Multisite RCT of 3 Neurorehabilitation Therapies for Infants with Asymmetrical CP

3种不对称CP婴儿神经康复治疗的多点随机对照试验

SHARON RAMEY (2014-03-01 to 2018-02-28) $2,965,975

Project ID: R01HD074574 (NICHD)

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Abstract

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.

脑瘫（CP）是最常见的儿童神经运动障碍类别，导致生产力和健康的终身损伤以及高成本。迄今为止，通过充分的动力RCT，没有任何形式的婴儿疗法被证明是有效的;此外，通常和习惯疗法往往不能产生临床上有意义的益处。该修订申请基于2项独立初步研究的新发现，这些研究显示接受替代形式的约束诱导运动疗法（CIMT）的婴儿的益处。使用多站点RCT设计，72名患有单侧或不对称CP的婴儿（6-18岁）将被随机分配接受3种手动形式的多组分疗法中的一种。主要结果包括单侧和双侧活动中受影响的上肢（UE）技能的客观评估（基线时间为1周，6周期和治疗后12点），以及基于新型fNIRS方案的脑侧化改变。婴儿。具体目标是：1）比较3种有希望形式的婴儿-CIMT的剂量（3小时/天X 21天）和它们的关键治疗要素（塑形，集体实践，家庭，嵌入式）的效果游戏和日常活动，由训练有素的治疗师与父母合作提供）但他们使用约束的方式不同 - 连续铸造，兼职夹板或无约束; 2）与无约束条件相比，评估与约束条件（连续或兼职）相关的压力水平和安全性。使用来自婴儿和父母的多个唾液皮质醇样本，父母自我报告和观察来评估压力。安全监测将包括运动范围，皮肤完整性，感官意识，铸造手臂和手的功能使用，以及涉及铸造侧的侧向性评分的变化。尽管先前的研究证实了对婴儿使用约束的一般安全性和可接受性，但是关于其潜在的益处与风险之间存在强烈竞争的假设。影响：如果一种或多种经过测试的婴儿疗法能够产生持续长达12个月后的大幅度益处，那么这些发现将对未来的临床实践产生很大影响。此外，在生命早期进行高效治疗可以为单侧和不对称CP患儿带来更高水平的独立性，学习，社交参与和生活质量。