UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041728 |
|---|---|
| Receipt number | R000047626 |
| Scientific Title | Dyscalculia Training App Exam |
| Date of disclosure of the study information | 2023/03/31 |
| Last modified on | 2023/09/11 11:52:53 |
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Basic information
Public title
Effect of training app on children with suspected dyscalculia
Acronym
Effects of dyscalculia training app
Scientific Title
Dyscalculia Training App Exam
Scientific Title:Acronym
DTA Test
Region
| Japan |
Condition
Condition
dyscalculia
Classification by specialty
| Pediatrics | Psychiatry | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to provide a training app for children who are predicted to have dyscalculia, and to verify its effect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Fluency in the task of assessing symptoms of
dyscalculia, and Numerical basic test
Key secondary outcomes
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
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Solving problems in ordinal (number series), radix (sense of quantity), and calculation (addition, subtraction, answers less than 20) in a game format. Content that can be executed in 1 minute per task is loaded with 3 levels x 20 questions in each area. By registering the individual ID, the implementation date, correct answer rate, and correct answer rate change graph are automatically recorded.
Interventions/Control_2
Set a period without training for 4weeks.
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
A child who was diagnosed with a dyscalculia at a hospital, was suspected of having a dyscalculia at school, or was assessed as having difficulty in math learning by a parent in the pre-evaluation chart and is in a regular class. Children up to the first or second grade.
Parents and their children who have written informed consent procedures and obtained their consent.
Children who have no trouble operating the training app
Key exclusion criteria
Those who cannot obtain the consent of their parents and their children.
Target sample size
80
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, Yonago City, Tottori, Japan
TEL
0859-38-6777
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
6838504
Address
36-1 Nisichou, Yonago City, Tottori, Japan
TEL
0859386868
Homepage URL
sawako-505i@tottori-u.ac.jp
Sponsor or person
Institute
Tottori University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tottori University Hospital
Address
36-1 Nisichou, Yonago City, Tottori, Japan
Tel
0859386868
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
| 2023 | Year | 03 | Month | 31 | 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
18
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
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 07 | Month | 10 | Day |
Date analysis concluded
| 2023 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 08 | Day |
Last modified on
| 2023 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047626
