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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 5 Years
Max Age: N/A

Referral Letter Required


Population Exclusion(s)

Pregnant Women


incomplete spinal cord injury;
Cerebral Palsy;
Muscular Dystrophies

Recruitment Keyword(s)



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

Investigational Drug(s)


Investigational Device(s)



Device: EA-KAFO

Supporting Site

NIH Clinical Center


- 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.


- To evaluate a new brace to improve crouch gait in children with CP.


- Children 5 17 years old with CP.

- Healthy volunteers 5 17 years old.


- 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.

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-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.


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

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.

Binder H, Eng GD. Rehabilitation management of children with spastic diplegic cerebral palsy. Arch Phys Med Rehabil. 1989 Jun;70(6):482-9.

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Principal Investigator

Referral Contact

For more information:

Thomas C. Bulea, Ph.D.
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 1-1469
10 Center Drive
Bethesda, Maryland 20892
(301) 451-7533

Jesse H. Matsubara
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 1-1469
10 Center Drive
Bethesda, Maryland 20892
(301) 451-7530

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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