A Study Testing Safety and Tolerance of the ReWalk Exoskeleton Suit

Study Overview
=================
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.

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.

Conditions
-----------------
Paraplegia, SCI

Intervention / Treatment
-----------------
* Device: ReWalk - a motorized exoskeleton suit


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>A group of paraplegics. | Device: ReWalk - a motorized exoskeleton suit<br>* The subject will wear the ReWalk suit and have training sessions for walking with the device.<br>* Other names: Exoskeleton suit;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observation and subject feedback |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subject tolerance |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ReWalk, Paraplegia, SCI