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

NCT01961557 | Completed FDA Device

• 2 other identifiers: 13021013-CC-0210
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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; Cerebral Palsy; Muscular Dystrophy; Spina Bifida

Keywords

incomplete spinal cord injury; EEG; Cerebral Palsy; Knee; Muscular Dystrophies

Outcome Measures

Primary Outcomes (1)

• Peak knee angle

  The primary outcome measure will be the effect of the intervention on crouch, as measured by peak knee angle during walking with the EA-KAFO. the outcome description refers to the general Extension Assist Knee Ankle Foot Orthosis (EA-KAFO). The outcome measure will be assessed across the different configurations of the EA-KAFO, which includes the configuration that contains the Active Motorized KAFO and the configuration that contains the Powerwalk Knee Exoskeleton.

  This outcome will be assessed twice, at the initial and final data assessment visits, as indicated in the protocol.

Secondary Outcomes (1)

• Secondary outcome measures

  At the same time

Study Arms (1)

There is a single study arm in this feasibility study.

EXPERIMENTAL

All participants will be evaluated using the different configurations of the EA-KAFO (see Table 1 in the protocol), which includes the configuration that contains the Active Motorized KAFO and the configuration that contains the Powerwalk Knee Exoskeleton. Each subject will serve as their own control to assess the effect of each configuration of the EA-KAFO interventions.

Device: EA-KAFO

Interventions

EA-KAFO DEVICE

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.

There is a single study arm in this feasibility study.

Eligibility Criteria

• Age: 5 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 5 years and above
• Either a healthy volunteer, have crouch gait with a diagnosis of spastic diplegic cerebral palsy, or have lower extremity weakness resulting in gait pathology from a diagnosis of muscular dystrophy, spina bifida, or incomplete spinal cord injury.
• Able to understand and follow simple directions based on parent report and physician observation during history and physical examination.
• Able to provide verbal/written assent.
• Less than 5 degrees of knee flexion contracture with hip extended in supine position. Hamstring contracture as assessed by straight leg raising test does not limit ability to participate in the study.
• Less than 10 degrees of plantar flexion contracture in neutral foot alignment.
• A measured foot-thigh angle of -10 to 25 degrees in prone position.
• Able to walk at least 10 feet without stopping with or without a walking aid
• Agreement to not drink caffeine for 24 hours before each EEG assessment (CP only) visit because it can modify brain activity

You may not qualify if:

• Any neurological, musculoskeletal or cardiorespiratory injury, health condition, or diagnosis other than cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury that would affect the ability to walk as directed for short periods of time.
• Participation in this protocol within the previous 1 year.
• A history of a seizure in the past year.
• Pregnancy

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• Molnar GE. Rehabilitation in cerebral palsy. West J Med. 1991 May;154(5):569-72.

  PMID: 1866952 BACKGROUND

• Yeargin-Allsopp M, Van Naarden Braun K, Doernberg NS, Benedict RE, Kirby RS, Durkin MS. Prevalence of cerebral palsy in 8-year-old children in three areas of the United States in 2002: a multisite collaboration. Pediatrics. 2008 Mar;121(3):547-54. doi: 10.1542/peds.2007-1270.

  PMID: 18310204 BACKGROUND

• Binder H, Eng GD. Rehabilitation management of children with spastic diplegic cerebral palsy. Arch Phys Med Rehabil. 1989 Jun;70(6):482-9. doi: 10.1016/0003-9993(89)90012-9.

  PMID: 2658915 BACKGROUND

• Shideler BL, Bulea TC, Chen J, Stanley CJ, Gravunder AJ, Damiano DL. Toward a hybrid exoskeleton for crouch gait in children with cerebral palsy: neuromuscular electrical stimulation for improved knee extension. J Neuroeng Rehabil. 2020 Sep 3;17(1):121. doi: 10.1186/s12984-020-00738-7.

  PMID: 32883297 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Muscular Dystrophies; Spinal Dysraphism; Cerebral Palsy

Condition Hierarchy (Ancestors)

Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neural Tube Defects; Nervous System Malformations; Congenital Abnormalities; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Study Officials

• Thomas C Bulea, Ph.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 11, 2013
• Study Start: July 2, 2015
• Primary Completion: June 5, 2025
• Study Completion: June 5, 2025
• Last Updated: May 7, 2026

Record last verified: 2025-07-17

Locations

US (1)