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Clinical Trials/NCT04282564
NCT04282564
Terminated
N/A

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

University Hospital, Toulouse1 site in 1 country3 target enrollmentFebruary 24, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cerebrovascular Accident
Sponsor
University Hospital, Toulouse
Enrollment
3
Locations
1
Primary Endpoint
Improved performance in significant activities of daily living
Status
Terminated
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 24, 2020
End Date
March 29, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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 Outcomes

  • Analytically measure of executive functions(10 weeks)
  • improvement in the sense of personal effectiveness(10 weeks)

Study Sites (1)

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