UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060102 |
|---|---|
| Receipt number | R000068740 |
| Scientific Title | The Effects of Using a Gesture Rhythm Game on Children's Motor and Cognitive Functions: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/12/17 |
| Last modified on | 2025/12/17 10:14:44 |
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Basic information
Public title
The Effects of Using a Gesture Rhythm Game on Children's Motor and Cognitive Functions: A Randomized Controlled Trial
Acronym
Examining the Effects of Gesture Rhythm Games on Children's Motor Skills and Cognitive Functions
Scientific Title
The Effects of Using a Gesture Rhythm Game on Children's Motor and Cognitive Functions: A Randomized Controlled Trial
Scientific Title:Acronym
Examining the Effects of Gesture Rhythm Games on Children's Motor Skills and Cognitive Functions
Region
| Japan |
Condition
Condition
Typically developing children, Developmental Coordination Disorder
Classification by specialty
| Pediatrics | Psychiatry | Rehabilitation medicine |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to verify the effectiveness of the Gesture Rhythm Game. Specifically, it aims to verify improvements in motor function, such as finger dexterity, and cognitive function, such as attention and motor imagery ability. Furthermore, it aims to verify increased activity in the DLPFC as a neurophysiological indicator of the mechanism of action.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT-2) Fine Motor Precision, Fine Motor Integration, Manual Dexterity, Bilateral Coordination
Key secondary outcomes
Gesture Rhythm Game Assessment
Grip Strength/Pinching Strength
Writing Task Assessment
Comprehensive Cognitive Function: Das-Naglieri Cognitive Assessment System (DN-CAS)
Attention Function: Test of Variables of Attention (TOVA)
Visuospatial Cognition: Mental Rotation
Pulse Wave Measurement
NIRS Measurement
Child's Quality of Life: Child Questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The gesture rhythm game operates by connecting a computer to Leapmotion. Tasks include mimicking finger movements, rock-paper-scissors, and losing rock-paper-scissors, all requiring rhythmic motion. Scores are calculated using a unique algorithm based on the task. Difficulty levels can be adjusted according to the participant's score, and multiple stages are prepared.The intervention group will perform the gesture rhythm game for 30 minutes per session, up to four times per week, for five weeks.
Interventions/Control_2
As a standby group, activities other than the gesture rhythm game were conducted.
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
| 5 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Aged 5 to 12 years old
Key exclusion criteria
Individuals with intellectual or visual disabilities who are unable to understand and perform gesture rhythm games
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Irie |
Organization
Kyoto University
Division name
Clinical Cognitive Neuroscience, Advanced Occupational Therapy, Human Health Sciences, Graduate School of Medicine
Zip code
606-8507
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto 606-8507
TEL
075-751-3968
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
Clinical Cognitive Neuroscience, Advanced Occupational Therapy, Human Health Sciences, Graduate Scho
Zip code
606-8507
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3968
Homepage URL
irie.keisuke.8n@kyoto-u.ac.jp
Sponsor or person
Institute
Clinical Cognitive Neuroscience, Advanced Occupational Therapy, Human Health Sciences, Graduate School of Medicine, 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 Graduate School of Medicine, Faculty of Medicine, and University Hospital Medical Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo Ward, Kyoto City, Kyoto Prefecture
Tel
075-753-4680
ethcom@kuhp.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 | 12 | Month | 17 | 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
| 2026 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2026 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2026 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 17 | Day |
Last modified on
| 2025 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068740
