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CTRI Number  CTRI/2024/05/067700 [Registered on: 21/05/2024] Trial Registered Prospectively
Last Modified On: 04/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   "Improving straightening movement of the knee joint: The effect of Instrument Assisted Soft Tissue Mobilization tool on Hamstring tightness in non- professional Football Players" 
Scientific Title of Study   Immediate effect of instrument assisted soft tissue mobilization on active knee extension range of motion among recreational football players with hamstring tightness. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sirwani Neha Sureshkumar 
Designation  MPT 1st year 
Affiliation  Yenepoya Physiotherapy College 
Address  Yenepoya physiotherapy Department, yenepoya (Deemed to be university), Deralakatte, Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8073813340  
Fax    
Email  physioneha09@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sirwani Neha Sureshkumar 
Designation  MPT 1st year 
Affiliation  Yenepoya Physiotherapy College 
Address  Yenepoya physiotherapy Department, yenepoya (Deemed to be university), Deralakatte, Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8073813340  
Fax    
Email  physioneha09@gmail.com  
 
Details of Contact Person
Public Query  
Name  M R Sivakumar 
Designation  Associate Professor 
Affiliation  Yenepoya Physiotherapy College 
Address  Yenepoya physiotherapy Department, yenepoya (Deemed to be university), Deralakatte, Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9448386457  
Fax    
Email  mrsivakumar@yenepoya.edu.in  
 
Source of Monetary or Material Support  
Principal Investigator, MPT 1st year, Yenepoya physiotherapy Department, yenepoya (Deemed to be university), Deralakatte, Mangalore, Karnataka, India-575018 
Yenepoya physiotherapy Department, yenepoya (Deemed to be university), Deralakatte, Mangalore, Karnataka, India- 575018 
 
Primary Sponsor  
Name  Sirwani Neha SUreshkumar 
Address  Yenepoya physiotherapy Department, yenepoya (Deemed to be university), Deralakatte, Mangalore, Karnataka, India-575018 
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 Neha Sureshkumar Sirwani  Yenepoya Soccer ground   Yenepoya (deemed to be University), University Road, Deralakatte, Mangaluru, Karnataka 575018
Dakshina Kannada
KARNATAKA 		 8073813340

physioneha09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
YenepoyaEthicalCommittee1   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Tightness of Hamstring muscle 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Instrument Assisted Soft Tissue Mobilization Tool  Instrument assisted soft tissue mobilization (IASTM) is a skilled myofascial intervention used for soft-tissue treatment. IASTM tool made up of stainless steel material. It is based on the principles of James cyriax cross-friction massage.It is a skilled intervention that includes the use of specialized tools to manipulate the skin, myofascia, muscles, and tendons by various direct compressive stroke techniques.The benefits of the use of IASTM occur in a short time in improving range of motion, reduction of pain. Total Duration 10 mins of iastm treatment and frequency will be mild to moderaqte as per the participants situation. 
Comparator Agent  Matrix Multi-Angle Lunges, Sidelye Up, High Knee exercise, Squats  Matrix Multi-Angle Lunges: The matrix multi-angle lunge is a combination of three different lunges. This exercise will strengthen the leg muscles to help improve movements in all directions. First is a lunge to the front, then to the side and then lunge backwards as if youre turning to chase someone. Sidelye Up: This exercise may look easy to execute, but it is a challenge for your hip muscles. This exercise targets the hip muscles that assist in lateral speed and agility. To perform this drill, lie on one side and separate the legs from each other (about a foot). Then, only using the lower forearm that is in contact with the ground for support, lift the hip off the ground and rise up as high as possible. Then return back down to the floor in a slow, rhythmic fashion. Furthermore, maintain the one-foot distance between the legs consistent throughout the entire movement. High Knee: Stand straight with your feet shoulder-width apart. Face forward and open your chest. Bring your knees up to waist level and then slowly land on the balls of your feet. Repeat until the set is complete. Squat: Stand with feet a little wider than hip width, toes facing front. Drive your hips back—bending at the knees and ankles and pressing your knees slightly open—as you Sit into a squat position while still keeping your heels and toes on the ground, chest up and shoulders back.Strive to eventually reach parallel, meaning knees are bent to a 90-degree angle. Press into your heels and straighten legs to return to a standing upright position.8 reps of 3 sets of each exercise with 60 secs of rest in between each set. total duration of exercise for each participant is 20 mins. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  -Participants having hamstring tightness.
-Angle of knee flexion less than 20 degree.
-Age group between 18 to 25 years.
-Amateur football players.
-Players should be playing football 3 to 5 days a week 
 
ExclusionCriteria 
Details  History of hamstring injury.
Individuals undergoing flexibility, strengthening, or any other program which can affect the study.
Any neurological disorders affecting lower limb.
Any skin allergy or open wounds present.
Any other musculoskeletal problems or lower limb.
Players going to gym regularly. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking
Modification(s)  		 Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Active Knee extension test  Before intervention and after 10 min of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   01/10/2024 
Date of Study Completion (India) 04/01/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This study is an experimental study that will be focusing on active knee extension range of motion for recreational football players having hamstring tightness. Amateur football players will be recruited from Yenepoya soccer ground. Players will then be checked for hamstring tightness with AKE test using digital goniometer.  30 players having less than 20 degrees of extension will be examine for inclusion and exclusion criteria and will be included in this study. 15 players will then be alotted to either an experimental group and 15 players will be alotted to a control group. The experimental group will undergo Instrument assisted soft tissue mobilization and exercises. The control group will undergo exercises only. Before and After the intervention Active knee extension test will be done. Raw data will be collected and analyzed using statistical tests.

 
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