Exploring the Efficacy of Combined Task-Specific and Cognitive Strategy Training in Subacute Stroke
Novel stroke rehabilitation approaches, such as task-specific training (TST), have shown promise in improving stroke 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 to 15 treatment hours. Cognitive Orientation to daily Occupational Performance (CO-OP) is an established treatment approach that uses cognitive strategies in combination with TST. 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 standard occupational therapy 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 versus contemporary treatment. The research approach consists of Part 1, Protocol Refinement, and Part 2, Exploratory Phase II Clinical Trial.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Exploring the Efficacy of Combined Task-Specific and Cognitive Strategy Training in Subacute Stroke: A Phase II Clinical Trial.|
- Performance Quality Rating Scale [ Time Frame: Baseline, Post-Intervention, 3-month follow-up ] [ Designated as safety issue: No ]The Performance Quality Rating Scale (PQRS) rates performance on a 10-point scale, with a score of 1 indicating "can't do the skill at all" and 10 indicating "does the skill very well". Inter-rater reliability in the stroke population has been estimated at 0.71 (ICC). An independent observer rates performances from video recorded trials of each skill at all assessment points.
- Canadian Occupational Performance Measure [ Time Frame: Baseline, Post-Intervention, 3-month follow-up ] [ Designated as safety issue: No ]The Canadian Occupational Performance Measure (COPM) is a standardized instrument for eliciting performance issues from the client perspective, and for capturing perceived changes in performance over time. The COPM will be used to elicit participant-selected goals, which will become the focus of treatment. It will also be used to rate self-perceived performance and performance satisfaction for each goal, by each participant. The COPM has demonstrated test-retest reliability of 0.89 in people with stroke. A change of 2 points or more on the COPM is considered clinically significant.
- Stroke Impact Scale Participation Domain [ Time Frame: Baseline, Post-Intervention, 3-month follow-up ] [ Designated as safety issue: No ]The Stroke Impact Scale (SIS) is a stroke-specific health status measure. The scale is comprised of nine domains, of which we are using one, the Participation Domain.
- Activity Card Sort [ Time Frame: Baseline, Post-Intervention, 3-month follow-up ] [ Designated as safety issue: No ]The Activity Card Sort (ACS) is a client-centred interview based instrument that identifies participation in instrumental, social, and high- and low- demand physical leisure activities. A sorting methodology is used to identify whether or not the person performed the activity before their stroke and the person identifies the activities that are most important to them. The properties of ACS have been tested in various populations and there is evidence for internal consistency, construct, concurrent, and discriminant validity.
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||April 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
CO-OP, a client-centred, performance-based, problem solving approach has 7 key features including: client-chosen goals, dynamic performance analysis, cognitive strategy use, guided discovery, and a specific 10 one-hour sessions intervention format. Participants randomized to the CO-OP group will continue to receive usual out-patient services, such as physiotherapy or speech-language therapy, but will receive CO-OP instead of usual occupational therapy.
CO-OP, a client-centred, performance-based, problem solving approach has 7 key features including: client-chosen goals, dynamic performance analysis, cognitive strategy use, guided discovery, and a specific 10-session intervention format. The client and the therapist work together, using the Canadian Occupational Performance Measure (COPM), to select 3 skills and establish baseline skill performance. In the second meeting, when CO-OP actually begins, the approach is introduced to the client and the global cognitive strategy (GOAL-PLAN-DO-CHECK) is learned. In all subsequent sessions this strategy is used as the main problem-solving framework to facilitate skill acquisition.
Active Comparator: Standard Occupational Therapy
Participants randomized to the SOT group will receive usual out-patient rehabilitation services, with slight modifications. Specifically, a research assistant will administer the COPM to assist participants to self-select 4 personally meaningful skills. The treating SOT occupational therapists will be asked to log the activities completed in each session, and the amount of time spent in therapy.
Behavioral: Standard OT
Usual out-patient occupational therapy.
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|Contact: Jorge Rios, BA||416226-6780 ext firstname.lastname@example.org|
|United States, Missouri|
|Rehabilitation Institute of St. Louis||Recruiting|
|St. Louis, Missouri, United States|
|Contact: Timothy J Wolf, OTD 314-249-4993 email@example.com|
|Principal Investigator: Timothy Wolf, OTD|
|St. John's Rehab Hospital||Recruiting|
|Toronto, Ontario, Canada, M2M 2G1|
|Contact: Sara E McEwen, PhD 416-226-6780 ext 7957 firstname.lastname@example.org|
|Principal Investigator: Sara E McEwen, BSc(PT), MSc, PhD|
|Principal Investigator:||Sara E McEwen, PhD||University of Toronto|