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

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ClinicalTrials.gov Identifier: NCT04282564
Recruitment Status : Not yet recruiting
First Posted : February 24, 2020
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : February 20, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2022

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




Primary Outcome Measures :
  1. Improved performance in significant activities of daily living [ Time Frame: 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

  2. Improved performance in significant activities of daily living [ Time Frame: 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 :
  1. improvement in the sense of personal effectiveness [ Time Frame: 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)

  2. Analytically measure of executive functions [ Time Frame: 10 weeks ]
    The analytical improvement of executive functions will be measured by the Trail Making Tes

  3. Analytically measure of executive functions [ Time Frame: 10 weeks ]
    The analytical improvement of executive functions will be measured by the number span (WAIS IV)

  4. Analytically measure of executive functions [ Time Frame: 10 weeks ]
    The analytical improvement of executive functions will be measured by the Stroop test

  5. Analytically measure of executive functions [ Time Frame: 10 weeks ]
    The analytical improvement of executive functions will be measured by the test "the Tower of London" and the Wisconsin Card Sorting test

  6. Analytically measure of executive functions [ Time Frame: 10 weeks ]
    The analytical improvement of executive functions will be measured by the Wisconsin Card Sorting test



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282564


Contacts
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Contact: Xavier De Boissezon 05 61 32 21 20 ext 33 deboissezon.x@chu-toulouse.fr
Contact: Sabrina Techene 05 61 32 40 93 ext 33 techene.s@chu-toulouse.fr

Locations
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France
University Hospital of Toulouse
Toulouse, France, 31000
Contact: Xavier De Boissezon, MD    05 61 32 21 20 ext 33    deboissezon.x@chu-toulouse.fr   
Contact: Sabrina Techene    05 61 32 40 93 ext 33    techene.s@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Xavier De Boissezon, MD University Hospital, Toulouse
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT04282564    
Other Study ID Numbers: RC31/19/0448
First Posted: February 24, 2020    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
CO-OP
executive functions
stroke
single-case experimental designs
transfer of knowledge
sens of self efficacy
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases