Participate CP 2: optimising participation in physically active leisure for children with cerebral palsy – protocol for a phase III randomised controlled trial

Introduction Children with cerebral palsy (CP) participate less in physical activities and have increased sedentary behaviour compared with typically developing peers. Participate CP is a participation-focused therapy intervention for children with CP with demonstrated efficacy in a phase II randomi...

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Main Authors: Robert S Ware, Roslyn N Boyd, Stewart Trost, Leanne Sakzewski, Jenny Ziviani, Iona Novak, Catherine Elliott, Sian Williams, Tracy Comans, Sarah Elizabeth Reedman, Annette Majnemer, Syed Afroz Keramat, Lynda McNamara, Keiko Shikako, Denise Brookes
Format: Article
Language:English
Published: BMJ Publishing Group 2023-10-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/13/10/e075570.full
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author Robert S Ware
Roslyn N Boyd
Stewart Trost
Leanne Sakzewski
Jenny Ziviani
Iona Novak
Catherine Elliott
Sian Williams
Tracy Comans
Sarah Elizabeth Reedman
Annette Majnemer
Syed Afroz Keramat
Lynda McNamara
Keiko Shikako
Denise Brookes
author_facet Robert S Ware
Roslyn N Boyd
Stewart Trost
Leanne Sakzewski
Jenny Ziviani
Iona Novak
Catherine Elliott
Sian Williams
Tracy Comans
Sarah Elizabeth Reedman
Annette Majnemer
Syed Afroz Keramat
Lynda McNamara
Keiko Shikako
Denise Brookes
author_sort Robert S Ware
collection DOAJ
description Introduction Children with cerebral palsy (CP) participate less in physical activities and have increased sedentary behaviour compared with typically developing peers. Participate CP is a participation-focused therapy intervention for children with CP with demonstrated efficacy in a phase II randomised controlled trial (RCT) to increase perceived performance of physical activity participation goals. This study will test the effectiveness of Participate CP in a multisite phase III RCT.Methods and analysis One hundred children with CP, aged 8–14 years, classified Gross Motor Function Classification System levels I–IV will be randomised to either (1) receive Participate CP once/week for 1 hour for 12 weeks, or (2) waitlist control, usual care group. The waitlist group will then receive Participate CP following the 26-week retention time point. Outcomes will be assessed at baseline, 12 weeks and then 26 weeks post baseline. The primary outcomes are (1) self-reported participation goal performance on the Canadian Occupational Performance Measure at 12 weeks and (2) daily time in moderate-to-vigorous physical activity. Secondary outcomes include home and community participation frequency, involvement and environmental supportiveness, contextual barriers to participation, quality of life, intrinsic motivation for physical activities, child perception of an autonomy-supportive climate for physical activities and physical literacy at 12 and 26 weeks post study entry.Ethics and dissemination The Children’s Health Queensland Hospital and Health Service, The University of Queensland and the New Zealand Health and Disability Ethics Committees have approved this study. Findings will be disseminated in peer-reviewed journals and conference presentations.Trial registration number ACTRN12618000206224.
