Evaluating a New Knee-Ankle-Foot Brace to Improve Gait in Children With Movement Disorders (NCT01961557) | Clinical Trial Compass
CompletedNot Applicable
Evaluating a New Knee-Ankle-Foot Brace to Improve Gait in Children With Movement Disorders
United States24 participantsStarted 2015-07-02
Plain-language summary
Background:
\- Cerebral palsy (CP) is the most common motor disorder in children. CP often causes crouch gait, an abnormal way of walking. Knee crouch has many causes, so no single device or approach works best for everybody. This study s adjustable brace provides many types of walking assistance. Researchers will evaluate brace options to find the best solution for each participant, and whether one solution works best for the group.
Objective:
\- To evaluate a new brace to improve crouch gait in children with CP.
Eligibility:
* Children 5 17 years old with CP.
* Healthy volunteers 5 17 years old.
Design:
* All participants will be screened with medical history and physical exam.
* Healthy volunteers will have 1 visit. They will do motion analysis, EMG, and EEG described below.
* Participants with CP will have 6 visits.
* Visit 1:
\<TAB\>1. Motion analysis: Balls will be taped to participants skin. This helps cameras follow their movement.
\<TAB\>2. EMG: Metal discs will be taped to participants skin. They measure electrical muscle activity.
\<TAB\>3. Participants knee movement will be tested.
\<TAB\>4. Participants will walk 50 meters.
\<TAB\>5. Participants legs will be cast to make custom braces.
* Visit 2:
* Participants will wear their new braces and have them adjusted.
* Steps 1 3 will be repeated.
* EEG: Small metal discs will be placed on the participants scalp. They record brain waves.
* Participants will have electrical stimulation of their knees and practice extending them.
* Participants will take several walks with the braces in different settings.
* Visits 3 5: participants will repeat the walking and some other steps from visit 2.
* Visit 6 will repeat visit 2.
Who can participate
Age range
5 Years – 100 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:
* Age 5 years and above
* Either a healthy volunteer, have crouch gait with a diagnosis of spastic diplegic cerebral palsy, or have lower extremity weakness resulting in gait pathology from a diagnosis of muscular dystrophy, spina bifida, or incomplete spinal cord injury.
* Able to understand and follow simple directions based on parent report and physician observation during history and physical examination.
* Able to provide verbal/written assent.
* Less than 5 degrees of knee flexion contracture with hip extended in supine position. Hamstring contracture as assessed by straight leg raising test does not limit ability to participate in the study.
* Less than 10 degrees of plantar flexion contracture in neutral foot alignment.
* A measured foot-thigh angle of -10 to 25 degrees in prone position.
* Diagnosed with knee extension deficiency as indicated by a crouched posture during gait lacking at least 20 degrees of knee extension at mid stance during walking as assessed visually, knee extensor muscle weakness which prevents full extension of the limb, or reliance upon braces or other aids which lock the knee during walking. (The exact level of knee extension deficiency, or crouch, will be quantified after inclusion using gait analysis.)
* Able to walk at least 10 feet without stopping with or without a walking aid
* Agreement to not drink caffeine for 24 hours before each EEG assessment (CP only) visit because it can modify brain activity
EXCLUSION CRIT…
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
Peak knee angle
Timeframe: This outcome will be assessed twice, at the initial and final data assessment visits, as indicated in the protocol.
Trial details
NCT IDNCT01961557
SponsorNational Institutes of Health Clinical Center (CC)