N/A N=19 Other

The ReWalk Exoskeletal Walking System for Persons With Paraplegia

Paraplegia

Bottom Line

View on ClinicalTrials.gov: NCT01454570 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2020

Primary outcome: Primary: Count to Achieve Mobility Skills — 9; 3; 0; 10 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: powered exoskeleton (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: James J. Peters Veterans Affairs Medical Center
Primary completion: Aug 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Count to Achieve Mobility Skills	9; 3; 0; 10; 1; 1	—

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.

Eligibility Criteria

Inclusion Criteria

Males or females with paraplegia
Duration of SCI >6 months
Ages 18 to 65 y
Height 160 to 190cm (63-75in or 5'3" to 6'3")
Weight 4.0 or clinical impression of the study physician or physical therapist)
Significant contractures defined as flexion contracture limited to 35º at the hip and 20º at the knee;
Diagnosis of heterotrophic ossification of the lower extremities;
Femoral neck or the total proximal femur bone mineral density T-scores 140, DBP>90)
Pregnancy and/or lactating females

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01454570). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.