INCITE: A randomised trial comparing constraint induced movement therapy and bimanual training in children with congenital hemiplegia.
INCITE: A randomised trial comparing constraint induced movement therapy and bimanual training in children with congenital hemiplegia.
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DOI：
10.1186/1471-2377-10-4
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发表时间：
2010-01-12
期刊：
影响因子：
2.6
通讯作者：
Jackson GD
中科院分区：
文献类型：
--
作者：
Boyd R;Sakzewski L;Ziviani J;Abbott DF;Badawy R;Gilmore R;Provan K;Tournier JD;Macdonell RA;Jackson GD
先天性偏瘫是脑瘫（CP）最常见的形式，每1300个活产儿中就有1个。这些儿童在使用受损上肢和双手协调能力方面受到限制，影响了日常活动和参与家庭、学校和社区生活。目前有两种不同的强化治疗方法。传统的治疗方法采用双手方法（BIM培训），最近，约束诱导运动疗法（CIMT）已成为一种有前途的单手方法。这些干预措施的有效性和最佳应答者的特征仍然不确定。本研究旨在比较CIMT与BIM培训的效果，以改善先天性偏瘫学童的ICF结果。将采用配对随机对照设计，根据年龄、性别、偏瘫部位和上肢功能水平对儿童进行配对。根据权力计算，将招募52名儿童（26对）作为样本。儿童将被随机分成两组，接受CIMT或BIM培训。两种干预措施都将使用基于强化活动的日营模式，各组在相同的环境中接受相同剂量的干预（10天内总共60小时）。一个新颖的马戏主题将被用来提高动机。各组将在基线时进行比较，然后在干预后的第3、26和52周进行比较。先天性偏瘫的严重程度将根据大脑结构（MRI和白质纤维跟踪）、经颅磁刺激（TMS）的皮质兴奋性、日常任务中的手部功能使用（手动能力分类系统）和大运动功能分类系统（GMFCS）进行分类。结果将涉及神经血管变化（功能性MRI，功能连接），脑（再）组织（TMS），身体结构和功能（运动范围，痉挛，力量和感觉），活动限制（上肢单手能力和双手运动协调），参与限制（家庭，学校和娱乐），环境（参与的障碍和促进因素）和生活质量。本文概述了一项配对随机试验的理论基础、研究假设和结果测量，该试验比较了CIMT和BIM培训，以改善整个ICF的结果。ACTRN12609000912280
Congenital hemiplegia is the most common form of cerebral palsy (CP) accounting for 1 in 1300 live births. These children have limitations in capacity to use the impaired upper limb and bimanual coordination deficits which impact on daily activities and participation in home, school and community life. There are currently two diverse intensive therapy approaches. Traditional therapy has adopted a bimanual approach (BIM training) and recently, constraint induced movement therapy (CIMT) has emerged as a promising unimanual approach. Uncertainty remains about the efficacy of these interventions and characteristics of best responders. This study aims to compare the efficacy of CIMT to BIM training to improve outcomes across the ICF for school children with congenital hemiplegia. A matched pairs randomised comparison design will be used with children matched by age, gender, side of hemiplegia and level of upper limb function. Based on power calculations a sample size of 52 children (26 matched pairs) will be recruited. Children will be randomised within pairs to receive either CIMT or BIM training. Both interventions will use an intensive activity based day camp model, with groups receiving the same dosage of intervention delivered in the same environment (total 60 hours over 10 days). A novel circus theme will be used to enhance motivation. Groups will be compared at baseline, then at 3, 26 and 52 weeks following intervention. Severity of congenital hemiplegia will be classified according to brain structure (MRI and white matter fibre tracking), cortical excitability using Transcranial Magnetic Stimulation (TMS), functional use of the hand in everyday tasks (Manual Ability Classification System) and Gross Motor Function Classification System (GMFCS). Outcomes will address neurovascular changes (functional MRI, functional connectivity), and brain (re)organisation (TMS), body structure and function (range of motion, spasticity, strength and sensation), activity limitations (upper limb unimanual capacity and bimanual motor coordination), participation restrictions (in home, school and recreation), environmental (barriers and facilitators to participation) and quality of life. This paper outlines the theoretical basis, study hypotheses and outcome measures for a matched pairs randomised trial comparing CIMT and BIM training to improve outcomes across the ICF. ACTRN12609000912280