Cerebrovascular AccidentFéCO-OPSANCT04282564
Improvement of Executive Functions With the CO-OP Method in the Adult Subject After Stroke
A study testing Co-OP treatment in people with Cerebrovascular Accident, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Co-OP treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2020to 29 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cerebrovascular Accident
- Being tested
- Co-OP treatment
- Keywords
- CO-OP, executive functions, stroke, single-case experimental designs, transfer of knowledge, sens of self efficacy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-OP treatmentOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Co-OP treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 10 weeks
Secondary outcomes (6)
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)
Measured: 10 weeks
Analytically measure of executive functions
The analytical improvement of executive functions will be measured by the Trail Making Tes
Measured: 10 weeks
Analytically measure of executive functions
The analytical improvement of executive functions will be measured by the number span (WAIS IV)
Measured: 10 weeks
Analytically measure of executive functions
The analytical improvement of executive functions will be measured by the Stroop test
Measured: 10 weeks
Analytically measure of executive functions
The analytical improvement of executive functions will be measured by the test "the Tower of London"
Measured: 10 weeks
Analytically measure of executive functions
The analytical improvement of executive functions will be measured by the Wisconsin Card Sorting test
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start24 Feb 2020
- Primary completion29 Mar 2022
- Study completion29 Mar 2022
Why it stopped: COVID lockdown + financial problems + no inclusion since lockdown
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier De Boissezon, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282564
- Sponsor's protocol ID
- RC31/19/0448
- Acronym
- FéCO-OPSA
- Status last verified
- Jun 2022
- First submitted
- 14 Feb 2020
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Executive Functions With the CO-OP Method in the Adult Subject After Stroke
- ClinicalTrials.gov ID
- NCT04282564
- Acronym / sponsor ID
- FéCO-OPSA / RC31/19/0448
- Conditions
- Cerebrovascular Accident
- Keywords
- CO-OP, executive functions, stroke, single-case experimental designs, transfer of knowledge, sens of self efficacy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID lockdown + financial problems + no inclusion since lockdown
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 29 Mar 2022 (actual)
- Study completion
- 29 Mar 2022 (actual)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CO-OP Arm (early phase A) | Experimental | Other: Co-OP treatmentPatients 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) | Experimental | Other: Co-OP treatmentPatients 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) | Experimental | Other: Co-OP treatmentPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Co-OP treatmentThe 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 | Other | CO-OP Arm (early phase A), CO-OP Arm (late phase A), CO-OP Arm (mid phase A) |
Primary outcome
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 Canadian Occupational Performance Measurement. The score is between 1 to 10
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
6 secondary outcomes
improvement in the sense of personal effectiveness
Time frame: 10 weeks
Analytically measure of executive functions
Time frame: 10 weeks
Analytically measure of executive functions
Time frame: 10 weeks
Analytically measure of executive functions
Time frame: 10 weeks
Analytically measure of executive functions
Time frame: 10 weeks
Analytically measure of executive functions
Time frame: 10 weeks
Results and safety
The study was stopped early (reason given: COVID lockdown + financial problems + no inclusion since lockdown). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Cerebrovascular Accident
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier De Boissezon, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Co-OP treatment in people with Cerebrovascular Accident, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID lockdown + financial problems + no inclusion since lockdown). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved performance in significant activities of daily living (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2022.