| CTRI Number |
CTRI/2025/09/095496 [Registered on: 30/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A 6-week foot exercise program to strengthen the feet and activation of hip muscles: How it helps people with flat feet to improve balance, and its effect on lower limb movement. |
|
Scientific Title of Study
|
The effect of 6 week of short foot exercises with isometric hip abduction on Navicular drop, dynamic balance and step up kinematics in adults with flexible flat foot: a randomized control 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 |
Riddhi Prakash Sonaiya |
| Designation |
Postgraduate Student |
| Affiliation |
DY Patil deemed to be University |
| Address |
6th floor, Physiotherapy department, DY Patil deemed to be University, School of Physiotherapy, plot no-2, sector-5, Nerul, Navi Mumbai
Mumbai MAHARASHTRA 400706 India |
| Phone |
9727830228 |
| Fax |
|
| Email |
dr.riddhirs20@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Riddhi Prakash Sonaiya |
| Designation |
Postgraduate Student |
| Affiliation |
D.Y Patil deemed to be University, School of Physiotherapy |
| Address |
6th floor, Physiotherapy department, DY Patil deemed to be University, School of Physiotherapy, plot no-2, sector-5, Nerul, Navi Mumbai
Mumbai MAHARASHTRA 400706 India |
| Phone |
9727830228 |
| Fax |
|
| Email |
dr.riddhirs20@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Twinkle Dabholkar |
| Designation |
Professor and Head of Musculoskeletal Department |
| Affiliation |
D.Y Patil deemed to be University, School of physiotherapy |
| Address |
6th floor, Physiotherapy department, DY Patil deemed to be University, School of Physiotherapy, plot no-2, sector-5, Nerul, Navi Mumbai
Mumbai MAHARASHTRA 400706 India |
| Phone |
9819870821 |
| Fax |
|
| Email |
twinkle.dabholkar@dypatil.edu |
|
|
Source of Monetary or Material Support
|
| D.Y Patil deemed to be University, School of Physiotherapy, Navi Mumbai, 400706, India |
|
|
Primary Sponsor
|
| Name |
DY Patil deemed to be University, School of Physiotherapy |
| Address |
DY Patil deemed to be University, School of Physiotherapy, 6th floor, Plot no-2, sector-5, Nerul, Navi Mumbai - 400706 |
| Type of Sponsor |
Private medical college |
|
|
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 Riddhi Prakash Sonaiya |
Dr. DY Patil deemed to be University, School of Physiotherapy |
DY Patil deemed to be University, School of Physiotherapy, 6th floor, plot no-2, sector-5, Nerul, Navi Mumbai Mumbai MAHARASHTRA |
09727830228
dr.riddhirs20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics commitee for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M214||Flat foot [pes planus] (acquired), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Short Foot Exercise |
3 session per week for 6 weeks-
Lesser toe extension, toe spread, doming, and hallux extension, Marble pick up, toe towel curl, tibialis posterior strengthening, iliopsoas stretching, Rolling a tennis ball, Pulling the foot with a towel around the heel, Write the alphabet. Calf muscle stretching, Resistive inversion and eversion with an elastic band, Maintaining balance in a stable and unstable base.
These exercise will be done in sitting position for week 1 and 2, in Standing position in week 3 and 4 and one leg standing position in week 5 and week 6 |
| Intervention |
Short Foot Exercise with Isometric Hip Abduction |
3 session per week for 6 weeks -
Lesser toe extension, toe spread, doming, and hallux extension, Marble pick up, toe towel curl, tibialis posterior strengthening, iliopsoas stretching, Rolling a tennis ball, Pulling the foot with a towel around the heel, Write the alphabet. Calf muscle stretching, Resistive inversion and eversion with an elastic band, Maintaining balance on a stable and unstable base.
All these exercise will be done with isometric hip abduction using Theraband in sitting position for first two weeks, followed by in standing in week 3 and week 4 and one leg standing in week 5 and 6. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Age- 18 to 30 years
2.Gender-male/female
3.Navicular Drop more than 10mm
3.BMI- 18 to 25
4.Arch Index – more than 0.28 cm²
5.Flexible flat foot
|
|
| ExclusionCriteria |
| Details |
1.Any back or lower limb injury in last 6 months
2.History of hip and Ankle surgery
3.Neurological disability
4.Pregnancy
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Star Excursion Balance Test to test dynamic balance,
Lower limb kinematics using Kinovea |
Baseline
after 6 weeks of training |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Navicular Drop,
Arch Index |
Baseline,
After 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/10/2025 |
| 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="5" 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
|
Flexible flat foot is characterized by a weakened medial longitudinal arch and compromised abductor halluces muscle function, which increases compensatory Tibialis anterior activity, leading to Hyperpronation of foot, tibial internal rotation, and altered lower-limb kinematics. Additionally, hip abductor and external rotator weakness contribute to dynamic knee valgus and hip adduction, further impairing lower-limb alignment. Short Foot Exercises (SFE) are commonly prescribed to strengthen intrinsic foot muscles, but evidence suggests that combining them with isometric hip abduction (IHA) may provide better outcomes. Prior studies have demonstrated improvements in static balance when SFE is combined with IHA, but their impact on dynamic balance and lower-limb kinematics remains unexplored. Therefore, this study seeks to investigate whether adding IHA to SFE enhances dynamic balance and lower-limb kinematics in adults with flexible flat feet. AIMS AND OBJECTIVES- The aim is to compare the effects of a 6-week program of SFE with IHA against SFE alone on Navicular drop, dynamic balance, step-up kinematics, and arch index • PRIMARY OBJECTIVES 1.To compare the effect of 6 week of short foot exercises with isometric hip abduction treatment protocol with short foot exercise alone on Dynamic balance assessed by Star excursion Balance Test in adults with flexible flat foot. 2. To compare the effect of 6 week of short foot exercises with isometric hip abduction treatment protocol with short foot exercise alone on Step up kinematics assessed by Kinovea software in adults with flexible flat foot. 1. To compare the effect of 6 week of short foot exercises with isometric hip abduction treatment protocol with short foot exercise alone on Navicular drop test in adults with flexible flat foot. 2.To compare the effect of 6 week of short foot exercises with isometric hip abduction treatment protocol with short foot exercise alone on Arch index in adults with flexible flat foot. MATERIALS AND METHODOLOGY- The Interventional study will be conducted for 6 weeks. 36 subjects with flexible flat foot based on inclusion and exclusion criteria will be recruited. Participants will be allocated into two groups: one receiving SFE alone, and the other SFE with IHA using resistance bands. After baseline assessment , participants will undergo a 6 week exercise protocol, performed three time a week under supervision. The intervention will last 6 weeks, with 3 sessions per week (45 minutes each) Outcome measures include Star Excursion Balance Test, step-up kinematics (hip abduction angle and dynamic knee valgus using Kinovea), Navicular drop test, and arch index . Data will be statistically analyzed using t-tests and ANOVA at the end of the study to determine the effectiveness of the training program. |