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NCT01961557 · ClinicalTrials.gov registry record · NA
Evaluating a New Knee-Ankle-Foot Brace to Improve Gait in Children With Movement Disorders
A NA study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
NCT01961557 is a NA study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 24 participants.
The verdict
NCT01961557, a NA study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
Study 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.
Interventions
- DEVICE EA-KAFO
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2015-07-02 |
| Est. Completion | 2025-06-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01961557
The ClinicalTrials.gov registry entry for NCT01961557 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which EA-KAFO is the first listed.
NCT01961557 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01961557 about?
NCT01961557 is a clinical study titled "Evaluating a New Knee-Ankle-Foot Brace to Improve Gait in Children With Movement Disorders". 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. ...
What is the current status of trial NCT01961557?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2015-07-02. Estimated completion is 2025-06-05.
What interventions are being tested in trial NCT01961557?
The interventions under investigation include: EA-KAFO (DEVICE).
Who is sponsoring clinical trial NCT01961557?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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