C-Brace II Spinal Cord Injury (NCT03930056) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
C-Brace II Spinal Cord Injury
United States30 participantsStarted 2019-04-16
Plain-language summary
A randomized, repeated measures comparative design study to compare use of a micro-processor controlled knee-ankle-foot orthosis vs. traditional care knee-ankle-foot-orthosis (KAFO) models following discharge from inpatient rehabilitation.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
All participants:
Inclusion Criteria:
* Be within 3-24 months post spinal cord injury diagnosis
* 18-80 years
* Must be able to demonstrate the ability to charge assigned sensors during 3-month home trial period on and off and sufficient memory ability to wear the devices each day during use of the orthoses.
Exclusion Criteria:
* Unstable neurological, cardiovascular, or cancer diagnoses.
* Cognitive impairments that limit study participation
In addition to the above inclusion criteria, the following criteria must be met to be designated into the study interventional tract (C-Brace II):
Inclusion criteria:
* Requires orthotic bracing for lower extremity instability, including the knee joint, unilaterally or bilaterally
Exclusion criteria:
* Body weight over 275 lbs
* Flexion contracture in the knee and/or hip joint in excess of 10 degrees
* Non-correctable knee varus/valgus in excess of 10 degrees
* Moderate to severe spasticity
* Leg length discrepancy in excess of 6" (15.24 cm)
* Inability to stabilize the trunk with or without assistive devices (crutches, cane, etc.)
* Inability to successfully use C-Brace trial tool in advancement of leg/s.
What they're measuring
1
Six Minute Walk Test (6MWT)
Timeframe: Change from baseline in 6MWT distance after using device at 3, 6, and 12 month follow-up.