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

Primary Purpose

Paraplegia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

powered exoskeleton

About this trial

This is an interventional other trial for Paraplegia focused on measuring exoskeleton walking system, paraplegia, paralysis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 <100kg (<220 lb)
Ability to give informed consent

Exclusion Criteria:

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
Severe concurrent medical disease, illness or condition
Recent lower extremity fracture within the past 2 years;
DXA results indicating a t-score below -3.0 and knee BMD <0.70 gm/cm2
Systemic or peripheral infection
Atherosclerosis, congestive heart failure, or history of myocardial infarction
Trunk and/or lower extremity pressure ulcers;
Other illness, that the study physician considers in his/her clinical judgment to be exclusionary
Severe spasticity (defined by an Ashworth score of >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 < -3.0
Psychopathology documentation in the medical record or history of that may conflict with study objectives
Hypertension (SBP>140, DBP>90)
Pregnancy and/or lactating females

Sites / Locations

James J. Peters Veterans Affairs Medical Center; Center of Excellence for the Major Consequences of SCI.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Powered Exoskeleton

Arm Description

persons with SCI trained to use a powered exoskeleton to ambulate overground

Outcomes

Primary Outcome Measures

Count to Achieve Mobility Skills

1. To determine efficacy for mobility defined as the ability to perform the following with the ReWalk-I exoskeletal system, without staff assistance: Sit-to-stand, Stand-to-sit, Standing balance for 1 minutes with both crutches, Standing balance for 30 seconds with one crutch, Ten meter walk in ≤2 minutes, Walk ≥30 meters in 6-minutes, and Ascend, turn around and descend 4 stairs in 5 minutes.

Secondary Outcome Measures

Full Information

NCT ID

NCT01454570

First Posted

September 14, 2011

Last Updated

August 13, 2020

Sponsor

James J. Peters Veterans Affairs Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01454570

Brief Title

The ReWalk Exoskeletal Walking System for Persons With Paraplegia

Acronym

VA_ReWalk

Official Title

The ReWalk Exoskeletal Walking System for Persons With Paraplegia

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

August 8, 2015 (Actual)

Study Completion Date

August 8, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

James J. Peters Veterans Affairs Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Paraplegia

Keywords

exoskeleton walking system, paraplegia, paralysis

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Powered Exoskeleton

Arm Type

Experimental

Arm Description

persons with SCI trained to use a powered exoskeleton to ambulate overground

Intervention Type

Device

Intervention Name(s)

powered exoskeleton

Primary Outcome Measure Information:

Title

Count to Achieve Mobility Skills

Description

Time Frame

ReWalk training at 4 and 12 weeks, and 1-month follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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 <100kg (<220 lb) Ability to give informed consent Exclusion Criteria: 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 Severe concurrent medical disease, illness or condition Recent lower extremity fracture within the past 2 years; DXA results indicating a t-score below -3.0 and knee BMD <0.70 gm/cm2 Systemic or peripheral infection Atherosclerosis, congestive heart failure, or history of myocardial infarction Trunk and/or lower extremity pressure ulcers; Other illness, that the study physician considers in his/her clinical judgment to be exclusionary Severe spasticity (defined by an Ashworth score of >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 < -3.0 Psychopathology documentation in the medical record or history of that may conflict with study objectives Hypertension (SBP>140, DBP>90) Pregnancy and/or lactating females

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ann M Spungen, EdD

Organizational Affiliation

Bronx JJPVAMC CoE 7A-13

Official's Role

Principal Investigator

Facility Information:

Facility Name

James J. Peters Veterans Affairs Medical Center; Center of Excellence for the Major Consequences of SCI.

City

Bronx

State/Province

New York

ZIP/Postal Code

10468

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

33712561

Citation

Tsai CY, Asselin PK, Hong E, Knezevic S, Kornfeld SD, Harel NY, Spungen AM. Exoskeletal-assisted walking may improve seated balance in persons with chronic spinal cord injury: a pilot study. Spinal Cord Ser Cases. 2021 Mar 12;7(1):20. doi: 10.1038/s41394-021-00384-8.

Results Reference

derived

PubMed Identifier

33171129

Citation

Asselin P, Cirnigliaro CM, Kornfeld S, Knezevic S, Lackow R, Elliott M, Bauman WA, Spungen AM. Effect of Exoskeletal-Assisted Walking on Soft Tissue Body Composition in Persons With Spinal Cord Injury. Arch Phys Med Rehabil. 2021 Feb;102(2):196-202. doi: 10.1016/j.apmr.2020.07.018. Epub 2020 Nov 7.

Results Reference

derived

PubMed Identifier

26230182

Citation

Asselin P, Knezevic S, Kornfeld S, Cirnigliaro C, Agranova-Breyter I, Bauman WA, Spungen AM. Heart rate and oxygen demand of powered exoskeleton-assisted walking in persons with paraplegia. J Rehabil Res Dev. 2015;52(2):147-58. doi: 10.1682/JRRD.2014.02.0060.

Results Reference

derived

Links:

URL

http://clinicaltrials.gov/ct2/show/NCT00627107

Description

A Study Testing Safety and Tolerance of the ReWalk Exoskeleton Suit (RW)

Learn more about this trial

The ReWalk Exoskeletal Walking System for Persons With Paraplegia

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