NCT03175055
Completed
Not Applicable
Phoenix Exoskeleton Clinical Study
US Bionics4 sites in 2 countries40 target enrollmentJune 1, 2017
ConditionsSCI - Spinal Cord Injury
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- SCI - Spinal Cord Injury
- Sponsor
- US Bionics
- Enrollment
- 40
- Locations
- 4
- Primary Endpoint
- Timed Up and Go (TUG)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study will evaluate the Phoenix device for safety and effectiveness at allowing persons with SCI who are non-ambulatory or poorly ambulatory to stand up and walk under a variety of conditions.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 Years of age or older in general good health
- •Weigh no more than 220lbs
- •Skin must be healthy where it touches the Phoenix
- •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
- •Hip width no greater than 18" (46 cm) measured when sitting.
- •Femur length between 12.3 inches (31.3 cm) and 19.8 inches (50.2 cm) measured between centers of hip and knee joints.
Exclusion Criteria
- •Pregnant or lactating females
- •Spinal cord injury level higher than T4
- •Severe muscle stiffness/tightness
- •Significant spasticity (Modified Ashworth Scale score of 3 or above)
- •Trunk or lower extremity pressure ulcer
- •Open Wounds
- •Unstable spine, un-healed limbs, or fractures
- •Severe sensitivity to touch
- •Presence of bone in soft tissue where bone normally does not exist (heterotopic ossification), limiting range of motion in the hip or knee joints
- •Joint instability, dislocation, moderate to severe hip dysplasia
Outcomes
Primary Outcomes
Timed Up and Go (TUG)
Time Frame: 10 weeks
10 Meter Walk Test (10MWT)
Time Frame: 10 weeks
6 Minute Walk Test (6MWT)
Time Frame: 10 weeks
Secondary Outcomes
- Surface Walk Test(10 weeks)
Study Sites (4)
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