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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035035
Receipt No. R000039930
Scientific Title Development of training application to children who suspect dyscalculia and arithmetic difficulty and verification of effect
Date of disclosure of the study information 2018/12/10
Last modified on 2018/11/27

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Basic information
Public title Development of training application to children who suspect dyscalculia and arithmetic difficulty and verification of effect
Acronym Development and effect of training application to children with dyscalculia
Scientific Title Development of training application to children who suspect dyscalculia and arithmetic difficulty and verification of effect
Scientific Title:Acronym Development and effect of training application to children with dyscalculia
Region
Japan

Condition
Condition dyscalculia
Classification by specialty
Psychiatry Child
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 NO
Dynamic allocation NO
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 165

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiro Maegaki
Organization Tottori University Hospital
Division name Neuropediatrics
Zip code
Address 36-1 Nishi-cho, Yonago, Tottori, Japan
TEL 0859386777
Email maegaki@tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sawako Ooba
Organization Tottori University Hospital
Division name Neuropediatrics
Zip code
Address 36-1 Nishi-cho, Yonago, Tottori, Japan
TEL 0859386775
Homepage URL
Email sawako-505@tottori-u.ac.jp

Sponsor
Institute Tottori University Hospital
Institute
Department

Funding Source
Organization JSPS KAKENHI Grant Number JP18H00167
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
Address
Tel
Email

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 就将小学校、尚徳小学校、弓ヶ浜小学校(鳥取県)

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 10 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
2018 Year 11 Month 26 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 27 Day
Last modified on
2018 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039930

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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