StrokeNCT07127536
Effects of the CO-OP Approach on Occupational Performance and Executive Function in Adults With Stroke
A study testing CO-OP (Cognitive Orientation to daily Occupational Performance) and Standard Occupational Therapy in people with Stroke, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this research study is to use the Cognitive Orientation to Daily Occupational Performance (CO-OP) approach with people who have experienced a stroke. This method helps individuals improve how they perform daily tasks by teaching them problem-solving strategies. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- CO-OP (Cognitive Orientation to daily Occupational Performance) and Standard Occupational Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being in the subacute phase after stroke (3 months < stroke onset < 2 years)
- First-ever stroke
- Brunnstrom stage 2 or above
- Ability to read and write
- Receiving rehabilitation services at Ankara Etlik City Hospital, Physical Medicine and Rehabilitation Hospital
Who cannot join
- Having any orthopedic, psychological, or neurological disorder other than stroke
- Having moderate to severe aphasia
- Having cognitive impairment (Mini-Mental State Examination score ≤ 24)
- Not willing to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Etlik City Hospital
Ankara, 06170
Damla Aygün Gürbüz, +905394638066, damlaaygun59@gmail.com
About this study
Official title: Effects of the Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach on Occupational Performance and Executive Function in Adults With Stroke: A Randomised Controlled Trial
The purpose of this research study is to use the Cognitive Orientation to Daily Occupational Performance (CO-OP) approach with people who have experienced a stroke. This method helps individuals improve how they perform daily tasks by teaching them problem-solving strategies.
This study will answer the following main questions:
Read more
Does the CO-OP approach help participants perform their daily activities more easily? Does the CO-OP approach support thinking skills such as planning and attention?
Researchers will look at changes in participants' daily activity performance and thinking skills before and after the CO-OP sessions.
Participants will be randomly assigned to one of two groups:
Complete simple tests before and after the sessions Practice real-life daily activities that are meaningful to them Intervention group: Will receive standard occupational therapy plus CO-OP sessions. The CO-OP sessions will take place 5 days a week for 4 weeks, with each session lasting 45 minutes.
Control group: Will receive only standard occupational therapy as part of usual care.
- Conditions
- Stroke
- Being tested
- CO-OP (Cognitive Orientation to daily Occupational Performance), Standard Occupational Therapy
- 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 (Cognitive Orientation to daily Occupational Performance)Behavioural
The CO-OP approach is a client-centered, performance-based intervention that uses cognitive strategies to help individuals improve performance in meaningful daily activities. In this study, CO-OP sessions will be delivered in addition to standard occupational therapy, 5 days per week for 4 weeks, with each session lasting 45 minutes. The intervention group will receive standard occupational therapy intervention in addition to CO-OP.
Standard Occupational Therapy Therapy sessions will follow the usual care protocols for stroke rehabilitation at the study site.
Standard Occupational TherapyBehavioural
Participants in this group will receive standard occupational therapy only, without the additional CO-OP intervention. Therapy sessions will follow the usual care protocols for stroke rehabilitation at the study site.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in this group will receive standard occupational therapy plus the CO-OP (Cognitive Orientation to daily Occupational Performance) approach. CO-OP sessions will be delivered 5 days per week for 4 weeks, with each session lasting 45 minutes. The intervention focuses on improving performance in meaningful daily activities and enhancing cognitive skills. Receives: Behavioral: CO-OP (Cognitive Orientation to daily Occupational Performance) |
| Control Group | Active comparator | Participants in this group will receive standard occupational therapy only, without the additional CO-OP intervention. Therapy sessions will follow the usual care protocols for stroke rehabilitation at the study site. Receives: Behavioral: Standard Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure
It is an assessment tool used to evaluate individuals' activity performance and satisfaction levels, and to identify problems encountered in daily life through a semi-structured interview. In this assessment, the individual rates their occupations in terms of performance and importance. In the first stage, problems are identified; in the next stage, the individual is asked to rate the importance of the identified occupations on a scale from 1 to 10. In the final stage, the individual selects the five most important activities and rates both performance and satisfaction for these activities on a scale from 1 to 10. Higher scores indicate higher activity performance and satisfaction.
Measured: Baseline and 4 weeks after the start of intervention.
Secondary outcomes (3)
Performance Quality Rating Scale
It is a performance-based observational rating scale used to evaluate the actual performance of activities selected by the individual. It is used together with the Canadian Occupational Performance Measure (COPM) to assess the quality of activity performance. The scale is scored from 1 to 10, where a score of 1 indicates that the individual is unable to perform the activity, and a score of 10 indicates that the activity is completed successfully. The activities identified in the COPM are performed without any verbal or physical guidance.
Measured: Baseline and 4 weeks.
Executive Function Performance Test
It is an assessment tool that evaluates the individual's need for assistance while performing simple daily tasks. It examines the execution of four essential instrumental activities of daily living required for self-care and independent living: simple cooking, telephone use, medication management, and bill payment. The test assesses the ability to meet executive function components in all four tasks: (1) task initiation, (2) task execution, and (3) task completion. The level of cueing required to support task performance is recorded on a five-point scale: 0 = no cueing needed, 1 = verbal guidance, 2 = gestural or physical cueing, 3 = direct verbal assistance, 4 = physical assistance, 5 = the examiner performs the task. The scoring range is 0-25 for each task, with a total score ranging from 0 to 100 across all four tasks. Higher scores indicate greater difficulty in executive functioning.
