Theologis Tim, Perry Daniel C, Rombach Ines, Keene David J, Marian Ioana R, Andrew Morag, Barry Catherine, Davis Loretta, Firth Gregory, Fletcher Heidi, Fordham Beth, Gregory Osborne Vivi, Gregory Osborne Helen, Katchburian Lesley, O'Mahoney Joanna, Parr Jeremy R, Rapson Rachel, Ryan Jennifer, Er Fema, Stone Megan, Wood Helen, Hopewell Sally
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences University of Oxford, Oxford, UK.
University of Liverpool, Liverpool, UK.
Bone Jt Open. 2025 May 1;6(5):506-516. doi: 10.1302/2633-1462.65.BJO-2024-0267.
AIMS: Dynamic muscle stretching exercises are one of the interventions frequently prescribed by physiotherapists for children with cerebral palsy (CP). However, there is wide variability in the exercise regimes used and limited evidence of their effectiveness. The SPELL trial will assess the clinical effectiveness of an individually tailored dynamic stretching programme, compared to usual care for ambulant children with spastic CP. METHODS: We are conducting a multicentre, two-arm, parallel group, superiority randomized controlled trial. We will recruit children aged four to 11 years with a diagnosis of spastic CP (bilateral or unilateral) and Gross Motor Function Classification System (GMFCS) levels I to III who are able to comply with assessment procedures and exercise programme with or without support. Participants will be recruited from at least 12 UK NHS Trust physiotherapy and related services. Participants (n = 334) will be randomized (centralized computer-generated one:one allocation ratio) to either: 1) a dynamic stretching exercise programme, with six one-to-one physiotherapy sessions over 16 weeks; or 2) usual NHS care, with a single physiotherapy session and an assessment, and advice regarding self-management and exercise. CONCLUSION: The primary outcome is functional mobility measured using the child-/parent-reported Gait Outcomes Assessment List (GOAL) at six months. Secondary outcomes are: joint range of motion (Cerebral Palsy Integrated Pathway protocol) and motor function (timed up and go test) at six months; functional mobility (GOAL) at 12 months; independence (GOAL subdomain A); balance (GOAL subdomain A, B, D); pain and discomfort (GOAL subdomain C); health-related quality of life (youth version of the EuroQol five-dimension questionnaire (EQ-5D-Y)); educational attendance; exercise adherence; and additional physiotherapy treatment at six and 12 months. The primary analysis will be intention to treat.
目的:动态肌肉拉伸运动是物理治疗师经常为脑瘫(CP)儿童开的干预措施之一。然而,所使用的运动方案差异很大,且其有效性的证据有限。SPELL试验将评估针对痉挛型行走能力的脑瘫儿童量身定制的动态拉伸方案与常规护理相比的临床效果。 方法:我们正在进行一项多中心、双臂、平行组、优效性随机对照试验。我们将招募年龄在4至11岁、诊断为痉挛型脑瘫(双侧或单侧)且粗大运动功能分类系统(GMFCS)为I至III级、能够在有或没有支持的情况下遵守评估程序和运动方案的儿童。参与者将从至少12个英国国民保健服务(NHS)信托机构物理治疗及相关服务部门招募。参与者(n = 334)将被随机分配(中央计算机生成1:1分配比例)至以下两组之一:1)动态拉伸运动方案,在16周内进行6次一对一物理治疗课程;或2)常规NHS护理,包括一次物理治疗课程及评估,并提供自我管理和运动方面的建议。 结论:主要结局是在6个月时使用儿童/家长报告的步态结局评估清单(GOAL)测量的功能移动性。次要结局包括:6个月时的关节活动范围(脑瘫综合路径方案)和运动功能(计时起立行走测试);12个月时的功能移动性(GOAL);独立性(GOAL子领域A);平衡(GOAL子领域A、B、D);疼痛和不适(GOAL子领域C);健康相关生活质量(欧洲五维健康量表青年版(EQ-5D-Y));教育出勤率;运动依从性;以及6个月和12个月时的额外物理治疗。主要分析将采用意向性分析。
Mult Scler. 2016-10
Health Technol Assess. 2022-2
Front Neurol. 2021-5-12
Children (Basel). 2021-3-23
Dev Med Child Neurol. 2021-8
Arch Phys Med Rehabil. 2019-9-12
IEEE Trans Neural Syst Rehabil Eng. 2019-8-9