The ReWalk Exoskeletal Walking System for Persons With Paraplegia
VA_ReWalk
2 other identifiers
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 14, 2011
CompletedFirst Posted
Study publicly available on registry
October 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2015
CompletedResults Posted
Study results publicly available
August 25, 2020
CompletedAugust 25, 2020
August 1, 2020
4.5 years
September 14, 2011
January 19, 2018
August 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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: 1. Sit-to-stand, 2. Stand-to-sit, 3. Standing balance for 1 minutes with both crutches, 4. Standing balance for 30 seconds with one crutch, 5. Ten meter walk in ≤2 minutes, 6. Walk ≥30 meters in 6-minutes, and 7. Ascend, turn around and descend 4 stairs in 5 minutes.
ReWalk training at 4 and 12 weeks, and 1-month follow-up
Study Arms (1)
Powered Exoskeleton
EXPERIMENTALpersons with SCI trained to use a powered exoskeleton to ambulate overground
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- 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;
- Severe spasticity (defined by an Ashworth score of \>4.0 or clinical impression of the study physician or physical therapist)
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
James J. Peters Veterans Affairs Medical Center; Center of Excellence for the Major Consequences of SCI.
The Bronx, New York, 10468, United States
Related Publications (3)
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.
PMID: 33712561DERIVEDAsselin 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.
PMID: 33171129DERIVEDAsselin 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.
PMID: 26230182DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Ann Spungen - PI
- Organization
- James J Peters VA Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Ann M Spungen, EdD
Bronx JJPVAMC CoE 7A-13
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Director of CoE / Health Science Specialist
Study Record Dates
First Submitted
September 14, 2011
First Posted
October 19, 2011
Study Start
February 1, 2011
Primary Completion
August 8, 2015
Study Completion
August 8, 2015
Last Updated
August 25, 2020
Results First Posted
August 25, 2020
Record last verified: 2020-08