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
|
|
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
|
|
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.
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