Abstract T P110: Combined Task-Specific and Cognitive Strategy Training in Subacute Stroke: A Phase II Randomized Controlled Trial

Abstract

Background and Objectives: Task-specific training (TST) may improve basic mobility and activities of daily living; however, used alone, these improvements are not generalized and transferred to home, community, or work settings, nor do they impact overall health status. In contrast, approaches incorporating cognitive strategy training have shown great promise in these areas, suggesting that a combined approach may have a greater overall effect. Cognitive Orientation to daily Occupational Performance (CO-OP) is an approach that uses cognitive strategies in combination with TST. The objective of this trial is to estimate the effect of CO-OP compared to standard out-patient rehabilitation on health status and functional skill performance in adults less than 3 months post stroke Methods: Participants less than 3 months post ischemic stroke (ICD-10 codes 163, 164) and admitted to outpatient rehabilitation services at 2 sites were randomized to receive either standard out-patient therapy (ST) or CO-OP. The main outcomes, administered pre, post, and at 3-month follow-up by a blind assessor, were health status (Stroke Impact Scale-SIS), and functional skill performance (Performance Quality Rating Scale-PQRS). Results: At the time of interim analysis, 21 participants (mean age 60.2 years, 33% female) were enrolled, 11 CO-OP and 10 ST. Post-test data were available for 14, follow-up for 8. SIS scores indicated larger changes for CO-OP for 7 of 9 domains, moderate effect for the composite physical health outcome SIS-16 at post-test (Cohen’s d=0.6), and large effect at follow-up (Cohen’s d=2.2). CO-OP had a large effect on PQRS scores for functional skills not trained in therapy (Cohen’s d=3.2), suggesting transfer beyond the clinical setting. Conclusions: The CO-OP treatment approach is associated with greater improvements than standard rehabilitation in most health status domains and in performance of skills untrained in therapy, indicating transfer beyond the clinical setting. A multi-site Phase III trial is warranted.