Chapter 5 LEARN 2 MOVE 7 - 12 years : a randomized controlled trial on the e ects of a physical ac vity s mula on program in children with cerebral palsy

Background Regular par cipa on in physical ac vi es is important for all children to stay  t and healthy. Children with cerebral palsy have reduced levels of physical ac vity, compared to typically developing children. The aim of the LEARN 2 MOVE 7-12 study is to improve physical ac vity by means of a physical ac vity s mula on program, consis ng of a lifestyle interven on and a  tness training program. Methods/Design This study will be a 6-month single-blinded randomized controlled trial with a 6-month follow up. Fi y children with spas c cerebral palsy, aged 7 to 12 years, with Gross Motor Func on Classi ca on System levels I-III, will be recruited in pediatric physiotherapy prac ces and special schools for children with disabili es. The children will be randomly assigned to either the interven on group or control group. The children in the control group will con nue with their regular pediatric physiotherapy, and the children in the interven on group will par cipate in a 6-month physical ac vity s mula on program. The physical ac vity s mula on program consists of a 6-month lifestyle interven on, in combina on with a 4-month  tness training program. The lifestyle interven on includes counseling the child and the parents to adopt an ac ve lifestyle through mo va onal interviewing, and home-based physiotherapy to prac se mobility-related ac vi es in the daily situa on. Data will be collected just before the start of the interven on (T0), a er the 4-month  tness training program (T4), a er the 6-month lifestyle interven on (T6), and a er six months of follow-up (T12). Primary outcomes are physical ac vity, measured with the StepWatch Ac vity Monitor and with self-reports. Secondary outcomes are  tness, capacity of mobility, social par cipa on and health-related quality of life. A random coe cient analysis will be performed to determine di erences in treatment e ect between the control group and the interven on group, with primary outcomes and secondary outcomes as the dependent variables.