Evaluating a New Knee-Ankle-Foot Brace to Improve Gait in Children With Movement Disorders
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01961557|
Recruitment Status : Recruiting
First Posted : October 11, 2013
Last Update Posted : March 29, 2018
- 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.
|Condition or disease|
The purpose of this protocol is to evaluate several configurations of a prototype Extension Assist Knee-Ankle-Foot Orthosis (EA-KAFO) in patients with cerebral palsy (CP), muscular dystrophy (MD), spina bifida (SB), or incomplete spinal cord injury (iSCI) who have knee extension deficiency. Three forms of assistance will be provided at the knee joint including a passive-damper component, functional electrical stimulation (FES) to the quadriceps, and a motorized assist. One form will provide variable resistance at the ankle joint which can also promote knee extension. These will be compared to traditional bracing which typically improves crouch by blocking some or all motion at one or both joints. We hypothesize that all assistive configurations will improve gait alignment and performance compared to the non-assisted conditions. We further hypothesize that a best solution for each participant will exist, but may vary across subjects due to the heterogeneity of these movement disorders. Preliminary data on brain activation using EEG will be collected during all walking conditions.
Thirty (30) subjects, age 5 and above, diagnosed with crouch gait from diplegic CP, (30) subjects, age 5 and above, with knee extension deficiency from MD, SB, or iSCI (15 from each group) and 10 age-matched healthy volunteers will be recruited.
This protocol will evaluate an EA-KAFO prototype consisting of a custom fabricated brace combined with a modular knee joint with three modes of operation: hinge (no assist), a passive spring-damper, and an active motorized assist. Since crouch can also be precipitated at the ankle, the orthotic ankle joint has an adjustable dynamic resistance (ADR) mechanism that can be locked (passive assist) to simulate a standard brace, free, or provide variable resistance to assist knee extension. Additionally, we will combine quadriceps FES with the hinge and the passive damper to create two hybrid configurations. The hinge and the passive damper (Ultraflex ) knee modules, and ADR ankle brace are FDA-approved (Class I), commercially available devices. The active motorized joint module and the two hybrid configurations have been evaluated by the FDA as non-significant risk to human subjects (Appendix F). Healthy controls will come for one visit, and participants with movement disorders will complete 6-10 visits: 1) initial assessment and casting for custom leg brace; 2) EA-KAFO configuration; 3) initial data collection and practice; 4-5) accommodation to brace configurations; 6) final data collection. Additional accommodation visits may be added if necessary, up to the maximum of 10 total visits. Motion capture, force plates, and electromyography (EMG) will be used for gait analysis while electroencephalography (EEG) will measure brain activity during walking.
The primary outcome is the amount of knee flexion during gait. The optimal solution for each individual will be that which provides the greatest reduction in peak knee angle. Secondary outcomes will include gait speed, knee extensor moment, and EEG activation profiles.
|Study Type :||Observational|
|Estimated Enrollment :||85 participants|
|Official Title:||Evaluating an Extension Assist Knee Ankle Foot Orthosis to Improve Gait in Children With Movement Disorders|
|Study Start Date :||October 10, 2013|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||September 30, 2020|
- Reduction in knee crouch (effectiveness) [ Time Frame: Assessed at Visit #2 and #6 while wearing devices ]
- Subjective opinions about each brace option (tolerability/acceptability) [ Time Frame: Immediately after each use. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01961557
|Contact: Sara F Sadeghi||(301) email@example.com|
|Contact: Thomas C Bulea, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Thomas C Bulea, M.D.||National Institutes of Health Clinical Center (CC)|