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CTRI Number  CTRI/2024/07/070954 [Registered on: 22/07/2024] Trial Registered Prospectively
Last Modified On: 21/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   How Brain Gym Exercises Can Boost Cognitive Function and Brain Health in Mobile Addicts 
Scientific Title of Study   Effect of Brain Gym Exercises on cognitive performance and Brain Derived Neurotrophic Factor levels in Mobile Addicts - A Pre- Post Experimental 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  Chilka Ruchita sushilkumar 
Designation  Post graduate  
Affiliation  KAHER Institute of Physiotherapy, Belagavi 
Address  Room no. 19, Neurophysiotherapy OPD, KAHER Institute of Physiotherapy, Nehru Nagar, Belagavi

Solapur
MAHARASHTRA
413005
India 
Phone  9606405575  
Fax    
Email  ruchitachilka2@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Raghavendrasingh Dharwadkar 
Designation  Assistant Professor 
Affiliation  KAHER Institute of Physiotherapy, Belagavi 
Address  Room no. 19, Department of Neurophysiotherapy, KAHER Institute of Physiotherapy, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9886288225  
Fax    
Email  raghavendrasingh@klekipt.edu.in  
 
Details of Contact Person
Public Query  
Name  Raghavendrasingh Dharwadkar 
Designation  Assistant Professor 
Affiliation  KAHER Institute of Physiotherapy, Belagavi 
Address  Room no. 19, Department of Neurophysiotherapy, KAHER Institute of Physiotherapy, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9886288225  
Fax    
Email  raghavendrasingh@klekipt.edu.in  
 
Source of Monetary or Material Support  
KLE Academy of Higher Education and Research, Nehru Nagar, Belagavi 590010, Karnataka, India 
 
Primary Sponsor  
Name  KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH 
Address  NEHRU NAGAR, BELAGAVI 
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 
Ruchita Chilka  KLEs DR. Prabhakar Kore Hospital and Research Center  Room no. 19, Department of Neurophysiotherapy, Nehru Nagar, Belagavi, 590010, Karnataka, India
Belgaum
KARNATAKA 		 9606405575

ruchitachilka2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KLE Academy of Higher Education  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Mobile Addicts 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Brain Gym Exercises  Brain Gym Exercises will be given for 3 times a week for 4 weeks 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Willingness of Participants,
Mobile addicts of age group 18-25 of all genders with scores more than 31 in females n 33 in males in SV-SAS scale,
Cognitive scores less than 400 in CogniFit app.
 
 
ExclusionCriteria 
Details  Individual with preexisting neurological condition
Any auditory or visual disorder
Previous history of depression and psychosis
On medications for psychological conditions
Fear of needles and/or blood


 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Brain Derived Neurotrophic Factor
Cognition Score 		 Baseline and 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="39"
Sample Size from India="39" 
Final Enrollment numbers achieved (Total)= "39"
Final Enrollment numbers achieved (India)="39" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/07/2024 
Date of Study Completion (India) 01/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 01/04/2025 
Estimated Duration of Trial   Years="0"
Months="10"
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
Modification(s)  		 Smartphone addiction is the excessive use of smartphones despite awareness of their consequences, leading to withdrawal symptoms and negative effects on mental health. Symptoms include problems in dangerous situations, social conflicts, loss of interest in other activities, and continuing behaviors despite negative effects. Excessive smartphone use can lead to stress, depression, sleep deprivation, decreased academic performance, reduced cognitive capacity, dissatisfaction with life, and poor quality of life.

Neuroplasticity, the ability of the brain to change its neural structure and function in response to environmental stimuli, is crucial for brain health. High levels of BDNF suggest better brain health. Cognitive function, which includes knowledge, attention, memory, judgment, language ability, computing power, space-time orientation ability, and reasoning ability, can be affected by smartphone use.

Researchers have found that exercises like aerobic exercises, cognitive training, mindfulness, resistance training, dual-task training, neurobic exercises, and brain gym exercises have an impact on various brain functions in both patients with neurological conditions and healthy individuals. Brain Gym, a structured nonaerobic physical exercise intervention, is believed to improve perception and stimulate the brain hemispheres, promoting faster communication and higher-level reasoning.

AIM:

To determine the effect of Brain Gym Exercises on cognitive performance and Brain Derived Neurotrophic Factor levels in Mobile Addicts.

OBJECTIVE:

To determine the effect of Brain Gym Exercises on cognitive performance using game based app and on neuroplasticity by studying Brain Derived Neurotrophic Factor levels in Mobile Addicts.

HYPOTHESIS

  • NULL HYPOTHESIS:

Brain Gym Exercises may not have an effect on cognitive performances and Brain Derived Neurotrophic Factor levels in Mobile Addicts.

  • ALTERNATE HYPOTHESIS:

Brain Gym Exercises may have an effect on cognitive performances and Brain Derived Neurotrophic Factor levels in Mobile Addicts.

      Study Type: Pre and Post Experimental Trial

Study Design: Interventional Study

Target Population: Mobile Addicts  of all genders

Age Group: 18-25 years

      Duration of Study: 12 months

      Sampling Design: Non- Probability Sampling

Sampling technique: Convenience sampling

Sampling Size: 39

OUTCOME MEASURES

·         BDNF levels- BDNF is a neurotrophin which plays role in neuronal survival, neurogenesis, synaptogenesis, and neuroplasticity.

 A higher level in BDNF would be related to better brain health.

 It is been reported that BDNF can across the blood-brain barrier, which is the membrane between brain and bloodstream, and there was a positive correlation between serum and cortical BDNF levels.

Therefore, the peripheral measurement of BDNF could be used to indicate the central BDNF levels

·         Cognition scores- To check the cognition a game based app named CogniFit is used.

Cronbach’s Alpha –above 7

The cognitive score is an aggregate measure of the current cognitive strength of different cognitive skills. The minimum cognitive score is 0 and the maximum is 800.

Score between 0 - 200: Below the average of your age.

Score between 200 - 400: Low scores, although within the average.

Score between 400 - 600: High scores within the average.

Score between 600 - 800: Cognitive situations above the average.

PROCEDURE

·         Prior to the commencement of the study, Ethical clearance will be obtained from institutional ethical committee.

·         According to ICMR guidelines the following research will be conducted as it involves human participation.

·         The study will be registered in Clinical Trials Registry- India (CTRI) after Ethical Clearance.

·         Subjects who fulfill the inclusion criteria will be recruited for the study after they provide the written consent for the same.

·         Initially, the cognition scores and BDNF levels of each participants obtained.

·         Then, the subjects will undergo intervention of Brain Gym Exercises. Subjects will be given detailed information about brain gym exercises. All the exercises will be taught to the participants.

·         A set of 10 exercises will be given 3 times a week for 4 weeks.10

·         The Brain Gym Exercises include

Marching at place

1 min

Cross Crawl

2 min (5 sets 8 reps)

Positive points

1 min (10 reps)

Step touch

5 mins (30 reps)

Neck Circles

2 mins (20 reps)

 

 

Cook’s Hook ups

 

5 mins

 

Brain Buttons

 

2 mins (10 reps)

 

Thinking Caps

 

1 min (15 reps)

 

Lazy Eight

 

1 min (5 sets)

 

Trace X

 

2 mins (10 reps)

 

 

·         Post Intervention Cognition scores and BDNF levels will be obtained.

·         The data collected will be statistically analyzed.



 
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