FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/08/057121 [Registered on: 31/08/2023] Trial Registered Prospectively
Last Modified On: 10/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Cluster Randomized Trial 
Public Title of Study   Comparison of effect of Brain Gym Exercise (Exercises that are training brain ) and Skipping Exercise (rope jumping) on Balance and Cognitive Function (cognitive abilities to perform a task )in adolescents.  
Scientific Title of Study   Comparison of effect of Brain Gym Exercise (BGE) and Skipping Exercise (SE) on Balance and Cognitive Function in adolescents.  
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 Archana Gore  
Designation  Assistant Professor  
Affiliation  Maharashtra University of Health Sciences  
Address  402, Physiotherapy School and Centre, Seth G. S. Medical College and KEM Hospital, OC Building, E Borges Road, opposite Tata Hospital,Parel, Mumbai 400O12

Mumbai
MAHARASHTRA
400012
India 
Phone  9082621220  
Fax    
Email  nilarch17@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chaitali S Kodam  
Designation  MPT student  
Affiliation  Physiotherapy School and Centre, Seth G. S. Medical College and KEM Hospital, Mumbai  
Address  Physiotherapy School and Centre, Seth G. S. Medical College and KEM Hospital, Acharya Donde Marg Parel, Mumbai 400O12

Mumbai
MAHARASHTRA
400012
India 
Phone  9284068525  
Fax    
Email  chaitalikodam76726@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Chaitali S Kodam  
Designation  MPT student  
Affiliation  Physiotherapy School and Centre, Seth G. S. Medical College and KEM Hospital, Mumbai  
Address  Physiotherapy School and Centre, Seth G. S. Medical College and KEM Hospital, Acharya Donde Marg Parel, Mumbai 400O12

Mumbai
MAHARASHTRA
400012
India 
Phone  9284068525  
Fax    
Email  chaitalikodam76726@gmail.com  
 
Source of Monetary or Material Support  
R. M. Bhatt School, Gokhale Society Lane , Parel Mumbai.  
 
Primary Sponsor  
Name  Self funded Chaitali Kodam  
Address  Physiotherapy School and centre, Seth G. S. Medical College and KEM Hospital Mumbai  
Type of Sponsor  Other [Government medical College student ] 
 
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 Chaitali Kodam  R. M. Bhatt High School   Classroom of 7th standard, A and B division. School building first floor
Mumbai
MAHARASHTRA 
9284068525

chaitalikodam76726@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Seth G. S. Medical College and KEM Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Balance and Cognitive function  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Brain Gym Exercise  Brain gym exercise for 30 minutes/day for 2 weeks, 5 days/week.This 30 minutes of Brain Gym exercises includes 5 minutes of warm up, 20 minutes of Brain Gym exercises and 5 minutes of cool down. The 20 minutes of BGE includes different varieties of exercises.  
Comparator Agent  Skipping exercises   Skipping exercise for 30 minutes/day for 2 weeks, 5 days/week. The 30 minutes includes 5 minutes of warm up, 20 minutes of skipping followed by 5 minutes of cool down. The 20 minutes of exercises includes alternate leg, double leg and backward skipping exercises.  
 
Inclusion Criteria  
Age From  11.00 Year(s)
Age To  13.00 Year(s)
Gender  Both 
Details  7th standard students of R M Bhatt school (Marathi medium)
Students who give their assent and parents informed consent
Both male and female students , who can read English, hindi, Marathi
 
 
ExclusionCriteria 
Details  Students with any neurological, musculoskeletal, cardiorespiratory disease
Who are not able to follow the instructions regarding skipping or brain gym exercises
Colour blindness (Ishihara chart)
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Balance by using Y Balance Test  Balance by using Y Balance Test 
 
Secondary Outcome  
Outcome  TimePoints 
Cognitive function using Stroop test   Cognitive function using Stroop test 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   15/09/2023 
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="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
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: Comparison of Effect of Brain Gym Exercise and Skipping on Balance and Cogntive Function in Adolescents. 

Adolescence (11–13 years old) is a crucial developmental stage for physiological maturation and physical fitness development. An adolescent reaches a new stage of cognitive development that moves them from the concrete mode of thinking as a child to more complex thinking processes. Cognitive function encompasses the domains of perception, attention, memory, learning, decision making and language abilities. Brain Gym exercise consists of a series of movements of the whole body that supposedly activate the brain, promote neurological repatterning, and simplify whole brain learning. Skipping is a simple, affordable and interesting activity. It promotes participation and overall physical fitness within and beyond the school setting. It is a whole-body activity that requires rhythm, coordination, agility, speed, and strength. (Hockersmith MR). Their comparative effects are not studied in literature. Thus in this study, we aim to compare the effects of brain gym exercise and skipping exrecise on balance and cognitive functions in adolescent students. The sample population includes school students of standard 7 th, divisions A and B, 30 students each. The outcome measures used are Y Balance Test to assess balance, reliability 0.681- 0.908 and validity 0.89 -0.97. Stroop colour and word test, childrens edition 2003, used to assess the processing speed, errors and inhibition to cognitive interference, test retest reliability: 0.73- 0.86, Construct vaildity: R2 = .31. The division A and B will be recruited randomly in the two intervention groups, Brain gym exercise group and Skipping exercise group intervention for 5 days a week, for two weeks. The everyday session will be of 30 minutes, which will include 5 minutes of warm up, 20 minutes of intervention and breaks, 5 minutes of cool down. The data collected will be analysed using paired t test and wilcoxon rank test. 

 
Close