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

August 13, 2020 updated by: Ann M. Spungen, EdD, James J. Peters Veterans Affairs Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10468
        • James J. Peters Veterans Affairs Medical Center; Center of Excellence for the Major Consequences of SCI.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
ReWalk training at 4 and 12 weeks, and 1-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

James J. Peters Veterans Affairs Medical Center

Investigators

  • Principal Investigator: Ann M Spungen, EdD, Bronx JJPVAMC CoE 7A-13

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

August 8, 2015

Study Completion (Actual)

August 8, 2015

Study Registration Dates

First Submitted

September 14, 2011

First Submitted That Met QC Criteria

October 18, 2011

First Posted (Estimate)

October 19, 2011

Study Record Updates

Last Update Posted (Actual)

August 25, 2020

Last Update Submitted That Met QC Criteria

August 13, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JJPVAMC: SPU-09-11
  • Protocol#: SPU-09-11 (Other Identifier: JamesJPetersVAMC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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