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

NCT07127536 | Recruiting

• 1 other identifier: AEŞH-EK1-2023-218
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 4 weeks after the start of intervention.

Secondary Outcomes (3)

• Performance Quality Rating Scale

  Baseline and 4 weeks.

• Executive Function Performance Test

  Baseline and 4 weeks.

• Stroke Impact Scale version-3.0

  Baseline and 4 weeks.

Study Arms (2)

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.

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.

Behavioral: Standard Occupational Therapy

Interventions

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.

Intervention Group

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.

Control Group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Etlik City Hospital

Ankara, 06170, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - PhD Student in Occupational Therapy, Hacettepe University

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 17, 2025
• Study Start: January 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

TU (1)