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

9 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

75

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Muhammad Luthfi Dharmawan, Subspecialist Degree
  • Número de teléfono: +6281122220052
  • Correo electrónico: m.luthfi@unpad.ac.id

Copia de seguridad de contactos de estudio

  • Nombre: Nofri Yandri, Medical Doctor
  • Número de teléfono: +6281267271717
  • Correo electrónico: nofriy14@gmail.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra de probabilidad

Población de estudio

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

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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
Subject is going to carry out Indonesian OCS Plus assessment in accordance with the procedure given by the application.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Validity and Reliability of Indonesian OCS Plus
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Colaboradores

Investigadores

  • Director de estudio: Vitriana Biben, Doctoral, Universitas Padjadjaran

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de octubre de 2026

Finalización del estudio (Estimado)

31 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

20 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de septiembre de 2026

Publicado por primera vez (Actual)

14 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de septiembre de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • IKFR-202604.02

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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