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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04905186
Other study ID # 202103125RINC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2021
Est. completion date May 23, 2022

Study information

Verified date June 2022
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date May 23, 2022
Est. primary completion date May 23, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Experiment 1: Executive function performance- correct response speed (CRS) CRS is the number of correct responses per unit time (correct responses/ second) Day 1
Primary Experiment 2: Executive function performance- correct response speed (CRS) CRS is the number of correct responses per unit time (correct responses/ second) Day 1
Primary Experiment 2: walking performance- gait speed The unit is m/s Day 1
Primary Experiment 2: walking performance- cadence The unit is steps/min Day 1
Primary Experiment 2: walking performance- stride length The unit is m Day 1
Primary 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
Primary 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
Primary 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 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. Day 1
Secondary 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. Day 1
Secondary 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. Day 1
Secondary 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. Day 1
Secondary 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. Day 1
Secondary 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. Day 1
Secondary 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. Day 1
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