The ReWalk Exoskeletal Walking System for Persons With Paraplegia

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Brief Title

The ReWalk Exoskeletal Walking System for Persons With Paraplegia

Official Title

The ReWalk Exoskeletal Walking System for Persons With Paraplegia

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.

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


Primary Outcome

Count to Achieve Mobility Skills




powered exoskeleton

Study Arms / Comparison Groups

 Powered Exoskeleton
Description:  persons with SCI trained to use a powered exoskeleton to ambulate overground


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

February 2011

Completion Date

August 8, 2015

Primary Completion Date

August 8, 2015

Eligibility Criteria

        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

          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




18 Years - 65 Years

Accepts Healthy Volunteers



Ann M Spungen, EdD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Secondary IDs

Protocol#: SPU-09-11

Responsible Party

Principal Investigator

Study Sponsor

James J. Peters Veterans Affairs Medical Center

Study Sponsor

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

Verification Date

August 2020