The ReWalk Exoskeletal Walking System for Persons With Paraplegia

Completed · Not applicable

Conditions studied: Paraplegia

In brief

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.

Key facts

Study ID

NCT01454570

Run by

James J. Peters Veterans Affairs Medical Center

People needed

19

Starts

2011-02-01

Expected to finish

2015-08-08

Last updated by the study team

2020-08-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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)
• 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

Where it is running

• James J. Peters Veterans Affairs Medical Center; Center of Excellence for the Major Consequences of SCI. — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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