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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

基本信息

批准号：
10618214
负责人：
Stacey Chapman Dusing
金额：
$ 55.9万
依托单位：
UNIVERSITY OF SOUTHERN CALIFORNIA
依托单位国家：
美国
项目类别：
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/10618214
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 Licensing Manuals Measures Medical center Methods Monitor Motor Motor Skills Movement Names Neuronal Plasticity Outcome Outcome Measure Parents Pattern Persons 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 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

项目摘要

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。

项目成果

期刊论文数量（4）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Embedding Play to Enrich Physical Therapy.

DOI：
10.3390/bs13060440
发表时间：
2023-05-24
期刊：
BEHAVIORAL SCIENCES
影响因子：
2.6
作者：
Fiss, Alyssa LaForme;Hakstad, Ragnhild Barclay;Looper, Julia;Pereira, Silvana Alves;Sargent, Barbara;Silveira, Jessica;Willett, Sandra;Dusing, Stacey C.
通讯作者：
Dusing, Stacey C.

Effect of the START-Play Physical Therapy Intervention on Cognitive Skills Depends on Caregiver-Provided Learning Opportunities.

START-Play 物理治疗干预对认知技能的影响取决于护理人员提供的学习机会。

DOI：
10.1080/01942638.2022.2054301
发表时间：
2022
期刊：
Physical & occupational therapy in pediatrics
影响因子：
2.1
作者：
Koziol,NatalieA;Butera,ChristianaD;Kretch,KariS;Harbourne,ReginaT;Lobo,MicheleA;McCoy,SarahW;Hsu,Lin-Ya;Willett,SandraL;Kane,AudreyE;Bovaird,JamesA;Dusing,StaceyC
通讯作者：
Dusing,StaceyC

"Learn the Signs. Act Early.": Updates and Implications for Physical Therapists.