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

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ClinicalTrials.gov Identifier: NCT00627107
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : November 30, 2010
Sponsor:
Information provided by:
ReWalk Robotics, Inc.

Study Description
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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
Paraplegia SCI Device: ReWalk - a motorized exoskeleton suit Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
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 : February 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

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Arms and Interventions
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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 Name: Exoskeleton suit


Outcome Measures
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Primary Outcome Measures :
  1. Observation and subject feedback [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. subject tolerance [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00627107


Locations
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Israel
Sheba Medical Center, Neurological Rehabilitation Department
Tel-Hashomer, Israel, 52621
Sponsors and Collaborators
ReWalk Robotics, Inc.
Investigators
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Principal Investigator: Gabi Zeilig, MD Sheba Medical Center
More Information
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Responsible Party: Dr. Gabi Zeilig, Head of the Neurological Rehabilitation Department (PI), Sheba Medical center
ClinicalTrials.gov Identifier: NCT00627107     History of Changes
Other Study ID Numbers: RW-002
First Posted: February 29, 2008    Key Record Dates
Last Update Posted: November 30, 2010
Last Verified: November 2010
Keywords provided by ReWalk Robotics, Inc.:
ReWalk, Paraplegia, SCI
Additional relevant MeSH terms:
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Paraplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms