Exploring the Efficacy of Combined Task-Specific and Cognitive Strategy Training in Subacute Stroke
Completed · Not applicable
Conditions studied: Stroke
In brief
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.
Key facts
- Study ID
- NCT01309165
- Run by
- St. John's Rehab Hospital
- People needed
- 35
- Starts
- 2011-04-01
- Expected to finish
- 2013-11-01
- Last updated by the study team
- 2019-02-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Aged 18 years of age or greater
- Admitted to out-patient rehabilitation post ischemic stroke
You may not qualify if…
- 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)
Where it is running
- Rehabilitation Institute of St. Louis — St Louis, Missouri, United States
- St. John's Rehab; Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
Full record on ClinicalTrials.gov
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