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

ReWalk Robotics

Status

Completed

Conditions

Spinal Cord Injuries (SCI)

Paraplegia

Treatments

Device: ReWalk - a motorized exoskeleton suit

Study type

Interventional

Funder types

Industry

Identifiers

NCT01251549

RW003 ver. 4

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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