A Study Testing Safety and Tolerance of the ReWalk Exoskeleton Suit

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Brief Title

A Study Testing Safety and Tolerance of the ReWalk Exoskeleton Suit

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.

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 Type

Interventional


Primary Outcome

Observation and subject feedback

Secondary Outcome

 subject tolerance

Condition

Paraplegia

Intervention

ReWalk - a motorized exoskeleton suit

Study Arms / Comparison Groups

 A
Description:  A group of paraplegics.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

6

Start Date

February 2008

Completion Date

January 2009

Primary Completion Date

January 2009

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 55 Years

Accepts Healthy Volunteers

No

Contacts

Gabi Zeilig, MD, , 

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT00627107

Organization ID

RW-002



Study Sponsor

ReWalk Robotics, Inc.


Study Sponsor

Gabi Zeilig, MD, Principal Investigator, Sheba Medical Center


Verification Date

November 2010