Back to resultsA Study Testing Safety and Tolerance of the ReWalk Exoskeleton Suit (RW)
Primary Purpose
Paraplegia, SCI
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
ReWalk - a motorized exoskeleton suit
Sponsored by
About this trial
This is an interventional supportive care trial for Paraplegia focused on measuring ReWalk, Paraplegia, SCI
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
Sites / Locations
- Sheba Medical Center, Neurological Rehabilitation Department
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
A group of paraplegics.
Outcomes
Primary Outcome Measures
Observation and subject feedback
Secondary Outcome Measures
subject tolerance
Full Information
NCT ID
NCT00627107
First Posted
February 21, 2008
Last Updated
November 27, 2010
Sponsor
ReWalk Robotics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00627107
Brief Title
A Study Testing Safety and Tolerance of the ReWalk Exoskeleton Suit
Acronym
RW
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 Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
ReWalk Robotics, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paraplegia, SCI
Keywords
ReWalk, Paraplegia, SCI
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
A group of paraplegics.
Intervention Type
Device
Intervention Name(s)
ReWalk - a motorized exoskeleton suit
Other Intervention Name(s)
Exoskeleton suit
Intervention Description
The subject will wear the ReWalk suit and have training sessions for walking with the device.
Primary Outcome Measure Information:
Title
Observation and subject feedback
Time Frame
3 months
Secondary Outcome Measure Information:
Title
subject tolerance
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabi Zeilig, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center, Neurological Rehabilitation Department
City
Tel-Hashomer
ZIP/Postal Code
52621
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
A Study Testing Safety and Tolerance of the ReWalk Exoskeleton Suit
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