ExoAtlet II For SCI Patients (NCT04215081) | Clinical Trial Compass
CompletedNot Applicable
ExoAtlet II For SCI Patients
Russia20 participantsStarted 2019-11-18
Plain-language summary
This study will evaluate the ExoAtlet II exoskeleton for safety and effectiveness of providing persons with a spinal cord injury (SCI) who are non-ambulatory or have limited ambulatory function, to stand up and ambulate under a variety of conditions.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 18 Years of age or older in general good health
✓. Weight, no more than 220lbs (100kg)
✓. Skin must be healthy where it touches the ExoAtlet 2.0
✓. Able to stand using a device such as a standing frame
✓. Have enough strength in your hands and shoulders to support yourself standing and walking using crutches or a walker
✓. Have good control of upper body
✓. Determined to have enough bone health to walk full weight bearing without risk of fracture. Meeting of this condition is at the discretion of your personal MD
✓. Passive range of motion (PROM) at shoulders, trunk, upper extremities and lower extremities within functional limits for safe gait and use of appropriate assistive device/stability aid
Exclusion criteria
✕. Spinal cord injury level higher than T4 or C7 ASIA D
✕. Severe muscle stiffness/tightness
✕. Significant spasticity (Modified Ashworth Scale score of 3 or above)