Beatrix Children's Hospital - Division of Developmental Neurology, University Medical Center Groningen, Groningen, The Netherlands.
BMC Pediatr. 2010 Nov 2;10:76. doi: 10.1186/1471-2431-10-76.
It is widely accepted that infants at risk for cerebral palsy need paediatric physiotherapy. However, there is little evidence for the efficacy of physiotherapeutic intervention. Recently, a new intervention program, COPCA (Coping with and Caring for infants with special needs - a family centered program), was developed. COPCA has educational and motor goals. A previous study indicated that the COPCA-approach is associated with better developmental outcomes for infants at high risk for developmental disorders. LEARN 2 MOVE 0-2 years evaluates the efficacy and the working mechanisms of the COPCA program in infants at very high risk for cerebral palsy in comparison to the efficacy of traditional infant physiotherapy in a randomized controlled trial. The objective is to evaluate the effects of both intervention programs on motor, cognitive and daily functioning of the child and the family and to get insight in the working elements of early intervention methods.
METHODS/DESIGN: Infants are included at the corrected age of 1 to 9 months and randomized into a group receiving COPCA and a group receiving traditional infant physiotherapy. Both interventions are given once a week during one year. Measurements are performed at baseline, during and after the intervention period and at the corrected age of 21 months. Primary outcome of the study is the Infant Motor Profile, a qualitative evaluation instrument of motor behaviour in infancy. Secondary measurements focus on activities and participation, body functions and structures, family functioning, quality of life and working mechanisms. To cope with the heterogeneity in physiotherapy, physiotherapeutic sessions are video-recorded three times (baseline, after 6 months and at the end of the intervention period). Physiotherapeutic actions will be quantified and related to outcome.
LEARN 2 MOVE 0-2 years evaluates and explores the effects of COPCA and TIP. Whatever the outcome of the project, it will improve our understanding of early intervention in children with cerebral palsy. Such knowledge is a prerequisite for tailor-made guidance of children with CP and their families.
The trial is registered under NTR1428.
人们普遍认为，脑瘫高危婴儿需要接受儿科物理治疗。然而，目前几乎没有证据表明物理治疗干预的疗效。最近，一种新的干预方案 COPCA（应对和照顾有特殊需要的婴儿-以家庭为中心的方案）已经开发出来。COPCA 具有教育和运动目标。先前的一项研究表明，COPCA 方法与发育障碍高风险婴儿的更好的发育结果相关。LEARN 2 MOVE 0-2 年在一项随机对照试验中比较了 COPCA 方案对非常高脑瘫风险婴儿的疗效和工作机制，以及传统婴儿物理治疗的疗效。其目的是评估两种干预方案对儿童和家庭的运动、认知和日常功能的影响，并深入了解早期干预方法的工作要素。
方法/设计：婴儿在矫正年龄 1 至 9 个月时被纳入研究，并随机分为接受 COPCA 治疗组和接受传统婴儿物理治疗组。两种干预措施每周进行一次，持续一年。在基线、干预期间和干预结束时以及矫正年龄 21 个月时进行测量。研究的主要结果是婴儿运动概况，这是一种婴儿运动行为的定性评估工具。次要测量重点是活动和参与、身体功能和结构、家庭功能、生活质量和工作机制。为了应对物理治疗的异质性，物理治疗课程被录像记录三次（基线、6 个月后和干预结束时）。物理治疗行动将被量化并与结果相关联。
LEARN 2 MOVE 0-2 年评估和探索了 COPCA 和 TIP 的效果。无论该项目的结果如何，它都将提高我们对脑瘫儿童早期干预的理解。这种知识是为脑瘫儿童及其家庭提供定制指导的前提。
该试验在 NTR1428 下注册。
