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.
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.