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Completed

NCT Number: NCT00627107

A Study Testing Safety and Tolerance of the ReWalk Exoskeleton Suit

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.

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Key information

Conditions

Paraplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms SCI Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheba Medical Center, Neurological Rehabilitation Department

Tel Litwinsky, 52621, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ReWalk - a motorized exoskeleton suit

Device

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

Other names: Exoskeleton suit

Primary outcomes

  1. Observation and subject feedback

    Time frame: 3 months

Secondary outcomes

  1. subject tolerance

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

ReWalk Robotics, Inc.

Industry

Registry information

Official study title

Study of the ReWalk Motorized Exoskeleton Suit That Enables Individuals With Lower Limbs Impairment to Walk and to Perform Other Basic Mobility Functions.

Acronym: RW

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 29, 2008
Registry last updated
Nov 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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