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

This study is currently recruiting participants.
Verified January 2012 by Argo Medical Technologies Ltd.
Sponsor:
Information provided by (Responsible Party):
Argo Medical Technologies Ltd.
ClinicalTrials.gov Identifier:
NCT01251549
First received: November 28, 2010
Last updated: January 9, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention
Paraplegia
Spinal Cord Injuries (SCI)
 Device: ReWalk - a motorized exoskeleton suit

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Safety and Performance Evaluation of ReWalk Reciprocating Gait Orthosis (RGO)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Argo Medical Technologies Ltd.:

Primary Outcome Measures:
  • Safety of use [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Number of participants with related adverse events as a Measure of Safety and Tolerability


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Continuously walking for 6 minutes after 18 sessions training with the ReWalk - exoskeleton suit performed at weekly intervals


Estimated Enrollment: 30
Study Start Date: March 2009
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01251549

Contacts
Contact: Hanna Levy, Dr. (972)-4-638-8837 hanna@qsitemed.com

Locations
United States, Pennsylvania
Albert Einstein Medical Center, Moss Rehabilitation Center Recruiting
Elkins Park, Pennsylvania, United States, 19027
Contact: Alberto Esquenazi, MD     215-663-6000     aesquena@einstein.edu    
Italy
Ospedale Valduce di Como, Centro Villa Beretta Italy Recruiting
Como, Italy
Contact: Hanna Levy, Dr     972-4-638-8837     hanna@qsitmed.com    
Principal Investigator: Franco Molteni, Dr            
Sponsors and Collaborators
Argo Medical Technologies Ltd.
Investigators
Principal Investigator: Alberto Esquenazi, MD Albert Einstein Medical Center, Moss Rehabilitation Center
  More Information

No publications provided

Responsible Party: Argo Medical Technologies Ltd.
ClinicalTrials.gov Identifier: NCT01251549     History of Changes
Other Study ID Numbers: RW003 ver. 4
Study First Received: November 28, 2010
Last Updated: January 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Argo Medical Technologies Ltd.:
ReWalk
Paraplegia
Spinal Cord Injuries (SCI)

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

ClinicalTrials.gov processed this record on May 16, 2013