New adjustable brace shows promise for kids with crouch gait
NCT ID NCT01961557
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 10 times
Summary
This study tested a new type of leg brace designed to help children with cerebral palsy and other movement disorders walk more easily. The brace was custom-made for each child and could be adjusted to provide different kinds of support. Researchers measured how well children walked with the brace to find the best settings for each person.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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24 people
The number who actually took part.
- Started
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Jul 2015
- Finished
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Jun 2025
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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5 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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 CRITERIA: * Any neurological, musculoskeletal or cardiorespiratory injury, health condition, or diagnosis other than cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury that would affect the ability to walk as directed for short periods of time. * Participation in this protocol within the previous 1 year. ADDITIONAL EXCLUSION CRITERIA FOR INDIVIDUALS WITH CEREBRAL PALSY: * A history of a seizure in the past year. * Pregnancy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can virtual reality rewire balance and leg control in cerebral palsy?
- AI learns to spot the two cues that define cerebral palsy motor levels
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