Neurodevelopmental Rehabilitation for Toddlers With Complex Heart Defects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01239784
Recruitment Status : Completed
First Posted : November 11, 2010
Last Update Posted : August 27, 2013
Information provided by (Responsible Party):
Brian McCrindle, The Hospital for Sick Children

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.

Condition or disease Intervention/treatment Phase
Heart Defects Behavioral: Home-based neurodevelopmental rehabilitation programme Phase 2

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.

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
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   12 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01239784

Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Principal Investigator: Brian McCrindle, MD The Hospital for Sick Children, Toronto Canada

Responsible Party: Brian McCrindle, Staff Cardiologist, The Hospital for Sick Children Identifier: NCT01239784     History of Changes
Other Study ID Numbers: 1000014278
First Posted: November 11, 2010    Key Record Dates
Last Update Posted: August 27, 2013
Last Verified: August 2013

Keywords provided by Brian McCrindle, The Hospital for Sick Children:
Heart Defects
Neurodevelopmental deficit
Neurodevelopmental Rehabilitation