Indonesian Version of Oxford Cognitive Screen-Plus Test in Stroke Patient (OCS-Plus)

September 9, 2026 updated by: Universitas Padjadjaran

Validity and Reliability Test of the Indonesian Version of Oxford Cognitive Screen-Plus in Stroke Patient

The incidence of stroke increases every year throughout the world. Neuropsychological assessment is the best way to identify post-stroke cognitive dysfunction. The importance of cognitive function in the post stroke rehabilitation program process requires a tool that can detect cognitive disorders more specifically and more sensitively. The investigator aim in this study was to develop Indonesian version of the OCS - Plus among stroke patient in Indonesia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Stroke causes not only motor deficits, but also cognitive dysfunction, which is frequently observed among stroke survivors. Most patients in the acute phase demonstrate impairment in at least one cognitive domain. The global burden of post-stroke cognitive impairment (PSCI) is substantial and may affect more than half of all stroke survivors. Cognitive impairment is also reported in approximately one-third to nearly one-half of patients within the first year after stroke. The clinical presentation of PSCI reflects the involvement of multiple brain networks as well as interaction with pre-existing neurodegenerative processes. PSCI has important clinical consequences, including reduced independence, limitations in activities of daily living, and poorer quality of life. This burden makes PSCI a major concern in the management and rehabilitation of stroke survivors.

Early evaluation of cognitive function is an essential component of clinical assessment after stroke. Clinical practice guidelines emphasize cognitive screening as a foundation for rehabilitation planning and patient follow-up.

Commonly used tools such as the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA) primarily focus on global cognitive deficits and demonstrate limited sensitivity in identifying domain-specific impairments, particularly in the subacute and chronic phases of stroke. Several domains that are commonly affected after stroke, including language, visuospatial processing, and praxis, are not adequately assessed by these instruments. Interpretation of test performance may also be biased by aphasia or neglect, both of which can influence the patient's responses.

Therefore, the OCS-Plus was designed to detect more subtle cognitive deficits, especially in executive function and memory, which are often overlooked by standard screening tools.

The Oxford Cognitive Screen-Plus (OCS-Plus) was developed as a digital cognitive screening tool designed to improve the sensitivity of cognitive impairment detection. Its assessment approach allows a more detailed evaluation of memory and executive function than conventional screening instruments. The OCS-Plus consists of multiple subtasks intended to identify differences across cognitive domains with greater specificity. Tablet-based administration offers advantages in the form of standardized procedures and reduced scoring error.

The digital format also enables more detailed response capture and automated reporting of results. Previous studies have shown that the OCS-Plus has good validity and greater sensitivity for detecting subtle cognitive impairment than other screening tools.

The development of the OCS-Plus has largely been conducted in Western populations, where linguistic and cultural contexts differ from those in Southeast Asia. These differences may influence test comprehension and performance, potentially affecting the validity of cognitive assessment. Despite the high burden of post-stroke cognitive impairment in this region, there is a lack of culturally adapted and validated domain-specific cognitive screening tools, limiting accurate diagnosis and optimal rehabilitation planning. This gap underscores the need to validate advanced screening tools such as the OCS-Plus in non-Western populations. This study is the first to culturally adapt and validate the OCS-Plus for use in an Indonesian population, addressing the lack of domain-specific cognitive screening tools in Southeast Asia. Therefore, this study aims to validate normative values for the the OCS-Plus in an Indonesian stroke population.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Muhammad Luthfi Dharmawan, Subspecialist Degree
  • Phone Number: +6281122220052
  • Email: m.luthfi@unpad.ac.id

Study Contact Backup

  • Name: Nofri Yandri, Medical Doctor
  • Phone Number: +6281267271717
  • Email: nofriy14@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The target population consists of stroke patients in West Java. The accessible population includes stroke patients undergoing treatment at the medical rehabilitation clinic and neurology clinic at RSUP Dr. Hasan Sadikin Bandung

Description

Inclusion Criteria:

  • Male or female18 years of age or older
  • Subacute and chronic stroke patients
  • Able to understand instructions
  • Able to read
  • Can speak Indonesian well
  • Willing to take part in research

Exclusion Criteria:

  • Have uncorrected severe visual and hearing impairments
  • Have cognitive rehabilitation before research
  • Inability to maintain concentration for approximately 30 minutes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Validity/Reliability Group
This group contain post stroke patient that will be given task to work on OCS Plus in accordance with the procedure from the aplication
Device: OCS Plus Assessment
Subject is going to carry out Indonesian OCS Plus assessment in accordance with the procedure given by the application.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Validity and Reliability of Indonesian OCS Plus
Time Frame: T0 - Baseline assessment (Day 1) -. Informed consent and Demographic -. MoCA-Ina -. Indonesian OCS-Plus T1 - Retest (48 hours after T0) -.Indonesian OCS-Plus repeated under standardized conditions -.No cognitive rehabilitation intervention between T0-T1

Task-specific OCS-Plus convergent and divergent validity was examined against task-matched validated MoCA tests in a pre-registered Spearman's Rho correlation analyses. Investigator's aimed for correlations >0.30 to demarcate convergence.

The reliability coefficient calculation technique used here is to use the Alpha Reliability Coefficient.
T0 - Baseline assessment (Day 1) -. Informed consent and Demographic -. MoCA-Ina -. Indonesian OCS-Plus T1 - Retest (48 hours after T0) -.Indonesian OCS-Plus repeated under standardized conditions -.No cognitive rehabilitation intervention between T0-T1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitas Padjadjaran

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Oxford

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Vitriana Biben, Doctoral, Universitas Padjadjaran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IKFR-202604.02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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