NCT01239784

Neurodevelopmental Rehabilitation for Toddlers With Complex Heart Defects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 12 Months – 24 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this project is to investigate the feasibility of using a home-based, parent-delivered model for providing neurodevelopmental rehabilitation programmes to infants who have had surgery for a complex heart defect.

Detailed description

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.

Conditions

• Heart Defects

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2010-11-11
• Last updated: 2013-08-27

Locations

1 site across 1 country: Canada