先天性偏瘫婴儿超早期康复的随机对照试验
Randomized Comparison Trial of Rehabilitation Very Early for Infants with Congenital Hemiplegia.
作者信息
Boyd Roslyn N, Greaves Susan, Ziviani Jenny, Novak Iona, Badawi Nadia, Pannek Kerstin, Elliott Catherine, Wallen Margaret, Morgan Catherine, Valentine Jane, Findlay Lisa, Guzzetta Andrea, Whittingham Koa, Ware Robert S, Fiori Simona, Maitre Nathalie L, Heathcock Jill, Scott Kimberley, Eliasson Ann-Christin, Sakzewski Leanne
机构信息
Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland, Queensland, Australia.
Department of Occupational Therapy, Royal Children's Hospital, Melbourne, Victoria, Australia.
出版信息
J Pediatr. 2025 Feb;277:114381. doi: 10.1016/j.jpeds.2024.114381. Epub 2024 Oct 29.
OBJECTIVE
To compare efficacy of constraint-induced movement therapy (Baby-CIMT) with bimanual therapy (Baby-BIM) in infants at high risk of unilateral cerebral palsy.
STUDY DESIGN
This was a single-blind, randomized-comparison-trial that had the following inclusion criteria: (1) asymmetric brain lesion (2) absent fidgety General Movements, (3) Hammersmith Infant Neurological Examination below cerebral palsy cut-points, (4) entry at 3-9 months of corrected age, and (5) >3-point difference between hands on Hand Assessment Infants (HAI). Infants were randomized to Baby-CIMT or Baby-BIM, which comprised 6-9 months of home-based intervention. Daily dose varied from 20 to 40 minutes according to age (total 70-89.2 hours). Primary outcome measure was the HAI after intervention, with secondary outcomes Mini-Assisting Hand Assessment and Bayley III cognition at 24 months of corrected age.
RESULTS
In total, 96 infants (51 male, 52 right hemiplegia) born median at 37-weeks of gestation were randomized to Baby-CIMT (n = 46) or Baby-BIM (n = 50) and commenced intervention at a mean 6.5 (SD 1.6) months corrected age. There were no between group differences immediately after intervention on HAI (mean difference [MD] 0.98 HAI units, 95% CI 0.94-2.91; P = .31). Both groups demonstrated significant clinically important improvements from baseline to after intervention (Baby-BIM MD 3.48, 95% CI 2.09-4.87; Baby-CIMT MD 4.42, 95% CI 3.07-5.77). At 24 months, 64 infants were diagnosed with unilateral cerebral palsy (35 Baby-CIMT, 29 Baby-BIM). Infants who entered the study between 3 and 6 months of corrected age had greater change in HAI Both Hands Sum Score compared with those who entered at ≥6 months of corrected age (MD 7.17, 95% CI 2.93-11.41, P = .001).
CONCLUSIONS
Baby-CIMT was not superior to Baby-BIM, and both interventions improved hand development. Infants commencing intervention at <6 months corrected age had greater improvements in hand function.
目的
比较强制性运动疗法（婴儿强制性运动疗法[Baby-CIMT]）与双手疗法（婴儿双手疗法[Baby-BIM]）对单侧脑瘫高危婴儿的疗效。
研究设计
这是一项单盲随机对照试验，纳入标准如下：（1）脑损伤不对称；（2）无不安运动；（3）哈默史密斯婴儿神经学检查低于脑瘫切点；（4）矫正年龄3至9个月时入组；（5）婴儿手部评估（HAI）双手得分相差>3分。婴儿被随机分为Baby-CIMT组或Baby-BIM组，接受为期6至9个月的家庭干预。根据年龄，每日干预时长为20至40分钟（总计70至89.2小时）。主要结局指标为干预后的HAI，次要结局指标为矫正年龄24个月时的简易辅助手评估和贝利婴幼儿发展量表第三版认知能力评估。
结果
共有96例中位孕周37周出生的婴儿（51例男性，52例右偏瘫）被随机分为Baby-CIMT组（n = 46）或Baby-BIM组（n = 50），平均矫正年龄6.5（标准差1.6）个月时开始干预。干预后立即进行的HAI评估显示，两组之间无差异（平均差[MD]0.98 HAI单位，95%置信区间0.94至2.91；P = 0.31）。两组从基线到干预后均显示出具有临床意义的显著改善（Baby-BIM组MD 3.48，95%置信区间2.09至4.87；Baby-CIMT组MD 4.42，95%置信区间3.07至5.77）。24个月时诊断出64例单侧脑瘫婴儿（35例Baby-CIMT组，29例Baby-BIM组）。矫正年龄3至6个月入组的婴儿与矫正年龄≥6个月入组的婴儿相比，HAI双手总分变化更大（MD 7.17，95%置信区间2.93至11.41，P = 0.001）。
结论
Baby-CIMT并不优于Baby-BIM，两种干预均改善了手部发育。矫正年龄<6个月开始干预的婴儿手部功能改善更大。
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