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NCT Number: NCT07127536

Effects of the CO-OP Approach on Occupational Performance and Executive Function in Adults With Stroke

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.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Etlik City Hospital

Ankara, 06170, Turkey (Türkiye)

Location status: Recruiting

Location contact

Damla Aygün Gürbüz

CONTACT

[email protected]

+905394638066

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

CO-OP (Cognitive Orientation to daily Occupational Performance)

Behavioral

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 Therapy

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Performance Quality Rating Scale

    Time frame: Baseline and 4 weeks.

    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.

  2. Executive Function Performance Test

    Time frame: Baseline and 4 weeks.

    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.

  3. Stroke Impact Scale version-3.0

    Time frame: Baseline and 4 weeks.

    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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 17, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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