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CTRI Number  CTRI/2024/07/071392 [Registered on: 26/07/2024] Trial Registered Prospectively
Last Modified On: 22/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Evaluation of lower extremity muscle function and jump biomechanics of gymnasts with and without ankle injuries. 
Scientific Title of Study   Evaluation of lower extremity eccentric muscle strength, anaerobic power and biomechanics of basic jump techniques among gymnasts with and without ankle injuries: a cross sectional pilot study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sakshi Palkrit  
Designation  Post-graduation student / MPT Scholar 
Affiliation  MGM School of Physiotherapy, MGM Institute of Health Sciences 
Address  Room no 55 Integrated Physiotherapy OPD MGM Institute of Health Sciences, MGM School of Physiotherapy Sector 1 Kamothe

Raigarh
MAHARASHTRA
410209
India 
Phone  9511726311  
Fax    
Email  sakshipalkrit@mgmsopnm.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Triveni Shetty 
Designation  Associate Professor 
Affiliation  MGM School of Physiotherapy, MGM Institute of Health Sciences 
Address  Room no 55 Integrated Physiotherapy OPD MGM School of Physiotherapy, MGM Institute of Health Science Sector 1, Kamothe

Mumbai
MAHARASHTRA
410209
India 
Phone  02227437866  
Fax    
Email  tshetty@mgmsopnm.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Triveni Shetty 
Designation  Associate Professor 
Affiliation  MGM School of Physiotherapy, MGM Institute of Health Sciences 
Address  Room no 55 Integrated Physiotherapy OPD MGM School of Physiotherapy, MGM Institute of Health Sciences, Sector 1, Kamothe

Raigarh
MAHARASHTRA
410209
India 
Phone  02227437866  
Fax    
Email  tshetty@mgmsopnm.edu.in  
 
Source of Monetary or Material Support  
MGM School of Physiotherapy MGM Institute of Health Sciences, Infrastructure and material support Sector 1 & 2 , Kamothe Navi Mumbai 
 
Primary Sponsor  
Name  MGM Institute of Health Sciences 
Address  MGM Institute of Health Sciences, Sector – 1, Kamothe, Navi Mumbai – 410209, Maharashtra, India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NA   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Triveni Shetty  MGM School of Physiotherapy, MGM Institute of Health Sciences  Room number 55 Integrated Physiotherapy OPD, MGM School of Physiotherapy Plot 1 Sector 1 & 2, Kamothe, Navi Mumbai - 410209
Mumbai
MAHARASHTRA 
02227437866

tshetty@mgmsopnm.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee – MGM Dental College and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S934||Sprain of ankle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  18.00 Year(s)
Gender  Female 
Details  Female gymnasts aged between 12 to 18 years who have been playing for over a year and practice for at least 7 hours per week. Participants included are gymnasts with chronic ankle injuries, whether or not associated with secondary injuries and gymnasts without any history of ankle injuries 
 
ExclusionCriteria 
Details  Individuals with acute musculoskeletal ankle injuries, those involved in sports other than gymnastics, and individuals with acute and chronic primary musculoskeletal injuries other than ankle injuries. Additionally, gymnasts with neurological disorders and those with cardio-respiratory disorders were also excluded from the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Lower extremity power
2. Eccentric Muscle strength of lower extremity
3. Kinematics of the spine, hip, knee & ankle.
 
Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1. Strength and endurance of the upper limb.
2. Abdominal core muscle strength.
3. Shoulder Flexibility.
4. Agility
5. lower extremity flexibility.
6. Speed
7. Balance.
8. Ankle and foot impairments.
 
Baseline 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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)   02/08/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   The study aims to investigate the impact of ankle injuries on various performance parameters in gymnasts. Gymnastics, encompassing both competitive sports and recreational activities, requires precise coordination, strength, and flexibility, with gymnasts often beginning training at a young age and reaching peak performance in their late teens. The study highlights the importance of eccentric muscle strength in performing gymnastic jumps and preventing injuries. Ankle injuries, which frequently occur during landing tasks, are a common issue among gymnasts. The research seeks to determine the association between lower extremity eccentric muscle strength, anaerobic power, and the biomechanics of basic jump techniques in gymnasts with and without ankle injuries. The methodology involves assessing these parameters through tests like the Vertical Jump Test, 30-second Squat Test, 2-D motion analysis using Kinovea, the Foot and Ankle Ability Measure, and the Gymnastics Functional Measurement Tool. The study will recruit female gymnasts aged 12-18 years, practicing for at least 7 hours per week, and will compare those with and without ankle injuries to evaluate differences in their performance and injury patterns. The findings aim to enhance understanding of how eccentric strength and biomechanics influence gymnastics performance and injury prevention 
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