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

Summary

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.

Conditions

• Stroke

Interventions

BEHAVIORAL

CO-OP

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• University of Toronto

  collaborator OTHER

• St. John's Rehab Hospital

  lead OTHER

Principal Investigators

• Sara E McEwen, PhD · University of Toronto

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-04-30

Primary Completion

2013-11-30

Completion

2013-11-30

Countries

• United States
• Canada

Study Locations