Measured: Baseline and 4 weeks.
Stroke Impact Scale version-3.0
This scale is designed to evaluate the quality of life after stroke as perceived by patients themselves or their caregivers. It consists of 8 subscales and 59 items. Each item is scored using a 5-point Likert scale based on the level of difficulty experienced during the past week. Scores for each domain range from 0 to 100. In addition, the scale includes a single-item visual analog scale from 0 to 100 to assess perceived recovery after stroke (0 = no recovery, 100 = full recovery). Higher scores indicate better function and less impact of stroke.
Measured: Baseline and 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start1 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Aygün Gürbüz, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127536
- Sponsor's protocol ID
- AEŞH-EK1-2023-218
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach on Occupational Performance and Executive Function in Adults With Stroke: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07127536
- Acronym / sponsor ID
- AEŞH-EK1-2023-218
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 17 Aug 2025 (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 purpose of this research study is to use the Cognitive Orientation to Daily Occupational Performance (CO-OP) approach with people who have experienced a stroke. This method helps individuals improve how they perform daily tasks by teaching them problem-solving strategies.
This study will answer the following main questions:
Does the CO-OP approach help participants perform their daily activities more easily? Does the CO-OP approach support thinking skills such as planning and attention?
Researchers will look at changes in participants' daily activity performance and thinking skills before and after the CO-OP sessions.
Participants will be randomly assigned to one of two groups:
Complete simple tests before and after the sessions Practice real-life daily activities that are meaningful to them Intervention group: Will receive standard occupational therapy plus CO-OP sessions. The CO-OP sessions will take place 5 days a week for 4 weeks, with each session lasting 45 minutes.
Control group: Will receive only standard occupational therapy as part of usual care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: CO-OP (Cognitive Orientation to daily Occupational Performance)Participants in this group will receive standard occupational therapy plus the CO-OP (Cognitive Orientation to daily Occupational Performance) approach. CO-OP sessions will be delivered 5 days per week for 4 weeks, with each session lasting 45 minutes. The intervention focuses on improving performance in meaningful daily activities and enhancing cognitive skills. |
| Control Group | Active comparator | Behavioral: Standard Occupational TherapyParticipants in this group will receive standard occupational therapy only, without the additional CO-OP intervention. Therapy sessions will follow the usual care protocols for stroke rehabilitation at the study site. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being in the subacute phase after stroke (3 months < stroke onset < 2 years)
- First-ever stroke
- Brunnstrom stage 2 or above
- Ability to read and write
- Receiving rehabilitation services at Ankara Etlik City Hospital, Physical Medicine and Rehabilitation Hospital
Key exclusion criteria (4 listed)
- Having any orthopedic, psychological, or neurological disorder other than stroke
- Having moderate to severe aphasia
- Having cognitive impairment (Mini-Mental State Examination score ≤ 24)
- Not willing to participate 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 (Cognitive Orientation to daily Occupational Performance)The CO-OP approach is a client-centered, performance-based intervention that uses cognitive strategies to help individuals improve performance in meaningful daily activities. In this study, CO-OP sessions will be delivered in addition to standard occupational therapy, 5 days per week for 4 weeks, with each session lasting 45 minutes. The intervention group will receive standard occupational therapy intervention in addition to CO-OP. Standard Occupational Therapy Therapy sessions will follow the usual care protocols for stroke rehabilitation at the study site. | Behavioural | Intervention Group |
| Standard Occupational TherapyParticipants in this group will receive standard occupational therapy only, without the additional CO-OP intervention. Therapy sessions will follow the usual care protocols for stroke rehabilitation at the study site. | Behavioural | Control Group |
Primary outcome
Canadian Occupational Performance Measure
Time frame: Baseline and 4 weeks after the start of intervention.
It is an assessment tool used to evaluate individuals' activity performance and satisfaction levels, and to identify problems encountered in daily life through a semi-structured interview. In this assessment, the individual rates their occupations in terms of performance and importance. In the first stage, problems are identified; in the next stage, the individual is asked to rate the importance of the identified occupations on a scale from 1 to 10. In the final stage, the individual selects the five most important activities and rates both performance and satisfaction for these activities on a scale from 1 to 10. Higher scores indicate higher activity performance and satisfaction.
3 secondary outcomes
Performance Quality Rating Scale
Time frame: Baseline and 4 weeks.
Executive Function Performance Test
Time frame: Baseline and 4 weeks.
Stroke Impact Scale version-3.0
Time frame: Baseline and 4 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: Yes
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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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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.
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 (Cognitive Orientation to daily Occupational Performance) and Standard Occupational Therapy in people with Stroke, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 22 Aug 2025. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measure (time frame: Baseline and 4 weeks after the start of intervention.). 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 22 Aug 2025.