Improvement of Executive Functions With the CO-OP Method in the Adult Subject After Stroke

Study Overview
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Brief Summary
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The research focuses on top-down intervention approaches and more specifically on the Cognitive Orientation to daily Occupational Performance (CO-OP) method in the rehabilitation of executive function disorders in adult post-stroke subjects in chronic phase. The main objective of this study is therefore to improve performance in significant activities of daily living for people with chronic post-stroke dysexecutive disorders.

Detailed Description
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Today, approaches to intervention with adults after stroke can be categorized into two groups: bottom-up approaches (neurodevelopmental, sensory integration, mental imagery, cognitive stimulation, perceptual-motor/kinesthetic training...) and top-down approaches (task-oriented approach, neuromotor task training, occupational performance coaching, the CO-OP approach). Although bottom-up intervention approaches have existed for several years longer than top-down approaches, in general, top-down intervention approaches have shown better results. In the latest work with post-stroke adults with objective cognitive impairment, the data indicate the relevance of CO-OP in improving performance and satisfaction, attention, inhibition and flexibility or apathy. This study aims to demonstrate the effectiveness of the CO-OP approach in adult post-stroke patients in chronic phase, specifically on planning function, through the Single Case Experimental Design methodology by randomized intervention (3 patients) over 6 weeks of treatment and 10 weeks of evaluation.

Official Title
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Improvement of Executive Functions With the CO-OP Method in the Adult Subject After Stroke

Conditions
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Cerebrovascular Accident

Intervention / Treatment
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* Other: Co-OP treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stroke responsible for a dysexecutive syndrome authenticated by the GREFEX battery Stroke more than 6 months old (chronic phase) Social security affiliation Signing of a free and informed consent following clear and detailed information. Exclusion Criteria: Disorder of comprehension objectified by the - LAnguage Screening Test (LAST) (minimum score 4/8 in expression and 6/7 in comprehension) Significant anosognosia of dysexecutive syndrome Pregnant women Neurological condition other than stroke or psychiatric disorder Patient following a rehabilitation with a liberal therapist targeting executive functions during the period of participation in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CO-OP Arm (early phase A)<br>Patients will be integrated during the traditional day hospitalization follow-up, at the rate of 3 sessions per week. The patient will have 2 phases : phase A: CO-OP treatment during 6 week and phase B : without specific treatment during 3 weeks. | Other: Co-OP treatment<br>* The Cognitive Orientation to daily Occupational Performance (CO-OP) approach is described as a patient-centred, performance-oriented approach to activities and problem solving that allows skills to be acquired through a process of strategy use and guided discovery. The CO-OP protocol is composed of seven key characteristics: i) the goals chosen by the patient, ii) dynamic performance analysis, iii) the use of cognitive strategies, iv) guided discovery, v) the principles of empowerment, vi) the involvement of a relative, vii) the structure of the intervention (Polatajko and Mandich, 2004/2017). CO-OP is an evidence-based approach to intervention, including evidence of its effectiveness on a physical, cognitive and emotional dimension in adults with stroke<br>|
| Experimental: CO-OP Arm (mid phase A)<br>Patients will be integrated during the traditional day hospitalization follow-up, at the rate of 3 sessions per week. The patient will have 2 phases : phase A: CO-OP treatment during 6 week and phase B : without specific treatment during 2.5 weeks. | Other: Co-OP treatment<br>* The Cognitive Orientation to daily Occupational Performance (CO-OP) approach is described as a patient-centred, performance-oriented approach to activities and problem solving that allows skills to be acquired through a process of strategy use and guided discovery. The CO-OP protocol is composed of seven key characteristics: i) the goals chosen by the patient, ii) dynamic performance analysis, iii) the use of cognitive strategies, iv) guided discovery, v) the principles of empowerment, vi) the involvement of a relative, vii) the structure of the intervention (Polatajko and Mandich, 2004/2017). CO-OP is an evidence-based approach to intervention, including evidence of its effectiveness on a physical, cognitive and emotional dimension in adults with stroke<br>|
| Experimental: CO-OP Arm (late phase A)<br>Patients will be integrated during the traditional day hospitalization follow-up, at the rate of 3 sessions per week. The patient will have 2 phases : phase A: CO-OP treatment during 6 week and phase B : without specific treatment during 2 weeks. | Other: Co-OP treatment<br>* The Cognitive Orientation to daily Occupational Performance (CO-OP) approach is described as a patient-centred, performance-oriented approach to activities and problem solving that allows skills to be acquired through a process of strategy use and guided discovery. The CO-OP protocol is composed of seven key characteristics: i) the goals chosen by the patient, ii) dynamic performance analysis, iii) the use of cognitive strategies, iv) guided discovery, v) the principles of empowerment, vi) the involvement of a relative, vii) the structure of the intervention (Polatajko and Mandich, 2004/2017). CO-OP is an evidence-based approach to intervention, including evidence of its effectiveness on a physical, cognitive and emotional dimension in adults with stroke<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved performance in significant activities of daily living | Improved performance in significant activities of daily living will be measured bi-weekly by the Canadian Occupational Performance Measurement. The score is between 1 to 10 | 10 weeks | 
| Improved performance in significant activities of daily living | Improved performance in significant activities of daily living will be measured bi-weekly by the Performance Quality Rating Scale. The score is between 1 to 10 | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in the sense of personal effectiveness | The improvement in the sense of personal effectiveness will be measured by New General Self-Efficacy Scale (8 questions with response to 1 for strongly disagree to 5 for strongly agree) | 10 weeks | 
| Analytically measure of executive functions | The analytical improvement of executive functions will be measured by the Trail Making Tes | 10 weeks | 
| Analytically measure of executive functions | The analytical improvement of executive functions will be measured by the number span (WAIS IV) | 10 weeks | 
| Analytically measure of executive functions | The analytical improvement of executive functions will be measured by the Stroop test | 10 weeks | 
| Analytically measure of executive functions | The analytical improvement of executive functions will be measured by the test the Tower of London | 10 weeks | 
| Analytically measure of executive functions | The analytical improvement of executive functions will be measured by the Wisconsin Card Sorting test | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CO-OP, executive functions, stroke, single-case experimental designs, transfer of knowledge, sens of self efficacy