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

针对脑瘫幼儿坐位和伸手的物理治疗干预效果评估

• 批准号: 10220097
• 负责人: Stacey Chapman Dusing
• 金额: $ 61.1万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-01 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10220097
• 关键词: 2 year old; Address; Adherence; Affect; Age; Age-Months; Basal Ganglia; Basic Science; Cellular Phone; Cerebral Palsy; Child; Childhood; Clinical; Clinical Trials; Cognitive; Common Data Element; Communities; Computer software; Control Groups; Data; Development; Diagnosis; Disabled Persons; Dose; Early Diagnosis; Early Intervention; Education; Eligibility Determination; Enrollment; Environment; Family; Family Characteristics; Frequencies; Guidelines; Home; Impairment; Infant; Injury; Intervention; Manuals; Measures; Medical center; Methods; Monitor; Motor; Motor Skills; Movement; Names; Neuronal Plasticity; Outcome; Outcome Measure; Parents; Pattern; Physical therapy; Play; Population; Problem Solving; Protocols documentation; Provider; Randomized; Readiness; Rehabilitation therapy; Reporting; Research; Risk; Sample Size; Science; Secondary Prevention; Self-Direction; Site; Strategic Planning; Stress; Subgroup; Therapeutic Intervention; Time; Toddler; Training; Treatment Efficacy; United States; United States National Institutes of Health; Videotape; Visit; base; cognitive development; cognitive skill; comparative efficacy; comparison group; comparison intervention; efficacy evaluation; experience; follow-up; gray matter; group intervention; high risk; improved; infancy; innovation; motor learning; physical therapist; physically handicapped; predicting response; prevent; recruit; response; service intervention; skills; treatment as usual; white matter

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.

拟议项目的目的是比较两种完全开发的物理疗法的功效 对患有脑性麻痹 (CP) 或具有高风险的 8-24 个月大的儿童进行干预。坐在一起和 伸手玩耍 (START-Play) 的目标是婴儿期坐着、伸手和解决基于运动的问题 促进全球发展。常规护理物理治疗 (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整的临床试验的基础上，该试验评估了该药物的功效 START-Play 干预与非剂量匹配对照组进行比较。直接提出的研究 解决了进行剂量匹配临床试验的需要，以考虑干预剂量对疗效的影响。 START-Play 与同一剂量匹配的 UCPT（3 个月内 24 次就诊）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 基于两组不同的关键原则的干预措施的有效性。 START-Play 以发展为基础 除了我们广泛的初步功效数据之外，还有基础科学、运动学习和神经可塑性。 START-Play 已通过协议手册、培训文档和保真度测量进行了全面描述。这 UCPT 干预基于对照组社区干预的录像 正在进行的临床试验的会议和家长报告。使用之前的研究进行保真度测量 量化这些干预措施重点的差异，并将用于保持对这两种干预措施的遵守 干预组。 美国不同地区的三个站点将从当地干预和医疗人员中招募人员 总共有 150 名 4 至 24 个月大的脑瘫婴儿或高风险婴儿的中心， 当他们表现出早坐和伸手的准备技能时。 CP 风险将基于早期发现 指南和所有结果测量均包含在 NIH 支持的脑功能通用数据元素中 麻痹。每个婴儿将被随机分为一组，并接受 START-Play 或 UCPT 干预 为期 3 个月，随访期从基线延长 12 个月。 主要目标检查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结果的差异。此外，我们将开始 通过评估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、基底的存在 神经节或灰质损伤。