COGNITIVE ORIENTED STRATEGY AUGMENTED REHABILITATION (COSTAR) FOR STROKE

描述（由申请人提供）：该 R03 申请的中心论点是将认知导向策略纳入当代中风康复中，将导致更有效的功能技能习得、更好地长期保留所学技能，以及将所学技能推广到家庭、社区和工作环境。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。当前项目的目标是在 I 期随机对照试验 (RCT) 中评估新康复方案的可行性和初步疗效，该方案增强了当前中风康复方案、任务特定训练 (TST) 以及认知导向策略的使用。新的治疗方案称为认知导向策略增强康复（COSTAR）。本研究的具体目标旨在完成 COSTAR 下一阶段的开发，并为未来的 II 期随机对照试验做好准备，以确定该方法在改善中风后预后方面的功效。本研究的第一个具体目标是完成 COSTAR 的迭代试点测试并完善 COSTAR 协议。这将通过对 3-4 名中风参与者测试 COSTAR 协议来完成，以确保 (1) COSTAR 不再需要修改； (2) 治疗师能够可靠地进行干预； (3) 研究者、治疗师、患者或家属不再有任何疑问/疑虑； (4) 结果测量能够在合理的时间范围内可靠地实施。本研究的第二个具体目标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) 受训技能的表现质量； (2) 受训技能的掌握率； (3) 将治疗中学到的技能推广到家庭、社区和工作环境中； (4) 未经训练的技能的表现质量（转移）； (5) 全面参与日常生活活动。连续数据的方差分析的 2x2 重复测量分析和分类数据的卡方分析将用于确定组间和组内结果测量的差异。如果基线数据表明样本对于以下潜在关键变量有所不同，则分析将调整为ANCOVA：（1）年龄； (2) 性别； （三）文化程度； （四）婚姻状况； (5) 基线损伤。这些数据将用于完成功效分析，以确定 II 期 RCT 所需的样本量。该提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，中风患者面临功能衰退的高风险，这种方法旨在以有效且高效的方式增强他们的独立性，并使他们在康复计划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.