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

Cerebrovascular Accident Clinical Trial

— FéCO-OPSA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04282564
• Other study ID #: RC31/19/0448
• Status: Terminated
• Phase: N/A
• Start date: February 24, 2020
• Est. completion date: March 29, 2022

Study information

• Verified date: June 2022
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 29, 2022
• Est. primary completion date: March 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

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

Locations

Country	Name	City	State
France	University Hospital of Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	10 weeks
Primary	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	10 weeks
Secondary	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)	10 weeks
Secondary	Analytically measure of executive functions	The analytical improvement of executive functions will be measured by the Trail Making Tes	10 weeks
Secondary	Analytically measure of executive functions	The analytical improvement of executive functions will be measured by the number span (WAIS IV)	10 weeks
Secondary	Analytically measure of executive functions	The analytical improvement of executive functions will be measured by the Stroop test	10 weeks
Secondary	Analytically measure of executive functions	The analytical improvement of executive functions will be measured by the test "the Tower of London"	10 weeks
Secondary	Analytically measure of executive functions	The analytical improvement of executive functions will be measured by the Wisconsin Card Sorting test	10 weeks