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

Completed · Not applicable

Conditions studied: Paraplegia, Spinal Cord Injuries (SCI)

In brief

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.

Key facts

Study ID

NCT01251549

Run by

ReWalk Robotics, Inc.

People needed

32

Starts

2009-03-01

Expected to finish

2013-03-01

Last updated by the study team

2016-10-05

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Albert Einstein Medical Center, Moss Rehabilitation Center — Elkins Park, Pennsylvania, United States
• Ospedale Valduce di Como, Centro Villa Beretta Italy — Como, Italy

Full record on ClinicalTrials.gov

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