Evaluation of the Efficacy of a Physical Therapy Intervention Targeting Sitting and Reaching for Young Children with Cerebral Palsy

该项目的目的是比较两种完全发展的物理疗法的疗效。 对8-24个月有脑性瘫痪(CP)风险或高风险的婴儿进行干预。坐在一起， 在婴儿期达到游戏(开始-游戏)目标坐着、伸手和基于运动的问题解决 提升全球发展水平。日常护理理疗(UCPT)侧重于提高运动技能和 防止损伤。该项目建立在一项几乎完成的临床试验的基础上，评估了 开始-播放干预与非剂量匹配对照组进行比较。建议的研究直接 解决了剂量匹配临床试验的必要性，以考虑干预剂量对疗效的影响。 Start-Play与UCPT中提供的匹配剂量(3个月内24次访问)的直接比较 环境(家庭)，并由有执照的物理治疗师提供，将允许直接比较 基于两套不同关键原则的干预措施的有效性。Start-Play基于发展 以及基础科学、运动学习和神经可塑性，以及我们广泛的初步疗效数据。 Start-Play已通过协议手册、培训文档和保真度措施进行了全面描述。这个 UCPT干预是基于视频会议的对照组社区干预 正在进行的临床试验的会议和家长报告。之前研究中使用的保真度衡量标准 量化这些干预措施的侧重点的差异，并将用于保持对这两项措施的遵守 干预组。 美国不同地区的三个地点将从当地干预和医疗机构招募 中心总共为150名4-24个月大的患有脑瘫或脑瘫高危婴儿提供服务， 当他们表现出提前就座和伸手的准备技能时。CP的风险将基于早期发现 指南和所有结果测量都包含在NIH支持的脑部通用数据元素中 瘫痪。每个婴儿将被随机分成一组，并接受Start-Play或UCPT干预 3个月，从基线开始随访12个月。 主要目标是研究坐姿、粗大运动和认知发展随时间的变化。 将检查两个干预组之间的结果差异。此外，我们将开始 通过评估以下两者之间的关系来确定对发育运动干预反应的预测因素 干预结果和1)婴儿和家庭特征，2)白质、小脑、基底 神经节或灰质损伤。

The purpose of the proposed project is to compare the efficacy of two fully developed physical therapy interventions in 8-24 months olds with or at high risk of having Cerebral Palsy (CP). Sitting Together And Reaching To Play (START-Play) targets sitting, reaching and motor-based problem solving in infancy to improve global development. Usual Care Physical Therapy (UCPT) focuses on advancing motor skills and preventing impairments. The project builds on a nearly complete clinical trial evaluating the efficacy of the START-Play intervention compared to a non-dose matched comparison group. The proposed study directly addressed the need for a dose-matched clinical trial to consider the impact of dose of intervention on efficacy. A direct comparison of START-Play with the dose matched (24 visits in 3 months) UCPT provided in the same environment (homes) and provided by licensed physical therapists will allow for a direct comparison of the efficacy of interventions based on two different set of key principles. START-Play is based on developmental and basic science, motor learning, and neuroplasticity, in addition to our extensive preliminary efficacy data. START-Play has been fully described with a protocol manual, training documents, and fidelity measures. The UCPT intervention is based on videotaped session of the comparison group community based intervention sessions and parent report for the ongoing clinical trial. A fidelity measure used the previous research quantifies differences in the focus of these interventions and will be used to maintain adherence to both intervention groups. Three sites in different regions of the United States will recruit from local intervention and medical centers for a total of 150 infants with or at high risk of having cerebral palsy between ages 4-24 months of age, when they show readiness skills for early sitting and reaching. Risk for CP will be based on the early detection guidelines and all outcome measures are included in the NIH supported Common Data Elements for Cerebral Palsy. Each infant will be randomized into a group and will receive the START-Play or the UCPT intervention for 3 months, with follow up extending for 12 months from baseline. The primary objectives examine change over time in sitting gross motor and cognitive development. Differences in outcomes between the two intervention groups will be examined. In addition, we will begin to identify predictors of response to developmental motor interventions by evaluating the relationship between intervention outcomes and 1) infant and family characteristics, 2) presence of white matter, cerebellar, basal ganglion, or gray matter injury.