| 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
|
|
|
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
|
|
|
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. |