UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057426 |
|---|---|
| Receipt number | R000065618 |
| Scientific Title | Verification of the effects of video games using data gloves on changes in cognitive and motor performance and their effects on the central nervous system |
| Date of disclosure of the study information | 2025/03/28 |
| Last modified on | 2025/03/27 18:17:09 |
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Basic information
Public title
Verification of the effects of video games using data gloves on changes in cognitive and motor performance and their effects on the central nervous system
Acronym
Investigating the effects of video game interventions on cognitive and motor performance
Scientific Title
Verification of the effects of video games using data gloves on changes in cognitive and motor performance and their effects on the central nervous system
Scientific Title:Acronym
Verification of the effects of video games on changes in cognitive and motor performance and their central nervous system
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to demonstrate the effectiveness of interventions using video games using measures of coordinated movement, neuropsychological indicators, and neurophysiological indicators. We hypothesize that video games using data gloves will have a stronger effect on improving cognitive performance, including coordinated movement and attention functions, and activating related brain functions than video games using controllers, and we will conduct a randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Coordination test scores at the first visit and one month after the intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Video games using data gloves
Interventions/Control_2
Video games using controllers
Interventions/Control_3
placebo
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
| 6 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(a) The subject has normal corrected vision.
(b) The subject is between 6 and 64 years of age at the time of registration.
(c) If the subject is 16 years of age or older, informed consent has been obtained for participation in the study.
Key exclusion criteria
(a) Those with neurological or orthopedic disorders that make voluntary movement of the limbs difficult
(b) Those with visual, hearing, or intellectual impairments (IQ below 70) that may interfere with the execution of the research tasks
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Irie |
Organization
Kyoto University
Division name
Human Health Science
Zip code
6068507
Address
53 Shogoin Kawaramachi, Sakyo-ku, Kyoto City
TEL
0757533968
irie.keisuke.8n@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Irie |
Organization
Kyoto University
Division name
Human Health Science
Zip code
6068507
Address
53 Shogoin Kawaramachi, Sakyo-ku, Kyoto City
TEL
0757513968
Homepage URL
irie.keisuke.8n@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
KURA-ZEMI,Co.,Ltd
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
Kyoto University
Address
53 Shogoin Kawaramachi, Sakyo-ku, Kyoto City
Tel
0757513968
irie.keisuke.8n@kyoto-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
| 2025 | Year | 03 | Month | 28 | 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
| 2025 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 27 | Day |
Last modified on
| 2025 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065618
