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COMPLETED
NCT01961557
NA

Evaluating a New Knee-Ankle-Foot Brace to Improve Gait in Children With Movement Disorders

Sponsor: National Institutes of Health Clinical Center (CC)

View on ClinicalTrials.gov

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.

Official title: Evaluating an Extension Assist Knee Ankle Foot Orthosis to Improve Gait in Children With Movement Disorders

Key Details

Gender

All

Age Range

5 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2015-07-02

Completion Date

2025-06-05

Last Updated

2026-04-14

Healthy Volunteers

No

Interventions

DEVICE

EA-KAFO

This study tests a single device that contains multiple potential configurations as outlined in Table 1 of the protocol. Each participant be evaluated in multiple configurations, minimally including the baseline configuration and the motor assist condition at the knee.

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States