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CTRI Number  CTRI/2023/05/053315 [Registered on: 31/05/2023] Trial Registered Prospectively
Last Modified On: 20/05/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Mixed - qualitative and quantitative 
Study Design  Single Arm Study 
Public Title of Study   Psycho- social factors association with motor proficiency 
Scientific Title of Study   Development of measurement criteria for academic performance and its association with psycho- social factors and motor proficiency in physiotherapy undergraduates 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mariya Jiandani PT 
Designation  Associate Professor 
Affiliation  PT School & Center Seth GSMC & KEMH 
Address  PT School & Center Seth GSMC & KEMH 1st floor KEM Orthopaedic centre Dr Ernest Borges RD Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820191106  
Fax    
Email  mpjiandani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ankita Shripat PT 
Designation  Assistant Professor 
Affiliation  Terna Physiotherapy College 
Address  Terna Physiotherapy College
Terna Physiotherapy College
Mumbai
MAHARASHTRA
400706
India 
Phone  9321255894  
Fax    
Email  arshripat@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ankita Shripat PT 
Designation  Assistant Professor 
Affiliation  Terna Physiotherapy College 
Address  Terna Physiotherapy College
Terna Physiotherapy College
Mumbai
MAHARASHTRA
400706
India 
Phone  9321255894  
Fax    
Email  arshripat@gmail.com  
 
Source of Monetary or Material Support  
KEM Hospital and Seth GS Medical College Research Society KEM Hospital and Seth GS Medical College Acharya Donde Marg Parel Mumbai 400 012 
 
Primary Sponsor  
Name  KEM Hospital and Seth GS Medical College Research Society 
Address  KEM Hospital and Seth GS Medical College Research Society KEMH Parel 
Type of Sponsor  Government medical college 
 
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 
Dr Mariya Jiandani PT  PT School & Centre GSMC & KEMH  PT School & Centre GSMC & KEMH 1st floor kemh orthopedic centre KEMH Parel
Mumbai
MAHARASHTRA 
9820191106

mpjiandani@gmail.com 
Dr Ankita Shripat PT  Terna Physiotherapy College  Terna Physiotherapy College 3rd floor Terna medical College sector 12 Nerul
Mumbai
MAHARASHTRA 
9321255894

arshripat@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
KEMH Institutional Ethics Commmittee IEC- III  Approved 
Terna Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  none 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  26.00 Year(s)
Gender  Both 
Details  Third and Fourth Year undergraduate physiotherapy students whose age is less than 26 years from physiotherapy Colleges 
 
ExclusionCriteria 
Details  Students with locomotor disability
Students with recent physical injuries
Students with known history of cardiovascular problems in whom minimal exercise are contraindicated
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The Multidimensional Scale of Perceived Social Support
The Depression Anxiety and Stress Scale 21 Items
Bruininks Oseretsky Test of Motor Proficiency Second Edition Brief or short Form
IQ test
Self- rating scale of self directed learning
Academic Performance

 
only once 
 
Secondary Outcome  
Outcome  TimePoints 
none  NA 
 
Target Sample Size   Total Sample Size="270"
Sample Size from India="270" 
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   Phase 2 
Date of First Enrollment (India)   06/12/2023 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This study aims to explore various psycho- social factors associated with academic performance. Since, physiotherapy is a skill – based profession association with motor proficiency is also studied. Also, the study aims to develop a criteria to classify slow and advanced performers to facilitate remedial action and improve their proficiency.

The study will be conducted in 4 phases

Phase I – this phase of the study is to rationalize the need of study through a semi – structured interview to understand the perception of the physiotherapy academicians about the factors affecting academic performance.

Phase II of the study is evaluation of the third and fourth year physiotherapy students for motor proficiency, psycho – social factors, intelligence and level of self- directed learning in 3 stratified groups of students with poor, fair and good academic performance

Phase III of the study is to establish the association of all the above factors evaluated in phase II and to develop a criteria to classify slow and advanced performers based on the association.

Phase IV of the study is weigh the developed criteria to classify slow and advanced performers through a consensus method of Delphi process

 
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