UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060858 |
|---|---|
| Receipt number | R000064763 |
| Scientific Title | Effects of introducing a finger sensor game on children with developmental difficulties who use after-school day care services |
| Date of disclosure of the study information | 2026/03/06 |
| Last modified on | 2026/03/06 21:59:12 |
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Basic information
Public title
Impact of introducing hand sensor games in after-school day services
Acronym
Impact of introducing hand sensor games in after-school day services
Scientific Title
Effects of introducing a finger sensor game on children with developmental difficulties who use after-school day care services
Scientific Title:Acronym
Effects of introducing a finger sensor game on children with developmental difficulties who use after-school day care services
Region
| Japan |
Condition
Condition
Children attending after-school day services
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effects of a game intervention using hand and finger sensors for children attending after-school day care facilities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Trail Making Test(Before initiation, at the end of the 4-week intervention and 2 weeks after the end)
Key secondary outcomes
Modified Stroop Test Part,D-CAT,Span assignment,star deletion test(Before initiation, at the end of the 4-week intervention and 2 weeks after the end)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Game intervention using hand sensor(4 week)
Interventions/Control_2
How I usually spend my time
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
| 6 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Age at the time of obtaining consent is between 6 years old and 12 years old
2.Children attending after-school day services
3.Children who have agreed to participate in this study
Key exclusion criteria
1.Children with physical disabilities
2.Children with difficulty in verbal communication
3.Children who are already playing digital rehabilitation games using Leap motion at least once a month
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Yasuaki |
| Middle name | |
| Last name | Kusumoto |
Organization
Fukushima Medical University School of Health Sciences
Division name
Department of Physical Therapy
Zip code
960-8516
Address
10-6 Sakaemachi, Fukushima city, Fukushima
TEL
024-581-5503
kusumoto@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Yasuaki |
| Middle name | |
| Last name | Kusumoto |
Organization
Fukushima Medical University School of Health Sciences
Division name
Department of Physical Therapy
Zip code
960-8516
Address
10-6 Sakaemachi, Fukushima city, Fukushima
TEL
024-581-5503
Homepage URL
kusumoto@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University School of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University Ethics Review Committee
Address
Hikarigaoka 1, Fukushima City, Fukushima Prefecture
Tel
024-547-1111
fmurec@fmu.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
| 2026 | Year | 03 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 06 | Day |
Last modified on
| 2026 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000064763
