UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050441 |
|---|---|
| Receipt number | R000057450 |
| Scientific Title | Effect of ipsilateral movement using the health appliance Solar Pole on brain activity |
| Date of disclosure of the study information | 2023/03/01 |
| Last modified on | 2023/02/27 19:12:11 |
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Basic information
Public title
Effect of ipsilateral movement using the health appliance Solar Pole on brain activity
Acronym
Effect of ipsilateral movement using the health appliance Solar Pole on brain activity
Scientific Title
Effect of ipsilateral movement using the health appliance Solar Pole on brain activity
Scientific Title:Acronym
Effect of ipsilateral movement using the health appliance Solar Pole on brain activity
Region
| Japan |
Condition
Condition
Healthy subject
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Solar Pole is a health appliance designed based on "cognitive movement training" by Dr. Hiromichi Kobayashi, professor emeritus of the University of Tokyo.
So far, there have been research reports on the improvement of prefrontal cortex activity and cognitive ability by improving physical function, but the relationship between physical exercise and cognitive ability by this health appliance, Solar Pole, is still unknown. Therefore, in this study, we decided to evaluate the activity of the prefrontal cortex during body movements using Solar Pole in healthy young subjects.
If the results of this study show a relationship between physical exercise and prefrontal cortex activity, it will lead to more appropriate use of the health appliance Solar Pole.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of prefrontal cortex activity associated with ipsilateral movement using a solar pole
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
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
Ipsilateral movements of limbs using the health appliance Solar Pole
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
| 24 | years-old | <= |
Age-upper limit
| 34 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy young people aged 24 to 34 years.
Key exclusion criteria
Subjects who have physical and/or mental/psychological difficulties with ipsilateral exercises using Solar Pole and those who have a history of such problems are excluded.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Michiharu |
| Middle name | |
| Last name | Shimosaka |
Organization
Nihon University
Division name
School of Dentistry at Matsudo
Zip code
271-8587
Address
Sakae-cho nishi 2-870-1, Matudo, Chiba, Japan
TEL
0473609386
ishii.tomohiro@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Ishii |
Organization
Nihon University
Division name
School of Dentistry at Matsudo
Zip code
271-8587
Address
Sakae-cho nishi 2-870-1, Matudo, Chiba, Japan
TEL
0473609386
Homepage URL
ishii.tomohiro@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Tomohiro Ishii
Funding Source
Organization
others
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University School of Dentistry at Matsudo
Address
Sakae-cho Nishi 2-870-1, Matsudo, Chiba,Japan
Tel
0473609386
ishii.tomohiro@nihon-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
| 2023 | Year | 03 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 03 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 27 | Day |
Last modified on
| 2023 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057450
