Multi-site RCT of Pediatric Constraint-Induced Movement Therapy (CIMT)

儿科约束诱导运动疗法 (CIMT) 的多部位随机对照试验

• 批准号: 8703733
• 负责人: STEPHANIE C. DELUCA
• 金额: $ 65.73万
• 依托单位: VIRGINIA POLYTECHNIC INST AND ST UNIV
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-27 至 2017-07-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8703733
• 关键词: Address; Advanced Development; Affect; Aftercare; Behavioral; Bilateral; Blinded; Cerebral Palsy; Child; Childhood; Clinical; Clinical Research Protocols; Competence; Coupled; Data; Data Set; Diagnostic; Evidence based practice; Future; Hand; Home environment; Individual; Individual Differences; Long-Term Effects; Maintenance; Measures; Meta-Analysis; Motor Activity; Movement; Neuronal Plasticity; Outcome; Outcome Measure; Parents; Property; Protocols documentation; Psychometrics; Randomized; Randomized Controlled Trials; Reporting; Research; Research Design; Role; Schools; Site; Spastic Cerebral Palsy; Splint Device; Testing; Time; Training; Treatment Protocols; Upper Extremity; Variant; Videotape; Visually Impaired Persons; base; constraint induced movement therapy; cost; design; dosage; efficacy testing; evidence base; hemiparesis; improved; innovation; primary outcome; response; skills; theories; tool

DESCRIPTION (provided by applicant): Unilateral (hemiparetic) cerebral palsy (CP) affects an estimated 229,000 individuals in the U.S., with CP rates increasing in young children. Most traditional forms of therapy have proven ineffective, although they remain in widespread use. Two major research reviews (cf. Huang et al, 2010; Sakzewski et al, 2009) conclude that pediatric constraint-induced movement therapy (CIMT) is one of the most promising new therapies, despite wide variation in and vigorous debate about its key features. Two urgent, unresolved issues concern the effects associated with (a) different dosage levels of pediatric CIMT and (b) different types and duration of constraint. The proposed study is a multi-site, randomized controlled trial (RCT) of 144 children (3 - 6 yrs old) with hemiparetic CP. The multiple baseline 2 X 2 RCT study design will compare the effects of 2 dosage levels (3.0 hrs/day for 21 days versus 1.5 hrs/day for 21 days) under 2 distinct constraint conditions (Full-time cast versus Part-time splint). Children will first be studied in a control condition, receivin their usual therapy over 3 months, and then crossover to be randomly assigned to one of 4 CIMT treatment groups: (1) 3.0 hrs/day dosage, Full-time cast; (2) 3.0 hrs/day, Part-time splint; (3) 1.5 hrs/day, Full-time cast; and (4) 1.5 hrs/day, Part-time splint. For all groups, parents wil receive systematic training to help practice and extend their children's new and improved upper extremity skills. Children will be followed 3 months post-treatment. Children's neuromotor competence will be assessed via a comprehensive battery of standardized and innovative tools, administered 5 times over 8 months by individuals blinded to the subjects' control and treatment conditions. The primary outcome measures are the Assisted Hand Assessment (AHA), the Pediatric Motor Activity Log (PMAL), and the modified QUEST. Independent scoring of videotaped sessions and parent reports will supplement lab assessments, along with data transmitted from accelerometers. Specific Aim 1 focuses on comparing the effects of 2 dosage levels of pediatric CIMT. Specific Aim 2 compares the effects of 2 forms and duration of constraint, selected because of competing hypotheses about their impact on children and cortical re-organization. Specific Aim 3 uses clinical diagnostic and baseline data about subjects' individual differences to explore hypotheses about differential response to CIMT, including their levels of engagement during treatment, the types and magnitude of short- and longer-term changes detected, and whether other changes are documented beyond the realm of neuromotor competence (i.e., "spillover effects"). The results of this study will advance the development of rigorous, evidence-based standards for the practice of CIMT, with the potential for large-scale implementation to produce major benefits for children with CP.

描述（由申请人提供）：单方面（偏瘫）脑瘫（CP）影响了美国估计有229,000名个人，幼儿CP率增加。大多数传统的疗法形式已被证明是无效的，尽管它们仍在广泛使用中。两项主要的研究评论（参见Huang等人，2010年； Sakzewski等，2009）得出结论，尽管小儿约束诱导的运动疗法（CIMT）是最有前途的新疗法之一，尽管关于其关键特征的广泛差异和激烈的争论。两个紧急解决的问题涉及（a）不同剂量水平的小儿CIMT和（b）不同类型和约束持续时间相关的影响。拟议的研究是144名儿童（3-6岁）的多站点，随机对照试验（RCT），其偏瘫CP。多基线2 x 2 RCT研究设计将比较2个不同的约束条件（全日制铸造与兼职夹板），比较2个剂量水平（21天/天，21天/天/天的1.5小时/天/天）的影响。儿童将首先在控制状态下研究，在3个月内应对他们的常规治疗，然后分频器随机分配给4个CIMT治疗组之一：（1）3.0小时/天剂量，全职铸造； （2）3.0小时/天，兼职夹板； （3）1.5小时/天，全职演员； （4）1.5小时/天，兼职夹板。对于所有小组，父母都会接受系统的培训，以帮助练习并扩展孩子的新上肢技能。治疗后三个月将遵循儿童。儿童的神经运动能力将通过全面的标准化和创新工具进行评估，该工具在8个月内通过对受试者的控制和治疗条件视而不见的个人进行了5次。主要结果指标是辅助手评估（AHA），小儿运动活动日志（PMAL）和修改后的任务。独立评分录像会议和父母报告将补充实验室评估，以及从加速度计传输的数据。具体目标1的重点是比较2个剂量水平的小儿CIMT的影响。特定目标2比较了两种形式和约束持续时间的影响，这是因为他们对儿童的影响和皮质重组的竞争假设而被选择。特定目标3使用有关受试者个体差异的临床诊断和基线数据，以探讨有关对CIMT差异反应的假设，包括它们在治疗过程中的参与水平，所检测到的短期和长期变化的类型和幅度，以及其他变化是否已记录在神经运动能力领域之外的其他变化（即溢出效应，”）。这项研究的结果将推动CIMT实践的严格，基于证据的标准的发展，并有可能大规模实施为CP儿童带来重大利益。