Status:

COMPLETED

A Study Testing Safety and Tolerance of the ReWalk Exoskeleton Suit

Lead Sponsor:

ReWalk Robotics, Inc.

Conditions:

Paraplegia

SCI

Eligibility:

All Genders

18-55 years

Phase:

NA

Brief Summary

The ReWalk enables people with lower limb disabilities to carry out routine ambulatory functions (stand, walk, climb stairs etc.). It can be used by people with disabilities such as spinal cord injury...

Detailed Description

The ReWalk comprises light wearable brace support suit, which integrates DC motors at the joints, rechargeable batteries, an array of sensors and a computer-based control system. It is snugly fitted o...

Eligibility Criteria

Inclusion

  • Chronic (at least 6 months after injury) complete cervical(C7-8) or thoracic (T1-T12) spinal cord injury
  • Age between 18-55
  • Male and non-pregnant non-lactating female
  • Regular use of RGO or bing able to stand up using a device (e.g. EasyStand)
  • under 100 kg and between 155-200 cm of height

Exclusion

  • History of severe neurological injuries other than SCI (MS, CP, ALS, TBI etc)
  • Severe concurrent medical diseases: infections, heart or lung, pressure sores
  • Unstable spine or unhealed limbs or pelvic fractures
  • Psychiatric or cognitive situations that may interfere with the study

Key Trial Info

Start Date :

February 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2009

Estimated Enrollment :

6 Patients enrolled

Trial Details

Trial ID

NCT00627107

Start Date

February 1 2008

End Date

January 1 2009

Last Update

November 30 2010

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Sheba Medical Center, Neurological Rehabilitation Department

Tel Litwinsky, Israel, 52621