Mild Cognitive ImpairmentNCT05885867
The Activation and Walking Speed of the Prefrontal Cortex of the Elderly Mild Cognitive Impairment During Dual Task.
An observational study of Mild Cognitive Impairment and Dual Task, run by Sahmyook University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Dual Task
- What is being tested?
- Seniors with mild cognitive impairment over 65 years of age
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 27 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 May 2023to 5 Jun 2023
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Older adult
Study population: For mild cognitive impairment 65 and older who can do dual tasks.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Dual Task Performance on the Activation and Walking Speed of the Prefrontal Cortex of the Elderly With Mild Cognitive Impairment During Straight and Curved Walking.
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:
Read more
- 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.
Read the detailed 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.
- Conditions
- Mild Cognitive Impairment, Dual Task
- Being tested
- Seniors with mild cognitive impairment over 65 years of age
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seniors with mild cognitive impairment over 65 years of ageBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: through study completion, an average of 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start31 May 2023
- Primary completion5 Jun 2023
- Study completion5 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 27 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Sahmyook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yumin Lee, Sahmyook University
- Investigators
- YuMin Lee, MS candidate, Principal investigator, Sahmyook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885867
- Sponsor's protocol ID
- SYU 2023-02-013-002
- Status last verified
- Sep 2023
- First submitted
- 26 Apr 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dual Task Performance on the Activation and Walking Speed of the Prefrontal Cortex of the Elderly With Mild Cognitive Impairment During Straight and Curved Walking.
- ClinicalTrials.gov ID
- NCT05885867
- Acronym / sponsor ID
- SYU 2023-02-013-002
- Conditions
- Mild Cognitive Impairment, Dual Task
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Sahmyook UniversityUniversity, hospital or other
- Study start
- 31 May 2023 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 5 Jun 2023 (actual)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- For mild cognitive impairment 65 and older who can do dual tasks.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seniors with mild cognitive impairment over 65 years of ageA 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. | Behavioural | – |
Primary outcome
prefrontal cortex activity for single and dual tasks
Time frame: through study completion, an average of 1 week.
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.
Walking speed for single and dual tasks
Time frame: through study completion, an average of 1 week.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
Related trials for Mild Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YuMin Lee, MS candidate principal investigator
Sahmyook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment and Dual Task, run by Sahmyook University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prefrontal cortex activity for single and dual tasks (time frame: through study completion, an average of 1 week.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.