| CTRI Number |
CTRI/2025/05/087817 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
26/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Can strengthening core and foot muscles improve ankle movement in people with flat feet? |
|
Scientific Title of Study
|
EFFECT OF CORE MUSCLE STRENGTHENING AND SHORT FOOT EXERCISES ON THE KINEMATICS OF ANKLE JOINT IN FLAT FOOT: A QUASI-EXPERIMENTAL 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 |
Vishal Parmar |
| Designation |
Post graduate student |
| Affiliation |
NITTE Institute of Physiotherapy, NITTE (Deemed to be university) |
| Address |
Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University),Deralakatte, Mangaluru
Department of Physiotherapy, Room number 20, second base division,NITTE Institute of Physiotherapy, NITTE (Deemed to be University),Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8955292573 |
| Fax |
|
| Email |
vp073567@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saumya Srivastava |
| Designation |
Associate Professor |
| Affiliation |
NITTE Institute of Physiotherapy, NITTE (Deemed to be university) |
| Address |
Department of Physiotherapy, Room number 20, second base division,NITTE Institute of Physiotherapy, NITTE (Deemed to be University),Deralakatte, Mangaluru
Department of Physiotherapy, Room number 20, second base division,NITTE Institute of Physiotherapy, NITTE (Deemed to be University),Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9740244077 |
| Fax |
|
| Email |
saumyasri2000@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Vishal Parmar |
| Designation |
Post graduate student |
| Affiliation |
NITTE Institute of Physiotherapy, NITTE (Deemed to be university) |
| Address |
Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University),Deralakatte, Mangaluru
Department of Physiotherapy, Room number 20, second base division,NITTE Institute of Physiotherapy, NITTE (Deemed to be University),Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8955292573 |
| Fax |
|
| Email |
vp073567@gmail.com |
|
|
Source of Monetary or Material Support
|
| NITTE Institute of Physiotherapy, NITTE (Deemed to be unversity) will provide basicinfrastructure facilities. no other monitary support is required |
|
|
Primary Sponsor
|
| Name |
Nitte Institute of Physiotherapy NITTE deemed to be univer |
| Address |
Department of Physiotherapy, room number 20, second base division,NITTE Institute of Physiotherapy, NITTE (Deemed to be University),Deralakatte, Mangaluru, Karnataka, 575018, India |
| 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 |
| Vishal Parmar |
InstitutionalEthicsCommittee ofNITTE InstituteofPhysiotherapy |
Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University),Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA |
8955292573
vp073567@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of NITTE Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Young adults having flat foot deformity |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CORE MUSCLE STRENGTHENING AND SHORT FOOT EXERCISES |
Participants will be provided with the treatment alternative day-per-week treatments for 8 weeks for 40 minutes with 8 seconds hold of 15 repetitions for both groups. After completion of the 8-week protocol treatment, again the individual will be evaluated based on kinematics, plantar pressure, and foot posture index.
Subjects in the experimental group will get the additional core strengthening protocol along with short foot exercises treatment for flat foot, these exercises will be performed for 3 sets of 15 repetitions for each side hold 8-second and 8-second relaxation. The additional core muscle strengthening exercises include.
1. Curl-up
2. Short foot exercise
3. Side Bridge exercise
4. Bird dog exercise
5. Hip abductor strengthening
6. Ball squeeze exercise
|
| Comparator Agent |
Short foot exercises. |
Participants will be provided with the treatment alternative day-per-week treatments for 8 weeks for 40 minutes with 8 seconds hold of 15 repetitions for both groups. After completion of the 8-week protocol treatment, again the individual will be evaluated based on kinematics, plantar pressure, and foot posture index.
Subjects in the control group will get short foot exercises. The patients will perform an average of three series of 15 repetitions of each exercise once daily. For all exercises, the final static position will be held for 8-sec and 8-sec relaxation between each exercise. There will be an increase in the number of repetitions or load progression according to individual tolerance.
1.Short foot exercises
2.Toe curls
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Young adults with flat foot from NITTE Institute of Physiotherapy
2. Age 18-25 years old
3. Students have flat foot
4. Navicular drop test score exceeding 9mm
5. Foot posture index (FPI) score 6 to 12
|
|
| ExclusionCriteria |
| Details |
1. Having rigid flat foot
2. Participants reporting foot disorders (hallux valgus, hallux rigidus)
3. Participants with neurologic or orthopedic problems that can affect the lower extremity
4. Participants with a history of hip, ankle and knee surgery.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the joint kinematics in ankle and knee joint Gait-ON software in treadmill is used. |
Once the individual is included in the study, readings will be taken as baseline values (Pre) and after 8 weeks of treatment (Post). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
OHM 3000, a plantar pressure system
Foot Posture Index |
Once the individual is included in the study, readings will be taken as baseline values (Pre) and after 8 weeks of treatment (Post). |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
20/06/2025 |
| 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="1"
Months="0"
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
|
Introduction Flatfoot is a condition characterized by the collapse of the medial longitudinal arch, which affects gait and weight distribution. This study explores how strengthening exercises targeting core muscles and intrinsic foot muscles can impact foot posture and biomechanics, potentially improving stability, shock absorption, and reducing associated musculoskeletal disorders. Need for the Study Flatfoot is linked to conditions like scoliosis, lower back pain, and knee issues. While short foot exercises have been shown to improve foot posture, their combined effect with core strengthening on ankle joint kinematics remains underexplored. This study aims to fill this research gap. The study aims to assess the combined effect of core muscle strengthening and short foot exercises on the kinematics of the ankle joint in individuals with flat feet. Methodology -
Study Design: Quasi-experimental -
Participants: Young adults (18-25 years) with flatfoot from the NITTE Institute -
Sample Size: 34 (17 per group) -
Intervention: Experimental group receives both core muscle strengthening and short foot exercises, while the control group receives only short foot exercises -
Duration: 8 weeks (40-minute sessions, 3 times per week) -
Outcome Measures: GaitON software for motion analysis, OHM 3000 for plantar pressure assessment, and Foot Posture Index Expected Outcome The study hypothesizes that the combination of core strengthening and foot exercises will result in significant improvements in ankle joint kinematics compared to short foot exercises alone. Statistical analysis will be conducted using SPSS software. This research will contribute to physiotherapy interventions for flatfoot, providing evidence-based rehabilitation strategies for improving foot posture and movement mechanics. |