Clinical Trial Comparing C-Brace to Knee Ankle Foot Orthosis (KAFO)/Stance Control Orthosis (SCO) (NCT03906656) | Clinical Trial Compass
CompletedNot Applicable
Clinical Trial Comparing C-Brace to Knee Ankle Foot Orthosis (KAFO)/Stance Control Orthosis (SCO)
United States, Austria, Germany149 participantsStarted 2019-03-11
Plain-language summary
Prospective, international, multi-center, open-labeled, randomized, controlled cross-over trial to evaluate effectiveness and benefits in patients with lower limb impairment in activities of daily living comparing the C-Brace microprocessor-controlled stance and swing orthosis to standard of care use of knee ankle foot orthosis/stance control orthoses
Who can participate
Age range
18 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.
Inclusion Criteria:
* Patient has been tested with the Trial Tool (DTO) and demonstrated the potential to utilize the C-Brace successfully
* Patient has a BBS score \< 45
* Lower limb functional impairment according to CE label wording
* Prior active and compliant use of unilateral or bilateral KAFO or SCO in the past 3 months prior to enrollment in the study
* Patient meets minimum physical requirements to be fitted with a C-Brace, such as muscle status, joint mobility, leg axis and proper control of the orthosis must be guaranteed.
* The User must fulfill the physical and mental requirements for perceiving optical/acoustic signals and/or mechanical vibrations
* The existing muscle strength of the hip extensors and flexors must permit the controlled swing-through of the limb (compensation using the hip is possible).
* Patient´s commitment to use C-Brace 2 at least 1-2 hours per day 5 days per week-
* Patient is ≥ 18 years old
* Patient is willing and able to independently provide informed consent.
* Person is willing to comply with study procedures
Exclusion Criteria:
* Patient who is not able to follow the entire study visits or is unwilling/unable to follow the instructions
* Patient was not able to use DTO
* Patient who is not using an orthosis at least 1 to 2 hours/ day for 5 days per week
* Patient with body weight \> 125 kg (includes body weight and heaviest object (weight) carried)
* Patient with Orthoprosthesis
* Patient with flexion contracture in the knee and/or…
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
Primary Efficacy: Berg Balance Scale (BBS)
Timeframe: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period