: 
To quantify and compare the neuromuscular, cardiopulmonary responses and gait kinematics 
during walking with and without C-brace in individuals with hemiparesis or hemiplegia. We plan 
to recruit patients with hemiparesis or hemiplegia following stroke who present with gait 
impairments. It is expected that subjects will demonstrate varying degrees of energy 
expenditures, neuromuscular responses, functional status and gait characteristics between 
walking with and without C-brace, depending on their current walking ability. We hypothesize 
that the changes in cardiopulmonary responses, neuromuscular responses of major lower 
muscle groups and gait characteristics will be greater in persons with lower functional status 
and more severe gait impairments. 
 
Outcome Measures: 
We will measure the following parameters during gait with and without C-Brace at completion 
of training sessions and at follow up. 
 Timed Up and Go: Assesses mobility, balance, walking ability, and fall risk in older 
adults. The test measures the time it takes the subject to perform a sit to stand from a 
chair with arms, walk to a mark on the ground 10 feet away and return to the seated 
position in the chair with arms. This test has been used in assessing stroke recovery 
with high reliability and validity[18]. 
 10 Meter Walk Test (10MWT): Measure of gait speed. Subjects will walk a total of 14 
meters at their preferred walking speed and at a fast pace. The test measures the time 
it takes the subject to complete the middle 10 meters of the walk. 
 Kinematics and electromyography (EMG): Bilateral upper and lower extremity 
kinematics and surface electromyography (sEMG) recordings will be collected during 
10MWT. Infrared light emitting diode markers will be attached to bilateral lower 
extremities. The marker data will be recorded using the NDI Optotrak Certus motion 
capture system. Marker data will be processed using custom Matlab program to 

IRB NUMBER: HSC-MS-16-0031 
IRB APPROVAL DATE: 03/16/2017 
 
determine lower extremity joint excursion and joint angular velocities. For EMG, we will 
place bipolar surface electrodes on the bilateral major leg muscles to record 
electromyography (1000Hz, Motion Labs 16-Channel EMG System). We will calculate the 
EMG amplitude and burst duration over the whole gait cycle during the 10MWT. 
 Six-minute walk test (6MWT): This test assesses distance walked over 6 minutes as a 
sub-maximal test of aerobic capacity/endurance. It has good responsiveness to detect 
improvements in capacity to walk in stroke patients [19]. 
 Metabolic expenditure during walking: Oxygen consumption during 6MWT will be 
determined using a portable metabolic system. Metabolic data will be collected on a 
breath-by-breath basis during gait assessment. Prior to the testing, the system will be 
calibrated using room air and reference gas mixture. During the testing, the subject will 
wear the face mask at all times and will be asked to breathe normally. Subjects will also 
wear a heart rate monitor. The data will be synchronized with kinematic and 
electromyography data for further analysis. This task will be performed during walking 
with and without C-Brace. 
 
Specific Aim 2: 
To investigate the association between the gait improvement (i.e. gait speed and walking 
distance) in walking with C-Brace and baseline neuromuscular, cardiopulmonary characteristics 
that affects gait performance, cognition and physical function in individuals with hemiparesis or 
hemiplegia. We also aim to develop an algorithm to characterize the patients who may receive 
the maximal benefit of using C-Brace for walking. We hypothesize that the improvements 
observed in walking with C-Brace are related to muscle strength, range of motion, severity of 
spasticity and the functional status and the degree of relations may be varied. We will then 
identify the key parameters based on association to develop an algorithm to characterize the 
patients who may receive the maximal benefit of using C-Brace for walking. 
 
Outcome Measures: 
The following assessments will be measured at baseline and follow-up (without wearing C- 
brace): 
 Folstein Mini Mental State Examination (MMSE): Mini Mental State Examination 
provides information about orientation, attention, learning, calculation, delayed recall, 
and construction. Several studies report acceptable validity of MMSE as a screening 
instrument and its relationship to functional outcome in stroke population[20]. 
 Lower limb muscle strength and range of motion: Muscle strength will be measured and 
quantified by using dynamometers on major bilateral lower limb muscles such as hip 
flexors and extensors, hip abductors and adductors, knee flexors and extensors and 
ankle dorsiflexors and plantarflexors. Range of motion will be measured on bilateral hip, 
knee and ankle joints using goniometry. 
 Fugl-Meyer Assessment – Lower Extremity and Balance: This test evaluates and 
measures recovery of movement in individual post stroke. Fugl-Meyer has been used in 
both clinical and research settings and is one of the most widely used quantitative 
measures of motor impairment [21]. It uses an ordinal scale for scoring of 17 items for 

