UMIN-CTR Clinical Trial

Basic information
Public title	The Effectiveness of Indigenous Pattern of Perceptual Enrichment and Its Effectiveness with Fernald's Method on Improving the Ability to Read &dyslexia in Children in the Third Grade Elementary School of Hamadan
Acronym	The Effectiveness of Indigenous Perceptual Enrichment Pattern and Fernald's Method on Reading Ability& dyslexia
Scientific Title	The Effectiveness of Indigenous Pattern of Perceptual Enrichment and Its Effectiveness with Fernald's Method on Improving the Ability to Read & dyslexia in Children in the Third Grade Elementary School of Hamadan
Scientific Title:Acronym	Reading Ability& dyslexia
Region	Asia(except Japan)

Condition
Condition	9-year-old boy students
Classification by specialty	Psychiatry Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The Effectiveness of Indigenous Perceptual Enrichment Pattern and The Effectiveness of Fernald's Method on Improving Reading Ability & dyslexia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Phase I

Assessment
Primary outcomes	The indigenous pattern of perceptual enrichment and effectiveness of Fernald's method is effective in improving reading ability
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
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	5
Purpose of intervention	Treatment
Type of intervention	Behavior,custom Other
Interventions/Control_1	Pre-test 9-year-old boy students will first be taken.
Interventions/Control_2	The9-year-old boy students in the study were divided into control and experimental groups.
Interventions/Control_3	The intervention is performed on the experimental group and the control group does not receive any treatment.
Interventions/Control_4	Implement a perceptual enrichment model and related training package, as well as implement the Fernald Data method
Interventions/Control_5	Running time will be Twenty-one sessions sessions in group, once a week.
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	9 years-old <=
Age-upper limit	9 years-old >=
Gender	Male
Key inclusion criteria	Having diagnostic criteria for dyslexia based on the diagnostic and statistical guide of mental disorders of the fifth edition. 2- Gaining the lowest reading score based on reading test and facade dyslexia. 3- Being in the third grade and having nine years. 4- Having an IQ of 90 to 120 based on Raven's intelligence scale. 5 - Boy sex 6 - No other disorder or physical illness 7 - Do not take drugs such as Ritalin and Risperidone. And 8- no parallel treatment
Key exclusion criteria	Under the age of nine, having an IQ of less than 90 to 120, based on Raven's IQ, Being a Girl, taking medications such as Ritalin and Risperidone, having no parallel treatment.
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Hamid Middle name Last name Taher Neshatdoost
Organization	Faculty of Humanities Isfahan
Division name	Assistant Professor
Zip code	8498139366
Address	Isfahan Gate Shiraz University of Isfahan Department of PsychologyPsychologyProfessor
TEL	00989139757808
Email	h.neshat@edu.ui.ac.ir

Public contact
Name of contact person	1st name Hamid Reza Middle name Last name Salehi
Organization	Educational PsychologyAzad of Isfaha
Division name	Faculty of Humanities
Zip code	8357139098
Address	Islamic Azad University, Isfahan Branch (Khorasgan), Khorasgan, Isfahan, Iran.
TEL	00989133105922
Homepage URL
Email	mitra.752001@yahoo.com

Sponsor
Institute	Hamid Reza Salehi & Khorasgan Islamic Azad University
Institute
Department

Funding Source
Organization	Hamid Reza Salehi & Khorasgan Islamic Azad University
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization	Iran

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	University khorasghan
Address	University blvd . Purple. East Jay Street. Esfahan
Tel	00989133105922
Email	mitra.752001@yahoo.com

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	2021 Year 01 Month 03 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	2020 Year 05 Month 08 Day
Date of IRB	2020 Year 05 Month 18 Day
Anticipated trial start date	2020 Year 08 Month 10 Day
Last follow-up date	2020 Year 11 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 07 Month 03 Day
Last modified on	2020 Year 07 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046807

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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