Comparing Functional Outcomes in Individuals Using Micro-processor Controlled Orthosis Versus Sta… (NCT02089880) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Comparing Functional Outcomes in Individuals Using Micro-processor Controlled Orthosis Versus Stance Control Orthosis
United States24 participantsStarted 2014-02
Plain-language summary
The study will specifically evaluate the potential of the C-Brace to improve the functional mobility and quality of life in individuals with lower extremity impairments due to neurologic or neuromuscular disease, orthopedic disease or trauma, as compared to the stance control orthosis.
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.
Inclusion Criteria:
* Lower extremity functional impairment due to neurologic or neuromuscular disease, orthopedic disease or trauma.
* Prior active and compliant use of unilateral Knee-ankle-foot orthosis (KAFO) or Stance control orthosis (SCO).
* Age 18 - 80 years.
* Demonstrate a reciprocal gait pattern using the SCO and C-Brace trial tools.
* Cognitive ability to understand and the willingness to sign a written informed consent.
* Subjects must be able to demonstrate the ability to turn the global positioning sensor (GPS) and Actigraph units on and off and sufficient memory ability to wear the devices each day during use of the orthoses.
Exclusion Criteria:
* Passive ankle range of motion (PROM) of the lower extremity requiring the knee-ankle-foot orthosis (KAFO) of less than 2 degrees.
* Body weight \>275 pounds.
* Unstable neurological or cardiovascular/pulmonary disease, cancer.
* Knee flexion contracture resulting in the inability to actively use C-Brace or SCO.
* Participating in physical therapy currently or within 1 month of starting protocol, specific to orthotic use and gait training.
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 using device 1 at 8 weeks and using device 2 at 16 weeks.