Randomized Controlled Trial of Pediatric CI Therapy

儿科 CI 治疗的随机对照试验

• 批准号: 6544979
• 负责人: Edward Taub
• 金额: $ 36.44万
• 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 2006-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6544979
• 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(申请人提供)：这项研究的总体目标是测试一种新形式的儿科康复疗法--即儿科CI疗法--的有效性，以促进与脑性瘫痪相关的偏瘫儿童新的和改善的运动行为。这是基于一种理论上有根据的疗法，该疗法被证明对患有慢性中风的成年患者有效，并产生皮质重组(参见。Taub等人，1993；Liepert等人，2000)。儿童氯化疗法包括(1)完全限制健侧上肢和(2)重复使用患肢，每天6小时，连续21天密集整形。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，在儿童氯化疗法后，幼儿的上肢技能有了显著的提高。我们建议对52名偏瘫脑瘫儿童(2-6岁)进行前瞻性、随机对照研究。具体目标是：(1)测试与传统疗法相比，儿科氯化疗法改善上肢运动和功能使用的有效性；(2)评估在接下来的12个月中是否持续改善(如果检测到)；以及(3)评估儿科氯化疗法是否与其他适应行为领域(例如，躯干控制、活动、沟通和自助技能)的显著提高相关。这项研究具有重要意义，因为目前还没有一种形式的儿科康复被证明有效(Barry，2001)，尽管物理和作业疗法被广泛应用于治疗脑性瘫痪的幼儿(Ramey et al；2000)。