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Algorithmic-Based Evaluation and Treatment Approach for Robotic Gait Training

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ClinicalTrials.gov Identifier: NCT03057652
Recruitment Status : Recruiting
First Posted : February 20, 2017
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
Shuo-Hsiu Chang, The University of Texas Health Science Center, Houston

Brief Summary:
The purpose of this study is to develop an algorithmic-based evaluation and treatment approach for wearable robotic exoskeleton (WRE) gait training for patients with neurological conditions.

Condition or disease Intervention/treatment Phase
Complete Spinal Cord Injury Incomplete Spinal Cord Injury Acquired Brain Injury Multiple Sclerosis Device: ReWalk Device: EKSO Device: REX Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Each of the participants will receive training with each of the 3 wearable robotic exoskeletons (WRE) examined in this study, and the order of receipt will be randomized.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Algorithmic-Based Evaluation and Treatment Approach for Robotic Gait Training
Actual Study Start Date : March 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ReWalk, then EKSO, then REX
Subjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per device.
Device: ReWalk

ReWalk is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices.

ReWalk training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. ReWalk phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours.


Device: EKSO

EKSO is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices.

EKSO training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. EKSO phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours.


Device: REX

REX is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices.

REX training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. REX phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours.


Experimental: ReWalk, then REX, then EKSO
Subjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per device.
Device: ReWalk

ReWalk is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices.

ReWalk training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. ReWalk phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours.


Device: EKSO

EKSO is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices.

EKSO training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. EKSO phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours.


Device: REX

REX is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices.

REX training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. REX phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours.


Experimental: EKSO, then ReWalk, then REX
Subjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per device.
Device: ReWalk

ReWalk is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices.

ReWalk training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. ReWalk phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours.


Device: EKSO

EKSO is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices.

EKSO training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. EKSO phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours.


Device: REX

REX is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices.

REX training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. REX phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours.


Experimental: EKSO, then REX, then ReWalk
Subjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per device.
Device: ReWalk

ReWalk is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices.

ReWalk training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. ReWalk phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours.


Device: EKSO

EKSO is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices.

EKSO training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. EKSO phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours.


Device: REX

REX is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices.

REX training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. REX phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours.


Experimental: REX, then EKSO, then ReWalk
Subjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per device.
Device: ReWalk

ReWalk is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices.

ReWalk training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. ReWalk phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours.


Device: EKSO

EKSO is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices.

EKSO training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. EKSO phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours.


Device: REX

REX is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices.

REX training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. REX phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours.


Experimental: REX, then ReWalk, then EKSO
Subjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per device.
Device: ReWalk

ReWalk is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices.

ReWalk training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. ReWalk phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours.


Device: EKSO

EKSO is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices.

EKSO training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. EKSO phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours.


Device: REX

REX is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices.

REX training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. REX phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours.





Primary Outcome Measures :
  1. Change in over ground gait speed as assessed by the 10 Meter Walk Test without WRE [ Time Frame: within one week before start of WRE training, within 2 weeks after start of WRE training ]
    The 10 Meter Walk Test (10MWT) will assess subject's self-selected gait speed.

  2. Change in walking endurance as assessed by the 6 Minute Walk Test without WRE [ Time Frame: within one week before start of WRE training, within 2 weeks after start of WRE training ]
    The 6 Minute Walk Test (6MWT) assesses the distance walked in 6 minutes.

  3. Change in muscle activity as assessed by electromyography (EMG) during 10MWT without WRE [ Time Frame: within one week before start of WRE training, within 2 weeks after start of WRE training ]
    Surface EMG sensors will be placed on the skin of subjects' lower extremities during 10MWT.

  4. Change in muscle activity as assessed by electromyography (EMG) during 6MWT without WRE [ Time Frame: within one week before start of WRE training, within 2 weeks after start of WRE training ]
    Surface EMG sensors will be placed on the skin of subjects' lower extremities during 6MWT.

