Evaluating a new brace to improve walking in children with movement disorders
Evaluating an Extension Assist Knee Ankle Foot Orthosis to Improve Gait in Children With Movement Disorders
This study is testing a new knee-ankle-foot brace to see if it can help children with movement disorders walk better than with regular braces.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 85 (estimated) |
| Ages | 5 Years to 100 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT01961557 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of a new knee-ankle-foot brace designed to improve crouch gait in children with conditions such as cerebral palsy, muscular dystrophy, spina bifida, and incomplete spinal cord injury. Participants will undergo a series of evaluations, including motion analysis and electromyography, to determine the best configuration of the brace for each individual. The study will compare the new brace's performance against traditional bracing methods to identify improvements in gait alignment and performance.
Who should consider this trial
Good fit: Ideal candidates include children aged 5 to 17 with crouch gait due to cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury.
Not a fit: Patients with significant knee flexion or plantar flexion contractures that limit their ability to participate may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to enhanced mobility and quality of life for children with movement disorders.
How similar studies have performed: Previous studies have shown promise in using assistive devices for improving gait in similar populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Thomas C Bulea, Ph.D. — National Institutes of Health Clinical Center (CC)
- Study coordinator: Jesse H Matsubara
- Email: jesse.matsubara@nih.gov
- Phone: (301) 451-7530
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.