NCT06348901

Brief Summary

The goal of this type of study: clinical trial is to assess K-OCS clinical utility in participant population. The main aims: validate the reliability and validity of the Korean version of the Oxford Cognitive Screen (K-OCS) analyze its sensitivity, specificity, and diagnostic accuracy, and compare its examination participation rates with existing assessment tools to determine the effectiveness of K-OCS in detecting post-stroke cognitive impairment.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 5, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

April 5, 2024

Status Verified

March 1, 2024

Enrollment Period

3.5 years

First QC Date

March 31, 2024

Last Update Submit

March 31, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Measurement of K-OCS

    Measurement of k-ocs is a process of validating K-OCS and assess its clinical utility

    Between November 2020 and April 2022

Secondary Outcomes (4)

  • Measurement of Korean version of mini-mental state examination (K-MMSE)

    Between November 2020 and April 2022

  • Measurement Korean Version of the Oxford cognitive screen (K-OCS)

    Between November 2020 and April 2022

  • Measurement of national institute of health care stroke scale (NIHSS)

    Between November 2020 and April 2022

  • Measurement of fuctional independence meausure (FIM)

    Between November 2020 and April 2022

Study Arms (1)

Healthy subjects and Stroke patients

Healthy subjects and Stroke patients

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stroke patients and healthy voluteers

You may qualify if:

  • Adults over 20 years of age
  • More than 72 hours elapsed since the onset of stroke symptoms.
  • After hearing a detailed explanation of this study and fully understanding it, the subject or legal representative voluntarily decides to participate and agrees in writing to observe the precautions
  • Involved individuals diagnosed with stroke by neurology and rehabilitation medicine specialists based on data acquired from 3T GE Signa System (General Electric, Milwaukee, WI), brain magnetic resonance imaging (MRI), and computed tomography (CT).

You may not qualify if:

  • For healthy voluteers
  • Over 20 years of age
  • A person who is performing an independent daily life
  • A person who voluntarily decides to participate and agrees in writing to abide by the precautions after hearing a detailed explanation of this study and fully understanding it

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation Medicine, CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, 13496, South Korea

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

March 31, 2024

First Posted

April 5, 2024

Study Start

September 1, 2021

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

April 5, 2024

Record last verified: 2024-03

Locations