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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01251549
Recruitment Status : Completed
First Posted : December 2, 2010
Last Update Posted : October 5, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Paraplegia Spinal Cord Injuries (SCI) Device: ReWalk - a motorized exoskeleton suit

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Safety and Performance Evaluation of ReWalk Reciprocating Gait Orthosis (RGO)
Study Start Date : March 2009
Primary Completion Date : March 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Experimental: A
A group of paraplegics.
Device: ReWalk - a motorized exoskeleton suit
The subject will wear the ReWalk suit and have training sessions for walking with the device
Other Name: Exoskeleton suit

Primary Outcome Measures :
  1. Safety of use [ Time Frame: 3 months ]
    Number of participants with related adverse events as a Measure of Safety and Tolerability

Secondary Outcome Measures :
  1. Efficacy [ Time Frame: 3 months ]
    Continuously walking for 6 minutes after 18 sessions training with the ReWalk - exoskeleton suit performed at weekly intervals

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01251549

United States, Pennsylvania
Albert Einstein Medical Center, Moss Rehabilitation Center
Elkins Park, Pennsylvania, United States, 19027
Ospedale Valduce di Como, Centro Villa Beretta Italy
Como, Italy
Sponsors and Collaborators
ReWalk Robotics, Inc.
Principal Investigator: Alberto Esquenazi, MD Albert Einstein Medical Center, Moss Rehabilitation Center

Responsible Party: ReWalk Robotics, Inc.
ClinicalTrials.gov Identifier: NCT01251549     History of Changes
Other Study ID Numbers: RW003 ver. 4
First Posted: December 2, 2010    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 2016

Keywords provided by ReWalk Robotics, Inc.:
Spinal Cord Injuries (SCI)

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Neurologic Manifestations
Signs and Symptoms