UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040993
Receipt number R000046807
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
Date of disclosure of the study information 2021/01/03
Last modified on 2020/07/03 01:12:05

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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 or person

Institute

Hamid Reza Salehi & Khorasgan Islamic Azad University

Institute

Department

Personal name



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

Value
https://center6.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