Evaluating a New Knee-Ankle-Foot Brace to Improve Gait in Children With Movement Disorders
Public ClinicalTrials.gov record NCT01961557. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Evaluating an Extension Assist Knee Ankle Foot Orthosis to Improve Gait in Children With Movement Disorders
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01961557
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 24 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 5 Years to 100 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 1, 2015
- Primary completion
- Jun 4, 2025
- Completion
- Jun 4, 2025
- Last update posted
- Aug 31, 2026
2015 – 2025
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01961557, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 31, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01961557 live on ClinicalTrials.gov.