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



Status:Completed
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:4/2/2016
Start Date:March 2009
End Date:August 2013
Contact:Hanna Levy, Dr.
Email:hanna@qsitemed.com
Phone:(972)-4-638-8837

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Trial Summary
Trial Overview
Inclusion Criteria
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.


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
We found this trial at
1
site
Albert Einstein Medical Center, Moss Rehabilitation Center
Elkins Park, Pennsylvania 19027
?
mi
from
Elkins Park, PA
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