Queensland Cerebral Palsy and Rehabilitation Research Centre, Faculty of Medicine, The University of Queensland Child Health Research Centre, South Brisbane, Queensland, Australia
School of Allied Health, Curtin University, Carlisle, Western Australia, Australia.
BMJ Open. 2023 Mar 29;13(3):e068774. doi: 10.1136/bmjopen-2022-068774.
For children with cerebral palsy (CP), who are marginally ambulant, gross motor capacity peaks between 6 and 7 years of age with a subsequent clinical decline, impacting their ability to engage in physical activity. Active Strides-CP is a novel package of physiotherapy targeting body functions, activity and participation outcomes for children with bilateral CP. This study will compare Active Strides-CP to usual care in a multisite randomised waitlist-controlled trial.
150 children with bilateral CP (5-15 years), classified in Gross Motor Function Classification System (GMFCS) levels III and IV will be stratified (GMFCS III vs IV, age 5-10 years; 11-15 years and trial site) and randomised to receive either (1) 8 weeks of Active Strides-CP two times/week for 1.5 hours in clinic and one time/week for 1 hour alternating home visits and telehealth (total dose=32 hours) or (2) usual care. Active Strides-CP comprises functional electrical stimulation cycling, partial body weight support treadmill training, overground walking, adapted community cycling and goal-directed training. Outcomes will be measured at baseline, immediately post-intervention at 9 weeks and at 26 weeks post-baseline for retention. The primary outcome is the Gross Motor Function Measure-66. Secondary outcomes include habitual physical activity, cardiorespiratory fitness, walking speed and distance, frequency/involvement of community participation, mobility, goal attainment and quality of life. Analyses will follow standard principles for randomised controlled trials using two-group comparisons on all participants on an intention-to-treat basis. Comparisons between groups for primary and secondary outcomes will be conducted using regression models. A within-trial cost utility analysis will be performed.
The Children's Health Queensland Hospital and Health Service, The University of Queensland, The University of Melbourne and Curtin University Human Research Ethics Committees have approved this study. Results will be disseminated as conference abstracts and presentations, peer-reviewed articles in scientific journals, and institution newsletters and media releases.
ACTRN12621001133820.
对于运动功能处于边缘状态的脑瘫儿童，其粗大运动能力在 6 至 7 岁时达到峰值，随后出现临床下降，从而影响其参与体育活动的能力。主动步态脑瘫是一种针对双侧脑瘫儿童身体功能、活动和参与结果的新型物理治疗方案。本研究将在多地点随机等待对照试验中比较主动步态脑瘫与常规护理。
将 150 名双侧脑瘫儿童（5-15 岁）按照粗大运动功能分类系统（GMFCS）水平 III 和 IV 进行分层（GMFCS III 与 IV、5-10 岁；11-15 岁和试验地点），并随机分为两组，分别接受以下两种治疗：（1）8 周的主动步态脑瘫治疗，每周两次，每次 1.5 小时在诊所进行，每周一次，每次 1 小时交替进行家庭访问和远程医疗（总剂量=32 小时）；或（2）常规护理。主动步态脑瘫治疗包括功能性电刺激自行车运动、部分体重支持跑步机训练、地面步行、适应性社区自行车运动和目标导向训练。在基线、干预后 9 周和基线后 26 周进行评估，以评估保留情况。主要结果是粗大运动功能测量-66。次要结果包括习惯性体力活动、心肺功能适应性、步行速度和距离、社区参与的频率/参与度、移动性、目标实现和生活质量。分析将遵循随机对照试验的标准原则，对所有参与者进行意向治疗分析。使用回归模型对两组间的主要和次要结果进行比较。将进行试验内成本效用分析。
昆士兰儿童健康医院和健康服务中心、昆士兰大学、墨尔本大学和科廷大学人类研究伦理委员会已批准该研究。结果将以会议摘要和演示文稿、科学期刊上的同行评议文章、机构通讯和媒体发布的形式传播。
ACTRN12621001133820。
