UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of cognitive characteristic of children with reading difficulties.
Title of the study (Brief title)	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	Hiroshi Tamai
Organization	Osaka Medical Collage
Division name	Department of Pediatrics
Address	2-7 Daigaku-machi, Takatsuki-city Osaka
TEL	072-683-1221
Email	ped001@osaka-med.ac.jp

Public contact
Name of contact person	Yoriko Akao
Organization	Osaka Medical Collage
Division name	Department of Pediatrics, LD center
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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