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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029277
Receipt No. R000033393
Scientific Title Investigation of cognitive characteristic of children with reading difficulties.
Date of disclosure of the study information 2017/10/01
Last modified on 2017/09/25

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Basic information
Public title Investigation of cognitive characteristic of children with reading difficulties.
Acronym Investigation of cognitive characteristic of children with reading difficulties.
Scientific Title Investigation of cognitive characteristic of children with reading difficulties.
Scientific Title:Acronym Investigation of cognitive characteristic of children with reading difficulties.
Region
Japan

Condition
Condition developmental dyslexia
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate cognitive characteristic about children with the reading difficulties.
Basic objectives2 Others
Basic objectives -Others We propose the teaching method according to cognitive characteristics.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes WISC 4, LC scale for School-Age children(LCSA), Picture Vocabulary Test-Revised(PVT-R), Reading test
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 2days
WISC-4, Picture Vocabulary Test-Revised, LC scale for School-age children, Reading test
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
12 years-old >=
Gender Male and Female
Key inclusion criteria The children who are under the standard score of T-supporting program for hiragana reading skill.
Key exclusion criteria He doesn't go to school.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Tamai
Organization Osaka Medical Collage
Division name Department of Pediatrics
Zip code
Address 2-7 Daigaku-machi, Takatsuki-city Osaka
TEL 072-683-1221
Email ped001@osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoriko Akao
Organization Osaka Medical Collage
Division name Department of Pediatrics, LD center
Zip code
Address 2-7 Daigaku-machi, Takatsuki-city Osaka
TEL 072-683-1221
Homepage URL
Email yakao-omc@umin.ac.jp

Sponsor
Institute Osaka Medical Collage
Institute
Department

Funding Source
Organization Ministry of science and technology (MEXT)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Hokkaido University
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

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 01 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
2017 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 01 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
2017 Year 09 Month 25 Day
Last modified on
2017 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033393

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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