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RW: A Study Testing Safety and Tolerance of the ReWalk Exoskeleton Suit

Sponsor
ReWalk Robotics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00627107
Collaborator
(none)
6
Enrollment
1
Location
1
Arm
11
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: ReWalk - a motorized exoskeleton suit
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Study of the ReWalk Motorized Exoskeleton Suit That Enables Individuals With Lower Limbs Impairment to Walk and to Perform Other Basic Mobility Functions.
Study Start Date :
Feb 1, 2008
Actual Primary Completion Date :
Jan 1, 2009
Actual Study Completion Date :
Jan 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

A group of paraplegics.

Device: ReWalk - a motorized exoskeleton suit
The subject will wear the ReWalk suit and have training sessions for walking with the device.
Other Names:
  • Exoskeleton suit

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Observation and subject feedback [3 months]

    Secondary Outcome Measures

    1. subject tolerance [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sheba Medical Center, Neurological Rehabilitation Department Tel-Hashomer Israel 52621

    Sponsors and Collaborators

    • ReWalk Robotics, Inc.

    Investigators

    • Principal Investigator: Gabi Zeilig, MD, Sheba Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00627107
    Other Study ID Numbers:
    • RW-002
    First Posted:
    Feb 29, 2008
    Last Update Posted:
    Nov 30, 2010
    Last Verified:
    Nov 1, 2010
    Keywords provided by , ,
    ReWalk, Paraplegia, SCI
    Additional relevant MeSH terms:
    Paraplegia

    Study Results

    No Results Posted as of Nov 30, 2010