Morgan Catherine, Novak Iona, Dale Russell C, Guzzetta Andrea, Badawi Nadia
School of Medicine, University Of Notre Dame Australia, Frenchs Forest 2086, NSW, Australia.
BMC Neurol. 2014 Oct 7;14:203. doi: 10.1186/s12883-014-0203-2.
Cerebral palsy is the most common physical disability of childhood and early detection is possible using evidence based assessments. Systematic reviews indicate early intervention trials rarely demonstrate efficacy for improving motor outcomes but environmental enrichment interventions appear promising. This study is built on a previous pilot study and has been designed to assess the effectiveness of a goal - oriented motor training and enrichment intervention programme, "GAME", on the motor outcomes of infants at very high risk of cerebral palsy (CP) compared with standard community based care.
METHODS/DESIGN: A two group, single blind randomised controlled trial (n = 30) will be conducted. Eligible infants are those diagnosed with CP or designated "at high risk of CP" on the basis of the General Movements Assessment and/or abnormal neuroimaging. A physiotherapist and occupational therapist will deliver home-based GAME intervention at least fortnightly until the infant's first birthday. The intervention aims to optimize motor function and engage parents in developmental activities aimed at enriching the home learning environment. Primary endpoint measures will be taken 16 weeks after intervention commences with the secondary endpoint at 12 months and 24 months corrected age. The primary outcome measure will be the Peabody Developmental Motor Scale second edition. Secondary outcomes measures include the Gross Motor Function Measure, Bayley Scales of Infant and Toddler Development, Affordances in the Home Environment for Motor Development - Infant Scale, and the Canadian Occupational Performance Measure. Parent well-being will be monitored using the Depression Anxiety and Stress Scale.
This paper presents the background, design and intervention protocol of a randomised trial of a goal driven, motor learning approach with customised environmental interventions and parental education for young infants at high risk of cerebral palsy.
This trial is registered on the Australian New Zealand Clinical Trial register: ACTRN12611000572965.
脑瘫是儿童期最常见的身体残疾，通过循证评估可以实现早期检测。系统评价表明，早期干预试验很少能证明对改善运动结局有效，但环境丰富化干预似乎很有前景。本研究基于之前的一项试点研究开展，旨在评估一项以目标为导向的运动训练与丰富化干预计划（“GAME”）与标准社区护理相比，对脑瘫（CP）极高风险婴儿运动结局的有效性。
方法/设计：将进行一项两组单盲随机对照试验（n = 30）。符合条件的婴儿是那些根据全身运动评估和/或异常神经影像学诊断为CP或被指定为“CP高危”的婴儿。物理治疗师和职业治疗师将至少每两周进行一次家庭式GAME干预，直至婴儿满周岁。该干预旨在优化运动功能，并让家长参与旨在丰富家庭学习环境的发育活动。干预开始16周后进行主要终点测量，次要终点在矫正年龄12个月和24个月时测量。主要结局指标将是第二版皮博迪发育运动量表。次要结局指标包括粗大运动功能测量、贝利婴幼儿发育量表、家庭环境中运动发育的可供性 - 婴儿量表以及加拿大职业表现测量。将使用抑郁焦虑压力量表监测家长的幸福感。
本文介绍了一项随机试验的背景、设计和干预方案，该试验采用目标驱动的运动学习方法，对脑瘫高危幼儿进行定制化环境干预和家长教育。
本试验已在澳大利亚新西兰临床试验注册中心注册：ACTRN12611000572965。
