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Executive FunctionNCT04905186

Different Domains of Executive Function Dual Task Walking on Brain Activation and Gait Performance in Healthy Adults

An observational study of Executive Function and Neurosciences, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Executive Function, Neurosciences
How many people
39 participants
Where
1 siteTaiwan
Study dates
1 Aug 2021to 23 May 2022
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 20 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: The population in this study are heathy adults.

Who may be able to join

  • 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)

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Taiwan University Hospital

    Taipei

Other trials in Taiwan

About this study

Official title: 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.

Keywords
executive function, dual task walking, difficulty level, brain activity, motor performance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04905186
Study groupRoleWhat they receive
healthy adultsThis is a cross-over study with no intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Experiment 1: Executive function performance- correct response speed (CRS)

    CRS is the number of correct responses per unit time (correct responses/ second)

    Measured: Day 1

  2. Experiment 2: Executive function performance- correct response speed (CRS)

    CRS is the number of correct responses per unit time (correct responses/ second)

    Measured: Day 1

  3. Experiment 2: walking performance- gait speed

    The unit is m/s

    Measured: Day 1

  4. Experiment 2: walking performance- cadence

    The unit is steps/min

    Measured: Day 1

  5. Experiment 2: walking performance- stride length

    The unit is m

    Measured: Day 1

  6. Experiment 2: dual task performance- dual task costs(DTC) in mobility

    DTC in mobility = (single task gait speed - dual task gait speed) / single task gait speed x 100%

    Measured: Day 1

  7. Experiment 2: dual task performance- dual task costs(DTC) in executive function

    DTC in executive function = (single task correct response speed - dual task correct response speed) / single task correct response speed x 100%

    Measured: Day 1

  8. Experiment 2: dual task performance- combine mean of dual task costs(DTC)

    combine mean of DTC = ( DTC in mobility + DTC in executive function) / 2

    Measured: Day 1

Secondary outcomes (7)

  1. Experiment 1: Brain activation over prefrontal cortex

    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.

    Measured: Day 1

  2. Experiment 1: Brain activities over supplementary motor area

    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.

    Measured: Day 1

  3. Experiment 1: Brain activities over premotor cortex

    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.

    Measured: Day 1

  4. Questionnaire in Chinese version

    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.

    Measured: Day 1

  5. Experiment 2: Brain activities over prefrontal cortex

    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.

    Measured: Day 1

  6. Experiment 2: Brain activities over supplementary motor area

    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.

    Measured: Day 1

  7. Experiment 2: Brain activities over premotor cortex

    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.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2021
  2. Study start1 Aug 2021
  3. Primary completion23 May 2022
  4. Study completion23 May 2022

Resources

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
Case crossover
Time perspective
Cross-sectional
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04905186
Sponsor's protocol ID
202103125RINC
Status last verified
Jun 2022
First submitted
13 May 2021
Last updated
14 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Executive Function and Neurosciences, run by National Taiwan University Hospital at 1 site in Taiwan.

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 3 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 14 Jun 2022. 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 Taiwan. 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?

Experiment 1: Executive function performance- correct response speed (CRS) (time frame: Day 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04905186.

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 14 Jun 2022.

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