UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029277 |
|---|---|
| Receipt number | 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 15:15:17 |
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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
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
yakao-omc@umin.ac.jp
Sponsor or person
Institute
Osaka Medical Collage
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033393
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
