NCT05885867

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 26, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

May 31, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2023

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

5 days

First QC Date

April 26, 2023

Last Update Submit

September 1, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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.

Interventions

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.

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

For mild cognitive impairment 65 and older who can do dual tasks.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahmyook university

Seoul, Nowon-gu, 01795, South Korea

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Aging

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Growth and DevelopmentPhysiological Phenomena

Study Officials

  • YuMin Lee, MS candidate

    Sahmyook University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist

Study Record Dates

First Submitted

April 26, 2023

First Posted

June 2, 2023

Study Start

May 31, 2023

Primary Completion

June 5, 2023

Study Completion

June 5, 2023

Last Updated

September 6, 2023

Record last verified: 2023-09

Locations