Randomized Controlled Trial of Pediatric CI Therapy

描述（由申请人提供）：本研究的总体目标是测试一种新形式的儿科康复治疗（即儿科CI治疗）的疗效，以促进脑瘫相关轻偏瘫幼儿的新的和改善的运动行为。这是基于一种理论上的治疗方法，该方法对慢性中风的成年患者有效，并能产生皮质重组（cf. Taub等人，1993; Liepert等人，2000年）。儿科Cl治疗包括（1）完全束缚未受累上肢和（2）重复使用受累肢体，连续21天每天进行6小时的强化塑形手术。拟议的研究建立在一项初步研究的结果的基础上，该研究表明儿科氯离子治疗后幼儿的上肢技能有显着提高。 我们建议进行一项前瞻性的随机对照研究，52名儿童（2 - 6岁）的偏瘫型脑性瘫痪。具体目的是：（1）测试儿科Cl治疗与常规治疗相比改善上肢运动和功能使用的疗效;（2）评估改善（如果检测到）是否在接下来的12个月内持续;（3）评估儿科Cl治疗是否与其他适应行为领域（例如，躯干控制、移动性、沟通和自助技能）。这项研究具有极其重要的意义，因为目前没有任何形式的儿科康复被证明是有效的（巴里，2001），尽管在治疗患有脑性麻痹的幼儿中广泛使用物理和职业疗法（Ramey等; 2000）。

DESCRIPTION (provided by applicant): The overall objective of this research is to test the efficacy of a new form of pediatric rehabilitation therapy -namely, Pediatric CI therapy - to promote new and improved motor behavior in young children with hemiparesis associated with cerebral palsy. This is based on a theoretically-grounded therapy shown to be effective with adult patients with chronic stroke and to produce cortical reorganization (cf. Taub et al., 1993; Liepert et al., 2000). Pediatric Cl therapy involves (1) total restraint of the unaffected upper extremity and (2) repetitive use of the affected extremity, using intensive shaping procedures for 6 hours/day for 21 consecutive days. The proposed research builds on findings from a preliminary study that demonstrated significant gains in young children's upper extremity skills following Pediatric Cl therapy. We propose to conduct a prospective, randomized controlled study with 52 children (ages 2-6) with hemiparetic cerebral palsy. The specific aims are:(1) to test the efficacy of Pediatric Cl therapy compared to Conventional therapy to improve upper extremity movement and functional use;(2) to evaluate whether improvement (if detected) is sustained over the next 12 months; and(3) to assess whether Pediatric Cl therapy is associated with significant gains in other adaptive behavior domains (e.g., trunk control, mobility, communication, and self-help skills).This research is of paramount significance because there currently are no forms of pediatric rehabilitation proven efficacious (Barry, 2001), despite widespread use of physical and occupational therapy in treatment of young children with cerebral palsy (Ramey et al; 2000).