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:10392473
- 负责人:
- 金额:$ 57.14万
- 依托单位:
- 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:
- 关键词:2 year oldAddressAdherenceAffectAgeAge-MonthsBasal GangliaBasic ScienceCellular PhoneCerebral PalsyChildChildhoodClinicalClinical TrialsCognitiveCommon Data ElementCommunitiesComputer softwareControl GroupsDataDevelopmentDiagnosisDisabled PersonsDoseEarly DiagnosisEarly InterventionEducationEligibility DeterminationEnrollmentEnvironmentFamilyFamily CharacteristicsFrequenciesGuidelinesHomeImpairmentInfantInjuryInterventionManualsMeasuresMedical centerMethodsMonitorMotorMotor SkillsMovementNamesNeuronal PlasticityOutcomeOutcome MeasureParentsPatternPersonsPhysical therapyPlayPopulationProblem SolvingProtocols documentationProviderRandomizedReadinessRehabilitation therapyReportingResearchRiskSample SizeScienceSecondary PreventionSelf-DirectionSiteStrategic PlanningStressSubgroupTherapeutic InterventionTimeToddlerTrainingTreatment EfficacyUnited StatesUnited States National Institutes of HealthVideotapeVisitbasecognitive developmentcognitive skillcomparative efficacycomparison groupcomparison interventionefficacy evaluationexperiencefollow-upgray mattergroup interventionhigh riskimprovedinfancyinnovationmotor learningphysical therapistphysically handicappedpredicting responsepreventrecruitresponseservice interventionskillstreatment as usualwhite 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.
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。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Stacey Chapman Dusing其他文献
Stacey Chapman Dusing的其他文献
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{{ truncateString('Stacey Chapman Dusing', 18)}}的其他基金
Sharing Developmental, Meta, and Video Data from Preterm Infants Enrolled in the SPEEDI Clinical Trial
共享参加 SPEEDI 临床试验的早产儿的发育、元数据和视频数据
- 批准号:
10789838 - 财政年份:2023
- 资助金额:
$ 57.14万 - 项目类别:
Efficacy of Motor and Cognitive Intervention for Infants Born Very Preterm
运动和认知干预对极早产婴儿的功效
- 批准号:
10744698 - 财政年份:2022
- 资助金额:
$ 57.14万 - 项目类别:
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:
10618214 - 财政年份:2020
- 资助金额:
$ 57.14万 - 项目类别:
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 - 财政年份:2020
- 资助金额:
$ 57.14万 - 项目类别:
Efficacy of Motor and Cognitive Intervention for Infants Born Very Preterm
运动和认知干预对极早产婴儿的疗效
- 批准号:
9977258 - 财政年份:2018
- 资助金额:
$ 57.14万 - 项目类别:
Efficacy of Motor and Cognitive Intervention for Infants Born Very Preterm
运动和认知干预对极早产婴儿的疗效
- 批准号:
9752648 - 财政年份:2018
- 资助金额:
$ 57.14万 - 项目类别:
Efficacy of Motor and Cognitive Intervention for Infants Born Very Preterm
运动和认知干预对极早产婴儿的功效
- 批准号:
10224285 - 财政年份:2018
- 资助金额:
$ 57.14万 - 项目类别:
Efficacy of Motor and Cognitive Intervention for Infants Born Very Preterm
运动和认知干预对极早产婴儿的功效
- 批准号:
10437697 - 财政年份:2018
- 资助金额:
$ 57.14万 - 项目类别:
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