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spelling doaj.art-1c9671ddd71441e0b4620ac4644a28be2023-11-02T13:10:07ZengBMJ Publishing GroupBMJ Open2044-60552023-10-01131010.1136/bmjopen-2023-075570Participate CP 2: optimising participation in physically active leisure for children with cerebral palsy – protocol for a phase III randomised controlled trialRobert S Ware0Roslyn N Boyd1Stewart Trost2Leanne Sakzewski3Jenny Ziviani4Iona Novak5Catherine Elliott6Sian Williams7Tracy Comans8Sarah Elizabeth Reedman9Annette Majnemer10Syed Afroz Keramat11Lynda McNamara12Keiko Shikako13Denise Brookes14Menzies Health Institute Queensland, Griffith University, Nathan, Queensland, AustraliaQueensland Cerebral Palsy and Rehabilitation Research Centre, Faculty of Medicine, The University of Queensland Child Health Research Centre, South Brisbane, Queensland, AustraliaSchool of Human Movement and Nutrition Sciences, The University of Queensland, Saint Lucia, Queensland, AustraliaQueensland Cerebral Palsy and Rehabilitation Research Centre, Faculty of Medicine, The University of Queensland Child Health Research Centre, South Brisbane, Queensland, AustraliaSchool of Health and Rehabilitation Science, The University of Queensland - Saint Lucia Campus, Saint Lucia, Queensland, AustraliaFaculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, AustraliaTelethon Kids Institute, Nedlands, Western Australia, AustraliaSchool of Allied Health, Curtin University, Perth, Western Australia, AustraliaCentre for Health Services Research, Faculty of Medicine, The University of Queensland, Brisbane, Queensland, AustraliaQueensland Cerebral Palsy and Rehabilitation Research Centre, Faculty of Medicine, The University of Queensland Child Health Research Centre, South Brisbane, Queensland, AustraliaSchool of Physical and Occupational Therapy, McGill University, Montreal, Québec, CanadaChild Health Research Centre, Faculty of Medicine, The University of Queensland, South Brisbane, Queensland, AustraliaPhysiotherapy Department, Cairns and Hinterland Hospital and Health Service, Cairns, Queensland, AustraliaSchool of Physical and Occupational Therapy, McGill University, Montreal, Québec, CanadaChild Health Research Centre, Faculty of Medicine, The University of Queensland, South Brisbane, Queensland, AustraliaIntroduction Children with cerebral palsy (CP) participate less in physical activities and have increased sedentary behaviour compared with typically developing peers. Participate CP is a participation-focused therapy intervention for children with CP with demonstrated efficacy in a phase II randomised controlled trial (RCT) to increase perceived performance of physical activity participation goals. This study will test the effectiveness of Participate CP in a multisite phase III RCT.Methods and analysis One hundred children with CP, aged 8–14 years, classified Gross Motor Function Classification System levels I–IV will be randomised to either (1) receive Participate CP once/week for 1 hour for 12 weeks, or (2) waitlist control, usual care group. The waitlist group will then receive Participate CP following the 26-week retention time point. Outcomes will be assessed at baseline, 12 weeks and then 26 weeks post baseline. The primary outcomes are (1) self-reported participation goal performance on the Canadian Occupational Performance Measure at 12 weeks and (2) daily time in moderate-to-vigorous physical activity. Secondary outcomes include home and community participation frequency, involvement and environmental supportiveness, contextual barriers to participation, quality of life, intrinsic motivation for physical activities, child perception of an autonomy-supportive climate for physical activities and physical literacy at 12 and 26 weeks post study entry.Ethics and dissemination The Children’s Health Queensland Hospital and Health Service, The University of Queensland and the New Zealand Health and Disability Ethics Committees have approved this study. Findings will be disseminated in peer-reviewed journals and conference presentations.Trial registration number ACTRN12618000206224.https://bmjopen.bmj.com/content/13/10/e075570.full
spellingShingle Robert S Ware
Roslyn N Boyd
Stewart Trost
Leanne Sakzewski
Jenny Ziviani
Iona Novak
Catherine Elliott
Sian Williams
Tracy Comans
Sarah Elizabeth Reedman
Annette Majnemer
Syed Afroz Keramat
Lynda McNamara
Keiko Shikako
Denise Brookes
Participate CP 2: optimising participation in physically active leisure for children with cerebral palsy – protocol for a phase III randomised controlled trial
BMJ Open
title Participate CP 2: optimising participation in physically active leisure for children with cerebral palsy – protocol for a phase III randomised controlled trial
title_full Participate CP 2: optimising participation in physically active leisure for children with cerebral palsy – protocol for a phase III randomised controlled trial
title_fullStr Participate CP 2: optimising participation in physically active leisure for children with cerebral palsy – protocol for a phase III randomised controlled trial
title_full_unstemmed Participate CP 2: optimising participation in physically active leisure for children with cerebral palsy – protocol for a phase III randomised controlled trial
title_short Participate CP 2: optimising participation in physically active leisure for children with cerebral palsy – protocol for a phase III randomised controlled trial
title_sort participate cp 2 optimising participation in physically active leisure for children with cerebral palsy protocol for a phase iii randomised controlled trial
url https://bmjopen.bmj.com/content/13/10/e075570.full
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