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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Paraplegia SCI | Device: ReWalk - a motorized exoskeleton suit | Not Applicable |
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 |
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
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- Observation and subject feedback [ Time Frame: 3 months ]
- subject tolerance [ Time Frame: 3 months ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
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

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
Israel | |
Sheba Medical Center, Neurological Rehabilitation Department | |
Tel-Hashomer, Israel, 52621 |
Principal Investigator: | Gabi Zeilig, MD | Sheba Medical Center |
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:
Paraplegia Paralysis Neurologic Manifestations Nervous System Diseases Signs and Symptoms |