LEARN 2 MOVE 2-3: a randomized controlled trial on the efficacy of child-focused intervention and context-focused intervention in preschool children with cerebral palsy

Abstract

BackgroundLittle is known about the efficacy and the working mechanisms of physical and occupational therapy interventions for children with cerebral palsy (CP). In recent years a shift from a child-focused intervention approach to a more context-focused intervention approach can be recognized. Until now the evidence on the efficacy and the working mechanisms of these interventions for children with CP is inconclusive. This study aims to evaluate the efficacy and working mechanisms of two intervention approaches compared to regular care intervention in improving mobility and self-care skills of children (2-3 years) with CP and their families: a child-focused intervention approach and a context-focused intervention approach.Methods/DesignA multi-centre, randomized controlled trial research design will be used. Ninety-four children with CP (Gross Motor Function Classification System (GMFCS) level I-IV; age 2 to 3 years), their parents, and service providers (physical and occupational therapists) will be included. During a period of six months children will receive child-focused, context-focused or regular care intervention. Therapists will be randomly assigned to deliver either a child-focused intervention approach, a context-focused intervention approach or regular care intervention. Children follow their therapist into the allocated intervention arm. After the six months study-intervention period, all participants return to regular care intervention. Outcomes will be evaluated at baseline, after six months and at a three months follow-up period. Primary outcome is the capability of functional skills in self-care and mobility, using the Functional Skills Scale of the Pediatric Evaluation of Disability Inventory (PEDI). Other outcomes will be quality of life and the domains of the International Classification of Functioning, Disability and Health - for Children and Youth (ICF-CY), including body function and structure, activities (gross motor capacity and performance of daily activities), social participation, environmental variables (family functioning, parental empowerment).DiscussionThis paper presents the background information, design, description of interventions and protocol for this study on the efficacy and working mechanisms of child-focused intervention approach and context-focused intervention approach compared to regular care intervention in mobility and self-care skills of children (2-3 years) with CP.Trial registrationThis study is registered in the Dutch Trial Register as NTR1900

Family‐centred service: differences in what parents of children with cerebral palsy rate important

“…This study is based on data collected in three research projects with families of children with CP in the Netherlands: Pediatric Rehabilitation Research in the Netherlands (PERRIN) CP 0–5 (Gorter et al ), PERRIN CP 5–9 (Smits et al ) and LEARN 2 MOVE 2–3 (Ketelaar et al ). The PERRIN studies followed children with CP and their families longitudinally (from age 1 to 5 years and from age 5 to 9 years, respectively, with a focus on the development of daily functioning and the relation with child, family and care variables).…”

International Classification of Functioning, Disability and Health Core Sets for children and youth with cerebral palsy: a consensus meeting

“…In recent decades, functional abilities including social participation have been increasingly the focus of study in children and youth with CP . The research community highlights the importance of addressing functional goals in the treatment of children and youth with CP.…”

Efficacy of three therapy approaches in preschool children with cerebral palsy: a randomized controlled trial

“…A representative of a major Dutch association of people with a physical disability (JV) was involved in the design and research process. The design of the LEARN 2 MOVE 2–3 study has been described in detail previously . The Medical Ethics Committee of the University Medical Center Utrecht, the Netherlands, approved the study.…”

“…Children received the assigned study intervention for 6 months; a child‐focused approach, a context‐focused approach, or a regular care approach. The principles of child‐focused versus context‐focused approaches have been described in detail in the literature . Briefly, both approaches started with setting goals and determining the treatment plan.…”

“…Therefore, it is difficult to unravel the results of the Focus on Function Study, as groups differed both on the content of intervention and on the goal‐setting procedure. Building on the Focus on Function Study, and in an attempt to further understand the efficacy of child‐focused and context‐focused approaches, we designed a study which used the same goal‐setting procedure as a starting point for both approaches . The ‘regular care’ for preschool children with CP probably consists of a mixture of child‐focused and context‐focused approaches .…”