| CTRI Number |
CTRI/2024/10/075149 [Registered on: 11/10/2024] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Association of flatfoot and factors affecting lower limb alignment |
|
Scientific Title of Study
|
Prevalence of flatfoot among college students and it’s association with factors affecting lower limb alignment |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shamna T |
| Designation |
Postgraduate student |
| Affiliation |
Yenepoya University |
| Address |
Yenepoya Naringana campus ,physiotherapy department,derlakatte manglore,Karnataka
Dakshina Kannada
KARNATAKA
575018
India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8606484275 |
| Fax |
|
| Email |
shamnat2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Harsha M Naik |
| Designation |
Assistant Professor |
| Affiliation |
Yenepoya University |
| Address |
Yenepoya Naringana campus ,physiotherapy department,derlakatte manglore,Karnataka
Dakshina Kannada
KARNATAKA
575018
India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8073836187 |
| Fax |
|
| Email |
harshamnaik@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Harsha M Naik |
| Designation |
Assistant Professor |
| Affiliation |
Yenepoya University |
| Address |
Yenepoya Naringana campus ,physiotherapy department,derlakatte manglore,Karnataka
Dakshina Kannada
KARNATAKA
575018
India
KARNATAKA
575018
India |
| Phone |
8073836187 |
| Fax |
|
| Email |
harshamnaik@yenepoya.edu.in |
|
|
Source of Monetary or Material Support
|
| Yenepoya Physiotherapy College, Deralakatte, Karnataka pin code-575018 |
|
|
Primary Sponsor
|
| Name |
Shamna T |
| Address |
Yenepoya physiotherapy College,Deralakatte, Mangalore, Karnataka Pincode-575018 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harsha M Naik |
Yenepoya Medical College Hospital |
7th floor C wing, Department of physiotherapy
Dakshina Kannada
KARNATAKA |
8073836187
Harshamnaik@yenepoya.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Volunteers screened with flatfloot |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Undergraduate and postgraduate student in Yenepoya University Age group (18-25)
Both male and female |
|
| ExclusionCriteria |
| Details |
a. Person with medical condition(Recent injury,fracture,surgery,trauma,) b. Person with recurrent Ankle sprain
c. Person with one limb shorter than other |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Foot posture index
Navicular drop test
Hand held dynamometer
Pelvic inclinometer
Straight leg raise test |
Baseline(One time assessment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="282"
Sample Size from India="282"
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)
|
25/10/2024 |
| 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="1"
Months="6"
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 - NO
|
|
Brief Summary
|
The study investigates the association between flat foot and lower limb alignment Also it gives the idea about the Prevelence of flat foot in the university This study will be helpful to determine the prevalence flatfoot and it’s association with the lower limb alignment thus eventually will be effective for rehabilitation. |