Eliasson Ann-Christin, Holmström Linda, Aarne Päivikki, Nakeva von Mentzer Cecilia, Weiland Ann-Louise, Sjöstrand Lena, Forssberg Hans, Tedroff Kristina, Löwing Kristina
Department of Women's and Children's Health, Karolinska Institutet, 171 76, Stockholm, Sweden.
Division of Speech and Language Pathology, Department of CLINTEC, Karolinska Institutet, Stockholm, Sweden.
BMC Pediatr. 2016 Nov 3;16(1):175. doi: 10.1186/s12887-016-0711-x.
Children with cerebral palsy (CP) have life-long motor disorders, and they are typically subjected to extensive treatment throughout their childhood. Despite this, there is a lack of evidence supporting the effectiveness of early interventions aiming at improving motor function, activity, and participation in daily life. The study will evaluate the effectiveness of the newly developed Small Step Program, which is introduced to children at risk of developing CP during their first year of life. The intervention is based upon theories of early learning-induced brain plasticity and comprises important components of evidence-based intervention approaches used with older children with CP.
A two-group randomised control trial will be conducted. Invited infants at risk of developing CP due to a neonatal event affecting the brain will be randomised to either the Small Step Program or to usual care. They will be recruited from Astrid Lindgren Children's Hospital at regular check-up and included at age 3-8 months. The Small Step Program was designed to provide individualized, goal directed, and intensive intervention focusing on hand use, mobility, and communication in the child's own home environment and carried out by their parents who have been trained and coached by therapists. The primary endpoint will be approximately 35 weeks after the start of the intervention, and the secondary endpoint will be at 2 years of age. The primary outcome measure will be the Peabody Developmental Motor Scale (second edition). Secondary assessments will measure and describe the children's general and specific development and brain pathology. In addition, the parents' perspective of the program will be evaluated. General linear models will be used to compare outcomes between groups.
This paper presents the background and rationale for developing the Small-Step Program and the design and protocol of a randomized controlled trial. The aim of the Small Step Program is to influence development by enabling children to function on a higher level than if not treated by the program and to evaluate whether the program will affect parent's ability to cope with stress and anxiety related to having a child at risk of developing CP.
ClinicalTrials.gov Identifier NCT02166801 . Registered June 12, 2014.
脑瘫（CP）患儿存在终身运动障碍，通常在整个童年期都要接受广泛治疗。尽管如此，缺乏证据支持旨在改善运动功能、活动能力和日常生活参与度的早期干预措施的有效性。本研究将评估新开发的“小步计划”的有效性，该计划在生命的第一年引入有患脑瘫风险的儿童。该干预基于早期学习诱导脑可塑性理论，包含了用于大龄脑瘫儿童的循证干预方法的重要组成部分。
将进行两组随机对照试验。因影响大脑的新生儿事件而有患脑瘫风险的受邀婴儿将被随机分为“小步计划”组或常规护理组。他们将在阿斯特丽德·林德格伦儿童医院定期检查时招募，纳入年龄为3 - 8个月。“小步计划”旨在在孩子自己家中环境中提供个性化、目标导向且强化的干预，重点关注手部使用、移动能力和沟通能力，由经过治疗师培训和指导的父母实施。主要终点将在干预开始后约35周，次要终点将在2岁时。主要结局指标将是皮博迪发育运动量表（第二版）。次要评估将测量和描述儿童的一般和特定发育情况以及脑部病理。此外，将评估父母对该计划的看法。将使用一般线性模型比较两组的结局。
本文介绍了开发“小步计划”的背景和基本原理以及随机对照试验的设计和方案。“小步计划”的目的是通过使儿童在比未接受该计划治疗时更高的水平上发挥功能来影响发育，并评估该计划是否会影响父母应对与有患脑瘫风险孩子相关的压力和焦虑的能力。
ClinicalTrials.gov标识符NCT02166801。于2014年6月12日注册。
