- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04905186
Different Domains of Executive Function Dual Task Walking on Brain Activation and Gait Performance in Healthy Adults
June 12, 2022 updated by: National Taiwan University Hospital
The Effects of Different Domains of Executive Function Dual Task Walking on Brain Activation and Gait Performance in Healthy Adults
The aim of this study is to investigate the effects of different domains of executive function (EF) during dual task walking condition on brain activation and gait performance in healthy adults.
There are two experiments will be conducted in this study.
Experiment 1 is a pilot study to determine the same level of difficulty in 3 EF domains, including inhibition, working memory and cognitive flexibility.
Experiment 2 is carried out to investigate the effects of 3 different domains of EF which difficulties are controlled on gait performance and brain activation in dual task condition.
10 subjects will perform Stroop test (2s/3s/4s to change question), backward digit spans (3/4/5 digits) and naming test in Experiment 1.
In Experiment 1, the primary outcome is the correct response speed (CRS) while secondary outcome will be the brain activity.
In Experiment 2, 30 subjects will perform the single cognitive task A (SCTA, Stroop test), single cognitive task B (SCTB, backward digit spans), single cognitive task C (SCTC, naming test), single walking task (SWT), dual task A (DTA, walking while performing cognitive task A), dual task B (DTB, walking while performing cognitive task B) and dual task C (DTC, walking while performing cognitive task C).
The CRS, gait performance, brain activity and the dual task costs (DTC) will be recorded in the Experiment 2. Brain activities in prefrontal cortex (PFC), premotor cortex (PMC) and supplementary motor area (SMAs) will be measured by functional near-infrared spectroscopy (fNIRS) during this study.
One-way ANOVA with Tukey post-hoc test will be performed to establish the effect of different type of executive task on CRS or the brain activity.
The differences of gait parameters and brain activity in different condition in the Experiment 2 will be examined by one-way ANOVA with repeated measured.
Furthermore, the Pearson correlation coefficient will be used to examine the correlation of brain activation and executive function performance or gait parameters.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
39
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan
- National Taiwan University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The population in this study are heathy adults.
Description
Inclusion Criteria:
- 20-30 years (Experiment 1 & 2)
- Mini-Mental State Examination (MMSE) score greater than 24 points (Experiment 1 & 2)
- ability to walk 10 meters independently without an assistive device (Experiment 2)
Exclusion Criteria:
- any neurologic, orthopedic or psychological diseases (Experiment 1 & 2)
- color vision deficiency (Experiment 1 & 2)
- had the fall experiences within 6 months before the study (Experiment 2)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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healthy adults
This is a cross-over study with no intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Experiment 1: Executive function performance- correct response speed (CRS)
Time Frame: Day 1
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CRS is the number of correct responses per unit time (correct responses/ second)
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Day 1
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Experiment 2: Executive function performance- correct response speed (CRS)
Time Frame: Day 1
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CRS is the number of correct responses per unit time (correct responses/ second)
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Day 1
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Experiment 2: walking performance- gait speed
Time Frame: Day 1
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The unit is m/s
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Day 1
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Experiment 2: walking performance- cadence
Time Frame: Day 1
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The unit is steps/min
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Day 1
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Experiment 2: walking performance- stride length
Time Frame: Day 1
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The unit is m
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Day 1
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Experiment 2: dual task performance- dual task costs(DTC) in mobility
Time Frame: Day 1
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DTC in mobility = (single task gait speed - dual task gait speed) / single task gait speed x 100%
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Day 1
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Experiment 2: dual task performance- dual task costs(DTC) in executive function
Time Frame: Day 1
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DTC in executive function = (single task correct response speed - dual task correct response speed) / single task correct response speed x 100%
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Day 1
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Experiment 2: dual task performance- combine mean of dual task costs(DTC)
Time Frame: Day 1
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combine mean of DTC = ( DTC in mobility + DTC in executive function) / 2
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Experiment 1: Brain activation over prefrontal cortex
Time Frame: Day 1
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The unit is micro mole (μmol).
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics, including oxygenated-hemoglobin and de-oxygenated hemoglobin.
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Day 1
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Experiment 1: Brain activities over supplementary motor area
Time Frame: Day 1
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The unit is micro mole (μmol).
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics, including oxygenated-hemoglobin and de-oxygenated hemoglobin.
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Day 1
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Experiment 1: Brain activities over premotor cortex
Time Frame: Day 1
|
The unit is micro mole (μmol).
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics, including oxygenated-hemoglobin and de-oxygenated hemoglobin.
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Day 1
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Questionnaire in Chinese version
Time Frame: Day 1
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used for the participants to sort the task by the difficulty level based on their own experiences.The participants will be asked to grade the tasks from 1-10 scale.
Scale one is the simplest and 10 is the hardest.
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Day 1
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Experiment 2: Brain activities over prefrontal cortex
Time Frame: Day 1
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The unit is micro mole (μmol).
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics, including oxygenated-hemoglobin and de-oxygenated hemoglobin.
|
Day 1
|
Experiment 2: Brain activities over supplementary motor area
Time Frame: Day 1
|
The unit is micro mole (μmol).
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics, including oxygenated-hemoglobin and de-oxygenated hemoglobin.
|
Day 1
|
Experiment 2: Brain activities over premotor cortex
Time Frame: Day 1
|
The unit is micro mole (μmol).
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics, including oxygenated-hemoglobin and de-oxygenated hemoglobin.
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Day 1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2021
Primary Completion (Actual)
May 23, 2022
Study Completion (Actual)
May 23, 2022
Study Registration Dates
First Submitted
May 13, 2021
First Submitted That Met QC Criteria
May 23, 2021
First Posted (Actual)
May 27, 2021
Study Record Updates
Last Update Posted (Actual)
June 14, 2022
Last Update Submitted That Met QC Criteria
June 12, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 202103125RINC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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