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

This study has been completed.
Sponsor:
Collaborators:
Sunnybrook Health Sciences Centre
Washington University School of Medicine
University of Toronto
Information provided by (Responsible Party):
Sara McEwen, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01309165
First received: March 4, 2011
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Stroke
Behavioral: CO-OP
Behavioral: Standard Occupational Therapy
Phase 2

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by St. John's Rehab Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 35
Study Start Date: April 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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 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.
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.
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 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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01309165

Locations
United States, Missouri
Rehabilitation Institute of St. Louis
St. Louis, Missouri, United States, 63108
Canada, Ontario
St. John's Rehab; Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M2M 2G1
Sponsors and Collaborators
St. John's Rehab Hospital
Sunnybrook Health Sciences Centre
Washington University School of Medicine
University of Toronto
Investigators
Principal Investigator: Sara E McEwen, PhD University of Toronto
  More Information

No publications provided

Responsible Party: Sara McEwen, Research Scientist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01309165     History of Changes
Other Study ID Numbers: CIHR 230433
Study First Received: March 4, 2011
Last Updated: February 11, 2014
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by St. John's Rehab Hospital:
stroke
cognition
cognitive strategies
motor skill acquisition
participation

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 23, 2014