Randomized Comparison Trial of Rehabilitation Very Early for Infants with Congenital Hemiplegia

IF 3.9 2区医学 Q1 PEDIATRICS

Journal of Pediatrics Pub Date : 2024-10-29 DOI:10.1016/j.jpeds.2024.114381

Roslyn N. Boyd MSc PT, PhD , Susan Greaves BSc OT, PhD , Jenny Ziviani BSc OT, PhD , Iona Novak BSc OT, PhD , Nadia Badawi MD, PhD , Kerstin Pannek PhD , Catherine Elliott BSc OT, PhD , Margaret Wallen BSc OT, PhD , Catherine Morgan BSc PT, PhD , Jane Valentine MD, PhD , Lisa Findlay BSc OT , Andrea Guzzetta MD, PhD , Koa Whittingham PhD , Robert S. Ware PhD , Simona Fiori MD, PhD , Nathalie L. Maitre MD, PhD , Jill Heathcock PhD PT , Kimberley Scott PhD PT , Ann-Christin Eliasson BSc OT, PhD , Leanne Sakzewski BSc OT, PhD

{"title":"Randomized Comparison Trial of Rehabilitation Very Early for Infants with Congenital Hemiplegia","authors":"Roslyn N. Boyd MSc PT, PhD , Susan Greaves BSc OT, PhD , Jenny Ziviani BSc OT, PhD , Iona Novak BSc OT, PhD , Nadia Badawi MD, PhD , Kerstin Pannek PhD , Catherine Elliott BSc OT, PhD , Margaret Wallen BSc OT, PhD , Catherine Morgan BSc PT, PhD , Jane Valentine MD, PhD , Lisa Findlay BSc OT , Andrea Guzzetta MD, PhD , Koa Whittingham PhD , Robert S. Ware PhD , Simona Fiori MD, PhD , Nathalie L. Maitre MD, PhD , Jill Heathcock PhD PT , Kimberley Scott PhD PT , Ann-Christin Eliasson BSc OT, PhD , Leanne Sakzewski BSc OT, PhD","doi":"10.1016/j.jpeds.2024.114381","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><div>To compare efficacy of constraint-induced movement therapy (Baby-CIMT) with bimanual therapy (Baby-BIM) in infants at high risk of unilateral cerebral palsy.</div></div><div><h3>Study design</h3><div>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.</div></div><div><h3>Results</h3><div>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; <em>P</em> = .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, <em>P</em> = .001).</div></div><div><h3>Conclusions</h3><div>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.</div></div>","PeriodicalId":54774,"journal":{"name":"Journal of Pediatrics","volume":"277 ","pages":"Article 114381"},"PeriodicalIF":3.9000,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Pediatrics","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0022347624004840","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PEDIATRICS","Score":null,"Total":0}

引用次数: 0

Abstract

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.

查看原文本刊更多论文

先天性偏瘫婴儿早期康复随机比较试验

目的比较约束诱导运动疗法（Baby-CIMT）与双指疗法（Baby-BIM）对单侧脑瘫（UCP）高风险婴儿的疗效：研究设计：单盲、随机比较试验，纳入标准如下：(研究设计：单盲随机对比试验，纳入标准如下：(i) 非对称脑损伤；(ii) 无烦躁不安的一般运动；(iii) 哈默史密斯婴儿神经系统检查低于脑瘫临界点；(iv) 3 至 9 个月矫正年龄（CA）；(v) 婴儿手部评估（HAI）两手相差 3 分以上。婴儿被随机分配到 Baby-CIMT 或 Baby-BIM，其中包括 6 到 9 个月的家庭干预。根据年龄不同，每天的干预时间从 20 到 40 分钟不等（总时间为 70-89.2 小时）。主要结果是干预后的HAI，次要结果是24个月CA时的Mini-Assisting Hand Assessment和Bayley III认知能力：96 名婴儿（51 名男婴，52 名右侧偏瘫婴儿）的中位数妊娠期为 37 周，他们被随机分配到 Baby-CIMT（46 名）或 Baby-BIM（50 名），并在平均 6.5 个月（标准差 1.6 个月）的 CA 开始接受干预。干预后，两组间的HAI无差异（平均差异[MD] 0.98 HAI单位，95%置信区间[CI] 0.94-2.91；P=0.31）。从基线到干预后，两组均有明显的临床改善（Baby-BIM MD 3.48，95%CI 2.09-4.87；Baby-CIMT MD 4.42，95%CI 3.07-5.77）。24 个月时，64 名婴儿被诊断为 UCP（35 名婴儿-CIMT，29 名婴儿-BIM）。与CA≥6个月的婴儿相比，CA 3至6个月的婴儿HAI双手总分变化更大（MD 7.17，95% CI 2.93，11.41，P=0.001）：婴儿-CIMT 不优于婴儿-BIM，两种干预措施都能改善婴儿的手部发育。开始干预的婴儿

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Journal of Pediatrics 医学-小儿科

CiteScore

6.00

自引率

2.00%

发文量

696

审稿时长

31 days

期刊介绍： The Journal of Pediatrics is an international peer-reviewed journal that advances pediatric research and serves as a practical guide for pediatricians who manage health and diagnose and treat disorders in infants, children, and adolescents. The Journal publishes original work based on standards of excellence and expert review. The Journal seeks to publish high quality original articles that are immediately applicable to practice (basic science, translational research, evidence-based medicine), brief clinical and laboratory case reports, medical progress, expert commentary, grand rounds, insightful editorials, “classic” physical examinations, and novel insights into clinical and academic pediatric medicine related to every aspect of child health. Published monthly since 1932, The Journal of Pediatrics continues to promote the latest developments in pediatric medicine, child health, policy, and advocacy. Topics covered in The Journal of Pediatrics include, but are not limited to: General Pediatrics Pediatric Subspecialties Adolescent Medicine Allergy and Immunology Cardiology Critical Care Medicine Developmental-Behavioral Medicine Endocrinology Gastroenterology Hematology-Oncology Infectious Diseases Neonatal-Perinatal Medicine Nephrology Neurology Emergency Medicine Pulmonology Rheumatology Genetics Ethics Health Service Research Pediatric Hospitalist Medicine.