UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047979 |
|---|---|
| Receipt number | R000054699 |
| Scientific Title | Relationship between the teaching method of the antagonistic gymnastics task and cerebral haemodynamics in the prefrontal cortex |
| Date of disclosure of the study information | 2022/06/07 |
| Last modified on | 2022/06/07 20:08:35 |
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Basic information
Public title
Relationship between the teaching method of the antagonistic gymnastics task and cerebral haemodynamics in the prefrontal cortex
Acronym
Relationship between the teaching method of the antagonistic gymnastics task and cerebral haemodynamics in the prefrontal cortex
Scientific Title
Relationship between the teaching method of the antagonistic gymnastics task and cerebral haemodynamics in the prefrontal cortex
Scientific Title:Acronym
Relationship between the teaching method of the antagonistic gymnastics task and cerebral haemodynamics in the prefrontal cortex
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the differences in cerebral haemodynamics in the prefrontal cortex during task performance and the accuracy of task performance between different teaching methods (first-person ipsilateral imitation and third-person anatomical imitation) for the antagonistic gymnastics task.
Basic objectives2
Others
Basic objectives -Others
Differences in oxygenated haemoglobin concentration due to differences in teaching
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cerebral blood flow in the prefrontal cortex.
Key secondary outcomes
Number of errors, subjective difficulty (Visual analog scale), Trail Making Test-B
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
1st person teaching.
Interventions/Control_2
Third person teaching.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Persons who have the athletic ability to perform the task
Persons who are 20 years of age or older at the time of obtaining consent
Persons who, after receiving a full explanation of their participation in the study, have given written consent of their own free will
Key exclusion criteria
Persons with a history of central nervous system disorders
Persons deemed unsuitable as subjects by the principal investigator
Target sample size
114
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Sagari |
Organization
Shinshu University
Division name
Division of Occupational Therapy School of Health Science
Zip code
3900821
Address
3-1-1 asahi matsumoto nagano japan
TEL
0263-37-2404
sagaria@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Sagari |
Organization
Shinshu University
Division name
Division of Occupational Therapy School of Health Science
Zip code
3900821
Address
3-1-1 asahi matsumoto nagano japan
TEL
0263-37-2404
Homepage URL
sagaria@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Shinshu University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Ethics Committee, Faculty of Medicine, Shinshu University
Address
3-1-1 Asahi, Matsumoto, Nagano 390-8621 JAPAN
Tel
0263-37-2572
mdrinri@shinshu-u.ac.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
| 2022 | Year | 06 | Month | 07 | 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
80
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
| 2019 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 07 | Day |
Last modified on
| 2022 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054699
