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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Hip flexors tightness |
|
Intervention / Comparator Agent
|
|
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. |