APPLES: Early Childhood Constraint Therapy for Sensory/Motor Impairment in Cerebral Palsy

苹果：针对脑瘫感觉/运动障碍的儿童早期约束疗法

• 批准号: 10491692
• 负责人: Nathalie Maitre
• 金额: $ 64.82万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-21 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10491692
• 关键词: Address; Affect; Age; Area; Attention; Biological; Brain; Businesses; Cerebral Palsy; Child; Child Rearing; Childhood; Consensus; Control Groups; Cues; Data; Development; Developmental Therapeutics Program; Diagnosis; Early Diagnosis; Early Intervention; Education; Effectiveness; Emotional; Ensure; Feedback; Frequencies; Funding; Geography; Goals; Guidelines; Hand; Hand functions; Health Services Accessibility; Healthcare Systems; Home; Infant; Institution; Intervention; Knowledge; Link; Measurement; Measures; Medical; Methods; Modeling; Monitor; Motor; Motor Activity; Motor Skills; Movement Disorders; Neurosciences; Outcome; Parents; Patient Outcomes Assessments; Performance; Phase; Protocols documentation; Psychology; Psychometrics; Public Health; Randomized; Randomized Controlled Trials; Rehabilitation therapy; Reporting; Reproducibility; Resources; Schedule; Sensorimotor functions; Sensory; Severities; Site; Standardization; Testing; Upper Extremity; Vision; Waiting Lists; active method; arm function; base; blind; cohort; coping; cost effectiveness; design; early childhood; effective therapy; effectiveness study; evidence base; expectation; experience; functional outcomes; hand rehabilitation; improved; knowledge base; motor impairment; motor learning; multimodality; novel; physically handicapped; primary outcome; programs; psychoeducational; rehabilitation strategy; remote health care; secondary endpoint; sex; socioeconomics; somatosensory; sound; standard care; standard of care; success; telehealth; treatment comparison; treatment effect

PROJECT SUMMARY/ABSTRACT Long-term goals of this application are to develop safe, effective, and scalable interventions with a strong basis in neuroscience, to improve the upper extremity (UE) function of children with cerebral palsy (CP). Our UE intervention called “APPLES” is parent-administered, medical team-directed, uses soft constraint and “sticky-mittens” and bimanual therapy. Our first R01 showed that it effectively improved UE function, cortical somatosensory processing, and reach smoothness, while being safe for the developing brain and body in infants (6-24 months) with CP. Our competing renewal addresses remaining gaps in knowledge: is there an earliest age at which APPLES is most effective, can APPLES be successfully delivered through telehealth, and because parents are delivering APPLES, are there evidence-based supports that we can offer them to be more effective, and do all parents need these supports equally. We also specifically address new NCMRR priorities for: (1) “multimodal approaches that promote plasticity and sensorimotor function”, (2) “patient-reported outcomes as ... secondary endpoints in trials”, and (3) “development of scalable strategies”. We call our new intervention APPLES-tele, as it will be delivered through telehealth and start in infants as young as 3 months. In addition, we test the relative efficacy of APPLES-tele vs. standard care group and vs. a novel parent-centered approach (PCA) that is infant- and CP-specific. PCA consists of education in infant motor learning, adaptive strategies for CP, and positive psychology in parenting (from the scientifically-proven Triple P Positive Parenting Program model). PCA will help parents develop “authoritative parenting”, an optimal parenting style proven to promote better long-term developmental outcomes. The design is a randomized controlled trial with both business-as-usual and active treatment comparisons; two groups receive PCA and APPLES-tele, but in different order. The other receives standard care. Both 6- week interventions will have the same weekly-telehealth schedule. Assessments are at baseline, at 6- weeks and 12 weeks. We use standardized tests of hand function and development, validated measures of parent-treatment fidelity, and parent-relevant measures of performance. Interventions and assessments are protocolized and monitored to ensure rigor and reproducibility. We leverage a large cohort of parents and children across 4 centers already linked through our successful implementation network for early detection of CP, with diverse socioeconomic and geographic conditions in an area > 11% of the US. We aim to demonstrate improvements in UE function are greater in the APPLES-tele-first group than in both control groups after the first 6-weeks of intervention. Conversely, we will show parent CP-specific knowledge and parent-child emotional connection are greater in the PCA-first group than the other 2 groups. We will then explore whether relative efficacy of PCA-then-APPLES vs. APPLES-then-PCA on infants’ UE function across the entire 12 weeks depends on initial level of authoritative parenting.

项目总结/摘要 该应用程序的长期目标是开发安全，有效和可扩展的干预措施， 目的：在神经科学的基础上，改善脑瘫患儿上肢功能。我们 被称为“APPLES”的UE干预由父母管理，医疗团队指导，使用软约束， “粘手套”和双手疗法。我们的第一个R 01表明，它有效地改善了UE功能，皮质 体感处理，并达到平滑，同时对发育中的大脑和身体是安全的， 婴儿（6-24个月）CP。我们的竞争性更新解决了剩余的知识差距： APPLES最有效的最早年龄，能否通过远程保健成功地提供APPLES， 因为父母们在送苹果，我们是否可以为他们提供基于证据的支持， 更有效，所有的父母都需要这些支持。我们还专门针对新的 NCMRR优先考虑：（1）“促进可塑性和感觉运动功能的多模式方法”，（2） “患者报告的结果是...试验中的次要终点”，以及（3）“可扩展的 战略”。我们称我们的新干预为APPLES-tele，因为它将通过远程医疗提供， 3个月大的婴儿。此外，我们还测试了APPLES-远程与标准治疗的相对疗效 组和与一种新的家长为中心的方法（PCA），是婴儿和CP的具体。PCA包括 婴儿运动学习的教育，CP的适应策略，以及父母的积极心理学（来自 三P积极育儿计划（Triple P Positive Parenting Program）。PCA将帮助父母发展 “权威式父母教养”是一种最佳的父母教养方式，被证明能促进孩子的长期发展。 结果。设计是一项随机对照试验，包括常规治疗和积极治疗 比较;两组接受PCA和APPLES-tele，但顺序不同。另一个是标准的 在乎这两个为期6周的干预措施将有相同的每周远程保健时间表。评估在 基线，6周和12周。我们使用标准化的测试手的功能和发展，验证 父母对待子女的忠诚度和与父母相关的表现指标。干预措施和 对评估进行规程化和监测，以确保严格性和可重复性。我们利用了一大批 通过我们成功的实施网络， CP的早期检测，在超过美国11%的地区具有不同的社会经济和地理条件。 我们的目标是证明UE功能的改善在APPLES-tele-first组中比在两者中更大。 干预后6周的对照组。相反，我们将展示父母CP特定的知识 PCA优先组的亲子情感联系显著高于其他两组。我们将 然后探讨PCA-然后-APPLES与APPLES-然后-PCA对婴儿UE功能的相对疗效 在整个12周的时间里，这取决于权威性父母的初始水平。