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的疗效-即儿科CI治疗-促进脑瘫相关偏瘫幼儿新的和改善运动行为。这是基于一种有理论依据的治疗方法，该疗法对成年慢性中风患者有效，并能产生皮层重组（cf. Taub et al., 1993; Liepert et al., 2000）。儿科Cl治疗包括(1)完全限制未受影响的上肢和(2)重复使用受影响的肢体，连续21天每天使用6小时的强化整形手术。这项拟议的研究建立在一项初步研究的结果之上，该研究表明，儿童Cl治疗后，幼儿上肢技能显著提高。我们建议对52名患有偏瘫性脑瘫的儿童（2-6岁）进行前瞻性、随机对照研究。具体目的是：(1)比较儿科Cl治疗与常规治疗在改善上肢运动和功能使用方面的疗效；(2)评估改善（如果发现）是否在未来12个月内持续；(3)评估儿童Cl治疗是否与其他适应性行为领域（如躯干控制、行动能力、沟通和自助技能）的显著提高相关。这项研究具有至关重要的意义，因为目前还没有任何形式的儿科康复被证明是有效的（Barry, 2001），尽管在治疗幼儿脑瘫中广泛使用物理和职业疗法（Ramey et al; 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).