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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06348901
• Other study ID #: 2021-09-001
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: February 28, 2025

Study information

• Verified date: March 2024
• Source: Bundang CHA Hospital
• Contact: Eunyoung Cho
• Phone: +82-10-2753-0285
• Email: a220242[@]chamc.co.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Other known NCT identifiers

• NCT06329232

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Gender: All
• Age group: 20 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Stroke

Locations

Country	Name	City	State
Korea, Republic of	Department of Rehabilitation Medicine, CHA Bundang Medical Center	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Bundang CHA Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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