| CTRI Number |
CTRI/2025/09/094901 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
13/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to compare foot muscle strengthening exercises with regular exercises to see their effect on walking pattern and foot pressure in college students with flat feet |
|
Scientific Title of Study
|
Effect of Intrinsic foot muscle strengthening versus
Conventional Exercises on Plantar Pressure During Walking in Asymptomatic College
Students with Flexible Flat Feet: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Durvesh Gurap |
| Designation |
PG Student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
PARUL INSTITUTE OF PHYSIOTHERAPY PARUL UNIVERSITY VADODARA GUJARAT 391760
Vadodara
GUJARAT
391760
India |
| Phone |
8459032800 |
| Fax |
|
| Email |
durveshgurap@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Singh |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
PARUL SEVASHRAM HOSPITAL ORTHO PHYSIOTHERAPY DEPARTMENT ROOM NO 18 PARUL UNIVERSITY VADODARA GUJARAT 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9586120583 |
| Fax |
|
| Email |
priyanka.singh34667@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Singh |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
PARUL SEVASHRAM HOSPITAL ORTHO PHYSIOTHERAPY DEPARTMENT ROOM NO 18 PARUL UNIVERSITY VADODARA GUJARAT 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9586120583 |
| Fax |
|
| Email |
priyanka.singh34667@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Durvesh Gurap |
| Address |
PARUL INSTITUTE OF PHYSIOTHERAPY PARUL UNIVERSITY VADODARA GUJARAT 391760 |
| 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 |
| Durvesh Gurap |
Parul University |
PARUL SEVASHRAM HOSPITAL ORTHO PHYSIOTHERAPY DEPARTMENT ROOM NO 18 PARUL UNIVERSITY VADODARA GUJARAT 391760
Vadodara
GUJARAT |
8459032800
durveshgurap@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PUIECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Flexible Flat Foot |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional foot Exercises |
6 weeks, 3 sessions per week |
| Intervention |
Intrinsic foot muscle exercises |
6 weeks, 3 sessions per week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1 College students aged 18-25 year.
2 Students with Flexible flat feet.
3 Asymptomatic, with no history of foot pain or related musculoskeletal issues.
4 Students with Navicular Drop test positive.
5 Willing to participate in the study and adhere to the exercise regimen. |
|
| ExclusionCriteria |
| Details |
1 Individual having congenital anomalies in Lower limb.
2 Recent surgery, fracture or dislocation of lower limb.
3 Limb Length discrepancy of more than 1.5cm.
4 Presence of Corn or Calluses in foot.
• Use of any custom orthotic or specialized foot wear that may influence plantar pressure distribution. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Plantar Pressure distribution while walking. |
1.Baseline
2.6weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
30/09/2025 |
| 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="0"
Months="6"
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
|
Need of Study: Flexible flat feet are common in asymptomatic college students and may cause altered biomechanics and discomfort. While intrinsic foot muscle strengthening is a common intervention its effect on plantar pressure distribution during walking remains unclear. This study aims to examine whether strengthening these muscles influences plantar pressure in individuals with flexible flat feet potentially guiding effective strategies to improve foot mechanics and overall foot health.
Brief: The human foot is a highly complex structure vital for weight bearing, balance, walking and running, and its evolution distinguishes humans from other animals. Flat feet defined by a reduced medial longitudinal arch are common and often asymptomatic but can lead to problems such as plantar fasciitis and metatarsalgia. Their global prevalence is about 13.6 percentage i.e 12.8 percentage in males and 14.4 percentage in females with variations across regions 20 percentage in the U.S. 5 percentage in Saudi Arabia, and between 25 to 40 percentage in Indonesian populations. Among individuals aged 18 to 25 years around 20 to 30 percentage have flat feet. Strengthening the intrinsic foot muscles helps maintain the integrity of the medial longitudinal arch and prevents pronation related injuries.
The IFMs are the primary stabilizers of the medial longitudinal arch and contribute to posture, gait and proportional weight distribution. Flat foot causes biomechanical alterations that shift the body’s center of gravity and strain joints of the spine, hip, knee and lower leg leading to postural and stride issues. Short Foot Exercises are effective in strengthening the IFMs restoring the medial longitudinal arch improving posture and enhancing stability through increased sensory input from the foot. Janda and VaVrova demonstrated that SFEs activate the intrinsic muscles to elevate and shorten the arch thereby improving body position and balance. Although evidence supports the role of IFM strengthening further high quality studies are needed to confirm its effectiveness in adults with flat feet. |