Neurodevelopmental Rehabilitation for Toddlers With Complex Heart Defects

NCT ID: NCT01239784

Last Updated: 2013-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-06-30

Brief 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

Keywords

pediatrics; Heart Defects; Neurodevelopmental deficit; Neurodevelopmental Rehabilitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Home-based neurodevelopmental rehabilitation programme

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Brian McCrindle

Staff Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian McCrindle, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto Canada

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000014278

Identifier Type: -

Identifier Source: org_study_id