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CTRI Number  CTRI/2024/02/062827 [Registered on: 19/02/2024] Trial Registered Prospectively
Last Modified On: 18/02/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Prevalence of Dyslexia among primary school children in Belagavi city  
Scientific Title of Study   Prevalence of Dyslexia among primary school going children in Belagavi city - An observational study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mehreen Bandmaster 
Designation  MPT Paediatrics, Assistant professor, KAHER Institute of Physiotherapy 
Affiliation  KAHER Institute of Physiotherapy 
Address  Advanced Physiotherapy center, department of pediatric physiotherapy, room no 39, sagar floor, belgaum

Belgaum
KARNATAKA
590010
India 
Phone  8200734751  
Fax    
Email  mehreenbandmaster@klekipt.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Mehreen Bandmaster 
Designation  MPT Paediatrics, Assistant professor, KAHER Institute of Physiotherapy 
Affiliation  KAHER Institute of Physiotherapy 
Address  Advanced Physiotherapy center, department of pediatric physiotherapy, room no 39, sagar floor, belgaum

Belgaum
KARNATAKA
590010
India 
Phone  8200734751  
Fax    
Email  mehreenbandmaster@klekipt.edu.in  
 
Details of Contact Person
Public Query  
Name  Steven Dsilva 
Designation  undergraduate student(intern) 
Affiliation  KAHER Institute of Physiotherapy 
Address  Advanced Physiotherapy center, department of pediatric physiotherapy, room no 39, sagar floor, belgaum

Belgaum
KARNATAKA
590010
India 
Phone  8530207912  
Fax    
Email  spdsilva18@gmail.com  
 
Source of Monetary or Material Support  
KLE Dr Prabhakar Kore hospital and research centre, Nehru Nagar, Belgaum 
 
Primary Sponsor  
Name  KLE Academy of Higher Education And Research 
Address  Nehru Nagar Belagavi, Karnataka 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mehreen Bandmaster  KAHER Institute of Physiotherapy  Advanced Physiotherapy center, department of pediatric physiotherapy, room no 39, sagar floor, belgaum
Belgaum
KARNATAKA 		 8200734751

mehreenbandmaster@klekipt.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and ethical committee KAHER Institute of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Dyslexia 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Children attending English, kannada, marathi and hindi medium schools.
children residing in Belagavi city.
Parents of children willing to participate in the study. 
 
ExclusionCriteria 
Details  Children with hearing and speech disorders.
Children with known neurological conditions affecting higher functions.
Children with known behavioral and developmental disorders. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
DALI-DAB screening tool for ages 8-10  8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/02/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  27/02/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Title : Prevalence of Dyslexia among primary school going children in Belagavi city - An observational study


Objective : To determine the prevalence of dyslexia in primary school going children in Belagavi city using DALI-DAB screening tool.


Inclusion Criteria : Children attending English, Kannada, Marathi and Hindi medium schools in the age group of 8-10 years.
 
 Both male and female children will be included in the study. 

Children residing in Belagavi city.

Parents of the child willing to participate in the study.


Exclusion Criteria : Children with hearing and speech disorders. 

 Children with known neurological conditions affecting higher functions.

 Children with known behavioral and developmental disorders.


Outcome measures : DALI-DAB screening tool

Procedure ; 
 Ethical clearance will be obtained from the Institutional Ethical committee on the proposed study.  
Study will be registered under Clinical Trial Registry India (CTRI). Study will be started once the CTRI number will be obtained.
Permission from the school authorities will be obtained to conduct the study.
Children will be screened based on the inclusion and exclusion criteria prior to their enrolment into the study.
The study and its purpose will be explained to the parents in their vernacular language and any doubt regarding the study will be cleared.
A written informed consent in English, Kannada, Hindi, and Marathi language will be provided to the parents according to their convenience.
 Demographic data of the child like name, age, gender, date of birth, name of the school and their grade or percentage of the recent written exam will be obtained.
Parent or class teacher of the child will be given DALI-DAB screening tool and will be asked to mark the child under the components reading, writing, mathematics, communication, motor coordination, memory, and behavior.
If parents are filling, DALI-DAB tool will be sent at home of the child and they will be asked to return back the tool within 2 weeks.
 It will take up to 15-20 mins to fill all the components.
-After completion, the investigator will calculate the score and the child will be scored according to the scoring system.
-SCORING- On the middle screening tool, the English cut-off is set at 23 while the cut-off for the other three languages is set at 19.
 
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