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

BMC Pediatrics

Study Protocol

Johannes Verheijden¹  Jan Willem Gorter²  Marian J Jongmans³  Heleen A Reinders-Messelink⁴  Eline Lindeman⁵  Marjolijn Ketelaar⁶  Anne JA Kruijsen⁶  Olaf Verschuren⁶ 

[1] BOSK, Association of physical disabled persons and their parents, Utrecht, The Netherlands;CanChild Centre for Childhood Disability Research, McMaster University, Hamilton, Ontario, Canada;Partner of NetChild, Network for Childhood Disability Research in the Netherlands, The Netherlands;Faculty of Social Sciences, Department of Pedagogical and Educational Sciences, Utrecht University, Utrecht, The Netherlands;Wilhelmina Children's Hospital, Department of Pediatric Psychology, University Medical Center Utrecht, Utrecht, The Netherlands;Partner of NetChild, Network for Childhood Disability Research in the Netherlands, The Netherlands;Rehabilitation Center 'Revalidatie Friesland', Beetsterzwaag, The Netherlands;Center for Rehabilitation, University Medical Center Groningen, Groningen, The Netherlands;Rehabilitation Center De Hoogstraat, Center of Excellence for Rehabilitation Medicine Utrecht, Utrecht, The Netherlands;Rudolf Magnus Institute of Neuroscience, Department of Rehabilitation, Nursing Science and Sports, University Medical Center Utrecht, Utrecht, The Netherlands;Rehabilitation Center De Hoogstraat, Center of Excellence for Rehabilitation Medicine Utrecht, Utrecht, The Netherlands;Rudolf Magnus Institute of Neuroscience, Department of Rehabilitation, Nursing Science and Sports, University Medical Center Utrecht, Utrecht, The Netherlands;Partner of NetChild, Network for Childhood Disability Research in the Netherlands, The Netherlands;

关键词: Cerebral Palsy;    Intervention Approach;    Good Psychometric Property;    Gross Motor Function Classification System;    Goal Attainment Scaling;   

DOI  :  10.1186/1471-2431-10-80

 received in 2010-06-30, accepted in 2010-11-08,  发布年份 2010

来源: Springer

【 摘 要 】

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

【 授权许可】

CC BY   
© Ketelaar et al; licensee BioMed Central Ltd. 2010