COGNITIVE ORIENTED STRATEGY AUGMENTED REHABILITATION (COSTAR) FOR STROKE

中风认知导向策略增强康复 (COSTAR)

• 批准号: 8505523
• 负责人: Timothy J. Wolf
• 金额: $ 7.21万
• 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 2015-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8505523
• 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; public health relevance; 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.

描述（由申请人提供）：此R03申请的中心论点是，将面向认知的策略纳入当代中风康复中将导致更有效的功能技能获取，更好地保留技能的长期保留以及学到的技能和所学到的技能转移到家庭，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。当前的项目目标是在I期随机对照试验（RCT）中评估新的康复方案的可行性和前期疗效，该方案通过以认知为导向的策略使用了当前的中风康复方案，特定于任务的培训（TST）。新的治疗方案称为认知策略增强康复或肋骨。这项研究的具体目的旨在完成Costar开发的下一阶段，并为将来的II期RCT做准备，以确定这种方法在改善中风后的结果方面的功效。这项研究的第一个具体目的是完成Costar的迭代试点测试并完善肋骨协议。这将通过与3-4名参与者进行中风的肋骨协议来实现，以确保（1）不再需要对Costar进行任何必要的修改； （2）治疗师可以可靠地进行干预； （3）研究人员，治疗师，患者或家庭没有剩余的问题/问题； （4）可以在合理的时间范围内可靠地管理结果度量。这项研究的第二个具体目的是与具有中风的人一起完成探索性的单叶I阶段RCT，以比较Costar（n = 18）和TST（n = 18）方案。主要结果将是以下：（1）训练技能的表现质量； （2）对训练技能的基础收购率； （3）在家庭，社区和工作环境中学习的技能的概括； （4）未经训练技能的表现质量（转移）； （5）总体参与日常生活活动。 2x2重复测量的差异分析分析连续数据和卡方分析的分类数据将用于确定结果指标的组之间和内部的差异。如果基线数据表明对于潜在的关键变量（例如以下）的样本不同，则将对分析进行调整：（1）年龄； （2）性； （3）教育水平； （4）婚姻状况； （5）基线障碍。这些数据将用于完成功率分析，以确定II期RCT所需的样本量。该提案的创新是，它结合了两种已知的干预方法，以增强中风康复的有效性。意义在于，患有中风的人的功能下降的风险很高，这种方法旨在以有效和有效的方式提高独立性，并允许他们从康复计划中退出后长期保持独立性。