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Powered Exoskeletons in Persons With SCI

NCT02658656 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 424

Last updated 2024-11-04

Study results available
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Summary

Background Veterans with spinal cord injury (SCI) have many adverse secondary medical and quality of life (QOL) changes as a result of immobilization. Veterans with SCI who have completed rehabilitation after injury and are unable to ambulate receive a wheelchair as standard of care (SOC) for mobility. Powered exoskeletons are a technology that has recently become available as an alternate form of mobility by providing an external framework for support and computer controlled motorized hip and knee joints to assist with over ground ambulation.

Conditions

  • Spinal Cord Injury

Interventions

DEVICE

ReWalk 6.0

Exoskeletal Assisted Walking Device

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Ann M Spungen, EdD · James J. Peters Veterans Affairs Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-01
Primary Completion
2021-03-31
Completion
2021-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02658656 on ClinicalTrials.gov