UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045400 |
|---|---|
| Receipt number | R000050885 |
| Scientific Title | Research on the cerebral activity during e-sports match targeted at people with disabilities. |
| Date of disclosure of the study information | 2021/09/15 |
| Last modified on | 2024/03/10 18:15:36 |
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Basic information
Public title
Research on the cerebral activity during e-sports match targeted at people with disabilities.
Acronym
Research on the cerebral activity during e-sports match targeted at people with disabilities.
Scientific Title
Research on the cerebral activity during e-sports match targeted at people with disabilities.
Scientific Title:Acronym
Research on the cerebral activity during e-sports match targeted at people with disabilities.
Region
| Japan |
Condition
Condition
People with mental disorders (F0~F6 ICD-10), developmental disorders (F7-F9 ICD-10), or physical disability
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To provide useful information for players with mental or physical disabilities in the field of e-sports by measuring their brain functions from the standpoint of industrial health.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cerebral activity
Key secondary outcomes
subjective degree of concentration, skill in video games
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Single-player video game
Interventions/Control_2
Two-player video game match
Interventions/Control_3
Viewing the partner's video game play
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Person who can play video game without hindrance.
(2)Person with mental disorders, developmental disorders and/or physical disabilities
Key exclusion criteria
(1)Person who had experienced serious problems, such as convulsion.
(2)Person whose GAF score is less than 40.
(3)Person with gaming disorder (ICD-11).
(4)Person who are not allowed to participate in this study by the physician.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Senichiro |
| Middle name | |
| Last name | Kikuchi |
Organization
Gunma University Graduate School of Health Sciences
Division name
Department of Rehabilitation Sciences
Zip code
371-8514
Address
3-39-22, Showa-machi, Maebashi, Gunma
TEL
027-220-7111(ext.8939)
senichiro@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Senichiro |
| Middle name | |
| Last name | Kikuchi |
Organization
Gunma University Graduate School of Health Sciences
Division name
Department of Rehabilitation Sciences
Zip code
371-8514
Address
3-39-22, Showa-machi, Maebashi, Gunma
TEL
027-220-7111(ext.8939)
Homepage URL
senichiro@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Graduate School of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Onelife Cooporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Ethical Review Board for Medical Research Involving Human Subjects
Address
3-39-22, Showa-machi, Maebashi, Gunma
Tel
027-220-7111(ext.8740)
ciru_hitotaisho-irb@ml.gunma-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
| 2021 | Year | 09 | Month | 15 | 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
| 2023 | Year | 05 | Month | 01 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 07 | Day |
Last modified on
| 2024 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050885
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
