Home/Work, Community Mobility Skills in the ReWalk Exoskeleton in Persons With SCI

NCT02118194 | Completed

• 1 other identifier: JJPVAMC ReWalk2
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this project is to determine if non-ambulatory persons with spinal cord injury (SCI) who have already participated in at least 20 sessions of ReWalk training can be further trained to achieve more advanced skills for use in the home or work place environments and outdoor community mobility skills in the ReWalk exoskeleton.

Conditions

Spinal Cord Injury

Keywords

paraplegia; paralysis; robotics; walking; immobilization

Outcome Measures

Primary Outcomes (1)

• Number of sessions and level of assistance to achieve the advanced indoor and outdoor exoskeletal-assisted walking skills

  The walking tests (10mWT, 6-minWT, TUG) will be performed indoors on tile/linoleum and carpet and outdoors on concrete, asphalt, grass, dirt, uneven surfaces, curbs, curb cutouts, and ramps.

  Assessments are weekly during the 20-session protocol and at the end over a 6 week period

Secondary Outcomes (1)

• Number of sessions and level of assistance to achieve specific advanced indoor standing and door navigation skills

  Assessments are weekly during the 20-session protocol and at the end over a 6 week period

Other Outcomes (1)

• Number of sessions and level of assistance to achieve exoskeletal-assisted stair ascent and descent

  Assessments are weekly during the 20-session protocol an at the end over a 6 week period

Study Arms (1)

Paraplegia, spinal cord injury

An exoskeleton-assisted walking system for people with paralysis from spinal cord injury at thoracic level 1 and below (paraplegia) will be used.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Males and females with paraplegia (T1 and below) who are unable to walk on their own will be eligible for participation in this study.

You may qualify if:

• Males or females with spinal cord injury (SCI) who have already participated in at least 20 ReWalk training sessions.

You may not qualify if:

• Severe concurrent medical disease, illness or condition;
• Unhealed fractures;
• Systemic or peripheral infection;
• Atherosclerosis, congestive heart failure, or history of myocardial infarction;
• Trunk and/or lower extremity pressure ulcers;
• Severe spasticity (defined by an Ashworth score of \>4.0 or clinical impression of the study physician or physical therapist);
• Significant contractures or heterotropic ossification of the lower extremities that prevent flexion and extension of the joint;
• Distal femur and/or proximal tibia bone mineral density less than 0.59 cm2.
• Femoral neck or the total proximal femur bone mineral density T-scores \< -3.5;
• Psychopathology documentation in the medical record or history of that may conflict with study objectives;
• Hypertension (Systolic Blood Pressure \>140, Diastolic Blood Pressure \>90); and/or
• Pregnancy and/or lactating females.

Sponsors & Collaborators

• James J. Peters Veterans Affairs Medical Center: lead

Study Sites (1)

James J Peters VA Medical Center

The Bronx, New York, 10468, United States

Location

Related Publications (1)

• Yang A, Asselin P, Knezevic S, Kornfeld S, Spungen AM. Assessment of In-Hospital Walking Velocity and Level of Assistance in a Powered Exoskeleton in Persons with Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2015 Spring;21(2):100-9. doi: 10.1310/sci2102-100. Epub 2015 Apr 12.

  PMID: 26364279 DERIVED

Related Links

• Spinal Cord Damage Research Center website

MeSH Terms

Conditions

Spinal Cord Injuries; Paraplegia; Paralysis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ann M Spungen, EdD

  James J Peters VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Health Science Specialist

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: April 21, 2014
• Study Start: October 1, 2013
• Primary Completion: October 6, 2022
• Study Completion: October 1, 2023
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

US (1)