Focus on Function – a randomized controlled trial comparing two rehabilitation interventions for young children with cerebral palsy

A multi-centred randomized controlled trial research design will be used. Children will be recruited from a representative sample of children attending publicly-funded regional children's rehabilitation centers serving children with disabilities in Ontario and Alberta in Canada. Target sample size is 220 children with cerebral palsy aged 12 months to 5 years at recruitment date. Therapists are randomly assigned to deliver either a context-focused approach or a child-focused approach. Children follow their therapist into their treatment arm. Outcomes will be evaluated at baseline, after 6 months of treatment and at a 3-month follow-up period. Outcomes represent the components of the International Classification of Functioning, Disability and Health, including body function and structure (range of motion), activities (performance of functional tasks, motor function), participation (involvement in formal and informal activities), and environment (parent perceptions of care, parental empowerment).This paper presents the background information, design and protocol for a randomized controlled trial comparing a task/context-focused approach to a child-focused remediation approach in improving functional outcomes for young children with cerebral palsy.[clinical trial registration #: NCT00469872]Cerebral palsy comprises a complex, multi-dimensional group of non-progressive movement disorders resulting from damage to the brain prenatally, perinatally, or early in childhood. Incidence of cerebral palsy has remained constant over the past two decades at 2.0 to 2.5 per 1000 live births [1,2]. The long-term disability and costs to the health care system and society associated with cerebral palsy are significant. Cost of services to these children and their families is substantial, with health costs alone estimated at $1,406 per family per year (over $6 billion per year) [3]. Non-reimbursed costs to families for services, equipment, and lost family income can amount to thousands o