COGNITIVE ORIENTED STRATEGY AUGMENTED REHABILITATION (COSTAR) FOR STROKE

中风认知导向策略强化康复 (COSTAR)

• 批准号: 8384734
• 负责人: Timothy J. Wolf
• 金额: $ 7.6万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-01 至 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8384734
• 关键词: Activities of Daily Living; Address; Adult; Age; Analysis of Variance; Behavioral; Blinded; Clinical; Clinical Trials; Cognitive; Communities; Data; Detection; Development; Dimensions; Educational Background; Effectiveness; Ensure; Family; Funding; Future; Goals; Health; Health behavior; Home environment; Impairment; Individual; Intervention; Learning; Marital Status; Measures; Methods; Modification; Outcome; Outcome Measure; Participant; Patients; Performance; Persons; Phase; Phase II Clinical Trials; Pilot Projects; Population; Protocols documentation; Randomized Clinical Trials; Randomized Controlled Trials; Recovery; Recovery of Function; Rehabilitation therapy; Research; Research Personnel; Research Priority; Research Project Grants; Resources; Sample Size; Sampling; Stroke; Survivors; Testing; Time; Training; Treatment Protocols; United States; Work; Workplace; arm; base; behavior change; design; efficacy testing; evidence base; executive function; functional loss; health related quality of life; high risk; improved; innovation; instrumental activity of daily living; novel; post stroke; primary outcome; programs; sex; skill acquisition; skills; skills training; stroke rehabilitation

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. PUBLIC HEALTH RELEVANCE: Stroke is the most serious disabling condition in the United States and the developed world. Novel stroke rehabilitation approaches, such as task-specific training, have shown promise in improving an individual's recovery in the rehabilitation setting; however, evidence suggests that these improvements are not generalized or transferred to the home, community, or work settings. Thus, these interventions usually do not impact overall health and participation outcomes. This research will improve task-specific training as a stroke rehabilitation approach by integrating it with evidence-based cognitive-oriented strategies which have shown great promise as a way to address the limitations of task-specific training.

描述（由申请人提供）：该R 03申请的中心论点是，将认知导向策略纳入当代卒中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，以及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，以改善卒中后的整体健康和参与结果。目前的项目目标是在一项I期随机对照试验（RCT）中评估一种新的康复方案的可行性和初步疗效，该方案增强了目前的卒中康复方案，即任务特异性训练（TST），并使用认知导向策略。新的治疗方案被称为认知导向策略增强康复，或COSTAR。本研究的具体目的是完成COSTAR开发的下一阶段，并为未来的II期RCT做准备，以确定这种方法在改善卒中后结局方面的疗效。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。这将通过在3-4名卒中受试者中测试COSTAR方案来实现，以确保（1）对COSTAR没有更多必要的修改;（2）治疗治疗师可以可靠地实施干预;（3）研究者、治疗师、患者或家属没有剩余的问题/担忧;以及（4）结果测量可以在合理的时间范围内可靠地管理。本研究的第二个具体目的是完成一项探索性单盲I期RCT，对卒中患者进行比较，以比较COSTAR（n =18）和TST（n = 18）方案。主要结果如下：（1）经过培训的技能的表现质量;（2）经过培训的技能的基本获得率;（3）将治疗中学到的技能推广到家庭、社区和工作环境;（4）未经培训的技能的表现质量（转移）;以及（5）日常生活活动的总体参与。将使用连续数据的2x2重复测量方差分析和分类数据的卡方分析来确定组间和组内结局指标的差异。如果基线数据表明样本的潜在关键变量不同，则将分析调整为ANCOVA：（1）年龄;（2）性别;（3）教育水平;（4）婚姻状况;和（5）基线损伤。这些数据将用于完成把握度分析，以确定II期RCT所需的样本量。该建议的创新之处在于，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，中风患者的功能下降风险很高，这种方法旨在以有效和高效的方式提高他们的独立性，并允许他们在康复计划出院后长期保持独立性。 公共卫生相关性：中风是美国和发达国家最严重的致残性疾病。新的中风康复方法，如任务特定的训练，已显示出改善个人康复环境的希望;然而，有证据表明，这些改善并不普遍或转移到家庭，社区或工作环境。因此，这些干预措施通常不会影响总体健康和参与结果。本研究将通过将其与基于证据的认知导向策略相结合来改善特定任务训练作为中风康复方法，这些策略已显示出很大的希望，可以解决特定任务训练的局限性。