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

NCT01309165 | Completed Results

• 1 other identifier: CIHR 230433
• Study Type: interventional
• Target: 35
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

stroke; cognition; cognitive strategies; motor skill acquisition; participation

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Performance Quality Rating Scale (PQRS)

  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. Data reported are the average of participants' trained and untrained change scores e.g. Time 2 minus Time 1 and Time 3 minus Time 1. Therapist logs and institutional patient records were reviewed to establish which self-selected activities were trained during the occupational rehabilitation program. A self-selected activity was considered trained if there was any indication of practicing all or part of it or any and indication of discussions or education concerning the activity. If no evidence of training was found it was considered untrained.

  A) Time 1- Baseline, B) Time 2- post-intervention (approx. 6 weeks from baseline), C) Time 3- 3 month follow-up (approx. 17 weeks from baseline)

Secondary Outcomes (3)

• Change From Baseline in Canadian Occupational Performance Measure (COPM)

  A) Time 1- Baseline, B) Time 2- post-intervention (approx. 6 weeks from baseline), C) Time 3- 3 month follow-up (approx. 17 weeks from baseline)

• Change From Baseline in Stroke Impact Scale (SIS) Participation Domain

  A) Time 1- Baseline, B) Time 2- post-intervention (approx. 6 weeks from baseline), C) Time 3- 3 month follow-up (approx. 17 weeks from baseline)

• Change From Baseline in Activity Card Sort (ACS)

  A) Time 2- post-intervention (approx. 6 weeks from baseline), B) Time 3- 3 month follow-up (approx. 17 weeks from baseline)

Study Arms (2)

CO-OP

EXPERIMENTAL

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

Standard Occupational Therapy

ACTIVE COMPARATOR

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

Interventions

CO-OP BEHAVIORAL

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.

CO-OP

Standard Occupational Therapy BEHAVIORAL

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.

Standard Occupational Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• St. John's Rehab Hospital: lead
• Sunnybrook Health Sciences Centre: collaborator
• Washington University School of Medicine: collaborator
• University of Toronto: collaborator

Study Sites (2)

Rehabilitation Institute of St. Louis

St Louis, Missouri, 63108, United States

Location

St. John's Rehab; Sunnybrook Health Sciences Centre

Toronto, Ontario, M2M 2G1, Canada

Location

Related Publications (2)

• McEwen S, Polatajko H, Baum C, Rios J, Cirone D, Doherty M, Wolf T. Combined Cognitive-Strategy and Task-Specific Training Improve Transfer to Untrained Activities in Subacute Stroke: An Exploratory Randomized Controlled Trial. Neurorehabil Neural Repair. 2015 Jul;29(6):526-36. doi: 10.1177/1545968314558602. Epub 2014 Nov 21.

  PMID: 25416738 RESULT

• Wolf TJ, Polatajko H, Baum C, Rios J, Cirone D, Doherty M, McEwen S. Combined Cognitive-Strategy and Task-Specific Training Affects Cognition and Upper-Extremity Function in Subacute Stroke: An Exploratory Randomized Controlled Trial. Am J Occup Ther. 2016 Mar-Apr;70(2):7002290010p1-7002290010p10. doi: 10.5014/ajot.2016.017293.

  PMID: 26943113 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Statistical analysis was limited to univariate procedures and could not control for the effect of confounders; the usual care control was unstandardized; the study included a short follow-up period of 3 months after the post-intervention session.

Results Point of Contact

• Title: Dr. Sara McEwen
• Organization: Sunnybrook Research Institute

sara.mcewen@sunnybrook.ca

4162266780

Study Officials

• Sara E McEwen, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: March 4, 2011
• First Posted: March 7, 2011
• Study Start: April 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: February 8, 2019
• Results First Posted: February 8, 2019

Record last verified: 2018-09

Locations

CA (1); US (1)