COGNITIVE ORIENTED STRATEGY AUGMENTED REHABILITATION (COSTAR) FOR STROKE

描述(申请人提供)：本R03申请的中心论点是，将认知导向的策略融入当代中风康复将导致更有效的功能性技能获得，更好地长期保留所学技能，并将所学技能推广和转移到家庭、社区和工作环境中。该项目的长期目标是开发一种干预方法，以改善中风后的整体健康和参与结果。目前的项目目标是在I阶段随机对照试验(RCT)中评估一种新的康复方案的可行性和初步疗效，该方案补充了当前的卒中康复方案-任务特定训练(TST)，并使用了面向认知的策略。新的治疗方案被称为面向认知的策略增强康复，或COSTAR。这项研究的具体目的是为了完成Costar的下一阶段开发，并为未来的第二阶段随机对照试验做准备，以确定这种方法在改善中风后预后方面的有效性。这项研究的第一个具体目标将是完成CoSTAR的迭代试点测试，并完善CoSTAR协议。这将通过在3-4名中风患者中测试COSTAR协议来实现，以确保(1)COSTAR不再有必要的修改；(2)治疗治疗师可以可靠地实施干预；(3)研究人员、治疗师、患者或家属没有剩余的问题/顾虑；以及(4)可以在合理的时间框架内可靠地实施结果衡量标准。这项研究的第二个具体目标将是完成一项针对中风患者的探索性单盲I期随机对照试验，以比较COSTAR(n=18)和TST(n=18)方案。主要成果如下：(1)已培训技能的表现质量；(2)已培训技能的基础获得率；(3)在治疗中学习的技能在家庭、社区和工作环境中的推广；(4)未培训技能的表现质量(转让)；以及(5)对日常生活活动的全面参与。将使用连续数据的重复测量分析、方差分析和分类数据的卡方分析来确定组间和组内在结果测量上的差异。如果基线数据显示样本在潜在关键变量方面存在差异，分析将被调整到ANCOVA。这些变量包括：(1)年龄；(2)性别；(3)教育水平；(4)婚姻状况；(5)基线损害。这些数据将用于完成功率分析，以确定第二阶段随机对照试验所需的样本量。这一方案的创新之处在于，它结合了两种已知的干预方法，以提高中风康复的有效性。重要的是，中风患者功能下降的风险很高，这种方法寻求以一种既有效又高效的方式提高他们的独立性，并允许他们在出院后长期保持独立性。

DESCRIPTION (provided by applicant): The central thesis of this R03 application is that incorporating cognitive-oriented strategies into contemporary stroke rehabilitation will result in more efficient functional skill acquisition, better long-term retention of skills learned, and generalization and transfer of skills learned to home, community, and work settings. The long-term objective of this project is to develop an intervention approach that will improve overall health and participation outcomes after stroke. The current project objective is to evaluate in a phase I randomized controlled trial (RCT) the feasibility and preliminary efficacy of a new rehabilitation protocol that augments a current stroke rehabilitation protocol, task-specific training (TST), with cognitive-oriented strategy use. The new treatment protocol is called Cognitive-Oriented Strategy Augmented Rehabilitation, or COSTAR. The specific aims of this study were designed to complete the next phase of COSTAR's development and prepare for a future phase II RCT to determine the efficacy of this approach in improving outcomes after stroke. The first specific aim of this study will be to complete iterative pilot testing of COSTAR and refine the COSTAR protocol. This will be accomplished by testing the COSTAR protocol with 3-4 participants with stroke to ensure that (1) there are no more necessary modifications to COSTAR; (2) the treating therapists can reliably administer the intervention; (3) there are no remaining questions/concerns from the investigators, therapists, patients, or families; and (4) the outcome measures can reliably be administered in a reasonable time frame. The second specific aim of this study will be to complete an exploratory single-blinded phase I RCT with persons with stroke to compare the COSTAR (n =18) and the TST (n = 18) protocols. The primary outcomes will be the following: (1) quality of performance of trained skills; (2) rate of sill acquisition on trained skills; (3) generalization of skills learned in treatment to home, community and work environments; (4) quality of performance of untrained skills (transfer); and (5) overall participation in everyday life activities. 2x2 repeated measures analysis of variance analyses for continuous data and Chi-square analyses for categorical data will be used to determine the differences between and within groups on the outcome measures. Analyses will be adjusted to ANCOVA if baseline data indicate samples are different for potentially critical variables such as the following: (1) age; (2) sex; (3) education level; (4) marital status; and (5) baseline impairment. These data will be used to complete a power analysis to determine sample size necessary for a phase II RCT. The innovation of this proposal is that it combines two known intervention approaches in order to enhance the effectiveness of stroke rehabilitation. The significance is that those with stroke are at high risk for declining function and this approach seeks to increase their independence in a manner that is both effective and efficient and allow them to maintain their independence for the long term after discharge from a rehabilitation program.