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

October 4, 2016 updated by: ReWalk Robotics, Inc.
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Como, Italy
        • Ospedale Valduce di Como, Centro Villa Beretta Italy
  • United States
    • Pennsylvania
      • Elkins Park, Pennsylvania, United States, 19027
        • Albert Einstein Medical Center, Moss Rehabilitation Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Exoskeleton suit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of use
Time Frame: 3 months
Number of participants with related adverse events as a Measure of Safety and Tolerability
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: 3 months
Continuously walking for 6 minutes after 18 sessions training with the ReWalk - exoskeleton suit performed at weekly intervals
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ReWalk Robotics, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

November 28, 2010

First Submitted That Met QC Criteria

November 30, 2010

First Posted (Estimate)

December 2, 2010

Study Record Updates

Last Update Posted (Estimate)

October 5, 2016

Last Update Submitted That Met QC Criteria

October 4, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RW003 ver. 4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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