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A Study Testing Safety and Tolerance of the ReWalk Exoskeleton Suit

NCT ID: NCT00627107

Last Updated: 2010-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-01-31

Brief Summary

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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

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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.

Conditions

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Paraplegia SCI

Keywords

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ReWalk, Paraplegia, SCI

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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A

A group of paraplegics.

Group Type EXPERIMENTAL

ReWalk - a motorized exoskeleton suit

Intervention Type DEVICE

The subject will wear the ReWalk suit and have training sessions for walking with the device.

Interventions

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ReWalk - a motorized exoskeleton suit

The subject will wear the ReWalk suit and have training sessions for walking with the device.

Intervention Type DEVICE

Other Intervention Names

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Exoskeleton suit

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ReWalk Robotics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Sheba Medical center

Principal Investigators

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Gabi Zeilig, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Sheba Medical Center, Neurological Rehabilitation Department

Tel Litwinsky, , Israel

Site Status

Countries

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Israel

Other Identifiers

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RW-002

Identifier Type: -

Identifier Source: org_study_id