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NCT Number: NCT04905186

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.

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Key information

Conditions

Executive Function Neurosciences

Age range

20 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

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

    Time frame: Day 1

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

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

    Time frame: Day 1

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

  3. Experiment 2: walking performance- gait speed

    Time frame: Day 1

    The unit is m/s

  4. Experiment 2: walking performance- cadence

    Time frame: Day 1

    The unit is steps/min

  5. Experiment 2: walking performance- stride length

    Time frame: Day 1

    The unit is m

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

    Time frame: Day 1

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

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

    Time frame: Day 1

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

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

    Time frame: Day 1

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

Secondary outcomes

  1. Experiment 1: Brain activation over prefrontal 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.

  2. Experiment 1: 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.

  3. 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.

  4. Questionnaire in Chinese version

    Time frame: Day 1

    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.

  5. Experiment 2: Brain activities over prefrontal 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 27, 2021
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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