Hopewell Sally, Keene David J, Marian Ioana, Perry Daniel C, Rombach Ines, 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, Rapson Rachel, Ryan Jennifer, Saeedi Elnaz, Stone Megan, Wood Helen, Theologis Tim
Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
University of Exeter, Exeter, UK.
Bone Jt Open. 2025 May 1;6(5):517-527. doi: 10.1302/2633-1462.65.BJO-2024-0268.
Muscle strengthening exercises are one of the interventions frequently prescribed by physiotherapists for adolescents with cerebral palsy (CP). However, there is wide variability in the exercise regimes used and limited evidence of their effectiveness. The ROBUST trial will assess the clinical effectiveness of an individually tailored strengthening programme, including progressive resistance exercises and advice, compared to usual care for ambulant adolescents with spastic CP.
We are conducting a multicentre, two-arm, parallel group, superiority randomized controlled trial. We will recruit adolescents aged 12 to 18 years with a diagnosis of spastic CP (bilateral or unilateral) Gross Motor Function Classification System (GMFCS) levels I to III who are able to comply with the 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 1:1 allocation ratio) to either: 1) a progressive resistance 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 session, and advice regarding self-management and exercise.
The primary outcome is functional mobility measured using the child-/parent-reported Gait Outcomes Assessment List (GOAL) at six months. Secondary outcomes are: clinician-assessed muscle strength (Five Times Sit-to-Stand Test) 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 (six and 12 months). The primary analysis will be intention to treat.
肌肉强化锻炼是物理治疗师经常为患有脑瘫（CP）的青少年开出的干预措施之一。然而，所使用的锻炼方案存在很大差异，且其有效性的证据有限。“稳健试验”将评估针对痉挛型CP的能独立行走的青少年，与常规护理相比，个性化定制的强化锻炼方案（包括渐进性抗阻训练和建议）的临床效果。
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12至18岁、诊断为痉挛型CP（双侧或单侧）、粗大运动功能分类系统（GMFCS）为I至III级、无论有无支持都能遵守评估程序和锻炼方案的青少年。参与者将从至少12家英国国民健康服务体系（NHS）信托机构的物理治疗及相关服务部门招募。参与者（n = 334）将被随机分配（通过中央计算机生成的1:1分配比例）到以下两组之一：1）渐进性抗阻训练方案，在16周内进行六次一对一的物理治疗；或2）常规NHS护理，包括一次物理治疗和一次评估，并提供自我管理和锻炼方面的建议。
主要结局是在六个月时使用儿童/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：六个月时临床医生评估的肌肉力量（五次坐立试验）和运动功能（计时起立行走试验）；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）、疼痛与不适（GOAL子领域C）、健康相关生活质量（欧洲五维度健康量表青少年版；EQ - 5D - Y）、上学出勤率、锻炼依从性以及额外的物理治疗（六个月和十二个月时）。主要分析将采用意向性分析。
