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CTRI Number  CTRI/2023/07/054631 [Registered on: 03/07/2023] Trial Registered Prospectively
Last Modified On: 25/10/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   To know the number of school children who face problem in learning and to give exercise program to check whether it can help them get good marks in school.  
Scientific Title of Study   Prevalence of Learning Difficulties in school children and effect of Physical Activity on their Academic Performance 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Payal Mehta 
Designation  Assistant Professor 
Affiliation  Veer Narmad South Gujarat University 
Address  SPB Physiotherapy College, Ugat Bhesan road, Jahangirabad, Morabhagal, Surat

Surat
GUJARAT
395004
India 
Phone  7567926567  
Fax    
Email  mpayal1989@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neeta Vyas 
Designation  Professor 
Affiliation  P P Savani University 
Address  P P Savani University, NH 8, GETCO, Near BILTECH Company, Dhamdod, Kosamba, Surat

Surat
GUJARAT
394125
India 
Phone  93281277119  
Fax    
Email  neetavyassbb@gmail.com  
 
Details of Contact Person
Public Query  
Name  Payal Mehta 
Designation  Assistant Professor 
Affiliation  Veer Narmad South Gujarat University 
Address  SPB Physiotherapy College, Ugat Bhesan road, Jahangirabad, Morabhagal, Surat

Surat
GUJARAT
395004
India 
Phone  7567926567  
Fax    
Email  mpayal1989@gmail.com  
 
Source of Monetary or Material Support  
L P Savani Vidhyabhavan School 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 
Mrs Mita Vakil  Bhulka Vihar School  Bhulka Vihar School, Block no 624, Hazira road, Nr Pal Haveli, Bhatha , Surat, 394510
Surat
GUJARAT 		 9825135099

bhulkavihar455@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PPSU Ethical Review Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Physical Activity  jumping, running, stair climbing, pull and push activities, general stretching. 3 times a week for 6 weeks 
Intervention  Physical Activity  Core muscle exercises 3 times a week for 6 weeks 
 
Inclusion Criteria  
Age From  9.00 Year(s)
Age To  13.00 Year(s)
Gender  Both 
Details  School students willing to participate in the study. 
 
ExclusionCriteria 
Details  Visual and hearing disability, Physically handicap, Diagnosed Learning Disability, Diagnosed Mental Retardation, presence of
cardiovascular or respiratory diseases; head or spinal
injury; vestibular, or balance disorders and refusal of a child or
corresponding parents to participate 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
School Exam Results (Standardized Achievement Tests)  Baseline screening, 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
None  None 
 
Target Sample Size   Total Sample Size="385"
Sample Size from India="385" 
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)   15/07/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Prevalence of Learning Difficulties in School children and effect of Physical Activity on their Academic Performance.
Submitted by: Dr Payal Mehta
Supervised by: Dr Neeta Vyas
Name and Address of Work place: SPB Physiotherapy College, Ugat Bhesan road, Surat
Background: A Learning Difficulty refers to  a difficulty in learning that’s more specific and not global. Conditions like Dyslexia, Dyspraxia, Dyscalculia and Dysgraphia are all considered ‘Learning Difficulties’, they wouldn’t normally affect a person’s overall intelligence. Very few studies show effect of Physical Activity on Academic Performance of these children.
Aim: To find out the Prevalence of Learning Difficulties in school children in Surat(South Gujarat) and give them Core muscle exercises to see effect on their Academic Performance.
Methods: Phase I- Prevalence study. Find out number of school students(age 9 to 13 years) with Learning Difficulties by Learning Difficulties Screening Tool
Phase II- Interventional study. School exam results of the screened children will be assessed. These children will be divided equally into 2 groups by Odd Even method. One group will receive conventional physical activity while the other group will receive Core muscle exercises for 6 weeks. Again school results will be assessed (Standardized Achievement Test)
Possible Outcomes: School exam results(Standardized Achievement Test)
Keywords: Learning Difficulties, Physical Activity, core muscle exercises, School children
 
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