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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035038
Receipt No. R000039951
Scientific Title Difference in brain activity of chopstick operation learning process in right and left hands
Date of disclosure of the study information 2018/11/27
Last modified on 2018/11/27

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Basic information
Public title Difference in brain activity of chopstick operation learning process in right and left hands
Acronym Brain activity of chopstick operation learning process in right and left hands
Scientific Title Difference in brain activity of chopstick operation learning process in right and left hands
Scientific Title:Acronym Brain activity of chopstick operation learning process in right and left hands
Region
Japan

Condition
Condition right-handed healthy subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the time series change of brain activity in learning process of chopstick operation in right and left hands using functional near infrared spectroscopy.
Basic objectives2 Others
Basic objectives -Others To clarify the time series change of the brain activity in the learning process of daily living behavior such as chopstick operation in non-dominant hand and provide new knowledge in non-dominant hand training in rehabilitation scene.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cerebral blood flow dynamics during chopstick operation learning in each of left and right hands.The region of interest for measurement is the frontal pole, the dorsolateral prefrontal cortex, the frontal eye field, premotor cortex, primary motor areaof the right and left hemisphere.
Key secondary outcomes Measure as an indicator of whether chopstick operation has been learned.Measurement is performed before and after training.The content is the number of items to move with chopsticks and the muscle activity of the extensor digitorum muscle.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 perform chopstick operation practice with right hand and left hand.Practice is perform 9 sets of 30 seconds of chopsticks operation learning.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
45 years-old >
Gender Male and Female
Key inclusion criteria Invite research targets by public invitation.
To eliminate the effects of gender, the same number of males and females participates.
To eliminate the effects of the dominant cerebral hemisphere, only a right-handed person participates.
Key exclusion criteria ・Those who have experienced actively using chopsticks with the left hand.
・Persons who have serious diseases in the head and neck.
・Persons with mental illness.
・A person who is taking medication acting on the central nervous system.
Target sample size 34

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sayori Takeda
Organization Tokyo Metropolitan University
Division name Graduate School of Human Health Sciences
Zip code
Address 7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan
TEL 09053542654
Email ppsayori_takeda@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sayori Takeda
Organization Tokyo Metropolitan University
Division name Graduate School of Human Health Sciences
Zip code
Address 7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan
TEL 09053542654
Homepage URL
Email ppsayori_takeda@yahoo.co.jp

Sponsor
Institute Tokyo Metropolitan University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 27 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 07 Month 03 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 27 Day
Last modified on
2018 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039951

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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