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Safety and Performance Evaluation of ReWalk Reciprocating Gait Orthosis (RGO) | Clinical Trials | Clareo Health

COMPLETEDNA

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

NCT01251549•ReWalk Robotics, Inc.

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.

Eligibility

Age

18 - 55 years

Sex

ALL

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

Locations (2)

Albert Einstein Medical Center, Moss Rehabilitation Center

Elkins Park, Pennsylvania, United States

Ospedale Valduce di Como, Centro Villa Beretta Italy

Como, Italy

Key Dates

Start Date

March 1, 2009

Primary Completion Date

March 1, 2013

Completion Date

March 1, 2013

Last Updated

October 5, 2016

Enrollment

ACTUAL participants

Conditions

ParaplegiaSpinal Cord Injuries (SCI)

Interventions

ReWalk - a motorized exoskeleton suit

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 5, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Health Information for Persons With Spinal Cord Injury

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