Randomized Controlled Trial of Pediatric CI Therapy

儿科 CI 治疗的随机对照试验

• 批准号: 6795555
• 负责人: Edward Taub
• 金额: $ 32.48万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-04 至 2007-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6795555
• 关键词: arm; cerebral palsy; clinical research; clinical trial phase I; human subject; human therapy evaluation; immobilization of body part; limb movement; medical rehabilitation related tag; musculoskeletal disorder therapy; neuromuscular system; occupational therapy; patient oriented research; pediatrics; physical therapy; preschool child (1-5); psychomotor function; rehabilitation; restraint

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).

描述（由申请人提供）：本研究的总体目标是测试一种新型儿科康复疗法（即儿科 CI 疗法）的功效，以促进脑瘫相关偏瘫幼儿新的和改善的运动行为。这是基于一种有理论依据的疗法，该疗法被证明对患有慢性中风的成年患者有效，并能产生皮质重组（参见 Taub 等人，1993 年；Liepert 等人，2000 年）。儿科 Cl 疗法包括 (1) 完全约束未受影响的上肢，以及 (2) 重复使用受影响的肢体，每天使用 6 小时的强化塑形手术，连续 21 天。这项拟议的研究建立在一项初步研究的基础上，该研究表明，小儿 Cl 疗法后幼儿的上肢技能得到了显着提高。 我们建议对 52 名偏瘫脑瘫儿童（2-6 岁）进行一项前瞻性、随机对照研究。具体目标是：(1) 测试儿科 Cl 疗法与传统疗法相比在改善上肢运动和功能使用方面的功效；(2) 评估在未来 12 个月内是否能持续改善（如果检测到）； (3) 评估儿科 CI 疗法是否与其他适应性行为领域（例如躯干控制、活动能力、沟通和自助技能）的显着收益相关。这项研究具有极其重要的意义，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），尽管在治疗脑瘫幼儿时广泛使用物理和职业疗法（Ramey 等人） 阿尔； 2000）。