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CTRI Number  CTRI/2024/04/065992 [Registered on: 19/04/2024] Trial Registered Prospectively
Last Modified On: 18/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Soft Tissue Mobilization Techniques(IASTM and foam rolling) on calf muscle: Impact on Taekwondo Athletes Flexibility, Strength, and Balance. 
Scientific Title of Study   Effect of Instrument Assisted Soft Tissue Mobilization versus Foam Rolling Along With Conventional Therapy on Gastro-soleus Flexibility, Strength and Dynamic Balance amongst Taekwondo players- A Quasi Experimental 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  Dr Shruti Govind Khandelwal 
Designation  PG Student 
Affiliation  MAEERs College of Physiotherapy, Talegaon Dabhade 
Address  Room No. A-207, Musculoskeletal Physiotherapy Department, OPD Building 2nd floor, MAEERs College of Physiotherapy, Near Talegaon Station Road, Talegaon Dabhade.

Pune
MAHARASHTRA
410507
India 
Phone  9403239837  
Fax    
Email  khandelwalshruti25@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neetu Mahapatra 
Designation  Professor 
Affiliation  MAEER MIT Punes Physiotherapy College, Talegaon Dabhade 
Address  Room No. A-221, Musculoskeletal Physiotherapy Department, OPD Building 2nd floor, MAEERs College of Physiotherapy, Near Talegaon Station Road, Talegaon Dabhade.

Pune
MAHARASHTRA
410507
India 
Phone  9823236752  
Fax    
Email  neetu@mitmimer.com  
 
Details of Contact Person
Public Query
 
Name  Dr Neetu Mahapatra 
Designation  Professor 
Affiliation  MAEER MIT Punes Physiotherapy College, Talegaon Dabhade 
Address  Room No. A-221, Musculoskeletal Physiotherapy Department, OPD Building 2nd floor, MAEERs College of Physiotherapy, Near Talegaon Station Road, Talegaon Dabhade.

Pune
MAHARASHTRA
410507
India 
Phone  9823236752  
Fax    
Email  neetu@mitmimer.com  
 
Source of Monetary or Material Support  
MAEERs College of Physiotherapy, Talegaon Dabhade  
 
Primary Sponsor  
Name  MAEERs College of Physiotherapy, Talegaon Dabhade 
Address  MAEERs College of Physiotherapy, OPD Building 2nd floor, Near Talegaon Station Road, Talegaon Dabhade 410507  
Type of Sponsor  Private 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 
Dr Neetu Mahapatra  MAEERs College of Physiotherapy  Room No. A-207, Musculoskeletal Physiotherapy Department, OPD Building 2nd floor, MAEERs College of Physiotherapy, Near Talegaon Station Road, Talegaon Dabhade- 410507
Pune
MAHARASHTRA 
9823236752

neetu@mitmimer.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAEERs College of Physiotherapy Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Soft Tissue Mobilization using IASTM Tool and conventional therapy  Instrument Assisted Soft Tissue Mobilization for gastro-soleus muscle Conventional Therapy including Warm up by jogging, release of gastro-soleus muscle by IASTM tool, strengthening of the gastro-soleus muscle using theraband and stretching of the same. The protocol will be given for 4 weeks, twice a week. 
Intervention  Soft Tisue Mobilization using foam roller and conventional therapy  Soft Tissue Mobilization using foam roller Conventional Therapy including Warm up by jogging, release of gastro-soleus muscle by foam roller, strengthening of the gastro-soleus muscle using theraband and stretching of the same. The protocol will be given for 4 weeks, twice a week. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  24.00 Year(s)
Gender  Both 
Details  Player belt colour: Orange and above
Level of skill: Semi-professional Taekwondo players
Static flexibility test score:
For males: below 32.50
For females: below 30.50
 
 
ExclusionCriteria 
Details  Players with a history of lower limb surgery less than 6 months
Unhealed lower limb fracture
Recent lower limb soft tissue injury less than 3 weeks
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Static Flexibility Test for gastro-soleus muscle flexibility  0 weeks and 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Hand held dynamometer reading for gastro-soleus strength  0 weeks and 4 weeks 
Y balance score for dynamic balance  0 weeks and 4 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   25/05/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

BACKGROUND: Taekwondo is a modern sport from the twentieth century based on karatedo, which was introduced to Korea after World War II. The attacking techniques of taekwondo are categorized into those either using the feet (tae) or hands (kwon). The complex movements in taekwondo consist of many functional forms such as the double kick, direction-change, footwork, and roundhouse kick, and these movements are mostly adjusted and controlled by the feet. Literature has supported that as a result, there are several cases of injuries in the lower limbs of the athletes. Instrument assisted soft tissue mobilization (IASTM) is a popular treatment for myofascial restriction. IASTM uses specially designed instruments to provide a mobilizing effect to scar tissue and myofascial adhesions. Self-myofascial release (SMR) is a popular intervention used to enhance a client’s myofascial mobility. Common SMR tools include the foam roll and various types of roller massagers. The purpose of this study is to compare the effects of IASTM and foam rolling (self myofascial release) on muscle flexibility, strength and balance in the ankle joint.

METHODOLOGY: After selection of participants they will be divided into 2 groups i.e. A and B by using chit method (with replacement). Group A will be given IASTM with conventional therapy. Group B will be given Foam rolling with conventional therapy. In conventional physiotherapy both these groups will be given the same set of exercises.

Treatment will be given 2 days per week for 4 weeks to both the groups.

 
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