NCT04905186

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

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

May 13, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 27, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2022

Completed
Last Updated

June 14, 2022

Status Verified

June 1, 2022

Enrollment Period

10 months

First QC Date

May 13, 2021

Last Update Submit

June 12, 2022

Conditions

Keywords

executive functiondual task walkingdifficulty levelbrain activitymotor performance

Outcome Measures

Primary Outcomes (8)

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

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

    Day 1

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

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

    Day 1

  • Experiment 2: walking performance- gait speed

    The unit is m/s

    Day 1

  • Experiment 2: walking performance- cadence

    The unit is steps/min

    Day 1

  • Experiment 2: walking performance- stride length

    The unit is m

    Day 1

  • 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%

    Day 1

  • 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%

    Day 1

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

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

    Day 1

Secondary Outcomes (7)

  • Experiment 1: Brain activation over prefrontal cortex

    Day 1

  • Experiment 1: Brain activities over supplementary motor area

    Day 1

  • Experiment 1: Brain activities over premotor cortex

    Day 1

  • Questionnaire in Chinese version

    Day 1

  • Experiment 2: Brain activities over prefrontal cortex

    Day 1

  • +2 more secondary outcomes

Study Arms (1)

healthy adults

This is a cross-over study with no intervention.

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The population in this study are heathy adults.

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2021

First Posted

May 27, 2021

Study Start

August 1, 2021

Primary Completion

May 23, 2022

Study Completion

May 23, 2022

Last Updated

June 14, 2022

Record last verified: 2022-06

Locations