CTRI Number |
CTRI/2025/03/083058 [Registered on: 21/03/2025] Trial Registered Prospectively |
Last Modified On: |
20/03/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
Association between health care students lower limb muscular flexibility and their ability to stand up from the ground
|
Scientific Title of Study
|
To study the correlation of flexibility of lower limb muscles with the ability to get up from the floor in health care students. |
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 Tanvi Jain (PT) |
Designation |
PG Resident |
Affiliation |
College of Physiotherapy Sumandeep Vidyapeeth Deemed To Be University |
Address |
College of Physiotherapy
Sumandeep Vidyapeeth Deemed To Be University Piparia Waghodia
Vadodara Gujarat
Vadodara GUJARAT 391760 India |
Phone |
9764620890 |
Fax |
|
Email |
tanvijain0409@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Noel Macwan (PT) |
Designation |
Assistant Professor |
Affiliation |
College of Physiotherapy Sumandeep Vidyapeeth Deemed To Be University |
Address |
College of Physiotherapy
Sumandeep Vidyapeeth Deemed To Be University Piparia Waghodia
Vadodara Gujarat
Vadodara GUJARAT 391760 India |
Phone |
9898072014 |
Fax |
|
Email |
noel.cop@sumandeepvidyapeeth.edu.in |
|
Details of Contact Person Public Query
|
Name |
Dr Noel Macwan |
Designation |
Assistant Professor |
Affiliation |
College of Physiotherapy Sumandeep Vidyapeeth Deemed To Be University |
Address |
College of Physiotherapy
Sumandeep Vidyapeeth Deemed To Be University Piparia Waghodia
Vadodara Gujarat
Vadodara GUJARAT 391760 India |
Phone |
9898072014 |
Fax |
|
Email |
noel.cop@sumandeepvidyapeeth.edu.in |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Tanvi Jain |
Address |
College of Physiotherapy Sumandeep Vidyapeth Deemed to be Unviersity Piparia,Waghodia,Vadodara-391760 Vadodara
GUJARAT India |
Type of Sponsor |
Other [Self Funded] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 8 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Tanvi Jain |
college of Physiotherapy Sumandeep VIdyapeeth deemed to b university |
College of Physiotherapy
Sumandeep Vidyapeeth Deemed To Be University Piparia Waghodia
Vadodara Gujarat Vadodara GUJARAT |
09764620890
tanvijain0409@gmail.com |
Tanvi Jain |
college of Pharmacy |
college of Pharmacy Sumandeep Vidyapeeth Deemed To Be University Piparia Waghodia
Vadodara Gujarat Vadodara GUJARAT |
09764620890
tanvijain0409@gmail.com |
Tanvi Jain |
Deparment of Audiology and Speech Language Pathology |
Sumandeep Vidyapeeth Deemed To Be University Piparia Waghodia
Vadodara Gujarat Vadodara GUJARAT |
09764620890
tanvijain0409@gmail.com |
Tanvi Jain |
K.M Shah Dental College & Hospital |
Sumandeep Vidyapeeth Deemed To Be University Piparia Waghodia
Vadodara Gujarat Vadodara GUJARAT |
09764620890
tanvijain0409@gmail.com |
Tanvi Jain |
Smt B.K Shah Medical Institute & Research Centre |
Sumandeep Vidyapeeth Deemed To Be University Piparia Waghodia
Vadodara Gujarat Vadodara GUJARAT |
09764620890
tanvijain0409@gmail.com |
Tanvi Jain |
Sumandeep Ayurved Medicalll College & Hospital |
Sumandeep Vidyapeeth Deemed To Be University Piparia Waghodia
Vadodara Gujarat Vadodara GUJARAT |
09764620890
tanvijain0409@gmail.com |
Tanvi Jain |
Sumandeep Homeopathic Medical College & Hospital |
Sumandeep Vidyapeeth Deemed To Be University Piparia Waghodia
Vadodara Gujarat Vadodara GUJARAT |
09764620890
tanvijain0409@gmail.com |
Tanvi Jain |
Sumandeep Nursing College |
Sumandeep Vidyapeeth Deemed To Be University Piparia Waghodia
Vadodara Gujarat Vadodara GUJARAT |
09764620890
tanvijain0409@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Hamstring tightness |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Active Knee Extension Test |
It is used to check the hamstring muscles tightness |
Intervention |
Sitting -Rising Test |
it is used to check the flexibility of lower limb muscles with the ability to get up from the floor |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
30.00 Year(s) |
Gender |
Both |
Details |
Health care students having hamstring tightness |
|
ExclusionCriteria |
Details |
Acute or chronic musculoskeletal conditions ( more than 3 months) or history of musculoskeletal
conditions that would affect extensibility of hamstring group of muscles. Any neurological, cardio respiratory and psychological conditions that would affect the ability to
get up from the floor. Those regularly competing in sports event. Chronic low back, hip, knee, ankle pain more than 1 year. Those who are not comfortable or do not have habit of sitting on the floor. Those who are obese (i.e. BMI more than 27 or higher). |
|
Method of Generating Random Sequence
|
|
Method of Concealment
|
|
Blinding/Masking
|
|
Primary Outcome
|
Outcome |
TimePoints |
Scores of SRT using Sitting-Rising Test |
one time at the day of evaluation |
|
Secondary Outcome
|
Outcome |
TimePoints |
Degree of knee ranges using Active Knee Extension Test |
one time at the day of evaluation |
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
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)
|
09/05/2025 |
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
|
Once subject is recruited according to inclusion criteria then hamstring muscles tightness of the subject will be assessed using Active Knee Extension Test and then Sitting-Rising Test will be taken to check the flexibility of lower limb muscles. Then the flexibility of lower limb muscles with the ability to get up from the floor in health care students will be correlated. |