Practitioner-led, peer-group sports intervention combined with a context-focused intervention for children with cerebral palsy: a protocol of a feasibility randomised clinical trial

• Published in: BMJ open Vol. 13; no. 1; p. e068486
• Main Authors: Souto, Deisiane Oliveira, da Silva, Luana Cristina, de Sousa Junior, Ricardo Rodrigues, Clutterbuck, Georgina, Anaby, Dana, Longo, Egmar, Magalhães, Rafael Coelho, Camargos, Ana Cristina Resende, Leite, Hércules Ribeiro
• Format: Journal Article
• Language: English
• Published: England British Medical Journal Publishing Group 31.01.2023; BMJ Publishing Group LTD; BMJ Publishing Group
• Series: Protocol
• Subjects: Cerebral Palsy; Child; Children with disabilities; Clinical trials; community child health; developmental neurology & neurodisability; Disability; Empowerment; Exercise; Families & family life; Feasibility Studies; Humans; Intervention; Leisure; Motor Activity; Neurology; paediatric neurology; Participation; Pediatrics; Performance evaluation; Physical fitness; Randomized Controlled Trials as Topic; Recreation; Sports; Teenagers; Brazil; paediatric neurology; developmental neurology & neurodisability; community child health
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2022-068486

BackgroundThere is a need to investigate relevant, acceptable and feasible approaches that promote participation in leisure-time physical activity for children with cerebral palsy (CP). The aim of this study is to assess the feasibility of a randomised controlled trial comparing a peer-group intervention focused on improving physical literacy (Sports Stars) with the combination of Sports Stars and a context-focused intervention (Pathways and Resources for Engagement and Participation, PREP) for ambulant children with CP in Brazil.MethodsIn this feasibility trial, 18 ambulant children (aged 6–12 years) with CP will be randomised into two groups (nine per group): (1) Sports Stars and (2) Sports Stars plus PREP. The Sports Stars group will receive 8 weekly group sessions, focusing on developing the physical, social, cognitive and psychological skills required to participate in popular Brazilian sports. The combined Sports Stars and PREP group will receive Sports Stars in addition to eight individual PREP sessions focused on overcoming environmental barriers to participation. The primary outcome will include feasibility measures: willingness to participate in an RCT, eligibility and recruitment rates, maintenance of evaluator blinding, acceptability of screening procedures and random allocation, feasibility of evaluating outcomes, contamination between the groups, intervention adherence, treatment satisfaction, understanding of the intervention and implementation resources. Additional instruments will be applied to obtain data related to leisure-time physical activity participation goals, overall participation (home, school and community), physical literacy, level of physical activity and family empowerment. Outcomes will be assessed before, after and 12 weeks after intervention.Ethics and disseminationThis feasibility trial has been approved by ethical Federal University of Minas Gerais’ Ethics Review Committee (CAAE: 33238520.5.0000.5149). All potential subjects will provide written informed consent. The results of this study will be published in peer-reviewed journals and be presented at academic conferences.Trial registration numbersRBR-4m3b4b6, U1111-1256-4998.