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CTRI Number  CTRI/2024/09/073985 [Registered on: 17/09/2024] Trial Registered Prospectively
Last Modified On: 15/09/2024
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   Effectiveness of Post-Isometric Relaxation vs Jack Knife Technique on Flexibility Agility and Balance in Young Adults with Hamstring Tightness  
Scientific Title of Study   Effectiveness of post isometric relaxation versus jack knife technique on flexibility agility and dynamic balance in young healthy individuals with hamstring tightness pre-post 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  Raj Bhatt 
Designation  post graduate student 
Affiliation  SPB physiotherapy college 
Address  OPD 1, Musculoskeletal department, SPB Physiotherapy college, Ugat Bhesan Road, Rander Road Near Bhestan Jakatnaka, Jahangirabad, Morabhagal, Surat, Gujarat, India 395005

Surat
GUJARAT
395005
India 
Phone  9909812181  
Fax    
Email  rajbhatt642@yahoo.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Tanvi Banker 
Designation  Assistant professor  
Affiliation  SPB physiotherapy college 
Address  OPD 1, Musculoskeletal department, SPB Physiotherapy college, Ugat Bhesan Road, Rander Road Near Bhestan Jakatnaka, Jahangirabad, Morabhagal, Surat, Gujarat, India 395005

Surat
GUJARAT
395005
India 
Phone  8460835751  
Fax    
Email  tanvibanker@gmail.com  
 
Details of Contact Person
Public Query  
Name  Raj Bhatt 
Designation  post graduate student 
Affiliation  SPB physiotherapy college 
Address  OPD 1, Musculoskeletal department, SPB Physiotherapy college, Ugat Bhesan Road, Rander Road Near Bhestan Jakatnaka, Jahangirabad, Morabhagal, Surat, Gujarat, India 395005

Surat
GUJARAT
395005
India 
Phone  9909812181  
Fax    
Email  rajbhatt642@yahoo.in  
 
Source of Monetary or Material Support  
SPB Physiotherapy college , Ugat Bhesan Road, Rander Road Near Bhestan Jakatnaka, Jahangirabad, Morabhagal, Surat, Gujarat, India 395005 
 
Primary Sponsor  
Name  SPB physiotherapy college 
Address  Ugat Bhesan Road, Rander Road Near Bhestan Jakatnaka, Jahangirabad, Morabhagal, Surat, Gujarat 395005 
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 Raj Bhatt  SPB Physiotherapy college   musculoskeletal physiotherapy department, SPB Physiotherapy college, Ugat Bhesan Road, Rander Road Near Bhestan Jakatnaka, Jahangirabad, Morabhagal, Surat, Gujarat 395005
Surat
GUJARAT 		 9909812181

rajbhatt642@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of SPB Physiotherapy College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Hamstring tightness 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Jack knife stretching  Participant squats while holding their ankle joint with their hands. That is followed by a gradual extension of the knee joints, This position of maximum extension is achieved with the quadriceps femoris is at peak contraction . This position is then held for 5-7 s. As the subject do not produce movement in the final position, the movement is classified as a static stretch. However, contraction of the antagonist muscle (the quadriceps femoris) during the stretching period makes the movement a dynamic stretch. In the sports field, this type of stretching which are having component of static stretching with muscle contraction of the antagonist (quadriceps femoris) muscle is called as an active static stretch. 1 set of 5 repetitions of the stretch with each repetition held for 5-7 sec, 3 sessions per week for 4 weeks. 
Comparator Agent  Not applicable  Not applicable 
Intervention  Post isometric relaxation  Isometric contraction can be used to release stiff, shorten or tight muscle. Post isometric relaxation uses submaximal contraction of a tight muscle to release the tightness of muscle. Subject in supine lying with contralateral hip and knee semi flexed position. Therapist standing on the intervention side of the subject, facing the head end of the plinth. The leg to be treated flexed fully at hip and knee, and then was extended until the restriction barrier is identified. The leg of the treated side is placed on the therapist’s shoulder, for e.g. right leg on right shoulder. The subject is then instructed to gently bend the knee against the resistance (the counterforce is given by the therapist’s shoulder) starting slowly and using only sub maximal strength (20%-30%). Inhale, and slowly built up an isometric contraction; hold the breath during the 7-10 sec of contraction. Release the breath as slowly cease the contraction. Inhale and exhale fully once more following cessation of all efforts. During the second exhalation leg was straightened at the knee towards its new barrier. Procedure is repeated two more times and four time per week. If appropriate, add visual synkinesis (i.e. look in the direction of contraction and then the direction of release) additionally, respiratory synkinesis can also be used along with visual synkinesis. (breathe in during most contractions and exhale during release). 7-10 sec of contraction followed by relaxation and passive stretch for 5-7 sec, procedure is repeated for 3-4 times, 3 times per week for 4 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Those who are willing to participate in the study.
Age group between 18-25 years.
Both male and female participants will be included.
Subjects with asymptomatic bilateral hamstring tightness and in category less than or equal to average
according YMCA’s normative value for sit and reach test.
 