IRB NUMBER: HSC-MS-16-0031 
IRB APPROVAL DATE: 03/16/2017 
 
the lower limb component and 7 items on the Balance component of the F-M scale (0: 
cannot perform; 1: can perform partially; 2: can perform fully). 
 Modified Ashworth Scale (MAS): This test measures spasticity in patients with lesions of 
the Central Nervous System by testing resistance to passive movement about a joint 
with varying degrees of velocity. Scores range from 0-4, with 6 choices (i.e., 0, 1, 1+, 2, 3, 
4), with 0 indicating normal muscle tone, and 4 indicating very high spasticity. We will 
measure spasticity in lower limbs. 
 Timed Up and Go (TUG) Test: Assesses mobility, balance, walking ability, and fall risk in 
older adults. This test has been used in assessing stroke recovery with high reliability 
and validity [18]. The test measures the time it takes the subject to perform a sit to 
stand from a chair with arms, walk to a mark on the ground 10 feet away and return to 
the seated position in the chair with arms. 
 Berg Balance Scale (BBS): A 14-item objective measure designed to assess static balance 
and fall risk in adult populations, with maximum summed score of 56 (higher scores 
represent better functional outcome). This test has been widely used to measure 
functional recovery in stroke patients with high reliability [22]. 
 10 Meter Walk Test (10MWT): Measure of gait speed. Subjects will walk a total of 14 
meters at their preferred walking speed and at a fast pace. The test measures the time 
it takes the subject to complete the middle 10 meters of the walk. 
 Six-minute walk test (6MWT): This test assesses distance walked over 6 minutes as a 
sub-maximal test of aerobic capacity/endurance. It has good responsiveness to detect 
improvements in capacity to walk in stroke patients [19]. 
 Orthosis Evaluation Questionnaire: consists of 72 questions as compared to 81 
questions in the PEQ to be answered by the patients on a 100-mm visual analogue scale 
(VAS) with higher values representing better function. 
 
Assessment Timeline 
Assessment 
Screening 
Fitting 
Baseline 
C-Brace 
Training 
(3x/wk x 4wks) 
Post 
Training 
Home/ 
Community 
Use 
Follow 
Up 
Visit 1 
Visit 2, 3 
Visit 4 
Visit 5-16 
Visit 17 
4-6 weeks 
Visit 18 
10MWT 
X 
X 
X 
X 
Trial Tool to 
Operate device 
and casting 
X 
Diagnostic test 
orthosis and 
alignment 
assessment 
X 
C-Brace fitting 
finalized 
X 
MMSE 
X 
X 
Muscle Strength 
X 
X 
X 
Range of Motion 
X 
X 
X 
Fugl-Meyer 
X 
X 
MAS 
X 
X 
X 
TUG 
X 
X 
X 
BBS 
X 
X 

IRB NUMBER: HSC-MS-16-0031 
IRB APPROVAL DATE: 03/16/2017 
 
6MWT 
X 
X 
X 
C-Brace Training 
X 
sEMG 
X 
X 
Gait Kinematics 
X 
X 
Metabolic 
X 
X 
Orthosis 
Evaluation 
Questionnaire 
X 
 
 
DATA and SAFETY MONITORING 
We will use following strategies to prevent some expected events for this study: 
1) Loss of confidentiality or privacy 
Information obtained for this study will be kept private to the extent allowed by law. However, 
research information may be shared with the University of Texas Health Science Center at 
Houston Institutional Review Board (IRB), the research physician investigator, the research staff 
and others who are responsible for ensuring compliance with laws and regulations related to 
research. 
The study will be performed at at UT Health Motor Recovery Laboratory at the TIRR 
NeuroRecovery Research Center. All data collection records will be locked in the Study 
Coordinator’s office in a locked file cabinet. Energy consumption, sEMG and motion capture 
files will be saved to the research computer using de-identified data. All computers are 
password protected and therefore, only authorized persons have the access to the electronic 
files saved in computers and will adhere to TIRR MEMORIAL HERMANN standards. 
2) Loss of saved electronic data after a computer crash 
All original data will be maintained on paper data collection forms. De-identified data may be 
entered into computer for data analysis. A standard procedure of electronic file backup is 
established and enforced by the PI. All file backups are routinely performed in the local hard 
drive. However, if there are other unanticipated problems which occur during and after data 
collection: the original paper version of the data will be maintained in the locked file cabinet. 
3) Muscular soreness or fatigue 
Borg Rating of Perceived Exertion Scale (Borg) will be administrated periodically throughout the 
intervention sessions. Subject will be provided with rest period as needed, in particular if BORG 
rating ≥ 17. 
4) Loss of balance or fall from testing 
All subjects will be able to independently ambulate. The addition of the C-Brace will provide 
increased stability for the subject when standing and performing transitional movements. 
Therefore, the use of the C-Brace will reduce the risk of falls for subjects. There is a training 
period to allow the subject to become familiar with the C-Brace. One research team member 
will remain next to the subject throughout the training session and during all testing procedures 
to prevent loss of balance or fall whether sitting or standing. As subjects advance their skills and 
progress to independent users their fall risk will continue to decrease. 
If a fall or significant loss of balance occurs, one staff physician will be notified immediately. All 
adverse events will be reported per CPHS protocol. 
5) Possible skin irritation 

IRB NUMBER: HSC-MS-16-0031 
IRB APPROVAL DATE: 03/16/2017 
 
Local irritation, bruising, swelling, or temporary discomfort following wearing of the C-Brace 
may occur. Prior to donning the C-Brace subject’s skin will be inspected by a licensed Physical 
Therapist for baseline, and compared after doffing. Any differences will be recorded and 
followed up with the study physician accordingly. All adverse events will be reported per CPHS 
protocol. 
 
