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N/A N=35 Randomized Single-blind Treatment

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

Stroke

Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Change From Baseline in Performance Quality Rating Scale (PQRS) — 2.9; 1.8; 4.5; 1.5 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
CO-OP (Behavioral); Standard Occupational Therapy (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
St. John's Rehab Hospital
Primary completion
Nov 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Performance Quality Rating Scale (PQRS)
2.9; 1.8; 4.5; 1.5; 2.9; 0.5
SECONDARY
Change From Baseline in Canadian Occupational Performance Measure (COPM)
1.5; 2.3; 2.9; 2.3; 1.3; 1.9
SECONDARY
Change From Baseline in Stroke Impact Scale (SIS) Participation Domain
47.9; 54.6; 56.6; 56.9; 8.0; 1.9
SECONDARY
Change From Baseline in Activity Card Sort (ACS)
34.4; 28.1; 37.4; 29.6

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.

Eligibility Criteria

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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01309165). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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