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

Primary Purpose

Cerebrovascular Accident

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Co-OP treatment
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident focused on measuring CO-OP, executive functions, stroke, single-case experimental designs, transfer of knowledge, sens of self efficacy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University Hospital of Toulouse

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

CO-OP Arm (early phase A)

CO-OP Arm (mid phase A)

CO-OP Arm (late phase A)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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)
Analytically measure of executive functions
The analytical improvement of executive functions will be measured by the Trail Making Tes
Analytically measure of executive functions
The analytical improvement of executive functions will be measured by the number span (WAIS IV)
Analytically measure of executive functions
The analytical improvement of executive functions will be measured by the Stroop test
Analytically measure of executive functions
The analytical improvement of executive functions will be measured by the test "the Tower of London"
Analytically measure of executive functions
The analytical improvement of executive functions will be measured by the Wisconsin Card Sorting test

Full Information

First Posted
February 14, 2020
Last Updated
June 2, 2022
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT04282564
Brief Title
Improvement of Executive Functions With the CO-OP Method in the Adult Subject After Stroke
Acronym
FéCO-OPSA
Official Title
Improvement of Executive Functions With the CO-OP Method in the Adult Subject After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
COVID lockdown + financial problems + no inclusion since lockdown
Study Start Date
February 24, 2020 (Actual)
Primary Completion Date
March 29, 2022 (Actual)
Study Completion Date
March 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
Keywords
CO-OP, executive functions, stroke, single-case experimental designs, transfer of knowledge, sens of self efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CO-OP Arm (early phase A)
Arm Type
Experimental
Arm Description
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.
Arm Title
CO-OP Arm (mid phase A)
Arm Type
Experimental
Arm Description
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.
Arm Title
CO-OP Arm (late phase A)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Co-OP treatment
Intervention Description
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 Measure Information:
Title
Improved performance in significant activities of daily living
Description
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
Time Frame
10 weeks
Title
Improved performance in significant activities of daily living
Description
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
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
improvement in the sense of personal effectiveness
Description
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)
Time Frame
10 weeks
Title
Analytically measure of executive functions
Description
The analytical improvement of executive functions will be measured by the Trail Making Tes
Time Frame
10 weeks
Title
Analytically measure of executive functions
Description
The analytical improvement of executive functions will be measured by the number span (WAIS IV)
Time Frame
10 weeks
Title
Analytically measure of executive functions
Description
The analytical improvement of executive functions will be measured by the Stroop test
Time Frame
10 weeks
Title
Analytically measure of executive functions
Description
The analytical improvement of executive functions will be measured by the test "the Tower of London"
Time Frame
10 weeks
Title
Analytically measure of executive functions
Description
The analytical improvement of executive functions will be measured by the Wisconsin Card Sorting test
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier De Boissezon, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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