NCT01961557

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

Completed NA Last updated 14 April 2026

What this trial tests

NA trial testing EA-KAFO in Incomplete Spinal Cord Injury in 24 participants. Completed in 5 June 2025.

Timeline

2 July 2015

Primary endpoint
5 June 2025

5 June 2025

Quick facts

Lead sponsor	National Institutes of Health Clinical Center (CC)
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	device feasibility
Enrollment	24
Start date	2 July 2015
Primary completion	5 June 2025
Estimated completion	5 June 2025
Sites	1 location across United States

Drugs / interventions tested

• EA-KAFO

Conditions studied

• Incomplete Spinal Cord Injury — all drugs for Incomplete Spinal Cord Injury →
• Muscular Dystrophy — all drugs for Muscular Dystrophy →
• Spina Bifida — all drugs for Spina Bifida →
• Cerebral Palsy — all drugs for Cerebral Palsy →

Sponsor

National Institutes of Health Clinical Center (CC)

Who can join

Adults 5 to 100, any sex, with Incomplete Spinal Cord Injury or Muscular Dystrophy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Toward a hybrid exoskeleton for crouch gait in children with cerebral palsy: neuromuscular electrical stimulation for improved knee extension.
   Shideler BL, Bulea TC, Chen J, Stanley CJ, et al · · 2020 · cited 14× · PMID 32883297 · DOI 10.1186/s12984-020-00738-7
2. Gait Event Detection From Thigh Segment Kinematics in Children With Crouch Gait.
   Dembsky J, Rubin N, Bulea TC. · · 2026 · PMID 42146845 · DOI 10.1109/jtehm.2026.3679585