Department of Physical Medicine and Rehabilitation, Anam Hospital, Korea University College of Medicine, Seoul, South Korea.
Department of Rehabilitation Medicine, Pusan National University Hospital, Biomedical Research Institute, Pusan National University School of Medicine, Busan, South Korea.
JAMA Netw Open. 2022 Nov 1;5(11):e2240383. doi: 10.1001/jamanetworkopen.2022.40383.
There is no consensus on interventions to slow the progress of hip displacement in patients with cerebral palsy.
To investigate the efficacy of a novel hip brace in preventing progressive hip displacement in patients with cerebral palsy.
DESIGN, SETTING, AND PARTICIPANTS: This 2-group randomized clinical trial was conducted at 4 tertiary hospitals in South Korea from July 2019 to November 2021. Participants included children aged 1 to 10 years with nonambulatory cerebral palsy (Gross Motor Function Classification System level IV or V). Block randomization was used to assign an equal number of patients to the study and control groups via computerized random allocation sequences. Data were analyzed from November to December 2021.
The intervention group wore the hip brace for at least 12 hours a day for the study duration (ie, 12 months). Follow-up evaluations were performed after 6 and 12 months of wearing the brace. Both groups proceeded with conventional rehabilitation therapy during the trial.
The primary outcome was the Reimers migration index (MI) on radiography, as assessed by 3 blinded investigators. Primary outcome variables were analyzed using linear mixed models. Secondary outcomes include change in the Caregiver Priorities & Child Health Index of Life with Disabilities, on which lower scores indicate better quality of life.
A total of 66 patients were included, with 33 patients (mean [SD] age, 68.7 [31.6] months; 25 [75.8%] boys) randomized to the intervention group and 33 patients (mean [SD] age, 60.7 [24.9] months; 20 [60.6%] boys) randomized to the control group. The baseline mean (SD) MI was 37.4% (19.3%) in the intervention group and 30.6% (16.3%) in the control group. The mean difference of the MI between the intervention group and control group was -8.7 (95% CI, -10.2 to -7.1) percentage points at 6 months and -12.7 (95% CI, -14.7 to -10.7) percentage points at 12 months. The changes in the Caregiver Priorities & Child Health Index of Life with Disabilities were favorable in the study group and reached statistical significance at the 6-month follow-up compared with the control group (difference, -14.2; 95% CI, -25.2 to -3.3).
In this randomized clinical trial, the novel hip brace was significantly effective in preventing the progression of hip displacement, compared with the control group. It effectively improved quality of life in patients with nonambulatory cerebral palsy. Therefore, hip brace use could be a promising treatment method to delay hip surgery and improve the quality of life of patients with nonambulatory cerebral palsy.
ClinicalTrials.gov Identifier: NCT04033289.
目前对于脑瘫患者，尚无延缓髋关节移位进展的干预措施达成共识。
研究一种新型髋关节支具在预防脑瘫患者髋关节移位进展方面的疗效。
设计、地点和参与者：这是一项在韩国 4 家三级医院进行的 2 组随机临床试验，时间为 2019 年 7 月至 2021 年 11 月。参与者包括年龄在 1 至 10 岁之间、无法行走的脑瘫患者（粗大运动功能分级系统 [GMFCS] 水平 IV 或 V）。采用分组随机化方法，通过计算机随机分配序列将患者等分为研究组和对照组。数据于 2021 年 11 月至 12 月进行分析。
研究组在研究期间（即 12 个月）每天至少佩戴支具 12 小时。在佩戴支具 6 个月和 12 个月后进行随访评估。两组患者在试验期间均继续进行常规康复治疗。
主要结局为 3 名盲法评估者通过放射影像学评估的 Reimers 迁移指数（MI）。主要结局变量采用线性混合模型进行分析。次要结局包括照顾者优先级和儿童健康生活质量指数的变化，评分越低表明生活质量越好。
共纳入 66 例患者，其中 33 例（平均[标准差]年龄为 68.7[31.6]个月；25[75.8%]名男孩）患者随机分入干预组，33 例（平均[标准差]年龄为 60.7[24.9]个月；20[60.6%]名男孩）患者随机分入对照组。干预组的基线平均（标准差）MI 为 37.4%（19.3%），对照组为 30.6%（16.3%）。干预组与对照组的 MI 平均差值在 6 个月时为-8.7（95%CI，-10.2 至-7.1）个百分点，在 12 个月时为-12.7（95%CI，-14.7 至-10.7）个百分点。与对照组相比，研究组在照顾者优先级和儿童健康生活质量指数的变化更有利，且在 6 个月随访时达到统计学意义（差异，-14.2；95%CI，-25.2 至-3.3）。
在这项随机临床试验中，与对照组相比，新型髋关节支具在预防髋关节移位进展方面具有显著效果。它能有效改善无法行走的脑瘫患者的生活质量。因此，使用髋关节支具可能是一种有前途的治疗方法，可延迟髋关节手术并改善无法行走的脑瘫患者的生活质量。
ClinicalTrials.gov 标识符：NCT04033289。
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