COMPLETED

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

Conditions

Incomplete Spinal Cord Injury Muscular Dystrophy Spina Bifida Cerebral Palsy EEG Knee Muscular Dystrophies

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2015-07-02

Study Completion:2025-06-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT01961557

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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. * Diagnosed with knee extension deficiency as indicated by a crouched posture during gait lacking at least 20 degrees of knee extension at mid stance during walking as assessed visually, knee extensor muscle weakness which prevents full extension of the limb, or reliance upon braces or other aids which lock the knee during walking. (The exact level of knee extension deficiency, or crouch, will be quantified after inclusion using gait analysis.) * 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	* 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

Inclusion Criteria

Exclusion Criteria

* 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.
* Diagnosed with knee extension deficiency as indicated by a crouched posture during gait lacking at least 20 degrees of knee extension at mid stance during walking as assessed visually, knee extensor muscle weakness which prevents full extension of the limb, or reliance upon braces or other aids which lock the knee during walking. (The exact level of knee extension deficiency, or crouch, will be quantified after inclusion using gait analysis.)
* 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

* 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

Contacts and Locations

Principal Investigator

Thomas C Bulea, Ph.D.

PRINCIPAL_INVESTIGATOR

National Institutes of Health Clinical Center (CC)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Institutes of Health Clinical Center (CC)

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-07-02

Study Completion Date2025-06-05

Study Record Updates

Study Start Date2015-07-02

Study Completion Date2025-06-05

Terms related to this study

Keywords Provided by Researchers

incomplete spinal cord injury
EEG
Cerebral Palsy
Knee
Muscular Dystrophies

Additional Relevant MeSH Terms

Incomplete Spinal Cord Injury
Muscular Dystrophy
Spina Bifida
Cerebral Palsy