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CTRI Number  CTRI/2024/11/077010 [Registered on: 19/11/2024] Trial Registered Prospectively
Last Modified On: 13/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Correlation of Back of thigh muscle tightness with Foot Posture and Dynamic Balance in Young Adults  
Scientific Title of Study   Correlation of Hamstring Tightness with Foot Posture and Dynamic Balance in Young Adults – An Observational 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 Swati Kubal 
Designation  Assistant Professor (PT) 
Affiliation  Topiwala National Medical College and B.Y.L. Nair Charitable Hospital 
Address  Room No. 2, OPD-24 (M building), Physiotherapy department, P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai

Mumbai
MAHARASHTRA
400008
India 
Phone  8691948255  
Fax    
Email  swatikubal@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Swati Kubal 
Designation  Assistant Professor (PT) 
Affiliation  Topiwala National Medical College and B.Y.L. Nair Charitable Hospital 
Address  Room No. 2, OPD-24 (M building), Physiotherapy department, P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai

Mumbai
MAHARASHTRA
400008
India 
Phone  8691948255  
Fax    
Email  swatikubal@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Poonam Tungar 
Designation  Post Graduate Student (Physiotherapist) 
Affiliation  Topiwala National Medical College and B.Y.L. Nair Charitable Hospital 
Address  Room No. 2, OPD-24 (M building), Physiotherapy department, P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai

Mumbai
MAHARASHTRA
400008
India 
Phone  9545343093  
Fax    
Email  poonamtungar2000@gmail.com  
 
Source of Monetary or Material Support  
P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital,Mumbai- 400008 India  
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [] 
 
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 Swati Kubal  P.T School & Centre, T.N.M.C & B.Y.L Ch Nair Hospital  Room No. 2, OPD-24 (M building), Physiotherapy department, P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai Mumbai,MAHARASHTRA
Mumbai
MAHARASHTRA 		 8691948255

swatikubal@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Academic Research Projects (ECARP) PG Academic Committee T.N. Medical College and B.Y.L Nair Ch Hospital  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 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1) Individuals with hamstring tightness knee extension less than 70 degrees (with 90 degrees
of hip flexion)
2) Healthy individuals aged between 18 to 25 years
3) Both male and Female
4)
Individuals with normal BMI between 18 point 5 to 24 point 9 kg/m2
5) Subjects with good core strength (Minimum level 2)
6) Subjects’ willingness to participate 
 
ExclusionCriteria 
Details  1) Recent surgery
2) Fractures within past 6 months
3) Lower leg discrepancy (more than 1 or 1 point 5cm)
4) History of neurological and musculoskeletal problems
• Subjects involved in regular recreational sports activities.
• Subjects who go to gym or undergoing any training. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Degree of hamstring tightness by Passive Knee Extension Test
2. Evaluation of foot posture by Foot Posture Index
3. Evaluation of dynamic balance using Y balance test  		 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Screening of core strength using pressure biofeedback unit   6 months 
 
Target Sample Size   Total Sample Size="41"
Sample Size from India="41" 
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)   10/12/2024 
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   NEED OF STUDY:
Previous studies have shown that hamstring tightness can alter pelvic position and lower limb alignment which in turn affects the foot posture and balance. 
Hamstring tightness can compromise flexibility and joint mobility, influencing balance.
When coupled with irregular foot posture this may increase the risk of falls, especially during activities that require stability.
Therefore, it is crucial to understand the relation between hamstring tightness, foot posture and dynamic balance in young adults.
This study aims to explore this relationship and provide insights into the effects of hamstring tightness, foot posture and balance also the preventive measures and rehabilitation strategies for conditions related to these factors such as low back pain, gait
abnormalities, osteoarthritis and sport injuries.
Additionally, these connections may contribute for developing targeted interventions for improving flexibility, posture and balance in various individuals.

AIM:
To study correlation of hamstring tightness with foot posture and dynamic balance in young adults.

OBJECTIVES:
1. To assess hamstring tightness in participants using Passive Knee Extension
(PKE) Test.
2. To assess foot posture in participants using Foot Posture Index (FPI)
3. To assess dynamic balance in participants using Y Balance Test.
4. To determine the correlation of hamstring tightness with foot posture and dynamic balance in participants.


PROCEDURE: 
Participants will be enrolled in the study depending on the selection criteria and willingness to participate in the study.
Informed consent will be taken.
Case record form with demographic details will be filled.
Subjects with good core strength will be screened using pressure biofeedback unit.
Subjects with hamstring tightness will be included which will be assessed bilaterally using passive knee extension test.
Foot Posture Index (FPI) will be assessed under six criteria.
Balance will be assessed using Y balance test.
Data will be collected and analyzed.

DATA MANAGEMENT AND ANALYSIS PROCEDURE: 
All the data obtained from the participants will be kept confidential. The data will be stored in excel sheets for analysis.
➢ Plan for Statistical analysis are as follows:
• Hamstring tightness will be evaluated by passive knee extension test (PKE) and descriptive analysis will be done.
• Foot posture will be evaluated by Foot Posture Index (FPI) and descriptive analysis will be done.
• Dynamic balance will be evaluated by Y balance test and descriptive analysis will be done.
• Data will be tested for Normality.
• If the data passes the normality test, Parametric -Pearson correlation test will be used.
• If the data does not pass normality test, Non-parametric- Spearman correlation test will be used. 
 
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