The ReWalk Exoskeletal Walking System for Persons With Paraplegia
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Paraplegia
- Sponsor
- James J. Peters Veterans Affairs Medical Center
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Count to Achieve Mobility Skills
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Ann M. Spungen, EdD
Associate Director of CoE / Health Science Specialist
James J. Peters Veterans Affairs Medical Center
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)
- •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;
Outcomes
Primary Outcomes
Count to Achieve Mobility Skills
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.