Clinical trial NCT01309165: Exploring the Efficacy of Combined Task-Specific and Cognitive Strategy Training in Subacute Stroke
Official title: Exploring the Efficacy of Combined Task-Specific and Cognitive Strategy Training in Subacute Stroke: A Phase II Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
cognition
cognitive strategies
motor skill acquisition
participation
Lead sponsor: St. John's Rehab Hospital
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
name: Washington University School of Medicine
name: University of Toronto
First posted: 2011-03-07
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Activity and participation limitations occur in the majority of those living with the effects of stroke. Novel stroke rehabilitation approaches, such as task-specific training (TST), have shown promise in improving 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 to15 treatment hours.

Cognitive Orientation to daily Occupational Performance (CO-OP) is an established treatment approach that uses cognitive strategies in combination with TST. Cognitive strategies are learning strategies that are goal directed and derived from cognitive executive functions such as initiation, planning, and error detection, that support early and mid phase skill acquisition. TST is based on the principles of motor learning, such as optimal provision of feedback and practice schedules, and involves repetitive practice of specific tasks, skills, or activities. Research from the investigators lab demonstrated that CO-OP is associated with functional skill acquisition, retention, and generalization and transfer of skills beyond the rehabilitation setting in adults more than one year post-stroke. 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 TST alone 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 vs. contemporary treatment.

The research approach consists of Part 1, Protocol Refinement, and Part 2, Exploratory Phase II Clinical Trial. Part 1 addresses the first project goal of refining CO-OP for use with people less than three months post stroke. In Part 1, three to four adults, less than three months post stroke, will be recruited. The CO-OP protocol will be iteratively modified as necessary based on the experience with each participant, the treating therapists' logs, treatment outcome data, and research team consensus.

Part 2, Exploratory Phase II Clinical trial with Control Arm, will address the second and third project goals. Part 2 will make use of the treatment protocol refinements from Part 1. Based on data from our studies with more chronic patients, an estimated sample size of 28 patients, 14 per group, will provide 82% power to detect a treatment difference of 1.3 units on the Canadian Occupational Performance Measure (COPM), standard deviation 1.15. The main study outcomes will be changes in performance quality of both trained and untrained skills, as measured by the participant-rated COPM and the observer-rated Performance Quality Rating Scale (PQRS); and changes in participation, as measured by the Participation Domain of the Stroke Impact Scale (SIS). Data analysis will consist of descriptive statistics and between- and within-group differences. Variability in outcome measures will be coupled with estimates of clinically meaningful effect size to conduct sample size calculations for the future Phase III clinical trial. As well, data informative to feasibility will be examined, such as recruitment rate, attrition, mean number of sessions completed, and treatment satisfaction ratings.

The innovation of this proposal is that it will enhance stroke rehabilitation and important long-term functional and participation stroke outcomes through the efficient mechanism of adding cognitive strategy use to existing TST-based programs. The significance is high, in that those with stroke are at high risk for declining participation and increased resource utilization.

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)

Primary outcomes:
measure: Change From Baseline in Performance Quality Rating Scale (PQRS)
timeFrame: 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:
measure: Change From Baseline in Canadian Occupational Performance Measure (COPM)
timeFrame: 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)
measure: Change From Baseline in Stroke Impact Scale (SIS) Participation Domain
timeFrame: 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)
measure: Change From Baseline in Activity Card Sort (ACS)
timeFrame: A) Time 2- post-intervention (approx. 6 weeks from baseline), B) Time 3- 3 month follow-up (approx. 17 weeks from baseline)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Rehabilitation Institute of St. Louis
state: Missouri
city: Toronto
country: Canada
facility: St. John's Rehab; Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: University of Toronto
name: Sara E McEwen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.