STATISTICS 
Aim 1: 
The effects of C-Brace on dependent variables will be analyzed using separate 2-factor (group x 
condition) analyses of variance (ANOVA) with repeated measures on the walking condition 
(walking with and without C-Brace). The model will first test for the interaction to determine if 
3 groups (mild, moderate and severe) respond similarly across time. In the event of a significant 
interaction (p<.05) we will test for differences between among groups at each point in time 
(post hoc Tukey). 
 
Aim 2: 
Pearson product-moment correlation coefficients will be used to examine relationships among 
muscle strength, range of motion, spasticity, scores in Fugl-Meyer assessment and Berg Balance 
Scale. Hierarchical regression analyses will then be conducted to determine whether changes in 
gait speed and distance could be predicted on the basis of muscle strength, range of motion, 
spasticity, scores in Fugl-Meyer assessment and Berg Balance Scale. The order of entry will be 
based on presumed causal priority and to allow removal of confounding variables. 
 
Clinical Algorithm 
Algorithm and the order of the elements (Figure 1, in the middle) will be developed based on 
the results in the regression analysis. Figure shows the design of the algorithm. The 
characteristics are those we hypothesize could have impacts on the effects of using C-brace on 
walking performance. If the subject meets the minimal criteria of these elements, we could 
suggest the subject would receive the maximal benefits of using C-Brace. Larger scale study is 
needed to determine the minimal criteria for each element. 
 
Figure 1 

IRB NUMBER: HSC-MS-16-0031 
IRB APPROVAL DATE: 03/16/2017 
 
 
 
ETHICS 
The study will be performed under the prevue and in accordance with the rules set by 
the Committee for the Protection of Human Subjects (UT IRB). Potential subjects will be 
identified by physiatrists working in the outpatient clinic and/or on the inpatient wards at The 
Institute for Rehabilitation and Research (TIRR) Memorial Hermann. Once identified, the 
potential subjects will be approached and asked if they wish to discuss a study utilizing a new 
orthosis (C-Brace) to help people with hemiplegia after stroke achieve a better gait pattern 
(better walking). It will also be explained that choosing not to inquire further about the study 
will in no way jeopardize the relationship with anyone at TIRR or in the Memorial Hermann 
system. Once the potential subject agrees he/she will be introduced to either the Principal 
Investigator or the Study Coordinator. Once the potential subject agrees to discuss the study, 
the individual and anyone that the potential subject wishes to accompany him/her will go into a 
private room to discuss the contents of the consent form with either the Principal Investigator 
or the Study Coordinator. 
We will also post flyers in the TIRR Memorial Hermann outpatient clinics as well as online at the 
TIRR Memorial Hermann’s Neurorecovery Research Center website. 
After the consent is reviewed in its entirety, and after allowing ample time for questions, either 
the Principal Investigator or the Study Coordinator will give the potential subject time to discuss 
the study with whomever the potential subject cares to discuss the study with. If the subject 
agrees to enroll in the study, the Study Coordinator or Principal Investigator will review the 
informed consent form with the subject in its entirety. 
 
 
 
DATA HANDLING and KEEPING 

IRB NUMBER: HSC-MS-16-0031 
IRB APPROVAL DATE: 03/16/2017 
 
The subject’s name and demographic information will be collected prior to testing. Each 
subject will be assigned an identification number which will be used from this point forward. All 
measurements will be stored according to the identification number. The Study Coordinator’s 
locked office contains a locked file cabinet in which research materials are kept. All computers 
are password protected and only authorized persons have the access to the electronic files 
saved in computers. Paper data will be stored in the Study Coordinator’s office in a locked file 
cabinet. Access to the file cabinet will be given to the Primary Investigator and authorized team 
members. All electronic data stored on the hard drive of the desktop machine will be password 
protected and available only to the authorized research team members. Identifiable data will 
be stored for 5 years after the study is completed. Stored files will be deleted from the portable 
hard drive after 5 years as well. Identifiable data will be shredded at the end of 5 years after the 
completion of the study. 
 
QUALITY CONTROL and ASSURANCE 
To ensure research integrity, standard written procedures for all tests will be 
established by the Principle Investigator and the Study Coordinator who will then assess each 
team member’s competence for research conduction on a regular basis. Therefore, the testing 
protocol will be consistent throughout the entire data collection for this study. 
 
PUBLICATION PLAN 
The results of this study will be used for presentation at national conferences and 
publications in peer-reviewed journals. The publications will be provided without cost to the 
study participants. 
 
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