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

This study has been completed.

Sponsor:

Information provided by:

Argo Medical Technologies Ltd.

ClinicalTrials.gov Identifier:

NCT00627107

First received: February 21, 2008

Last updated: November 27, 2010

Last verified: November 2010

History of Changes

Purpose

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	Intervention
Paraplegia SCI	Device: ReWalk - a motorized exoskeleton suit


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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.

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Paraplegia

U.S. FDA Resources

Further study details as provided by Argo Medical Technologies Ltd.:

Primary Outcome Measures:

Observation and subject feedback [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

subject tolerance [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	6
Study Start Date:	February 2008
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627107

Locations


Israel
Sheba Medical Center, Neurological Rehabilitation Department
Tel-Hashomer, Israel, 52621

Sponsors and Collaborators

Argo Medical Technologies Ltd.

Investigators


Principal Investigator:	Gabi Zeilig, MD	Sheba Medical Center

More Information

No publications provided


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
Study First Received:	February 21, 2008
Last Updated:	November 27, 2010
Health Authority:	Israel: Ministry of Health

Keywords provided by Argo Medical Technologies Ltd.:


ReWalk, Paraplegia, SCI

ClinicalTrials.gov processed this record on March 03, 2015

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