  5. Change in energy expenditure as assessed by oxygen consumption during 10MWT without WRE [ Time Frame: within one week before start of WRE training, within 2 weeks after start of WRE training ]
    Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2). This task will be performed during the 10MWT.

  6. Change in energy expenditure as assessed by oxygen consumption during 6MWT without WRE [ Time Frame: within one week before start of WRE training, within 2 weeks after start of WRE training ]
    Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2). This task will be performed during the 6MWT.

  7. Change in gait kinematics as assessed by lower extremity joint excursion without WRE [ Time Frame: within one week before start of WRE training, within 2 weeks after start of WRE training ]
    Infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using motion capture system.

  8. Change in gait kinematics as assessed by lower extremity joint angular velocities without WRE [ Time Frame: within one week before start of WRE training, within 2 weeks after start of WRE training ]
    Infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using motion capture system.


Secondary Outcome Measures :
  1. Bone mineral density as assessed by whole body scan [ Time Frame: within one month before start of WRE training ]
    Subjects will undergo whole body bone scan according to standardized protocols.

  2. Cognitive impairment as assessed by Folstein Mini Mental State Examination [ Time Frame: within one month before start of WRE training ]
    Folstein Mini Mental State Examination provides information about orientation, attention, learning, calculation, delayed recall, and construction.

  3. Lower Extremity Muscle Strength as assessed by using a force gauge such as a handheld dynamometer [ Time Frame: within one month before start of WRE training ]
    We will measure lower extremity muscle strength using a force gauge such as a handheld dynamometer.

  4. Spasticity as assessed by the Modified Ashworth Scale (MAS) [ Time Frame: within one month before start of WRE training ]
    The Modified Ashworth Scale will be used to measure spasticity in lower limb.

  5. Range of motion for lower extremity joints as assessed by manual examination [ Time Frame: within one month before start of WRE training ]
    Range of joint motion of bilateral hip, knee and ankle joints. Subject will lie down on an examination table.

  6. Stability during the maximum distance an individual can reach forward from a seated position as assessed by Modified Functional Reach (MFR) [ Time Frame: within one month before start of WRE training ]
    Assesses a patient's stability by measuring the maximum distance an individual can reach forward from a seated position.

  7. Walking ability in ambulatory individuals with SC as assessed by Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI): [ Time Frame: within one month before start of WRE training ]
    Assesses functional walking ability in ambulatory individuals with SCI.

  8. Amount of physical assistance needed for walking following paralysis resulted from SCI as assessed by Walking Index of Spinal Cord Injury (WISCI-II) [ Time Frame: within one month before start of WRE training ]
    This test is performed by SCI population.

  9. Motor recovery after stroke as assessed by Fugl-Meyer Assessment [ Time Frame: within one month before start of WRE training ]
    Evaluates and measures recovery in post-stroke hemiplegic individuals.

  10. Confidence in performing various ambulatory activities as assessed by Activities-Specific Balance Confidence Scale [ Time Frame: within one month before start of WRE training ]
    Measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness. This is performed in ABI and MS population.

  11. User feedback as assessed by a questionnaire [ Time Frame: within one month before start of WRE training ]
    A questionnaire will be administered to allow participants to provide feedback regarding their experiences during intervention.

  12. Over ground gait speed as assessed by the 10 Meter Walk Test while wearing WRE [ Time Frame: within one month before start of WRE training ]
    The 10 Meter Walk Test (10MWT) will assess subject's self-selected gait speed. After WRE training has been completed, subjects will perform 10MWT while ambulating in the WRE.

  13. Change in walking endurance as assessed by the 6 Minute Walk Test while wearing WRE [ Time Frame: within one month before start of WRE training ]
    The 6 Minute Walk Test (6MWT) assesses the distance walked in 6 minutes. After WRE training has been completed, subjects will perform 6MWT while ambulating in the WRE.

  14. Change in muscle activity as assessed by electromyography (EMG) during 10MWT while wearing WRE [ Time Frame: within one month before start of WRE training ]
    Surface EMG sensors will be placed on the skin of subjects' lower extremities during 10MWT. After WRE training has been completed, subjects will be assessed by EMG during the 10MWT while ambulating in the WRE.

  15. Change in muscle activity as assessed by electromyography (EMG) during 6MWT while wearing WRE [ Time Frame: within one month before start of WRE training ]
    Surface EMG sensors will be placed on the skin of subjects' lower extremities during 6MWT. After WRE training has been completed, subjects will be assessed by EMG during the 6MWT while ambulating in the WRE.

  16. Change in energy expenditure as assessed by oxygen consumption during 10MWT while wearing WRE [ Time Frame: within one month before start of WRE training ]
    Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2). This task will be performed during the 10MWT. After WRE training has been completed, oxygen consumption will be assessed in subjects during the 10MWT while ambulating in the WRE.

  17. Change in energy expenditure as assessed by oxygen consumption during 6MWT while wearing WRE [ Time Frame: within one month before start of WRE training ]
    Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2). This task will be performed during the 6MWT. After WRE training has been completed, oxygen consumption will be assessed in subjects during the 10MWT while ambulating in the WRE.

  18. Change in gait kinematics as assessed by lower extremity joint excursion while wearing WRE [ Time Frame: within one month before start of WRE training ]
    Infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using motion capture system. After WRE training has been completed, subjects will be assessed while ambulating in the WRE.

  19. Change in gait kinematics as assessed by lower extremity joint angular velocities while wearing WRE [ Time Frame: within one month before start of WRE training ]
    Infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using motion capture system. After WRE training has been completed, subjects will be assessed while ambulating in the WRE.

  20. Change in H-reflex of soleus muscle as assessed by electromyography (EMG) [ Time Frame: within one week before start of WRE training, within 2 weeks after start of WRE training ]
    The tibialis nerve will be stimulated, and the size of each H-reflex will be measured as the peak-to-peak amplitude of the non-rectified EMG trace.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Spinal Cord Injury Inclusion Criteria:

  • Male or non-pregnant female
  • ≥18 years of age
  • Chronic (> 6 mo post) injury
  • Diagnosis of spinal cord injury
  • Able to achieve adequate fit within exoskeleton
  • Sufficient range of motion to attain normal, reciprocal gait pattern, and transition from normal sit to stand or stand to sit
  • Weight <220 pounds
  • Intact skin on all surfaces in contact with device and load bearing surfaces
  • Ability to perform informed consent
  • Cognitively intact and able to follow directions and demonstrate learning capability

Spinal Cord Injury Exclusion Criteria:

  • Pregnancy
  • Spinal instability
  • Non-English speaking
  • Unhealed limb or pelvic fractures or any condition restricting weight bearing in limbs
  • Diagnosis of other neurological injury other than SCI such as CVA, MS, ABI, CP
  • Uncontrolled spasticity (≥3 on Modified Ashworth Scale)[21]
  • Colostomy
  • Decreased range of motion or contractures in legs (>10° at hips, knees or ankles)
  • Uncontrolled autonomic dysreflexia
  • Unresolved deep vein thrombosis
  • Inability to tolerate standing due to cardiovascular issues or orthostatic hypotension
  • Severe comorbidities: active infections, heart, lung, or circulatory conditions
  • Pressure sores, impaired skin integrity

Acquired Brain Injury(ABI) Inclusion Criteria:

  • Male or non-pregnant female
  • ≥18 years of age
  • Chronic (> 6 mo post) injury
  • Able to achieve adequate fit within exoskeleton
  • Ability to perform informed consent
  • Sufficient range of motion to attain normal, reciprocal gait pattern, and transition from normal sit to stand or stand to sit
  • Weight <220 pounds
  • Intact skin on all surfaces in contact with device and load bearing surfaces
  • Cognitively intact and able to follow directions and demonstrate learning capability

Acquired Brain Injury(ABI) Exclusion Criteria:

  • Pregnancy
  • Spinal instability
  • Non-English speaking
  • Unhealed limb or pelvic fractures or any condition restricting weight bearing in limbs
  • Diagnosis of other neurological injury other than ABI such as SCI, MS, TBI, CP
  • Decreased range of motion or contractures in legs (>10° at hips, knees or ankles)
  • Inability to tolerate standing due to cardiovascular issues or orthostatic hypotension
  • Pressure sores, impaired skin integrity
  • Uncontrolled spasticity (≥3 on Modified Ashworth Scale)
  • Colostomy
  • Severe comorbidities: active infections, heart, lung, or circulatory conditions
  • Unresolved deep vein thrombosis

Multiple Sclerosis (MS) Inclusion Criteria:

  • Male or non-pregnant female
  • ≥18 years of age
  • Chronic (> 6 mo post) injury
  • Diagnosis of multiple sclerosis
  • Ability to perform informed consent
  • Sufficient range of motion to attain normal, reciprocal gait pattern, and transition from normal sit to stand or stand to sit
  • Weight <220 pounds
  • Able to achieve adequate fit within exoskeleton
  • Intact skin on all surfaces in contact with device and load bearing surfaces
  • Cognitively intact and able to follow directions and demonstrate learning capability

Multiple Sclerosis (MS) Exclusion Criteria:

  • Pregnancy
  • Spinal instability
  • Non-English speaking
  • Unhealed limb or pelvic fractures or any condition restricting weight bearing in limbs
  • Decreased range of motion or contractures in legs (>10° at hips, knees or ankles)
  • Inability to tolerate standing due to cardiovascular issues or orthostatic hypotension
  • Uncontrolled autonomic dysreflexia
  • Unresolved deep vein thrombosis
  • Pressure sores, impaired skin integrity
  • Uncontrolled spasticity (≥3 on Modified Ashworth Scale)
  • Colostomy
  • Severe comorbidities: active infections, heart, lung, or circulatory conditions[23,24]
  • Diagnosis of other neurological injury other than MS such as CVA, SCI, ABI, CP
  • MS Relapse in 3 months prior to recruitment

Able Bodied Inclusion Criteria:

  • Male or non-pregnant female
  • ≥18 years of age
  • Weight <220 pounds
  • Cognitively intact and able to follow directions and demonstrate learning capability[23]
  • Healthy individuals with no history or diagnosis of neurological injury
  • Sufficient range of motion to attain normal, reciprocal gait pattern, and transition from normal sit to stand or stand to sit
  • Able to achieve adequate fit within exoskeleton
  • Intact skin on all surfaces in contact with device and load bearing surfaces
  • Ability to perform informed consent[24]

Able Bodied Exclusion Criteria:

  • Pregnancy
  • Spinal instability
  • Non-English speaking
  • Unhealed limb or pelvic fractures or any condition restricting weight bearing in limbs
  • Diagnosis of neurological injury such as CVA, SCI, ABI, CP, MS
  • Decreased range of motion or contractures in legs (>10° at hips, knees or ankles)
  • Severe comorbidities: active infections, heart, lung, or circulatory conditions
  • Colostomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057652


Contacts
Contact: Shuo-Hsiu Chang, PT, PhD 713-799-7016 shuo-hsiu.chang@uth.tmc.edu
Contact: Ruta Paranjape, MS, CCRP 713-799-6976 Ruta.Paranjape@uth.tmc.edu

Locations
United States, Texas
TIRR Memorial Hermann Recruiting
Houston, Texas, United States, 77030
Contact: Shuo-Hsiu Chang, PT, PhD    713-799-7016    Shuo-Hsiu.Chang@uth.tmc.edu   
Contact: Marcie Kern, PT, MS    713-799-6995    Marcie.Kern@memorialhermann.org   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Shuo-Hsiu Chang, PT, PhD The University of Texas Health Science Center, Houston

Responsible Party: Shuo-Hsiu Chang, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03057652     History of Changes
Other Study ID Numbers: HSC-MS-15-0923
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Wounds and Injuries
Multiple Sclerosis
Brain Injuries
Spinal Cord Injuries
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Spinal Cord Diseases