 
ExclusionCriteria 
Details  Subjects unwilling to participate.
History of any trauma , fractures or other soft tissue injury (past 1 year) of
pelvis/hip/knee.
surgical history of hip or knee in past 1 year.
Radiating symptoms in the lower limb.
Past history of any contusion or strain on either quadriceps or hamstring muscle in last 1
year.
Subject having back pain.
Subject with presence of any bleeding disorders.
Inflammatory condition of hip or knee. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Y balance test for Dynamic balance
2. Sit & reach test for flexibility
3. T agility test for agility 		 for all 3 outcome at first day of treatment and after four weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   26/09/2024 
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   Effectiveness of post isometric relaxation versus jack knife technique on flexibility, agility and dynamic balance in young healthy individuals with hamstring tightness: pre-post experimental study.


1.1 Need of the study
            Different Stretching techniques can be used for preventing tightness of hamstrings and complications associated with it. Since there are less evidence for PIR as well as jack knife individually, while there are no studies comparing the both PIR and jack knife technique hence this is significant to evaluate the effect of it. The purpose of this study is to compare out the effect of PIR and jack knife stretching technique on flexibility, agility and dynamic postural control in asymptomatic individuals with hamstring tightness.

1.2 Objective 
1. To study the effectiveness of post isometric relaxation on individuals with asymptomatic hamstring tightness.
2. To study the effectiveness of Jack knife stretching technique on individuals with asymptomatic hamstring tightness. 
3. To compare the effect of post isometric relaxation and Jack knife stretching on individuals with asymptomatic hamstring tightness.

1.3 Methodology
1 Study Design: Experimental study 
2 Population: Bilateral asymptomatic hamstring tightness
3 Sample : Young healthy individuals aging between 18-25 years both male & female 
4 Sampling Technique: Convenient sampling 

1.4 Inclusion criteria 
• Those who are willing to participate in the study.
• Age group between 18-25 years.
• Both male and female participants will be included.
• Subjects with asymptomatic bilateral hamstring tightness and in category ≤ “average” according YMCA’s normative value for sit and reach test.

1.5 Exclusion criteria
• Subjects unwilling to participate.
• History of any trauma , fractures or other soft tissue injury (past 1 year) of pelvis/hip/knee. 
• surgical history of hip or knee in past 1 year.
• Radiating symptoms in the lower limb.
• Past history of any contusion or strain on either quadriceps or hamstring muscle in last 1 year.
• Subject having back pain.
• Subject with presence of any bleeding disorders.
• Inflammatory condition of hip or knee.

1.6 Procedure 
The patient will be screened on the basis of inclusion and exclusion criteria and their demographic data will be taken by an assessment Performa. Prior to the commencement of the study, detailed procedure of the study will be explained to the patients and a signed informed consent form will be taken from them. Then the patient will be randomly assigned to a 4-week intervention protocol and allocated randomly to Group A and Group B. The subjects will be allocated to any of the two groups by random allocation using chit method. The therapist will assess for Sit and reach test, star excursion balance test and t agility test before the intervention on the first day of the treatment. 

 Description of the groups is given below:
 Group A = Post isometric relaxation
 Group B = Jack knife technique

 On the first day of the first week, baseline measurements of sit and reach test, star excursion balance test and t agility test will be taken. Total treatment will be of 4 weeks with 3 sessions per week. Post assessment data of SR test, SEBT , t agility test will be taken at the end of 4 week.
 
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