Department of Paediatrics, The University of Melbourne, and Murdoch Children's Research Institute, Parkville, Australia.
School of Allied Health, Faculty of Health Sciences, Australian Catholic University, North Sydney, Australia.
Disabil Rehabil. 2023 Jun;45(12):2046-2056. doi: 10.1080/09638288.2022.2079734. Epub 2022 Jun 1.
To investigate the effects of providing rigid wrist-hand orthoses plus usual multidisciplinary care, on reducing hand impairments in children with cerebral palsy.
A pragmatic, multicentre, assessor-blinded randomised controlled trial aimed to enrol 194 children aged 5-15 years, with wrist flexor Modified Ashworth Scale score ≥1. Randomisation with concealed allocation was stratified by study site and passive wrist range. The treatment group received a rigid wrist-hand orthosis, to wear ≥6 h per night for 3 years. Analysis included repeated measures mixed-effects linear regression models, using intention-to-treat principles.
The trial stopped early due to insufficient recruitment: 74 children, across all Manual Ability Classification System levels, were randomised ( = 38 orthosis group; = 36 control). Mean age was 10.2 (SD 3.1) years (orthosis group) and 9.1 (SD 2.8) years (control). Data showed some evidence that rigid wrist-hand orthosis impacted passive wrist extension with fingers extended in the first year [mean difference between-groups at 6 months: 13.15° (95%CI: 0.81-25.48°, = 0.04); 12 months: 20.94° (95%CI: 8.20-33.69°, = 0.001)]. Beyond 18 months, participant numbers were insufficient for conclusive findings.
The study provided detailed data about short- and long-term effects of the wrist-hand orthosis and highlighted challenges in conducting large randomised controlled trials with this population. Australia and New Zealand Clinical Trials Registry: U1111-1164-0572 IMPLICATIONS FOR REHABILITATIONThere may be incremental benefit, for children with cerebral palsy, at 6 and 12 months on passive wrist range from wearing a rigid wrist-hand orthosis designed according to this protocol.The rigid-wrist-hand orthosis evaluated in this study, which allowed for some tailoring for individual children's presentations, differed in design from past recommendations for "resting hand" positioning.Longitudinal follow up of children with cerebral palsy prescribed a rigid wrist-hand orthosis is essential to monitor any benefit.Minor adverse events were commonly experienced when wearing the orthosis and should be discussed prior to prescription of a rigid wrist-hand orthosis.
研究提供刚性腕手矫形器加常规多学科护理对脑瘫患儿手部损伤的影响。
本研究为一项实用的、多中心、评估者盲法的随机对照试验，旨在纳入 194 名年龄在 5-15 岁之间、腕屈肌改良 Ashworth 量表评分为 1 分或以上的脑瘫患儿。采用隐匿分组的方法，根据研究地点和被动腕关节活动范围进行分层，对患儿进行随机分组。治疗组接受刚性腕手矫形器治疗，要求患儿夜间佩戴至少 6 小时，连续佩戴 3 年。采用意向治疗原则，使用重复测量混合效应线性回归模型进行分析。
由于招募人数不足，试验提前终止：共有 74 名患儿（所有手动能力分类系统水平）接受了随机分组（38 名接受矫形器治疗，36 名接受对照组治疗）。平均年龄为 10.2（标准差 3.1）岁（矫形器组）和 9.1（标准差 2.8）岁（对照组）。数据显示，刚性腕手矫形器在第一年对手部被动伸展有一定影响，表现为手指伸展时的腕关节被动伸展度增加[6 个月时组间平均差异：13.15°（95%可信区间：0.81-25.48°， = 0.04）；12 个月时：20.94°（95%可信区间：8.20-33.69°， = 0.001）]。18 个月后，由于参与者人数不足，无法得出明确的结论。
本研究提供了关于腕手矫形器短期和长期效果的详细数据，并强调了在该人群中开展大型随机对照试验所面临的挑战。澳大利亚和新西兰临床试验注册中心：U1111-1164-0572
对于脑瘫患儿，根据本研究方案设计的刚性腕手矫形器在 6 个月和 12 个月时可能对手部被动活动范围有额外获益。
本研究中评估的刚性腕手矫形器允许根据个体患儿的表现进行一些定制，其设计与过去推荐的“休息手”定位不同。
长期随访脑瘫患儿佩戴刚性腕手矫形器对于监测任何获益至关重要。
佩戴矫形器时常见轻微不良事件，应在开具刚性腕手矫形器前进行讨论。
