- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat 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
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Muhammad Luthfi Dharmawan, Subspecialist Degree
- Telefonszám: +6281122220052
- E-mail: m.luthfi@unpad.ac.id
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Nofri Yandri, Medical Doctor
- Telefonszám: +6281267271717
- E-mail: nofriy14@gmail.com
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Mintavételi módszer
Tanulmányi populáció
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
Kohorszok és beavatkozások
Csoport / Kohorsz |
Beavatkozás / kezelés |
|---|---|
|
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.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Validity and Reliability of Indonesian OCS Plus
Időkeret: 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
|
Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Tanulmányi igazgató: Vitriana Biben, Doctoral, Universitas Padjadjaran
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- IKFR-202604.02
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .