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CTRI Number  CTRI/2021/04/032781 [Registered on: 13/04/2021] Trial Registered Prospectively
Last Modified On: 11/04/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Smartphone usage with functional capacity in young adults 
Scientific Title of Study   Correlation of Smartphone usage with functional capacity in young adults 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dipti Geete 
Designation  Assistant professor 
Affiliation  PT School & Centre, Seth GSMC & KEM Hospital 
Address  401,PT School & Centre, Ground Floor, KEM Orthopaedic Centre, Acharya Dhonde Marg, Parel East, Mumbai 400012, Maharashtra

Mumbai
MAHARASHTRA
400012
India 
Phone  9869701464   
Fax    
Email  dipti_geete@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dipti Geete 
Designation  Assistant professor 
Affiliation  PT School & Centre, Seth GSMC & KEM Hospital 
Address  401,PT School & Centre, Ground Floor, KEM Orthopaedic Centre, Acharya Dhonde Marg, Parel East, Mumbai 400012, Maharashtra

Mumbai
MAHARASHTRA
400012
India 
Phone  9869701464  
Fax    
Email  dipti_geete@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dipti Geete 
Designation  Assistant professor 
Affiliation  PT School & Centre, Seth GSMC & KEM Hospital 
Address  401,PT School & Centre, Ground Floor, KEM Orthopaedic Centre, Acharya Dhonde Marg, Parel East, Mumbai 400012, Maharashtra

Mumbai
MAHARASHTRA
400012
India 
Phone  9869701464   
Fax    
Email  dipti_geete@yahoo.com  
 
Source of Monetary or Material Support  
PT School & Centre, Seth GSMC & KEMH 
 
Primary Sponsor  
Name  PT School Centre Seth GSMC KEMH 
Address  Acharya Donde Marg Parel Mumbai 400 012 
Type of Sponsor  Government 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 
Ms Dipti Geete  P T School & Centre Seth GSMC & KEMH   401, Physiotherapy OPD, Ground Floor, KEM Orthopaedic Centre, Acharya Donde Marg, Parel Mumbai 400 012
Mumbai
MAHARASHTRA 		 9869701464

dipti_geete@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Measuring functional capacity 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  24.00 Year(s)
Gender  Both 
Details  participants were selected from the above-mentioned age group and of both genders 
 
ExclusionCriteria 
Details  1.Musculoskeletal trauma
2.Central Nervous System involvement
3.Cardiovascular disease
4.Undergone thoracic or abdominal surgery
5.Contraindications to 6MWT [ATS Guidelines] Absolute contraindications- unstable angina or myocardial infarction during the previous month.
Relative contraindications- resting heart rate of more than 120, a systolic blood pressure of more than 180 mm Hg, a diastolic blood pressure of more than 100 mm Hg. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
6 Minute Walk Test Distance  6 Minute Walk Test Distance 
 
Secondary Outcome  
Outcome  TimePoints 
Single breath count  At Baseline 
General Recovery Time for vitals   At Baseline 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   15/04/2021 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
 Young Adults have inculcated, using the Smartphone as a part of (ADL)Activity of Daily Living. It could be for recreational or educational purposes, but it leads to drastic sedentary behavior adoption. Biomechanical changes in the upper quadrant of the body due to prolonged smartphone usage leads to musculoskeletal dysfunction. Adopting sitting postures for long-duration leads to changes in the vertebral column alignment. This postural change affects the length-tension relation of all the respiratory muscles, hence a decreased respiratory capacity. Prolonged sitting leads to changes in the cardiovascular and neuromusculoskeletal system,
due to biochemical changes and direct effects of deconditioning.
 All these systems encompass determining the functional ability of an individual.
(Aims and Methods): The study aims to find a correlation of smartphone usage with functional capacity in young adults. Fifty volunteers in the age group of 18-24 years participated in the study. Participants were first made to fill a written questionnaire regarding their physical activity behavior and smartphone usage. Smartphone usage was assessed by administering the Smartphone Addiction Proneness Scale(SAPS). Functional capacity was assessed by conducting a  6 Minute Walk Test and Single Breath Count. The distance covered and change in vitals post-test were noted.
 
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