Clinical Utility of Oxford Cognitive Screen Test to Screen Cognitive Impairment in Post Stroke Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Eunyoung Cho; Phone Number: +82-10-2753-0285; Email: a220242@chamc.co.kr

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
      • Recruiting
      • Department of Rehabilitation Medicine, CHA Bundang Medical Center
      • Contact: Eunyoung Cho; Phone Number: +82-10-2753-0285; Email: a220242@chamc.co.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Stroke patients and healthy voluteers

Description

1. For stroke patients 1) Inclusion Criteria:

   • 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).

     2) Exclusion Criteria:

   • Who cannot meet the inclusion criteria

2. For healthy voluteers 1) Inclusion Criteria:

   • 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

     2) Exclusion Criteria:

   • Who cannot meet the inclusion criteria

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Healthy subjects and Stroke, Tumor, TBI patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Korean version of mini-mental state examination (K-MMSE)	K-MMSE is a measurement of cognitive level. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe(≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. The raw score may also need to be corrected for educational attainement and age.	Between November 2020 and April 2022
Measurement Korean Version of the Oxford cognitive screen (K-OCS)	OCS is an assessment of major cognitive domains of memory, language, number, praxis, executive functions and attention.	Between November 2020 and April 2022
Measurement of national institute of health care stroke scale (NIHSS)	NIHSS is a measurement for assessing the severity of stroke patients. The scale is made up of 11 different elements that evaluate specific ability. The score for each ability is a number between 0 and 4, 0 being normal functioning and 4 being completely impaired. 42 is the highest score possible, the higher the score, the more impaired a stroke patient is.	Between November 2020 and April 2022
Measurement of fuctional independence meausure (FIM)	FIM is a measurment to evaluate the funciontional status. FIS is an 18-item including functional capability in six areas of self-care, continence, mobility, transfers, communication and cognition. Each of the 18 items are graded on a scale of 1-7, based on the level of independence in that item	Between November 2020 and April 2022

Collaborators and Investigators

• Sponsor: CHA University

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2023
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: March 19, 2024
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Stroke; Cognitive Dysfunction
• Other Study ID Numbers: Chauni

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No