Multisite RCT of 3 Neurorehabilitation Therapies for Infants with Asymmetrical CP

不对称脑瘫婴儿的 3 种神经康复治疗的多部位随机对照试验

• 批准号: 8631709
• 负责人: STEPHANIE C. DELUCA
• 金额: $ 79.52万
• 依托单位: VIRGINIA POLYTECHNIC INST AND ST UNIV
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-03-01 至 2018-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8631709
• 关键词: 7 year old; Adverse effects; Adverse event; Affect; Aftercare; Articular Range of Motion; Awareness; Behavior; Behavioral; Bilateral; Blinded; Brain; Cerebral Palsy; Child; Childhood; Clinical Trials Design; Congenital Abnormality; Data; Data Analyses; Development; Documentation; Elements; Enrollment; Future; Hand; Handedness; Health; Home environment; Hydrocortisone; Impairment; Infant; Laws; Lead; Learning; Life; Limb structure; Link; Long-Term Effects; Measures; Modeling; Monitor; Motor; Near-Infrared Spectroscopy; Neurorehabilitation; Occupational Therapy; Outcome; Parents; Patient Self-Report; Physical therapy; Play; Productivity; Protocols documentation; Quality of life; Randomized; Randomized Controlled Trials; Relative (related person); Reporting; Research Design; Rest; Risk; Safety; Salivary; Sampling; Sensory; Series; Shapes; Side; Skin; Splint Device; Stress; Testing; Time; Touch sensation; Training; Upper Extremity; arm; base; behavior observation; clinical practice; constraint induced movement therapy; cost; disability; dosage; effective therapy; evidence base; hemiparesis; human subject protection; improved; indexing; meetings; neuroimaging; novel; primary outcome; prospective; public health relevance; response; secondary outcome; skills; social; theories; tool; trial comparing

DESCRIPTION (provided by applicant): Cerebral palsy (CP) is the most common class of childhood neuromotor disabilities, resulting in lifelong impairments in productivity and health as well as high costs. To date, no form of infant therapy has proven efficacious via an adequately powered RCT; further, usual and customary therapies often fail to produce clinically meaningful benefits. This revised application builds on new findings from 2 independent preliminary studies showing benefits for infants who received alternative forms of constraint-induced movement therapy (CIMT). Using a multisite RCT design, 72 infants (6 - 18 mos old) with unilateral or asymmetrical CP will be randomly assigned to receive one of 3 manualized forms of multi-component therapies. Primary outcomes include objective assessments (at baseline then 1 wk, 6 mos, and 12 mos post-therapy) of affected upper extremity (UE) skills in unilateral and bilateral activities, as well as changes in brain lateralization based on a novel fNIRS protocol fo infants. The specific aims are: 1) to compare the effects of 3 promising forms of Infant-CIMT that are identical in dosage (3 hr/day X 21 days) and their key therapy elements (shaping, massed practice, home-based, embedded in play and everyday activities, provided by a trained therapist in partnership with parents) but that differ in their use of constraint - continuous casting, part-time splint, or no constraint; and 2) to assess stress levels and safety related to constraint condition (continuous or part-time) compared to no constraint. Stress will be assessed using multiple salivary cortisol samples from infants and parents, parent self-report, and observations. Safety monitoring will include range of motion, skin integrity, sensory awareness, functional use of the casted arm and hand, as well as changes in laterality scores involving the casted side. Even though prior studies affirm the general safety and acceptability of using constraint with infants, there are strongly competing hypotheses about its potential benefits versus risks. Impact: if one or more of the tested infant therapies produces large magnitude benefits lasting up to 12 mos later, then these findings would have a high impact on future clinical practice. Moreover, highly effective therapy very early in life may lead to much higher levels of independence, learning, social engagement, and quality of life for children with unilateral and asymmetrical CP.

描述（由申请人提供）：脑瘫（CP）是最常见的儿童神经运动障碍，导致生产率和健康的终身障碍以及高成本。迄今为止，尚无通过足够动力的RCT有效的婴儿疗法的形式。此外，通常和习惯疗法通常无法产生临床意义的好处。这项修订后的应用是基于2项独立初步研究的新发现，显示了接受约束诱导运动疗法（CIMT）替代形式的婴儿的好处。使用多站点RCT设计，将随机分配具有单侧或不对称CP的72名婴儿（6-18个MOS旧），以接收3种手动化形式的多组分疗法之一。主要结果包括对单侧和双侧活动的影响上肢（UE）技能的客观评估（基线，1周，6个MOS和12个MOS），以及基于新颖的FNIRS方案FO婴儿的脑外侧化的变化。具体目的是：1）比较在剂量（3小时/x 21天/天21天）中相同的3种有希望形式形式的效果，它们的关键疗法及其关键疗法元素（塑形，大规模练习，基于家庭的，基于家庭，嵌入了游戏和日常活动，由训练有素的治疗疗法与父母合作提供，但在约束方面没有差异，或者在约束方面不一致，或者不断地分散地分散; 2）与无约束相比，评估与约束条件（连续或兼职）有关的应力水平和安全性。将使用来自婴儿和父母的多个唾液皮质醇样本，父母的自我报告和观察来评估压力。安全监控将包括运动范围，皮肤完整性，感官意识，铸造手臂和手的功能使用以及涉及铸造方面的横向得分的变化。尽管先前的研究确认了对婴儿使用约束的一般安全性和可接受性，但关于其潜在收益与风险的竞争性假设有很强的假设。影响：如果一种或多种经过测试的婴儿疗法产生的幅度较大，则持续12个MO，那么这些发现将对未来的临床实践产生很大的影响。此外，对于单方面和不对称CP的儿童来说，在很早的生活中，高效的治疗可能会导致更高的独立性，学习，社会参与和生活质量。