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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

November 28, 2010
January 9, 2012
March 2009
April 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01251549 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Safety and Performance Evaluation of ReWalk Reciprocating Gait Orthosis (RGO)
Safety and Performance Evaluation of ReWalk Reciprocating Gait Orthosis (RGO)

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.
Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Paraplegia
  • Spinal Cord Injuries (SCI)
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
Experimental: Experimental: A
A group of paraplegics.
Intervention: Device: ReWalk - a motorized exoskeleton suit
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
August 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact: Hanna Levy, Dr. (972)-4-638-8837 hanna@qsitemed.com
United States,   Italy
 
NCT01251549
RW003 ver. 4
No
Argo Medical Technologies Ltd.
Argo Medical Technologies Ltd.
Not Provided
Principal Investigator: Alberto Esquenazi, MD Albert Einstein Medical Center, Moss Rehabilitation Center
Argo Medical Technologies Ltd.
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP