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

NCT ID: NCT07127536

Last Updated: 2025-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Group

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.

Group Type EXPERIMENTAL

CO-OP (Cognitive Orientation to daily Occupational Performance)

Intervention Type 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.

Control Group

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.

Group Type ACTIVE_COMPARATOR

Standard Occupational Therapy

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Standard Occupational Therapy

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Damla Aygün Gürbüz

Principal Investigator - PhD Student in Occupational Therapy, Hacettepe University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Etlik City Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Damla Aygün Gürbüz

Role: primary

+905394638066

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AEŞH-EK1-2023-218

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Clinical Monitoring Using ICF
NCT06753877 COMPLETED NA
Mirror Therapy in Stroke
NCT05312905 COMPLETED NA