The ReWalk Exoskeletal Walking System for Persons With Paraplegia

Study Overview
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Brief Summary
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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
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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.

Official Title
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The ReWalk Exoskeletal Walking System for Persons With Paraplegia

Conditions
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Paraplegia

Intervention / Treatment
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* Device: powered exoskeleton


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Powered Exoskeleton<br>persons with SCI trained to use a powered exoskeleton to ambulate overground | Device: powered exoskeleton<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | ReWalk training at 4 and 12 weeks, and 1-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exoskeleton walking system, paraplegia, paralysis