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CTRI Number  CTRI/2024/08/072869 [Registered on: 22/08/2024] Trial Registered Prospectively
Last Modified On: 12/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   To compare the quick effects of 2 Stretching Techniques in participants with tight muscles  
Scientific Title of Study   Comparison of Immediate effect of Muscle Energy Technique V/S Myo-Fascial release on Muscle Length and Functional Performance in Participants with Hamstring and Gastrosoleus Muscle Tightness – A Prospective Cohort 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  JAHNAVI R B 
Designation  PG student 
Affiliation  SDM College of physiotherapy 
Address  OPD No 05 Ortho Physiotherapy Department Shri Dharmasthala Manjunatheshwara College of Medical science and Hospital. Manjushree Nagar Sattur Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  8762075064  
Fax    
Email  jahnavirb07@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jahnavi R B 
Designation  PG student 
Affiliation  SDM College of physiotherapy 
Address  OPD No 05 Ortho Physiotherapy Department Shri Dharmasthala Manjunatheshwara College of Medical science and Hospital. Manjushree Nagar Sattur Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  8762075064  
Fax    
Email  jahnavirb07@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr SUNIL K M 
Designation  Professor and PG Guide 
Affiliation  SDM College of Physiotherapy 
Address  OPD No 05 Ortho Physiotherapy Department Shri Dharmasthala Manjunatheshwara College of Medical science and Hospital. Manjushree Nagar Sattur Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  9880260626  
Fax    
Email  sunilkm789@gmail.com  
 
Source of Monetary or Material Support  
SDM College of physiotherapy Manjushree Nagar, Sattur Dharwad Karnataka 580009 India 
 
Primary Sponsor  
Name  JAHNAVI R B 
Address  Shri Dharmasthala Manjunatheshwara College of Medical science and Hospital Manjushree Nagar, Sattur Dharwad Karnataka 580009 India 
Type of Sponsor  Other [Self- funded] 
 
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 
Jahnavi R B   SDM College of Medical Science and Hospital  OPD No. 5, Department of Orthopaedic Physiotherapy, Shri Dharmasthala Manjunatheswara College of Medical Science. Manjushree Nagar, Sattur, Dharwad
Dharwad
KARNATAKA 		 8762075064

jahnavirb07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC- SDM College of Medical sciences and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Tightness of Hamstring and Gastrosoleus 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1. students in the age group 18- 25
2. participants with unilateral as well as bilateral tightness of Hamstrings and Gastrosoleus muscles
3. participants willing to participate
 
 
ExclusionCriteria 
Details  1. participants with history of acute hamstring or Gastrosoleus strain
2. participants with tightness of other muscles in lower limb muscles other than Hamstring and Gastrosoleus
3. any recent fracture/ surgeries of the abdomen or lower limb
4. any congenital/ acquired deformity in the lower limb
5. Any contraindications for MFR and MET
6. diagnosed participants with neurological deficits, malignancy or skin disease traumatic injury of the lumbar spine less than 1 year
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
muscle length on
1. sit and reach test
2. ankle ROM 		 Outcome measures are taken before and after giving MET and Foam rolling 
 
Secondary Outcome  
Outcome  TimePoints 
functional performance on
1. walking speed
2. Y- balance test
3. vertical jump test.

 		 Outcome measures are taken before & after giving MET & Foam rolling 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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)   31/08/2024 
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 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   Muscle tightness is a complex condition characterized by limitation in joint ROM. The tightness in the muscle produces and causes asymmetry and restricts flexibility leading to loss of partial or full function for the affected muscle or muscle group. Muscle tightness is caused by a sedentary lifestyle and inadequate or low levels of physical activity which leads to a decrease in the ability of the muscle to deform, leading to a decrease in the range of motion at the joint on which it acts. The prolonged sitting hours required in most of the jobs, and educational systems can affect the flexibility of muscles and soft tissues, which is seen commonly in young students who have to attend long sedentary hours of teaching. Tightness of hamstring muscles have been linked to low back pain and abnormal gait and movement dysfunction in the lumbar spine, pelvis, and lower limbs. Hamstring tightness also affects physical performance. 
Physical performance is primarily measured by walking speed, balance, power, agility among others which are assessed using the lower limbs and are significantly influenced by hamstring and gastrosoleus length and strength.
Muscle Energy Technique (MET) and myo-fascial release (foam rolling) are the techniques which can efficiently improve the flexibility of muscles and have beneficial impact on functional activities in a short span of time
This study compares two of the primary lower limb muscles’ relationships with optimal length, flexibility, and association with functional performance immediately following two distinct release techniques in college students with Hamstring and Gastrosoleus tightness in order to determine which of the two release techniques has a greater influence on functional performance. 
 
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