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.

该项目的目的是比较两个充分发展的物理疗法的疗效 在8-24个月的奥尔兹患有或有脑瘫（CP）的高风险干预。坐在一起 达到发挥（开始发挥）的目标坐，达到和运动为基础的问题解决在婴儿期， 促进全球发展。运动护理物理治疗（UCPT）专注于提高运动技能， 防止损伤。该项目建立在一个接近完成的临床试验的基础上， START-Play干预与非剂量匹配对照组的比较。研究建议直接 解决了剂量匹配临床试验的需求，以考虑干预剂量对疗效的影响。 START-Play与剂量匹配（3个月内24次访视）的UCPT的直接比较， 环境（家庭）和有执照的物理治疗师提供的将允许直接比较 基于两套不同的关键原则的干预措施的有效性。START-Play基于发展 和基础科学，运动学习和神经可塑性，除了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充分描述。的 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。一个忠诚度的衡量标准使用以前的研究 量化了这些干预措施重点的差异，并将用于保持对两者的坚持 干预组。 美国不同地区的三个研究中心将从当地干预和医疗机构招募 中心共有150名4-24个月大的脑瘫婴儿或脑瘫高危婴儿， 当他们表现出早坐和早伸手的准备技能时。CP的风险将基于早期检测 指南和所有结果指标都包含在NIH支持的脑卒中常见数据元素中。 麻痹每名婴儿将被随机分组，并接受START-Play或UCPT干预 3个月，随访从基线延长12个月。 主要目的是检查随着时间的推移，坐在大运动和认知发展的变化。 将研究两个干预组之间结果的差异。此外，我们将开始 通过评估以下因素之间的关系，确定对发育性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）存在白色物质，小脑，基底 神经节或灰质损伤。