| CTRI Number |
CTRI/2026/01/101802 [Registered on: 22/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Foot Deformities and Body Weight in University Students. |
|
Scientific Title of Study
|
Prevalence of foot deformity and associated with BMI(Body Mass Index) among university 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 |
Bhavani R |
| Designation |
Student |
| Affiliation |
SRM institute of science and technology |
| Address |
SRM College of Physiotherapy room no PT12 5th floor SRM Medical college building SRM medical College hospital and research centre Kattankulathur
Chennai
TAMIL NADU
603203
India |
| Phone |
8637647873 |
| Fax |
|
| Email |
rm4561@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Niveditha Jayaraman |
| Designation |
Assistant professor |
| Affiliation |
SRM institute of science and technology |
| Address |
SRM College of Physiotherapy room no PT12 5th floor SRM Medical college building SRM medical College hospital and research centre Kattankulathur
Chennai
TAMIL NADU
603203
India |
| Phone |
8610018369 |
| Fax |
|
| Email |
niveditj@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Bhavani R |
| Designation |
Student |
| Affiliation |
SRM institute of science and technology |
| Address |
SRM College of Physiotherapy room no PT12 5th floor SRM Medical college building SRM medical College hospital and research centre Kattankulathur
Chennai
TAMIL NADU
603203
India |
| Phone |
8637647873 |
| Fax |
|
| Email |
rm4561@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Bhavani R |
| Address |
SRM College of Physiotherapy, SRM Medical college building, SRM medical College hospital and research centre, Kattankulathur, chennai, tamilnadu, 603203, India |
| Type of Sponsor |
Other [SELF SPONSER] |
|
|
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 |
| Bhavani R |
INSTITUTIONAL ETHICAL COMMITTEE MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
SRM College of Physiotherapy room no PT12 5th floor SRM Medical college building SRM medical College hospital and research centre Kattankulathur
Chennai
TAMIL NADU |
8637647873
rm4561@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Foot deformity |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged between 18 and 25 years.
Willing to provide informed consent.
Individuals with foot deformities.
Both male and female.
|
|
| ExclusionCriteria |
| Details |
History of foot trauma, surgery.
Congenital deformities.
Neuromuscular disorders affecting gait.
Pregnant women( due to temporary foot changes)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Measure BMI -
Foot function index
Foot posture index
Hallux valgus and hammer toe measured by goniometry
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="384"
Sample Size from India="384"
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)
|
02/02/2026 |
| 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="3"
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
|
Body mass index (BMI) was calculated using body weight in kilograms divided by height in meters squared and classified as underweight, normal, overweight, or obese according to World Health Organization guidelines. Hallux valgus was assessed using a goniometer by placing the fulcrum at the metatarsophalangeal joint, with the arms aligned along the first metatarsal and proximal phalanx of the hallux, and the severity of deformity was categorized as mild, moderate, or severe based on the measured angle. Hammer toe deformity was evaluated by measuring flexion at the proximal interphalangeal joint, where excessive flexion beyond the normal range indicated the presence of deformity. Foot posture was assessed using the Foot Posture Index (FPI-6), a validated tool that classifies the foot as supinated, neutral, or pronated based on observable criteria. The degree of foot posture abnormality ranged from highly supinated to highly pronated according to the total score. Foot-related pain, functional limitation, and walking ability were further assessed using the Foot Function Index, which measures the impact of foot problems on daily activities. |