Neurodevelopmental Rehabilitation for Toddlers With Complex Heart Defects
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Neurodevelopmental deficits are a common morbidity among children who receive surgical treatment for complex congenital heart defects in infancy. Over 40% of children with complex heart defects will have neurodevelopmental deficits that persist throughout childhood even after a successful surgical procedure in infancy1. These deficits are typically related to basic motor perceptual motor or visual motor skills. Problems integrating what is seen (visual perceptions) with body movement (motor skills) makes it difficult for children to participate in peer play and limits their ability to succeed in school, thereby having a significant impact on the child's quality of life.
Traditional, therapist-delivered rehabilitation programmes to address these delays in neurodevelopment have not previously been attempted. It would be difficult to provide direct rehabilitation programmes to these patients given that their defects are rare and few patients are located within the same geographical area. Home-based, parent-delivered rehabilitation programmes have previously been shown to be effective at improving the motor skills of school-age children with complex heart defects5. Since a home-based parent delivered model would enable the participation of infants regardless of geographic location, the feasibility of using such a model for delivering neurodevelopmental rehabilitation should be investigated.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Ontario
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Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
Families will be eligible to participate in this study if the child:
- Had the arterial switch operation (for transposition of the great arteries) or has had a Glenn procedure (for functional single ventricle).
- Is medically stable for normal infant activities.
- Is between 12 and 24 months of age in January 2010.
Exclusion Criteria:
Families will be excluded from study participation if:
- The child has a recognized syndrome or other disability affecting neurodevelopment.
- The child has had a medical procedure in the 3 months preceding the baseline study assessment.
- The cardiologist responsible for the child's care refuses to allow the child's participation.
- The child performs substantially above age-appropriate developmental milestones during the initial assessment (in which case an intervention is unlikely to have a detectable additional benefit).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: All Subjects
A total of 20 children and their parents will be recruited for this study.
Ten children will have had the Glenn procedure and 10 infants will have had the arterial switch operation.
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Participation in the study will require the parent and child to attend two assessment visits in addition to completing a series of parent and infant activities on a daily basis throughout the 10-week intervention period.
The parent-led activities will include activities such as walking with the child, stacking blocks, rolling a ball to the child, hiding a toy under a blanket for the child to find, encouraging the child to kick a rattle while the child is lying on his/her back, or crawling or rolling in different directions.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change from baseline in child's neurodevelopmental status at four months using the Peabody Development Motor Scales
Lasso di tempo: Baseline and four months
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The Peabody Development Motor Scale has demonstrated validity and reliability for children from birth to 5 years of age.
Six subtests (reflexes, stationary, locomotion, object manipulation, grasping, visual-motor integration) yield gross, fine and total motor quotient scores.
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Baseline and four months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Parents opinion on the home-based neurodevelopmental rehabilitation programme
Lasso di tempo: at 4 months
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During the final assessment, the researcher will interview the parent to obtain their perspective on delivering the study activities at home.
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at 4 months
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Research students experience and perception of guiding a home-based, parent-delivered rehabilitation programme
Lasso di tempo: at 4 months
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Research students participating in this project will also be interviewed regarding their experiences and perceptions of guiding a home-based, parent-delivered rehabilitation programme.
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at 4 months
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Brian McCrindle, MD, The Hospital for Sick Children, Toronto Canada
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 1000014278
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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