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

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Terminated

CT.gov ID

NCT04282564

Collaborator

(none)

Enrollment

Location

Arms

25.1

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebrovascular Accident	Other: Co-OP treatment	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 24, 2020

Actual Primary Completion Date :

Mar 29, 2022

Actual Study Completion Date :

Mar 29, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CO-OP Arm (early phase A) 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 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
Experimental: CO-OP Arm (mid phase A) 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 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
Experimental: CO-OP Arm (late phase A) 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 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

Arm

Intervention/Treatment

Experimental: CO-OP Arm (early phase A)

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

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

Experimental: CO-OP Arm (mid phase A)

Other: Co-OP treatment

Experimental: CO-OP Arm (late phase A)

Other: Co-OP treatment

Outcome Measures

Primary Outcome Measures

Improved performance in significant activities of daily living [10 weeks]
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
Improved performance in significant activities of daily living [10 weeks]
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

Secondary Outcome Measures

improvement in the sense of personal effectiveness [10 weeks]
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)
Analytically measure of executive functions [10 weeks]
The analytical improvement of executive functions will be measured by the Trail Making Tes
Analytically measure of executive functions [10 weeks]
The analytical improvement of executive functions will be measured by the number span (WAIS IV)
Analytically measure of executive functions [10 weeks]
The analytical improvement of executive functions will be measured by the Stroop test
Analytically measure of executive functions [10 weeks]
The analytical improvement of executive functions will be measured by the test "the Tower of London"
Analytically measure of executive functions [10 weeks]
The analytical improvement of executive functions will be measured by the Wisconsin Card Sorting test

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.