Neurodevelopmental Rehabilitation for Toddlers With Complex Heart Defects

Heart Defects Clinical Trial

Official title:

Neurodevelopmental Rehabilitation for Toddlers With Complex Heart Defects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01239784
• Other study ID #: 1000014278
• Status: Completed
• Phase: Phase 2
• First received: November 10, 2010
• Last updated: August 25, 2013
• Start date: October 2009
• Est. completion date: June 2010

Study information

• Verified date: August 2013
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months to 24 Months

Eligibility

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).

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Heart Defects

Intervention

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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in child's neurodevelopmental status at four months using the Peabody Development Motor Scales	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.	Baseline and four months	No
Secondary	Parents opinion on the home-based neurodevelopmental rehabilitation programme	During the final assessment, the researcher will interview the parent to obtain their perspective on delivering the study activities at home.	at 4 months	No
Secondary	Research students experience and perception of guiding a home-based, parent-delivered rehabilitation programme	Research students participating in this project will also be interviewed regarding their experiences and perceptions of guiding a home-based, parent-delivered rehabilitation programme.	at 4 months	No