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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024718
Receipt No. R000028435
Scientific Title Intervention study of the visual function training for application to developmental dyslexia.
Date of disclosure of the study information 2016/11/04
Last modified on 2017/11/07

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Basic information
Public title Intervention study of the visual function training for application to developmental dyslexia.
Acronym visual function training
Scientific Title Intervention study of the visual function training for application to developmental dyslexia.
Scientific Title:Acronym visual function training
Region
Japan

Condition
Condition normal adult
Classification by specialty
Pediatrics Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The dysfunction of reading and writing in developmental dyslexia were suspected to be due to visual function.
We investigated that effect of training on visual function in normal adults, using event-related brain potential (ERP).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The amount of change of the ERP amplitude before and after the training.
Key secondary outcomes The number of the correct answers of memory and attentional task(digit span, visual memory task, reading span task, visual attention span, and reading aloud test) before and after the training.
The number of the correct answers in training performance.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 visual attention training (25 days)
Interventions/Control_2 visual working memory training (25 days)
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
18 years-old <=
Age-upper limit
29 years-old >=
Gender Male and Female
Key inclusion criteria The person that we can examine it in Hokkaido University and training of 25th is possible without rest period more than two days.

The person who agreed to a participation after informed an adequate explanation for the study.
Key exclusion criteria The person who has received a diagnosis of theNeurodevelopmental Disorders in DSM-5 until now.

The person whom experimenter judged to be inappropriate as a participant.
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukio TSCUHIDA
Organization Graduate school of medicine, University of the Ryukyus
Division name Department of Neurosurgery
Zip code
Address 207, Uehara Nishihara-cho, Okinawa 903-0215, Japan
TEL 098-895-1171
Email tsuchida@mail.ryudai.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukio TSUCHIDA
Organization Graduate school of medicine, University of the Ryukyus
Division name Department of Neurosurgery
Zip code
Address 207, Uehara Nishihara-cho, Okinawa 903-0215, Japan
TEL 098-895-1171
Homepage URL
Email tsuchida@mail.ryudai.jp

Sponsor
Institute Graduate school of medicine, University of the Ryukyus
Department of Neurosurgery
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology.
Japan society for the promotion of science.
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Graduate School of Education, 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 北海道大学大学院教育学研究院

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 04 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
There was no general effect on visual working memory (WM) and visual attention (VA) span training. In the results of event related potentials, it was suggested that WM training, rather than VA span, improved early selective attention. This study suggests that WM training is more effective than VA span, but its effect may be limited.
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
2016 Year 11 Month 16 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 16 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2017 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 11 Month 04 Day
Last modified on
2017 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028435

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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