Working… Menu

The ReWalk Exoskeletal Walking System for Persons With Paraplegia (VA_ReWalk)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01454570
Recruitment Status : Completed
First Posted : October 19, 2011
Results First Posted : August 25, 2020
Last Update Posted : August 25, 2020
Information provided by (Responsible Party):
Ann M. Spungen, EdD, James J. Peters Veterans Affairs Medical Center

Brief Summary:
It is well appreciated that an extreme sedentary lifestyle from paralysis, contributes to many secondary medical problems such as diabetes and insulin resistance, obesity, constipation, poor blood pressure regulation, cardiovascular disease, reduced quality of life, and more. The ReWalk-I exoskeleton walking device permits investigation of the potential benefits of frequent upright posture and walking on many of the secondary consequences of spinal cord injury. The researchers are investigating the ability of persons with paraplegia to learn to stand and walk with the ReWalk-I and the effects of being upright and walking on several of these secondary medical consequences of spinal cord injury.

Condition or disease Intervention/treatment Phase
Paraplegia Device: powered exoskeleton Not Applicable

Detailed Description:
Potential participants will be pre-screened with the inclusion criteria for eligibility. The informed consent process will begin for those participants who have been determined to meet the inclusion criteria. After the potential participant's signed consent has been provided, further evaluations for eligibility will be performed (e.g., there are several medical and physical exclusion criteria). Those potential participants who meet both the inclusion and exclusion criteria will be eligible to enroll into the ReWalk-I study. Baseline evaluations and personalized measurements for fitting to the ReWalk-I will be performed over one week, before the training sessions begin. The ReWalk sessions will consist of a Learning Phase (12 sessions in 4 weeks) and a Training Phase (18 sessions in 6 weeks). These times may vary by each participant's ReWalk learning curve. Training will begin with sit-to-stand, stand-to-sit, and standing balance activities. Progression to walking will occur as skills advance. Each session will be an average 50 minutes, with 3 sessions per week. The skills to be learned include 1) sit-to-stand, 2) stand-to-sit, 3) 2-arm standing balance, 4) 1-arm standing balance, 5) walking, and 6) stair climbing. The study evaluations will be repeated after the Learning Phase, after the Training Phase and 1-month post training follow-up.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The ReWalk Exoskeletal Walking System for Persons With Paraplegia
Study Start Date : February 2011
Actual Primary Completion Date : August 8, 2015
Actual Study Completion Date : August 8, 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Powered Exoskeleton
persons with SCI trained to use a powered exoskeleton to ambulate overground
Device: powered exoskeleton

Primary Outcome Measures :
  1. Count to Achieve Mobility Skills [ Time Frame: ReWalk training at 4 and 12 weeks, and 1-month follow-up ]

    1. To determine efficacy for mobility defined as the ability to perform the following with the ReWalk-I exoskeletal system, without staff assistance:

    1. Sit-to-stand,
    2. Stand-to-sit,
    3. Standing balance for 1 minutes with both crutches,
    4. Standing balance for 30 seconds with one crutch,
    5. Ten meter walk in ≤2 minutes,
    6. Walk ≥30 meters in 6-minutes, and
    7. Ascend, turn around and descend 4 stairs in 5 minutes.

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.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Males or females with paraplegia
  2. Duration of SCI >6 months
  3. Ages 18 to 65 y
  4. Height 160 to 190cm (63-75in or 5'3" to 6'3")
  5. Weight <100kg (<220 lb)
  6. Ability to give informed consent

Exclusion Criteria:

  1. Diagnosis of neurological injury other than SCI including:

    • Multiple sclerosis (MS)
    • Stroke
    • Cerebral Palsy (CP)
    • Amyotrophic lateral sclerosis (ALS)
    • Traumatic Brain injury (TBI)
    • Spina bifida
    • Parkinson's disease (PD)
    • Other neurological condition that the study physician considers in his/her clinical judgment to be exclusionary
  2. Severe concurrent medical disease, illness or condition
  3. Recent lower extremity fracture within the past 2 years;
  4. DXA results indicating a t-score below -3.0 and knee BMD <0.70 gm/cm2
  5. Systemic or peripheral infection
  6. Atherosclerosis, congestive heart failure, or history of myocardial infarction
  7. Trunk and/or lower extremity pressure ulcers;
  8. Other illness, that the study physician considers in his/her clinical judgment to be exclusionary
  9. Severe spasticity (defined by an Ashworth score of >4.0 or clinical impression of the study physician or physical therapist)
  10. Significant contractures defined as flexion contracture limited to 35º at the hip and 20º at the knee;
  11. Diagnosis of heterotrophic ossification of the lower extremities;
  12. Femoral neck or the total proximal femur bone mineral density T-scores < -3.0
  13. Psychopathology documentation in the medical record or history of that may conflict with study objectives
  14. Hypertension (SBP>140, DBP>90)
  15. Pregnancy and/or lactating females

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 identifier (NCT number): NCT01454570

Layout table for location information
United States, New York
James J. Peters Veterans Affairs Medical Center; Center of Excellence for the Major Consequences of SCI.
Bronx, New York, United States, 10468
Sponsors and Collaborators
James J. Peters Veterans Affairs Medical Center
Layout table for investigator information
Principal Investigator: Ann M Spungen, EdD Bronx JJPVAMC CoE 7A-13
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Ann M. Spungen, EdD, Associate Director of CoE / Health Science Specialist, James J. Peters Veterans Affairs Medical Center Identifier: NCT01454570    
Other Study ID Numbers: JJPVAMC: SPU-09-11
Protocol#: SPU-09-11 ( Other Identifier: JamesJPetersVAMC )
First Posted: October 19, 2011    Key Record Dates
Results First Posted: August 25, 2020
Last Update Posted: August 25, 2020
Last Verified: August 2020
Keywords provided by Ann M. Spungen, EdD, James J. Peters Veterans Affairs Medical Center:
exoskeleton walking system
Additional relevant MeSH terms:
Layout table for MeSH terms
Neurologic Manifestations
Nervous System Diseases