UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035035
Receipt number 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 2023/06/01 10:02:52

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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 Yoshihiro
Middle name
Last name Maegaki

Organization

Tottori University Hospital

Division name

Neuropediatrics

Zip code

6838504

Address

36-1 Nishi-cho, Yonago, Tottori, Japan

TEL

0859386777

Email

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

Neuropediatrics

Zip code

6838504

Address

36-1 Nishi-cho, Yonago, Tottori, Japan

TEL

0859386775

Homepage URL


Email

sawako-505@tottori-u.ac.jp


Sponsor or person

Institute

Tottori University Hospital

Institute

Department

Personal name



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

Tottori University Hospital

Address

36-1 Nishi-cho, Yonago, Tottori, Japan

Tel

0859386777

Email

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

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

https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000039930

Publication of results

Partially published


Result

URL related to results and publications

not posted

Number of participants that the trial has enrolled

18

Results

The results of the numerical basic strength test before and after training showed no statistically significant difference between the two groups. Addition (training group( r )= -0.54, control group r = -0.22) was effective only in the training group. There was no difference between the sequence tasks (training group( r )= -0.42, control group( r)= -0.37) and subtraction (training group (r)=-0.24, control group( r)=-0.14).

Results date posted

2021 Year 11 Month 29 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

9 first graders and 9 second graders. All were enrolled in regular classes. Of the first graders, one has language delay and one has dyscalculia. One of the second graders with dyslexia and one with ADHD.

Participant flow

Randomly assigned: 18
Excluded after randomization: 0
Experiment group: Tracked: 4 Untraceable: 5
Control group: Tracked: 5 Untraceable: 4

Adverse events

None

Outcome measures

A Numerical Fundamental Force Test (NFFT)

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 11 Month 26 Day

Date of IRB

2018 Year 11 Month 26 Day

Anticipated trial start date

2018 Year 11 Month 30 Day

Last follow-up date

2020 Year 01 Month 30 Day

Date of closure to data entry

2020 Year 02 Month 20 Day

Date trial data considered complete

2020 Year 02 Month 20 Day

Date analysis concluded

2020 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 11 Month 27 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=R000039930


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name