UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044432 |
|---|---|
| Receipt number | R000050759 |
| Scientific Title | Development of training application to children who suspect dyscalculia and arithmetic difficulty and verification of effect 2021,2022ver |
| Date of disclosure of the study information | 2021/07/20 |
| Last modified on | 2023/06/01 10:05:45 |
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Basic information
Public title
Development of training application to children who suspect dyscalculia and arithmetic difficulty and verification of effect 2021,2022ver
Acronym
Development and effect of training application to children with dyscalculia 2021,2022ver
Scientific Title
Development of training application to children who suspect dyscalculia and arithmetic difficulty and verification of effect 2021,2022ver
Scientific Title:Acronym
Development and effect of training application to children with dyscalculia 2021,2022ver
Region
| Japan |
Condition
Condition
dyscalculia
Classification by specialty
| Pediatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development and effect of training application to children with dyscalculia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Screening test for children with dyscalculia
Key secondary outcomes
Mathematical academic test
Participation rate in training
Correct answer rate of training score
Evaluation of social validity by teachers
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Using the Training App
6 minutes per day x 15 days
The use of up to 30 days
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
| 6 | years-old | <= |
Age-upper limit
| 7 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
First grade children enrolled in regular elementary school classes
Child with consent of parents / principals / homeroom teacher for research
Key exclusion criteria
Children who can not obtain consent from parents / principals / homeroom teacher for research
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Maegaki |
Organization
Tottori University Hospital
Division name
Department of Child Neurology
Zip code
6838504
Address
36-1 Nisichou, YonagoCity Tottori, Japan
TEL
0859386777
maegaki@tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Sawako |
| Middle name | |
| Last name | Ooba |
Organization
Tottori University Hospital
Division name
Work-life balance support center
Zip code
683-8504
Address
36-1 Nisichou, Yonago City, Tottori, Japan
TEL
0859386868
Homepage URL
sawako-505@tottori-u.ac.jp
Sponsor or person
Institute
Tottori University
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI Grant NumberJP20K03028
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Center for Child Health and Development
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tottori University Hospital
Address
36-1 Nishi-cho, Yonago, Tottori, Japan
Tel
0859386777
sawako-505@tottori-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 | 07 | Month | 20 | 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
Main results already published
Date of protocol fixation
| 2021 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2024 | 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
| 2021 | Year | 06 | Month | 04 | Day |
Last modified on
| 2023 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050759
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
