The ReWalk Exoskeletal Walking System for Persons With Paraplegia (VA_ReWalk)
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ClinicalTrials.gov Identifier: NCT01454570 |
Recruitment Status
: Unknown
Verified April 2015 by Ann M. Spungen, EdD, James J. Peters Veterans Affairs Medical Center.
Recruitment status was: Recruiting
First Posted
: October 19, 2011
Last Update Posted
: April 10, 2015
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Sponsor:
James J. Peters Veterans Affairs Medical Center
Information provided by (Responsible Party):
Ann M. Spungen, EdD, James J. Peters Veterans Affairs Medical Center
Tracking Information | ||||
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First Submitted Date | September 14, 2011 | |||
First Posted Date | October 19, 2011 | |||
Last Update Posted Date | April 10, 2015 | |||
Study Start Date | February 2011 | |||
Estimated Primary Completion Date | April 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Percent change from baseline [ Time Frame: ReWalk training at 4 and 12 weeks, and 1-month follow-up ] 1. To determine efficacy for mobility defined as the ability to perform the following with the ReWalk-I exoskeletal system, without staff assistance:
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Original Primary Outcome Measures |
Percent change from baseline [ Time Frame: ReWalk training at 4 and 12 weeks, and 16-week follow-up ] 1. To determine efficacy for mobility defined as the ability to perform the following with the ReWalk-I exoskeletal system, without staff assistance:
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Change History | Complete list of historical versions of study NCT01454570 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
Percent change from baseline [ Time Frame: ReWalk training at 4 and 16 weeks, and 1-month follow-up ] Sitting and standing balance skills, bowel function, bladder function by survey, muscle spasms by survey, quality of life by survey, resting and exercise energy expenditure, body composition, and neurological tests. Additional mobility training will be observed for a timed-up-and-go (TUG) and a mild obstacle course (incline, decline, carpeting, step, simulated curb, walking in a figure 8)
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Original Secondary Outcome Measures |
Percent change from baseline [ Time Frame: ReWalk training at 4 and 16 weeks, and 16-week follow-up ] Sitting and standing balance skills, bowel function, bladder function by survey, muscle spasms by survey, quality of life by survey, resting and exercise energy expenditure, body composition, and neurological tests. Additional mobility training will be observed for a timed-up-and-go (TUG) and a mild obstacle course (incline, decline, carpeting, step, simulated curb, walking in a figure 8)
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Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | The ReWalk Exoskeletal Walking System for Persons With Paraplegia | |||
Official Title | The ReWalk Exoskeletal Walking System for Persons With Paraplegia | |||
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. | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population |
Persons who answer "no" to any of the above questions will not be eligible for the study |
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Condition | Paraplegia | |||
Intervention | Not Provided | |||
Study Groups/Cohorts | Not Provided | |||
Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Unknown status | |||
Estimated Enrollment |
40 | |||
Original Estimated Enrollment | Same as current | |||
Estimated Study Completion Date | November 2015 | |||
Estimated Primary Completion Date | April 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 65 Years (Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01454570 | |||
Other Study ID Numbers | JJPVAMC: SPU-09-11 Protocol#: SPU-09-11 ( Other Identifier: JamesJPetersVAMC ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Ann M. Spungen, EdD, James J. Peters Veterans Affairs Medical Center | |||
Study Sponsor | James J. Peters Veterans Affairs Medical Center | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | James J. Peters Veterans Affairs Medical Center | |||
Verification Date | April 2015 |