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CTRI Number  CTRI/2024/09/073691 [Registered on: 10/09/2024] Trial Registered Prospectively
Last Modified On: 08/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To check the effectiveness of active brain games for children ages between 9 to 12 years old for improvement in memory, attention and concentration for their better academic performance.  
Scientific Title of Study   Effect of cognitively engaging exergame based physical activity on executive functions in pre-adolescent: A Randomized control 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  Prachi sanghvi 
Designation  MPT Scholar 
Affiliation  parul institue of physiotherapy 
Address  room n0.201 3rd floor parul institute of physiotherapy, parul university, post limda, waghodia, Gujarat Vadodara

Vadodara
GUJARAT
391760
India 
Phone  8160868033  
Fax    
Email  prachi.sanghvi05@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  joyal tejpal  
Designation  assistant professor 
Affiliation  parul institute of physiotherapy 
Address  room n0.201 3rd floor parul institute of physiotherapy, parul university, post limda, waghodia, Gujarat Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9909981454  
Fax    
Email  joyaltejpal3@gmail.com  
 
Details of Contact Person
Public Query  
Name  joyal tejpal  
Designation  assistant professor 
Affiliation  parul institute of physiotherapy 
Address  room n0.201 3rd floor parul institute of physiotherapy, parul university, post limda, waghodia, Gujarat Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9909981454  
Fax    
Email  joyaltejpal3@gmail.com  
 
Source of Monetary or Material Support  
room no. 201 3rd floor parul institue of physiotherapy , parul university post. limbda, waghodia, gujarat, india pincode:391760 
 
Primary Sponsor  
Name  prachi sanghvi 
Address  room no. 201 3rd floor parul institue of physiotherapy , parul university post. limbda, waghodia, gujarat 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
prachi sanghvi  limda primary school   limda primary school , limda at and post. limda , waghodia road , vadodara, gujarat 391760
Vadodara
GUJARAT 		 8160868033

prachi.sanghvi05@gmail.com 
prachi sanghvi  madheli primary school   madheli primary school , near main mandir , madheli , at&post. limda wagodia road ,vadodara gujarat 391760
Vadodara
GUJARAT 		 8160868033

prachi.sanghvi05@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
parul university institutional ethics committee for human research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  normal 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  cognitively engaging exergame based physical activity  A tool to combine the advantages of highly controlled PA within the field is exergaming, a portmanteau of “exercise” and “gaming”. Exergaming is active video gaming that has been proven to be physically challenging and motivating. It enables researchers to manipulate PA characteristics under controlled circumstances. Go/no-go, and Flanker tasks, letter digit span and N-back task,local–global task, and the Wisconsin card sorting task. alternate days in weeks for 4 weeks 1 hour time 
Comparator Agent  control group  physical activities alternate days in week for 4 weeks 1 hour time 
 
Inclusion Criteria  
Age From  9.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Age: 9-12 yrs.
2.Both girls and boys will be included.
3.Children with corrected or normal vision and a healthy body are deemed eligible.
4.Parents willing to sign consent form.
5.Children with normal IQ (range between 90-109) 
 
ExclusionCriteria 
Details  • Children suffering from neurological disorder that might impair their abilities.
• Children suffering from any cardio-vascular disorder
1.Children suffering from any congenital disorders that might impair their abilities.
2.Children with Development delay.
3.Children having impairment in upper limb.
4.Children with mental retardation.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Executive function Questionnaire for children
 		 Before and after intervention
 
 
Secondary Outcome  
Outcome  TimePoints 
BRIEF [Behavior rating inventory of executive function]  3 times a week
4 weeks 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   15/10/2024 
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)   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   A sedentary lifestyle and physical inactivity (insufficient exercises time) are prevalent among children and adolescents and a severe deficit of cognitive as well as executive function. There has been an increasing interest in the beneficial influence of physical activity on cognitive brain functions especially in executive function. A three-factor model of executive functions stated that inhibitory control, working memory, and cognitive flexibility are the three core executive functions. When EF are impaired, children generally show abnormalities in social functions, emotions, and cognition, often accompanied by learning difficulties, conduct disorders, and maladaptive phenomena. Thus, such cognitive abilities in the growth and development stage are undoubtedly crucial for children and adolescents. Therefore, my need of study arises to establish improvement in executive function in preschool children with help of Cognitively Engaging Exergame Based Physical Activity so that the overall development and academic performance of children can be enhanced.   
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