A Study Testing Safety and Tolerance of the ReWalk Exoskeleton Suit

Not Applicable

Completed

• Conditions: Paraplegia; SCI
• Interventions: Device: ReWalk - a motorized exoskeleton suit

• Registration Number: NCT00627107
• Lead Sponsor: ReWalk Robotics, Inc.

Brief Summary

The ReWalk enables people with lower limb disabilities to carry out routine ambulatory functions (stand, walk, climb stairs etc.). It can be used by people with disabilities such as spinal cord injury, brain injury, stroke, multiple sclerosis, cerebral palsy and other severe walking impairments. The device promises to restore the dignity of disabled persons, enabling them to work and improve their general health and quality of life, as well as significantly reduce medical and other related expenses.

Detailed Description

The ReWalk comprises light wearable brace support suit, which integrates DC motors at the joints, rechargeable batteries, an array of sensors and a computer-based control system. It is snugly fitted on the body and worn underneath the clothing, if desired. ReWalk is a new realization of the Powered Exoskeleton concept, first tried about fifty years ago with no success. Employing an innovative, non-robotic design approach, it uniquely matches the user's capabilities with the control mechanisms. Upper-body movements of the user are detected and used to initiate and maintain walking processes. User stability and safety during ambulation is secured by concurrent use of safety aids such as crutches for walking and railing for stairs.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-21
• Study First Submitted QC: 2008-02-21
• Study First Posted: 2008-02-29
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-27
• Last Update Posted: 2010-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Chronic (at least 6 months after injury) complete cervical(C7-8) or thoracic (T1-T12) spinal cord injury
• Age between 18-55
• Male and non-pregnant non-lactating female
• Regular use of RGO or bing able to stand up using a device (e.g. EasyStand)
• under 100 kg and between 155-200 cm of height

Exclusion Criteria

• History of severe neurological injuries other than SCI (MS, CP, ALS, TBI etc)
• Severe concurrent medical diseases: infections, heart or lung, pressure sores
• Unstable spine or unhealed limbs or pelvic fractures
• Psychiatric or cognitive situations that may interfere with the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	ReWalk - a motorized exoskeleton suit	A group of paraplegics.

Primary Outcome Measures

Name	Time	Method
Observation and subject feedback	3 months

Secondary Outcome Measures

Name	Time	Method
subject tolerance	3 months

Trial Locations

Locations (1)

Sheba Medical Center, Neurological Rehabilitation Department; 🇮🇱 Tel-Hashomer, Israel