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CTRI Number  CTRI/2021/09/036494 [Registered on: 14/09/2021] Trial Registered Prospectively
Last Modified On: 28/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Comparison of dominant and non dominant leg in male football players and correlation of factor affecting single leg squat.  
Scientific Title of Study   Correlation of muscular strength and balance in relation to single leg squat analysis in male football players – an observational descriptive study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mrugnayani Patil 
Designation  PG Student 
Affiliation  MGM Institute of Physiotherapy 
Address  Division 3 Sports Physiotherapy OPD MGM Institute of Physiotherapy N6 Cidco Aurangabad
Division 3 Sports Physiotherapy OPD MGM Institute of Physiotherapy N6 Cidco Aurangabad
Aurangabad
MAHARASHTRA
431003
India 
Phone  8208765169  
Fax    
Email  mrugnayanipatil19@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sarath Babu 
Designation  PhD 
Affiliation  MGM Institute of Physiotherapy 
Address  Division 3 Sports Physiotherapy OPD MGM Institute of Physiotherapy N6 Cidco Aurangabad
Division 3 Sports Physiotherapy OPD MGM Institute of Physiotherapy N6 Cidco Aurangabad
Aurangabad
MAHARASHTRA
431003
India 
Phone  9309148769  
Fax    
Email  sharathcrisp@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sarath Babu 
Designation  PhD 
Affiliation  MGM Institute of Physiotherapy 
Address  Division 3 Sports Physiotherapy OPD MGM Institute of Physiotherapy N6 Cidco Aurangabad
Division 3 Sports Physiotherapy OPD MGM Institute of Physiotherapy N6 Cidco Aurangabad
Nagpur
MAHARASHTRA
431003
India 
Phone  9309148769  
Fax    
Email  sharathcrisp@gmail.com  
 
Source of Monetary or Material Support  
Division 3 Sports Physiotherapy OPD MGM Institute of Physiotherapy N6 Cidco Aurangabad 
 
Primary Sponsor  
Name  MGM Institute of Physiotherapy 
Address  MGM Institute of Physiotherapy N6 Cidco Aurangabad  
Type of Sponsor  Research institution and hospital 
 
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 
Mrugnayani Patil  MGM Institute Physiotherapy  Department of Sports Physitherapy division: MGM Physiotherapy OPD no 3
Aurangabad
MAHARASHTRA 
8208765169

mrugnayanipatil19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mahatma Gandhi Missions Ethics Committe for Research on Human Subjects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Football Players 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Male 
Details  1.Age 18 - 25 years
2.Atleast having experience of 2 years.
3.5 hr/week practice week. 
 
ExclusionCriteria 
Details  1. Any abnormality potentiate to reduce lower extremity reduced performance (club foot, flat foot,
chondromalacia patella, Osgood schlater, neurological, musculoskeletal pathology, etc.)
2. History of recent lower extremity trauma (<3 months)
3. History of any lower extremity surgery at least 6-month prior testing9
4. Pain or discomfort while performing any test or activity from study.
5. No vestibular disorder 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Single leg squat analysis
2. Dynamometer
3. Y Balance test 
30 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
1. Y Balance test  5 minutes 
 
Target Sample Size   Total Sample Size="93"
Sample Size from India="93" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/09/2021 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Applied for publication 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Aim: 
To study correlation of lower extremity strength and balance in relation to single leg squat depth and compare kinematic evaluation between dominant and non-dominant side

Objectives : 
1. To measure strength, balance and single leg squat analysis of lower extremity muscle group of dominant side.
2. To measure strength, balance and single leg squat analysis of lower extremity muscle group of non-dominant side.
3. To find correlation of strength and balance in relation to single leg squat test.
4. To compare strength, balance and single leg squat analysis of dominant and non - dominant side.


Study Design : Observational descriptive study

Study Setting : Tertiary care

Participants : football players

Procedure : After ethical clearance and CTRI approval, informed consent taken from subjects after fulfilment of inclusion criteria. Demographic data (Name, Age, BMI), limb length and leg dominance will be taken followed by 10 min warm up. Dynamometer strength for hip, knee and ankle muscles will be assessed followed by Y balance test and single leg squat analysis (Visual Quality score and kinovia quantitative analysis) for dominant and non dominant side. 

Main outcome measures : Hip, knee and ankle strength with dynamometer, Y balance test and Single leg squat analysis

Results : On going Study

Conclusion : Comparision between dominant and non dominant leg and correlation for different parameter of strength, balance, single leg squat analysis will be analyze
 
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