以从业者为主导、同伴小组运动干预结合以情境为中心的干预治疗脑瘫儿童：一项可行性随机临床试验方案。
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.
机构信息
Graduate Program in Rehabilitation Sciences, Physical Therapy Department, School of Physical Education, Physical Therapy and Occupational Therapy, Federal University of Minas Gerais, Minas Gerais, Brazil
Graduate Program in Rehabilitation Sciences, Physical Therapy Department, School of Physical Education, Physical Therapy and Occupational Therapy, Federal University of Minas Gerais, Minas Gerais, Brazil.
出版信息
BMJ Open. 2023 Jan 31;13(1):e068486. doi: 10.1136/bmjopen-2022-068486.
BACKGROUND
There 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.
METHODS
In 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 DISSEMINATION
This 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 NUMBERS
RBR-4m3b4b6, U1111-1256-4998.
背景
需要研究相关的、可接受的和可行的方法，以促进脑瘫儿童（CP）参与休闲时间的体育活动。本研究的目的是评估一项随机对照试验的可行性，该试验比较了以提高身体素养为重点的同伴小组干预（体育之星）与将体育之星与以环境为重点的干预措施（参与和参与的途径和资源，PREP）相结合，用于巴西的脑瘫儿童。
方法
在这项可行性试验中，将 18 名（年龄 6-12 岁）能走动的 CP 儿童随机分为两组（每组 9 名）：（1）体育之星和（2）体育之星加 PREP。体育之星组将接受每周 8 次的小组课程，重点是发展参与流行的巴西运动所需的身体、社会、认知和心理技能。结合了体育之星和 PREP 的组将在接受体育之星的基础上，再接受 8 次个人 PREP 课程，重点是克服参与的环境障碍。主要结果将包括可行性措施：参与 RCT 的意愿、合格和招募率、评估者盲法的维持、筛选程序和随机分配的可接受性、结果评估的可行性、组间污染、干预依从性、治疗满意度、对干预措施的理解和实施资源。将应用其他仪器来获取与休闲时间体育活动参与目标、整体参与（家庭、学校和社区）、身体素养、身体活动水平和家庭赋权相关的数据。结果将在干预前、干预后和干预后 12 周进行评估。
伦理和传播
这项可行性试验已获得联邦米纳斯吉拉斯大学伦理审查委员会的批准（CAE：33238520.5.0000.5149）。所有潜在的研究对象都将提供书面知情同意书。本研究的结果将发表在同行评议的期刊上，并在学术会议上发表。
试验注册号
RBR-4m3b4b6，U1111-1256-4998。
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