Rehabilitation Including Structured Active Play for Preschoolers With Cancer (RePlay)—Study Protocol for a Randomized Controlled Trial

Frontiers in Pediatrics

卷:10

He Zhang¹  Martin Kaj Fridh¹  Hanne Bækgaard Larsen²  Anna Pouplier²  Kjeld Schmiegelow²  Helle Winther³  Jan Christensen⁴  Peter Schmidt-Andersen⁴  Thomas Leth Frandsen⁵ 

[1] Department for Pediatrics and Adolescent Medicine, The Juliane Marie Center, Copenhagen University Hospital, Copenhagen, Denmark;

[2] Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark;

[3] Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark;

[4] Department of Occupational and Physiotherapy, Center of Head and Orthopedics, Copenhagen University Hospital, Copenhagen, Denmark;

[5] Mary Elizabeth's Hospital, Rigshospitalet for Children, Teens and Expecting Families, Copenhagen University Hospital, Copenhagen, Denmark;

关键词: preschool children;    rehabilitation;    structured active play;    physical activity;    gross motor function;    social skills;   

DOI  :  10.3389/fped.2022.834512

来源: DOAJ

【 摘 要 】

BackgroundChildren diagnosed with cancer experience muscle weakness and impaired physical function caused by treatment and related immobility. The situation forces them into a negative cycle of diminished participation in physical and leisure activities and isolation from peers; inhibiting the natural development of social and gross motor skills. This manuscript presents a protocol for a study that explores the effects of using structured active play to maintain preschoolers' age specific gross motor function and social and personal skills while undertaking intensive cancer treatment.MethodsThe study is a two-arm, superiority randomized controlled trial with an intervention and a control group designed to evaluate the effects of a structured active play intervention on gross motor function. Gross motor subtests of the Peabody Developmental Motor Scales, Second Edition (PDMS-2) are used for measurement; with the primary end-point at 6 months post-treatment initiation. Eighty-four preschool children (aged 1–5 years), newly diagnosed with cancer at the Copenhagen University Hospital are randomly assigned to either an intervention or control group, using a 1:1 allocation. The intervention group receives a combined in-hospital and home-based program that includes structured active play activities, while the control group receives standard care, including physiotherapy. During hospital admission, the intervention group undertakes 45-min structured active play group sessions three times weekly, conducted by exercise professionals. Parents receive training and supervision to facilitate daily individual sessions outside of group sessions. Secondary study outcomes target the children's overall function level in everyday life, general physical performance, and health-related quality of life. As well, children's and parents' experiences within the intervention are explored and the children's social and personal development is observed.DiscussionLimited evidence exists regarding the effectiveness of rehabilitation interventions, particularly those including active play, for preschoolers diagnosed with cancer. This manuscript reporting on a study protocol will enhance clarity and transparency in reporting and offer insights for others with interest in this same topic. Once completed, findings from this study could extend knowledge about the conduct and measurement of effectiveness in rehabilitation initiatives. If study findings suggest that the intervention is effective, structured active play may become a standard part of rehabilitation.Trial RegistrationClinicalTrials.gov: NCT04672681. Registered December 17, 2020. https://clinicaltrials.gov/ct2/show/NCT04672681.

【 授权许可】

Unknown