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CTRI Number  CTRI/2025/07/091851 [Registered on: 28/07/2025] Trial Registered Prospectively
Last Modified On: 29/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Brain Gym Exercises on skill related components among young football players - A randomized controlled trial  
Scientific Title of Study   Impact of Brain Gym Exercises on skill related components among developmental football players - A randomized controlled trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
ABS-IEC-2025-PHY-072  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shalini Prasad 
Designation  PG Student 
Affiliation  Abhinav Bindra sports medicine and research institute 
Address  Abhinav Bindra Sports Medicine and Research Institute, Department of physiotherapy, Utkal signature, Plot 269, NH5, Pahal, Bhubaneswar - 752101
Abhinav Bindra Sports Medicine and Research Institute, Department of physiotherapy, Utkal signature, Plot 269, NH5, Pahal, Bhubaneswar - 752101
Khordha
ORISSA
752101
India 
Phone  8867995105  
Fax    
Email  prasadshalini22@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shalini Prasad 
Designation  PG Student 
Affiliation  Abhinav Bindra Sports Medicine and Research Institute. 
Address  Abhinav Bindra Sports Medicine and Research Institute, Department of Physiotherapy, Utkal signature, Plot 273, Pahal, Bhubaneswar - 752101
Abhinav Bindra Sports Medicine and Research Institute, Department of Physiotherapy, Utkal signature, Plot 273, Pahal, Bhubaneswar - 752101
Khordha
ORISSA
752101
India 
Phone  08867995105  
Fax    
Email  prasadshalini22@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sunanda Bhowmik  
Designation  Assistant Professor 
Affiliation  Abhinav Bindra Sports Medicine and Research Institute 
Address  Abhinav Bindra Sports Medicine and Research Institute, Department of Physiotherapy, Utkal signature, Plot 273, Pahal, Bhubaneswar - 752101
Abhinav Bindra Sports Medicine and Research Institute, Department of Physiotherapy, Utkal signature, Plot 273, Pahal, Bhubaneswar - 752101
Khordha
ORISSA
752101
India 
Phone  8794839020  
Fax    
Email  sunanda@absmari.com  
 
Source of Monetary or Material Support  
STUDY SITE: JUNIOR GALLANT CLUB, Regd: 14061/411 Affiliated with Football Association of Odisha Baunsgalli, Cuttack, Odisha 
 
Primary Sponsor  
Name  Shalini Prasad Self 
Address  Abhinav Bindra Sports Medicine and Research Institute, Utkal Signature, plot 269, NH5, Pahal, Bhubaneswar - 752101 
Type of Sponsor  Other [] 
 
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 
Miss Jasmine  Mothers Public School  NH-16,Balianta,Bhubaneswar,752101
Khordha
ORISSA 		 7077697949

mothers.pahal@mothers.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ABSMARI ETHICS Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Developmental football players with 6-12 years of age group. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Group  Conventional group will perform 15 minutes of Warm Up followed 40 minutes of general self-administered stretches and coordination exercises. 
Intervention  Experimental Group  Experimental Group: first a 15-minute warm-up will be done followed by a session of Brain gym exercises for 40 minutes. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1)Age group (06-12)
2)Male & Female Both
3)MMSE Score- 24-30
4)Able to follow commands related to study
5)BMI greater than or equal to 18.5 to 24.9 kg/m^
 
 
ExclusionCriteria 
Details  1)Clinically diagnosed with Mental Disorders
2)Currently going through any Musculoskeletal Injuries
3)Pre-existing cognitive impairments
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1) Illinois change of direction test
2) Batak Lite Reaction Test 		 first assessment will be taken at baseline followed by re-assessment at 4 week following intervention.
1) Baseline
2) 4th Week  
 
Secondary Outcome  
Outcome  TimePoints 
Juggling Test   First assessment will be taken at baseline & re-assessment will be taken after 4 weeks following intervention.
1) Baseline
2) 4th Week 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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)   06/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 12-05-2025 and end date provided 12-11-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   The study conducts a Pre-Post Intervention randomized controlled trial. subjects will be divided into 2 groups i.e. exp. Group and other conventional group. All the participants will be informed about Brain Gym Exercises, after familiarization session, Pre-Test scoring will be done. Then Exp. group will be provided by brain Gym Exercises protocol for 4 weeks and parallelly conventional group will be performing self-administered stretches and coordination exercises. After 4 weeks of intervention Post test scoring will be done.   
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