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

ReWalk Robotics, Inc.32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Paraplegia Spinal Cord Injuries (SCI)

Interventions

ReWalk - a motorized exoskeleton suitDEVICE

The subject will wear the ReWalk suit and have training sessions for walking with the device

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (2)

Albert Einstein Medical Center, Moss Rehabilitation Center

Elkins Park, Pennsylvania, United States

Ospedale Valduce di Como, Centro Villa Beretta Italy

Como, Italy

Outcomes

Primary Outcomes

Safety of use

Number of participants with related adverse events as a Measure of Safety and Tolerability

Time frame: 3 months

Secondary Outcomes

Efficacy

Continuously walking for 6 minutes after 18 sessions training with the ReWalk - exoskeleton suit performed at weekly intervals

Time frame: 3 months

Data from ClinicalTrials.gov

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