Safety and Performance Evaluation of ReWalk Reciprocating Gait Orthosis (RGO)

Study Overview
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Brief Summary
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ReWalk suit developed by Argo Medical Technologies is designed to enable people with lower limb disabilities to carry out routine ambulatory functions (stand, walk etc.); it can be used by people with disabilities such as spinal cord injury, brain injury, stroke, multiple sclerosis, cerebral palsy and other pathologies that produce severe walking impairments.

Official Title
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Safety and Performance Evaluation of ReWalk Reciprocating Gait Orthosis (RGO)

Conditions
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Paraplegia, Spinal Cord Injuries (SCI)

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Complete cervical (C7-8) or thoracic (T1-T12) spinal cord injury according to American Spinal Injury Association (ASIA) guidelines Male and non-pregnant non-lactating female Age 18-55 At least 6 months after injury Regular use of RGO (Reciprocating Gait Orthosis) or KAFO's (Knee Ankle Foot Orthoses) or able to stand using a standing device (e.g., 'Easy stand') Patients must be capable of providing informed consent Height of 160 to 190 cm Weight of <100 kg Exclusion Criteria: History of severe neurological injuries other than SCI (Spinal Cord Injuries)(MS (Multiple Sclerosis), CP (Cerebral Palsy), ALS (Amyotrophic Lateral Sclerosis) , TBI (Traumatic Brain Injury) etc) Severe concurrent medical diseases: infections, circulatory, heart or lung, pressure sores Severe spasticity (Ashworth 4) or uncontrolled clonus Unstable spine or unhealed limbs or pelvic fractures Heterotopic ossification Significant contractures Psychiatric or cognitive situations that may interfere with the trial

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of use | Number of participants with related adverse events as a Measure of Safety and Tolerability | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Continuously walking for 6 minutes after 18 sessions training with the ReWalk - exoskeleton suit performed at weekly intervals | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ReWalk, Paraplegia, Spinal Cord Injuries (SCI)