Status:
COMPLETED
Safety and Performance Evaluation of ReWalk Reciprocating Gait Orthosis (RGO)
Lead Sponsor:
ReWalk Robotics, Inc.
Conditions:
Paraplegia
Spinal Cord Injuries (SCI)
Eligibility:
All Genders
18-55 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01251549
Start Date
March 1 2009
End Date
March 1 2013
Last Update
October 5 2016
Active Locations (2)
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1
Albert Einstein Medical Center, Moss Rehabilitation Center
Elkins Park, Pennsylvania, United States, 19027
2
Ospedale Valduce di Como, Centro Villa Beretta Italy
Como, Italy