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

NCT04282564 | Terminated

• 1 other identifier: RC31/19/0448
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Accident

Keywords

CO-OP; executive functions; stroke; single-case experimental designs; transfer of knowledge; sens of self efficacy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• improvement in the sense of personal effectiveness

  10 weeks

• Analytically measure of executive functions

  10 weeks

• Analytically measure of executive functions

  10 weeks

• Analytically measure of executive functions

  10 weeks

• Analytically measure of executive functions

  10 weeks

Study Arms (3)

CO-OP Arm (early phase A)

EXPERIMENTAL

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.

Other: Co-OP treatment

CO-OP Arm (mid phase A)

EXPERIMENTAL

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.

Other: Co-OP treatment

CO-OP Arm (late phase A)

EXPERIMENTAL

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.

Other: Co-OP treatment

Interventions

Co-OP treatment OTHER

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

CO-OP Arm (early phase A); CO-OP Arm (late phase A); CO-OP Arm (mid phase A)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital of Toulouse

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xavier De Boissezon, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 24, 2020
• Study Start: February 24, 2020
• Primary Completion: March 29, 2022
• Study Completion: March 29, 2022
• Last Updated: June 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)