UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035038 |
|---|---|
| Receipt number | 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 | 2020/06/01 21:25:35 |
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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 | Sayori |
| Middle name | |
| Last name | Takeda |
Organization
Tokyo Metropolitan University
Division name
Graduate School of Human Health Sciences
Zip code
116-8551
Address
7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan
TEL
09053542654
ppsayori_takeda@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Sayori |
| Middle name | |
| Last name | Takeda |
Organization
Tokyo Metropolitan University
Division name
Graduate School of Human Health Sciences
Zip code
116-8551
Address
7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan
TEL
09053542654
Homepage URL
ppsayori_takeda@yahoo.co.jp
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
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
Tokyo Metropolitan University
Address
7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan
Tel
0338191211
ppsayori_takeda@yahoo.co.jp
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
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 01 | Day |
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
| 2020 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039951
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| Registered date | File name |
| Research case data | |
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