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 range
18 Years – 80 Years
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.