NCT01961557Befejeződött
Evaluating a New Knee-Ankle-Foot Brace to Improve Gait in Children With Movement Disorders
Evaluating an Extension Assist Knee Ankle Foot Orthosis to Improve Gait in Children With Movement Disorders
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 16.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 24 (tényleges)
- Első benyújtás
- 2013. okt. 10.
- Kezdés
- 2015. júl. 2.
- Elsődleges befejezés
- 2025. jún. 5.
- Fő szponzor
- National Institutes of Health Clinical Center (CC)
- NCT-szám
- NCT01961557
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 24
- 2015. júl. 2. és az elsődleges befejezés (2025. jún. 5.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Participation in this protocol within the previous 1 year.
- ADDITIONAL EXCLUSION CRITERIA FOR INDIVIDUALS WITH CEREBRAL PALSY:
Más betegség
- 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.
- A history of a seizure in the past year.
Egyéb
- Pregnancy
A regiszterben nem jelölt feltételek
- INCLUSION 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
Életkor a regiszterben: 5 év – 100 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Egyesült Államok | Ismeretlen állapot |
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