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Post StrokeOCS-PlusNCT07817784

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

An observational study of Post Stroke and Cognitive Assessment, run by Universitas Padjadjaran.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post Stroke, Cognitive Assessment
What is being tested?
OCS Plus Assessment
Type of treatment
Medical device
How many people
75 participants
Where
No sites listed yet
Study dates
1 Sep 2026to 31 Dec 2026
Phase
Observational
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Muhammad Luthfi Dharmawan, Subspecialist Degree contact

+6281122220052

m.luthfi@unpad.ac.id

Nofri Yandri, Medical Doctor contact

+6281267271717

nofriy14@gmail.com

About this study

Official title: 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.

Read the 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.

Being tested
OCS Plus Assessment
Keywords
Cognitive Assessment, Post Stroke, Rehabilitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OCS Plus AssessmentDevice

    Subject is going to carry out Indonesian OCS Plus assessment in accordance with the procedure given by the application.

Study groups in NCT07817784
Study groupRoleWhat they receive
Validity/Reliability GroupThis group contain post stroke patient that will be given task to work on OCS Plus in accordance with the procedure from the aplication
Receives: Device: OCS Plus Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Validity and Reliability of Indonesian OCS Plus

    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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07817784
Sponsor's protocol ID
IKFR-202604.02
Acronym
OCS-Plus
Status last verified
Aug 2026
First submitted
20 Aug 2026
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Post Stroke and Cognitive Assessment, run by Universitas Padjadjaran.

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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact Muhammad Luthfi Dharmawan, Subspecialist Degree (+6281122220052, m.luthfi@unpad.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). 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 14 Sep 2026.

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