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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ReWalk Robotics, Inc.
ClinicalTrials.gov Identifier:
NCT01251549
First received: November 28, 2010
Last updated: October 4, 2016
Last verified: October 2016
  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:


Further study details as provided by ReWalk Robotics, Inc.:

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


Enrollment: 32
Study Start Date: March 2009
Study Completion Date: March 2013
Primary Completion Date: March 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   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Responsible Party: ReWalk Robotics, Inc.
ClinicalTrials.gov Identifier: NCT01251549     History of Changes
Other Study ID Numbers: RW003 ver. 4 
Study First Received: November 28, 2010
Last Updated: October 4, 2016
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on December 07, 2016