Neurodevelopmental Rehabilitation for Toddlers With Complex Heart Defects
|ClinicalTrials.gov Identifier: NCT01239784|
Recruitment Status : Completed
First Posted : November 11, 2010
Last Update Posted : August 27, 2013
|Condition or disease||Intervention/treatment||Phase|
|Heart Defects||Behavioral: Home-based neurodevelopmental rehabilitation programme||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Neurodevelopmental Rehabilitation for Toddlers With Complex Heart Defects|
|Study Start Date :||October 2009|
|Primary Completion Date :||June 2010|
|Study Completion Date :||June 2010|
Experimental: 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.
Behavioral: Home-based neurodevelopmental rehabilitation programme
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.
- Change from baseline in child's neurodevelopmental status at four months using the Peabody Development Motor Scales [ Time Frame: Baseline and four months ]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.
- Parents opinion on the home-based neurodevelopmental rehabilitation programme [ Time Frame: at 4 months ]During the final assessment, the researcher will interview the parent to obtain their perspective on delivering the study activities at home.
- Research students experience and perception of guiding a home-based, parent-delivered rehabilitation programme [ Time Frame: at 4 months ]Research students participating in this project will also be interviewed regarding their experiences and perceptions of guiding a home-based, parent-delivered rehabilitation programme.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01239784
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Brian McCrindle, MD||The Hospital for Sick Children, Toronto Canada|