Exploring the Efficacy of Combined Task-Specific and Cognitive Strategy Training in Subacute Stroke

Activity and participation limitations occur in the majority of those living with the effects
of stroke. Novel stroke rehabilitation approaches, such as task-specific training (TST), have
shown promise in improving recovery components such as basic mobility and activities of daily
living; however, evidence suggests these improvements are not generalized and transferred to
home, community, or work settings, and usually do not impact overall participation outcomes.
Further, these treatments are very intense, with total treatment times as high as 30 to 60
hours, making them clinically or economically unfeasible in many settings. In contrast,
approaches incorporating cognitive strategy training have shown great promise to not only
improve functional activity performance in people living with stroke, but also to facilitate
generalization and transfer beyond the clinical setting, and to do so in 10 to15 treatment
hours.

Cognitive Orientation to daily Occupational Performance (CO-OP) is an established treatment
approach that uses cognitive strategies in combination with TST. Cognitive strategies are
learning strategies that are goal directed and derived from cognitive executive functions
such as initiation, planning, and error detection, that support early and mid phase skill
acquisition. TST is based on the principles of motor learning, such as optimal provision of
feedback and practice schedules, and involves repetitive practice of specific tasks, skills,
or activities. Research from the investigators lab demonstrated that CO-OP is associated with
functional skill acquisition, retention, and generalization and transfer of skills beyond the
rehabilitation setting in adults more than one year post-stroke. Evidence from other research
groups and findings from our own participant interview data indicate that the approach may be
even more effective if introduced much earlier in the rehabilitation process, however, CO-OP
has not yet been tested in this sub-acute population. Therefore, the specific project goals
are:

1. To refine the CO-OP treatment approach for use with people less than three months post
stroke;

2. To evaluate, in a Phase II clinical trial, the preliminary efficacy of the refined
protocol compared to TST alone on immediate and longer-term skill performance and
participation;

3. To determine effect sizes for power calculations for a future Phase III clinical trial
to test the new protocol vs. contemporary treatment.

The research approach consists of Part 1, Protocol Refinement, and Part 2, Exploratory Phase
II Clinical Trial. Part 1 addresses the first project goal of refining CO-OP for use with
people less than three months post stroke. In Part 1, three to four adults, less than three
months post stroke, will be recruited. The CO-OP protocol will be iteratively modified as
necessary based on the experience with each participant, the treating therapists' logs,
treatment outcome data, and research team consensus.

Part 2, Exploratory Phase II Clinical trial with Control Arm, will address the second and
third project goals. Part 2 will make use of the treatment protocol refinements from Part 1.
Based on data from our studies with more chronic patients, an estimated sample size of 28
patients, 14 per group, will provide 82% power to detect a treatment difference of 1.3 units
on the Canadian Occupational Performance Measure (COPM), standard deviation 1.15. The main
study outcomes will be changes in performance quality of both trained and untrained skills,
as measured by the participant-rated COPM and the observer-rated Performance Quality Rating
Scale (PQRS); and changes in participation, as measured by the Participation Domain of the
Stroke Impact Scale (SIS). Data analysis will consist of descriptive statistics and between-
and within-group differences. Variability in outcome measures will be coupled with estimates
of clinically meaningful effect size to conduct sample size calculations for the future Phase
III clinical trial. As well, data informative to feasibility will be examined, such as
recruitment rate, attrition, mean number of sessions completed, and treatment satisfaction
ratings.

The innovation of this proposal is that it will enhance stroke rehabilitation and important
long-term functional and participation stroke outcomes through the efficient mechanism of
adding cognitive strategy use to existing TST-based programs. The significance is high, in
that those with stroke are at high risk for declining participation and increased resource
utilization.

Inclusion Criteria:

- Aged 18 years of age or greater

- Admitted to out-patient rehabilitation post ischemic stroke

Exclusion Criteria:

- more than 6 months post stroke onset

- those not requiring occupational therapy

- hemorrhagic stroke

- neurological diagnoses other than stroke

- major psychiatric illness

- moderate or severe aphasia (NIH Stroke Scale aphasia rating of 2 or more)

- dementia (Mini Mental State Exam scores of 24 or less)