| CTRI Number |
CTRI/2024/10/075523 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
comparative study |
| Study Design |
Other |
|
Public Title of Study
|
Flatfoot Vs Regular: Who has the better ankle stability and proprioception |
|
Scientific Title of Study
|
Evaluation of ankle proprioception and instability among individuals with and without flatfoot – a comparative study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aswathy Raju |
| Designation |
Post Graduate student |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
Mpt 2nd year classroom, MPT Division, Physiotherapy department, Yenepoya Physiotherapy College, Naringana, Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7356569962 |
| Fax |
|
| Email |
28227@yenepoya.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Harsha M Naik |
| Designation |
Assistant Professor |
| Affiliation |
Yenepoya Physotherapy College |
| Address |
Staff room, Staff division, Physiotherapy department, Yenepoya Physiotherapy College, Naringana, Deralakatte, Mangalore
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 Physotherapy College |
| Address |
Staff room, Staff division, Physiotherapy department, Yenepoya Physiotherapy College, Naringana, Deralakatte, Mangalore
KARNATAKA
575018
India |
| Phone |
8073836187 |
| Fax |
|
| Email |
harshamnaik@yenepoya.edu.in |
|
|
Source of Monetary or Material Support
|
| Yenepoya (deemed to be) University,Naringana, Deralakatte, Mangalore, Karnataka
pincode-575018
India |
|
|
Primary Sponsor
|
| Name |
Aswathy Raju |
| Address |
MPT 2nd year classroom, MPT
division, Physiotherapy department, Yenepoya Physiotherapy College, Naringana, Deralakatte, Mangalore, Karnataka
Pin code-575018
India |
| 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 |
| DrAswathy Raju |
Yenepoya (deemed to be) University |
Mpt 2nd year classroom, MPT Division, Physiotherapy department, Yenepoya Physiotherapy College, Naringana, Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India
Dakshina Kannada
KARNATAKA |
7356569962
28227@yenepoya.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics - 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
flatfoot and regular foot |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Undergraduate and postgraduate students of Yenepoya university |
|
| ExclusionCriteria |
| Details |
Person with medical conditions( recent injury, fracture, surgery, trauma)
Person with recurrent ankle sprain |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Joint position error score and
Anterior drawer test |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="153"
Sample Size from India="153"
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)
|
28/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/10/2024 |
| 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 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
|
Differences in foot posture may cause muscle imbalances resulting in an unbalanced evertor and invertor forces leading to ankle instability and injury. This study aims to evaluate ankle proprioception and ankle instability among young adults with and without flat feet. The research will be conducted among students aged 18 to 25 years at Yenepoya (Deemed to be) University. Participants will be screened using the navicular drop test for assessing foot posture. |