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CTRI Number  CTRI/2024/07/071370 [Registered on: 26/07/2024] Trial Registered Prospectively
Last Modified On: 23/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Physiotherapy (Not Including YOGA)
Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Impact of Online Brain Gym Exercises on Young Children at Risk of Behavioral Issues 
Scientific Title of Study   Effect Of Brain Gym Exercises Via Telerehabilitation In Toddlers And Preschoolers At Risk Of Behavioral Problems: Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Siddhi Mahesh Thakare 
Designation  Post Graduate Student 
Affiliation  KAHER Institute Of Physiotherapy 
Address  Advanced Physiotherapy center, room no 39, sagar floor, KLE Dr prabhakar kore Hospital Belgaum Karnataka 590010 Belgaum Karnataka 590010 India Belgaum KARNATAKA 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  8879889911  
Fax    
Email  siddhithakare3@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepa Metgud 
Designation  Professor, Head of Department of Pediatric Physiotherapy 
Affiliation  KAHER Institute Of Physiotherapy 
Address  Advanced Physiotherapy center, room no 39, sagar floor, KLE Dr prabhakar kore Hospital Belgaum Karnataka 590010 Belgaum Karnataka 590010 India Belgaum KARNATAKA 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  9845861236  
Fax    
Email  drdeepa_metgud@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Siddhi Mahesh Thakare 
Designation  Post Graduate Student 
Affiliation  KAHER Institute Of Physiotherapy 
Address  Advanced Physiotherapy center, room no 39, sagar floor, KLE Dr prabhakar kore Hospital Belgaum Karnataka 590010 Belgaum Karnataka 590010 India Belgaum KARNATAKA 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  8879889911  
Fax    
Email  siddhithakare3@gmail.com  
 
Source of Monetary or Material Support  
KLE Dr Prabhakar kore hospital and research center, Nehru nagar, Belagavi- 590010 Karnataka, India 
 
Primary Sponsor  
Name  Siddhi Mahesh Thakare 
Address  Advanced Physiotherapy center, room no 39, sagar floor, KLE Dr prabhakar kore Hospital Belgaum Karnataka 590010 Belgaum Karnataka 590010 India Belgaum KARNATAKA 590010 India 
Type of Sponsor  Other [Self Sponsored] 
 
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 Siddhi Thakare  KAHER Institute Of Physiotherapy  Advanced Physiotherapy center, room no 39, sagar floor, KLE Dr prabhakar kore Hospital Belgaum Karnataka 590010 Belgaum Karnataka 590010 India Belgaum KARNATAKA 590010 India
Belgaum
KARNATAKA 		 8879889911

siddhithakare3@gmail.com 
 
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  At risk of Behavioral Problems 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Brain gym excercises  Brain gym excercises will be given to intervention group for 3 days a week for 8 weeks and control group will be given parental advice 
Comparator Agent  Parental advice  Brain gym excercises will be given to intervention group for 3 days a week for 8 weeks and control group will be given parental advice  
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  Children between the age of 2 to 5 years residing in Belagavi city.
Both male and female children will be included
Children having borderline (T score 60-63) or clinical range (T score above 63) according to child behaviour checklist
Parents who consent for child’s participation in the study.
Parents having video call communication device with internet.
 
 
ExclusionCriteria 
Details  Children diagnosed with unstable medical condition.
Child unable to follow verbal commands.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Child Behavior Checklist for Ages 1.5–5 (CBCL/1½–5)  T0 at baseline and T1 at the time of post assessment at 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "31"
Final Enrollment numbers achieved (India)="31" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/08/2024 
Date of Study Completion (India) 08/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 08/03/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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   Early behavioral issues in children as they can lead to long-term mental, physical, and academic challenges hence early intervention should be given to improve long term outcomes.Brain Gym exercises, aimed at enhancing various skills, including reading, memory, and concentration, are being tested through telerehabilitation in toddlers and preschoolers at risk of behavioral problems. The study involves an experimental group receiving brain gym exercises and parental advice, while the control group only receives parental advice. The brain gym exercises will be conducted for 15-20 minutes per session, three days a week, for 8 weeks. 1st session will be given at home and following sessions through videocall supervising them. Child Behavior Checklist for children aged 1 ½ - 5 years.children aged 1 ½ - 5 years will be taken before and after the inetrvention. 
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