Clinical trial NCT04282564: Improvement of Executive Functions With the CO-OP Method in the Adult Subject After Stroke
Official title: Improvement of Executive Functions With the CO-OP Method in the Adult Subject After Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cerebrovascular Accident
Keywords: CO-OP
executive functions
stroke
single-case experimental designs
transfer of knowledge
sens of self efficacy
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Improved performance in significant activities of daily living
timeFrame: 10 weeks
measure: Improved performance in significant activities of daily living
timeFrame: 10 weeks
Secondary outcomes:
measure: improvement in the sense of personal effectiveness
timeFrame: 10 weeks
measure: Analytically measure of executive functions
timeFrame: 10 weeks
measure: Analytically measure of executive functions
timeFrame: 10 weeks
measure: Analytically measure of executive functions
timeFrame: 10 weeks
measure: Analytically measure of executive functions
timeFrame: 10 weeks
measure: Analytically measure of executive functions
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Xavier De Boissezon, MD
role: PRINCIPAL_INVESTIGATOR
References: