University of Plymouth, Derriford Road, Devon, PL6 8BH, UK.
Multiple Sclerosis and Health Measurement Research and Innovation, Faculty of Medicine and Dentistry, University of Plymouth, Devon, PL4 8AA, UK.
Physiotherapy. 2022 Sep;116:42-49. doi: 10.1016/j.physio.2022.01.001. Epub 2022 Jan 29.
To assess the feasibility of a randomised controlled trial (RCT) to evaluate the effect of different doses of standing time on hip migration rate in children with cerebral palsy (CP).
Children aged 1-12 years with CP GMFCS levels III-V were recruited and randomised to either doubling or continuing with their usual time in their standing frame. Caregivers kept a standing time diary. The primary outcome measure was Reimers hip migration percentage, measured at baseline, 12 and 24 months. A blinded assessor measured secondary clinical outcomes at baseline, 6 and 12 months. Feasibility results are reported following CONSORT guidelines.
Twenty-five children were recruited. Nineteen were randomised and 10 completed the 12-month intervention. The mean daily standing time in the intervention group was 49minutes (SD 39.1) (Monday-Sunday) and 58.1 (SD 44.1) minutes during weekdays. In children remaining in the trial, primary and secondary clinical outcome measures were available in 54% and 90% of children respectively. There were three serious adverse events, unrelated to standing.
It may be feasible to conduct an RCT to assess the effect of duration of standing on hip migration in children with CP with an altered protocol. The suggested target dose is 60minutes five times per week compared to a control group standing for 30minutes three times per week, over twelve months. Use of botulinum toxin need not be a criterion for exclusion and radiography should be included as a research cost. NHS Health Research Committee, South West ethics approval (ref 13/SW/0228).
评估一项随机对照试验（RCT）的可行性，以评估不同站立时间剂量对脑瘫（CP）儿童髋关节迁移率的影响。
招募年龄在 1-12 岁、CP GMFCS 水平为 III-V 的儿童，并将其随机分为双倍站立时间组或继续维持其常规站立时间组。照护者记录站立时间日记。主要结局指标为 Reimers 髋关节迁移百分比，在基线、12 个月和 24 个月时测量。盲法评估者在基线、6 个月和 12 个月时测量次要临床结局。按照 CONSORT 指南报告可行性结果。
共招募了 25 名儿童。19 名儿童被随机分组，其中 10 名完成了 12 个月的干预。干预组的平均每日站立时间为 49 分钟（SD 39.1）（周一至周日），工作日为 58.1 分钟（SD 44.1）。在继续参加试验的儿童中，主要和次要临床结局测量指标在 54%和 90%的儿童中可用。有 3 例严重不良事件与站立无关。
可能可以进行一项 RCT，以评估改变方案后，CP 儿童站立时间对髋关节迁移的影响。建议的目标剂量为每周 5 次、每次 60 分钟，与对照组每周 3 次、每次 30 分钟相比，为期 12 个月。使用肉毒毒素不必作为排除标准，并且应将放射摄影作为研究费用纳入。NHS 健康研究委员会，西南伦理批准（参考 13/SW/0228）。
