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Mobility Training to Improve Motor Behavior in Toddlers With or at Risk for Cerebral Palsy: A Pilot Study
Mobility Training to Improve Motor Behavior in Toddlers With or at Risk for Cerebral Palsy - A Pilot Study
Background:
- People who have cerebral palsy often have difficulty walking and moving their legs. Cerebral palsy is sometimes not identified until a child is almost 2 years of age, which means that early motor skill development can be affected and can have repercussions for later development. Studies in adults with neurological injuries (e.g., stroke, spinal cord injury) have shown that it is important to start intensive therapy soon after the injury, and it may be true that starting intensive therapy at a young age will be helpful for children with cerebral palsy. Researchers are interested in testing the effectiveness of a special body weight support system for mobility training in young children who have or are at risk for cerebral palsy.
Objectives:
- To study the effectiveness of a mobility training program on the motor skills of young children who have or are at risk for cerebral palsy.
Eligibility:
- Children between 12 and 36 months of age who have delayed motor skills and either have been diagnosed with cerebral palsy or show evidence of spasticity or brain damage.
Design:
- This study involves two 6-week study phases: a baseline phase and a mobility training program.
- Participants will be screened with a physical examination and medical history.
- During the baseline phase, participants will have mobility testing sessions once every 2 weeks. These tests will measure motor development and ability, including ease and speed of walking.
- Participants' parents/guardians will receive a mobility sensor for the child to wear at home for at least 6 hours (awake time) to measure activity and mobility levels outside of the testing sessions.
- After 6 weeks of baseline testing, participants will have 6 weeks of mobility training for 30 minutes 3 days per week. Training will involve motor tasks with weight support, conducted by a pediatric physical therapist. Activities may include walking, climbing inclines or steps, or squatting to reach toys. All sessions will be videotaped.
- To evaluate the effects of the therapy program, participants will have testing sessions every 2 weeks.
- Parents/guardians will also complete questionnaires to provide feedback on the effectiveness of the therapy program.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Maryland
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Bethesda, Maryland, Verenigde Staten, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
INCLUSION CRITERIA:
- 12-36 months of age
- greater than or equal to 4 months of gross motor delay corrected for gestational age (measured by Bayley Motor Scale)
- Diagnosis of bilateral spastic cerebral palsy OR neurological evidence of spasticity or brain damage
- Ability to pull to stand at a surface without assistance
- Cognitive ability to follow one-step commands
- Availability to return to NIH CC with parent or caregiver for required treatment and assessment sessions
EXCLUSION CRITERIA:
- Unilateral cerebral palsy
- Secondary orthopedic, neuromuscular or cardiovascular condition unrelated to CP
- Greater than six months of independent walking experience
- History of surgery or injury to the lower extremities in the past 6 months
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
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Change in motor delay
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Secundaire uitkomstmaten
Uitkomstmaat |
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Completion rate, change in gross motor function, change in functional mobility, change in walking speed, change in physical activity
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Medewerkers en onderzoekers
Publicaties en nuttige links
Algemene publicaties
- Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14. Erratum In: Dev Med Child Neurol. 2007 Jun;49(6):480.
- 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.
- Odding E, Roebroeck ME, Stam HJ. The epidemiology of cerebral palsy: incidence, impairments and risk factors. Disabil Rehabil. 2006 Feb 28;28(4):183-91. doi: 10.1080/09638280500158422.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 110037
- 11-CC-0037
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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