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CTRI Number  CTRI/2023/10/059250 [Registered on: 30/10/2023] Trial Registered Prospectively
Last Modified On: 29/10/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Hamstring muscle on acceleration time in young adults. 
Scientific Title of Study   Effect of eccentric vs. static stretch of hamstring muscle on acceleration time in young adults. 
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 Richa Hirendra Rai 
Designation  Professor, School of Physiotherapy, DPSRU 
Affiliation  Delhi Pharmaceutical Sciences And Research University  
Address  Room no.-605, Delhi Pharmaceutical Sciences and Research University, Pushp Vihar New Delhi

New Delhi
DELHI
110017
India 
Phone  9350267077  
Fax    
Email  richaraidpsru@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Richa Hirendra Rai 
Designation  Professor, School of Physiotherapy, DPSRU 
Affiliation  Delhi Pharmaceutical Sciences And Research University  
Address  Room no.-605, Delhi Pharmaceutical Sciences and Research University, Pushp Vihar New Delhi

New Delhi
DELHI
110017
India 
Phone  9350267077  
Fax    
Email  richaraidpsru@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Richa Hirendra Rai 
Designation  Professor, School of Physiotherapy, DPSRU 
Affiliation  Delhi Pharmaceutical Sciences And Research University  
Address  Room no.-605, Delhi Pharmaceutical Sciences and Research University, Pushp Vihar New Delhi

New Delhi
DELHI
110017
India 
Phone  9350267077  
Fax    
Email  richaraidpsru@gmail.com  
 
Source of Monetary or Material Support  
Delhi Pharmaceutical Sciences and Research Institute 
 
Primary Sponsor  
Name  Shalini Mishra 
Address  Delhi Pharmaceutical Sciences And Research University, Pushp Vihar, New Delhi -110017 
Type of Sponsor  Other [self] 
 
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 Richa Hirendra Rai  Delhi Pharmaceutical Sciences And Research University   Room no 605, New VC buidling, M.B. Road, Pushp Vihar, New Delhi-110017
South
DELHI 		 9350267077

richahrai@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research review Development Committee  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  Control  The participants will be requested and advised not to perform any stretching or any exercises/activities for 6 weeks. 
Intervention  Eccentric stretch  The stretch will be hold for 5 seconds and will be repeated 6 times with no rest between repetitions, resulting in a total of 30 seconds of stretching. Interventional protocol for 30 seconds, for 18 sittings (for approx. 3 days per week in 6 weeks) 
Intervention  Static Stretch  The participant will hold the stretch for a duration of 30 seconds. Interventional protocol for 30 seconds, for 18 sittings (for approx. 3 days per week in 6 weeks) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1. College students.
2. All students with restricted hamstring flexibility, characterized as a minimum 20 degrees loss of knee extension when hip is flexed at 90 degrees ( in the dominant leg).
3. Participants who will sign the informed consent form. 
 
ExclusionCriteria 
Details  1. Extremities have impairment of the hip, knee, thigh or lower lack for the previous one year.
2. Individual with a history of hip and knee injury.
3. Subjects with history of medical, surgical, musculoskeletal disorders, systemic conditions, congenital disorders or any other condition that can affect the outcome of the study.
4. Uncooperative student. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Acceleration time  At 0 sitting Acceleration time in seconds pre and post intervention
At 4th-6th sitting post intervention Acceleration time in seconds
At 10th-12th sitting postintervention Acceleration time in seconds
At 16th-18th sitting Acceleration time in seconds post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
1. Popliteal angle  At 0 sitting pre & post intervention popliteal angle
At 4th-6th sitting post intervention popliteal angle
At 10th-12th sitting post intervention popliteal angle
At 16th-18th sitting post intervention popliteal angle 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   10/11/2023 
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="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [richarai@dpsru.edu.in].

  6. For how long will this data be available start date provided 27-10-2023 and end date provided 27-10-2044?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Hamstring tightness is highly prevalent among college students of age group 18-25. Young adults regularly engage themselves in several sport activities. In certain sports, performance is greatly influenced by flexibility, technical skill, endurance, and the ability to repeatedly sprint and reduce acceleration time in sprinting. This study was initiated to determine if there any effect of eccentric vs. static stretch of hamstring muscle on acceleration time in young adults?

 
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