- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04905186
Different Domains of Executive Function Dual Task Walking on Brain Activation and Gait Performance in Healthy Adults
12. juni 2022 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
39
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Taipei, Taiwan
- National Taiwan University Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
20 år til 30 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
The population in this study are heathy adults.
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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healthy adults
This is a cross-over study with no intervention.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Experiment 1: Executive function performance- correct response speed (CRS)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Experiment 1: Brain activation over prefrontal cortex
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Questionnaire in Chinese version
Tidsramme: 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
Tidsramme: 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 supplementary motor area
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. august 2021
Primær færdiggørelse (Faktiske)
23. maj 2022
Studieafslutning (Faktiske)
23. maj 2022
Datoer for studieregistrering
Først indsendt
13. maj 2021
Først indsendt, der opfyldte QC-kriterier
23. maj 2021
Først opslået (Faktiske)
27. maj 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. juni 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. juni 2022
Sidst verificeret
1. juni 2022
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 202103125RINC
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