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CTRI Number  CTRI/2018/10/016004 [Registered on: 12/10/2018] Trial Registered Prospectively
Last Modified On: 08/10/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Comparing the flexor tightness and total lung capacity 
Scientific Title of Study   Correlation between hip flexor tightness and total lung capacity 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saumya Kothiyal 
Designation  Postgraduate student Musculoskeletal disorders 
Affiliation  MM Institute of physiotherapy and rehabilitation 
Address  Maharishi Markandeshwar Deemed to be University Mullana

Ambala
HARYANA
133207
India 
Phone  8650987709  
Fax    
Email  saumyakothiyal28@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrManu Goyal 
Designation  Associate profesor 
Affiliation  MM Institute of physiotherapy and rehabilitation 
Address  Maharishi Markandeshwar Deemed to be University Mullana, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala

Ambala
HARYANA
133207
India 
Phone  8059930229  
Fax    
Email  manu.goyal@mmumullana.org  
 
Details of Contact Person
Public Query
 
Name  Saumya Kothiyal 
Designation  Postgraduate student Musculoskeletal disorders 
Affiliation  MM Institute of physiotherapy and rehabilitation 
Address  Maharishi Markandeshwar Deemed to be University, Mullana

Ambala
HARYANA
133207
India 
Phone  8650987709  
Fax    
Email  saumyakothiyal28@gmail.com  
 
Source of Monetary or Material Support  
Maharishi Markandeshwar Insititute of Physiotherapy & Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana, Pin: 133207, India. 
 
Primary Sponsor  
Name  Dr Kanimozhi D 
Address  Maharishi Markandeshwar Insititute of Physiotherapy & Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Haryana 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
Sorabh Sharma  Maharishi Markandeshwar Insititute of Physiotherapy & Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Haryana 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Saumya Kothiyal   Markandeshwar Institute of Physiotherapy & Rehabilitation  Hostel no.7, and Physiotherapy out-patient department, Maharishi Markandeshwar Deemed to be University, Mullana
Ambala
HARYANA 
8650987709

saumyakothiyal28@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAHARISHI MARKANDESHWAR(DEEMED TO BE UNIVERSITY), INSTITUTIONAL ETHICS COMMITTEE, MULLANA, AMBALA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Hip flexors tightness 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Subjects with tightness of hip flexors will be included 
 
ExclusionCriteria 
Details  Subject with any cardiorespiratory disorder
Smokers
Any known congenital defects of lower extremities
Subjects with recent abdominal surgery
Subjects with PIVD and anterolisthesis
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Modified Thomas test

 
One time
 
 
Secondary Outcome  
Outcome  TimePoints 
Forced Expiratory Volume  One time 
 
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)   15/10/2018 
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   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Male and female participants with tightness of hip flexor will be recruited for this study. Written consent form for the voluntary participation of the subjects will be taken. Every subject will be assured that there will be no personal harm and the information obtained from them will be used only for research purpose and their privacy will be maintained. The entire demographic data such as name, age, gender, occupation, address, weight and height of each subject and general information about each subjects will be documented in the pre designed Performa. Height of the subject will be measured by measuring tape and the weight will be measured with the help of calibrated digital weighing machine and BMI will be calculated using the standard formula [BMI= weight (in kilograms) / height (in meter2)] subjects are tested for hip flexor tightness with help of modified Thomas test. The patient will be asked to sit at the edge of the couch and lie back on the couch holding both the knees across the chest ensuring the straightening of the lumbar spine and posterior rotation of the hip. The patient will lower the affected extremity by keeping the contralateral side to the chest himself/herself. 2 trails of each angles of hip flexion, knee flexion and hip abduction will be taken to determine the length of iliopsoas, quadriceps and TFL/ITB flexibility, respectively.

 
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