Clinical Trial: The ReWalk Exoskeletal Walking System for Persons With Paraplegia

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Observational

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 Summary: 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.
Sponsor: James J. Peters Veterans Affairs Medical Center

Current Primary Outcome: 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:

  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.


Original Primary Outcome: 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:

  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.


Current Secondary Outcome: 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)


Original Secondary Outcome: 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)


Information By: James J. Peters Veterans Affairs Medical Center

Dates:
Date Received: September 14, 2011
Date Started: February 2011
Date Completion: November 2015
Last Updated: April 8, 2015
Last Verified: April 2015