- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07817784
Indonesian Version of Oxford Cognitive Screen-Plus Test in Stroke Patient (OCS-Plus)
Validity and Reliability Test of the Indonesian Version of Oxford Cognitive Screen-Plus in Stroke Patient
Descripción general del estudio
Estado
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
Inscripción (Estimado)
Contactos y Ubicaciones
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
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
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
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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
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Subject is going to carry out Indonesian OCS Plus assessment in accordance with the procedure given by the application.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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
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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
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Vitriana Biben, Doctoral, Universitas Padjadjaran
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
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.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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