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

Not Applicable

Completed

• Conditions: Spinal Cord Injuries (SCI); Paraplegia
• Interventions: Device: ReWalk - a motorized exoskeleton suit

• Registration Number: NCT01251549
• Lead Sponsor: ReWalk Robotics, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2010-11-28
• Study First Submitted QC: 2010-11-30
• Study First Posted: 2010-12-02
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-04
• Last Update Posted: 2016-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: A	ReWalk - a motorized exoskeleton suit	A group of paraplegics.

Primary Outcome Measures

Name	Time	Method
Safety of use	3 months	Number of participants with related adverse events as a Measure of Safety and Tolerability

Secondary Outcome Measures

Name	Time	Method
Efficacy	3 months	Continuously walking for 6 minutes after 18 sessions training with the ReWalk - exoskeleton suit performed at weekly intervals

Trial Locations

Locations (2)

Albert Einstein Medical Center, Moss Rehabilitation Center; 🇺🇸 Elkins Park, Pennsylvania, United States

Ospedale Valduce di Como, Centro Villa Beretta Italy; 🇮🇹 Como, Italy