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

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Brief Title

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

Official Title

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

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.
    



Study Type

Interventional


Primary Outcome

Safety of use

Secondary Outcome

 Efficacy

Condition

Paraplegia

Intervention

ReWalk - a motorized exoskeleton suit

Study Arms / Comparison Groups

 Experimental: A
Description:  A group of paraplegics.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

32

Start Date

March 2009

Completion Date

March 2013

Primary Completion Date

March 2013

Eligibility 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
      

Gender

All

Ages

18 Years - 55 Years

Accepts Healthy Volunteers

No

Contacts

Alberto Esquenazi, MD, , 

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT01251549

Organization ID

RW003 ver. 4


Responsible Party

Sponsor

Study Sponsor

ReWalk Robotics, Inc.


Study Sponsor

Alberto Esquenazi, MD, Principal Investigator, Albert Einstein Medical Center, Moss Rehabilitation Center


Verification Date

October 2016