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

NCT01961557 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-05-22

No results posted yet for this 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.

Conditions

  • Incomplete Spinal Cord Injury
  • Muscular Dystrophy
  • Spina Bifida
  • Cerebral Palsy

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.

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Thomas C Bulea, Ph.D. · National Institutes of Health Clinical Center (CC)

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-02
Primary Completion
2025-06-05
Completion
2025-06-05
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01961557 on ClinicalTrials.gov