NCT02089880Active, not recruiting
Comparing Functional Outcomes in Individuals Using Micro-processor Controlled Orthosis Versus Stance Control Orthosis
Micro-processor Controlled Knee-Ankle-Foot Orthosis (C-Brace) Versus Stance-control Knee-Ankle-Foot Orthosis (SCO): Functional Outcomes in Individuals With Lower Extremity Impairment
Source: ClinicalTrials.gov · Last updated 1 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 26 Feb 2014
- Start date
- Feb 2014
- Primary completion date
- Dec 2025
- Lead sponsor
- Shirley Ryan AbilityLab
- NCT number
- NCT02089880
What you commit to
- Study type: Interventional
- Planned participants: 24
- From Feb 2014 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participating in physical therapy currently or within 1 month of starting protocol, specific to orthotic use and gait training.
Other illness
- Unstable neurological or cardiovascular/pulmonary disease, cancer.
Other
- 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.
- Knee flexion contracture resulting in the inability to actively use C-Brace or SCO.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rehabilitation Institute of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.