Children with cerebral palsy commonly receive ongoing physical and occupational therapy to facilitate development and to enhance functional independence in movement, self-care, play, school activities and leisure. The primary objective of this project is to conduct a multi-site clinical trial to evaluate the efficacy of a family-centered functional therapy (FCFT) approach in improving performance of functional tasks, mobility, participation in everyday activities, and quality of life in 220 children 12 months to 5 years of age who have cerebral palsy. A randomized clinical trial research design will be used to examine the efficacy of the FCFT approach compared to regular therapy care. 72 therapists (24 in Alberta and 48 in Ontario) will be randomly assigned to provide either FCFT or regular child-focused remediation therapy. Therapists in both groups will receive 3 days of training and expert consultants will be available to support the therapists throughout the study. We will recruit a population-based random sample of 220 children with cerebral palsy ages 12 months to 5 years at recruitment date. After stratification by age and severity, children will receive either FCFT or regular child-focused remediation therapy for a period of 6 months. Outcomes will be evaluated at baseline, after 6 months of treatment and at a 3-month follow-up period. Outcomes will be measured across the domains of the International Classification of Functioning, Disability, and Health including body function and structure (range of motion, spinal alignment), activities (performance of functional tasks, motor function), participation (involvement in formal and informal activities), and environment (parent perceptions of care, parental empowerment). The children's range of motion will also be evaluated by an independent, trained evaluator at baseline, 3, 6, and 9 months to monitor potential adverse effects. We hypothesize that the FCFT approach will significantly improve activity and participation outcomes while leading to no significant decreases in body function and structure outcomes.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
5R01HD044444-02
Application #
7116960
Study Section
Pediatrics Subcommittee (CHHD)
Program Officer
Nicholson, Carol E
Project Start
2005-09-01
Project End
2008-08-31
Budget Start
2006-09-01
Budget End
2007-08-31
Support Year
2
Fiscal Year
2006
Total Cost
$205,651
Indirect Cost
Name
Mcmaster University
Department
Type
DUNS #
207510108
City
Hamilton
State
ON
Country
Canada
Zip Code
L8 3-Z5
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Worth, Melanie; Darrah, Johanna; Magill-Evans, Joyce et al. (2014) Stability of parent report on Mobility and Self-Care item scores of the Pediatric Evaluation of Disability Inventory. Phys Occup Ther Pediatr 34:289-99
Law, Mary; King, Gillian; Petrenchik, Theresa et al. (2012) The assessment of preschool children's participation: internal consistency and construct validity. Phys Occup Ther Pediatr 32:272-87
Law, Mary C; Darrah, Johanna; Pollock, Nancy et al. (2011) Focus on function: a cluster, randomized controlled trial comparing child- versus context-focused intervention for young children with cerebral palsy. Dev Med Child Neurol 53:621-9
Darrah, Johanna; Law, Mary C; Pollock, Nancy et al. (2011) Context therapy: a new intervention approach for children with cerebral palsy. Dev Med Child Neurol 53:615-20