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

Not Applicable

Terminated

• Conditions: Cerebrovascular Accident
• Interventions: Other: Co-OP treatment

• Registration Number: NCT04282564
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-21
• Study Start: 2020-02-24
• Study First Posted: 2020-02-24
• Primary Completion: 2022-03-29
• Study Completion: 2022-03-29
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-02
• Last Update Posted: 2022-06-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CO-OP Arm (early phase A)	Co-OP treatment	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.
CO-OP Arm (mid phase A)	Co-OP treatment	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.
CO-OP Arm (late phase A)	Co-OP treatment	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Analytically measure of executive functions	10 weeks	The analytical improvement of executive functions will be measured by the Wisconsin Card Sorting test
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)

Trial Locations

Locations (1)

University Hospital of Toulouse; 🇫🇷 Toulouse, France