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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05885867
Other study ID # SYU 2023-02-013-002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 31, 2023
Est. completion date June 5, 2023

Study information

Verified date September 2023
Source Sahmyook University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The goal of this observational study is to compare to investigate the effect of dual task performance on straight and curved walking in elderly people with mild cognitive impairment. The main question[s] it aims to answer are: - The purpose of this study was to investigate the effect of dual task performance on the activity of the prefrontal cortex in the elderly with mild cognitive impairment during straight and curved walking. - The purpose of this study was to investigate the effect of dual task performance on gait speed during straight and curved walking in elderly people with mild cognitive impairment. Participants will: For mild cognitive impairment 65 and older who can do dual tasks. - single task (motor task) : an exercise task, which will perform a 10-meter walking test and a figure-eight walking test. - double task (motor task + cognitive task) : planned to perform a motor task and a cognitive task together. The cognitive task is scheduled to be a simple calculation problem so that it can be performed without great difficulty while walking.


Description:

The goal of this observational study is to compare to investigate the effect of dual task performance on straight and curved walking in elderly people with mild cognitive impairment. The main question[s] it aims to answer are: - The purpose of this study was to investigate the effect of dual task performance on the activity of the prefrontal cortex in the elderly with mild cognitive impairment during straight and curved walking. - The purpose of this study was to investigate the effect of dual task performance on gait speed during straight and curved walking in elderly people with mild cognitive impairment. Participants will A total of 30 subjects will perform a single task (motor task) and a double task (motor task + cognitive task), four tasks per subject, and the order of examination will be randomly assigned. The subject's prefrontal cortex activity will be measured using fNIRS (NIRSIT, OBELAB). The single task is an exercise task, which will perform a 10-meter walking test and a figure-eight walking test. The 10-meter walking test was developed to evaluate walking speed during short distance walking. The total length was set to 14 m, and a distance of 2 m was placed at the beginning and end to avoid being affected by acceleration and deceleration. The figure-eight gait test requires a person to walk in a figure-eight shape around two cones placed as a tool to measure curved walking ability. In this study, in order to perform the exercise task at the same distance, a straight line of 14 m will be made into a random line and set in the shape of a figure 8. Do not deviate more than 1 m from the object in the rotating section of the object. The dual task is planned to perform a motor task and a cognitive task together. The cognitive task is scheduled to be a simple calculation problem so that it can be performed without great difficulty while walking. The subject will perform a total of 3 repetitions and will have a 20-second break before starting each task.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date June 5, 2023
Est. primary completion date June 5, 2023
Accepts healthy volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - A person with a Korean version of the Simplified Mental Status Test (K-MMSE-2) score of 18-23. - A person who can walk using an auxiliary device. Exclusion Criteria: - A person who cannot walk 3 meters back and forth or stand up from a sitting position - A person sensitive to infrared lasers - A person with impaired vision and hearing

Study Design


Intervention

Behavioral:
Seniors with mild cognitive impairment over 65 years of age
A total of 30 subjects will perform four tasks per person for a single task (motor task) and a double task (motor task + cognitive task), and the test order will be randomly assigned. The subject's prefrontal cortex activity will be measured using fNIRS (NIRSIT, OBELAB). The single task will be to perform a 10-meter walk test and an 8-way walk test as exercise tasks. as not affected by acceleration and deceleration. The dual task will be carried out together with the exercise task and the cognitive task. The cognitive task will be a simple calculation problem so that it can be performed without much difficulty when walking.Subjects will perform a total of three iterations and have a break of 20 seconds before each task begins.

Locations

Country Name City State
Korea, Republic of Sahmyook university Seoul Nowon-gu

Sponsors (1)

Lead Sponsor Collaborator
Sahmyook University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary prefrontal cortex activity for single and dual tasks functional near-infrared spectroscopy : fNIRS, a non-invasive vascular-based neuroimaging technology, is a tool that uses light sources and photoreceptors to measure changes in the concentration of oxyhemoglobin (HbO2) in the cerebral cortex area due to the regulation of neural activity.
In this study, fNIRS measurements were performed by a wireless cw system (NIRSIT, OBELAB, Republic of Korea) an fNIRS device consisting of five double wavelength (780/850 nm) laser sources and seven detectors. The amount of HbO2 change while performing the task were measured. The device consists of 15 channels with a distance of 30 mm between each pair.
through study completion, an average of 1 week.
Primary Walking speed for single and dual tasks Using a stopwatch, real-time measurements will be made in the remaining sections except for the front and back 2m, considering acceleration and deceleration when walking along a straight 14m path and a curved path. through study completion, an average of 1 week.
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