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CTRI Number  CTRI/2025/08/092915 [Registered on: 12/08/2025] Trial Registered Prospectively
Last Modified On: 12/08/2025
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   Effects of foot exercises in adults with flatfoot 
Scientific Title of Study   Effect of Foot Intrinsic vs Tibialis Posterior Strengthening Exercises on Plantar Pressure in Adults with Flatfoot: 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  TEJASHWINI SHINDE 
Designation  MUSCULOSKELETAL PHYSIOTHERAPY RESIDENT 
Affiliation  Dr. BALASAHEB VIKHE PATIL RUURAL MEDICAL COLLEGE 
Address  Dr. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY, ORTHOPAEDIC PHYSIOTHERAPY DEPARTMENT, PRAVARA INSTITUTE OF MEDICAL SCIENCES TAL:RAHATA, LONI

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  8379936345  
Fax    
Email  tejashvini20@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr SUKHPREET PABLA 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Dr. BALASAHEB VIKHE PATIL RURAL MEDICAL COLLEGE 
Address  Dr. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY, ORTHOPAEDIC PHYSIOTHERAPY DEPARTMENT, PRAVARA INSTITUTE OF MEDICAL SCIENCES TAL:RAHATA, LONI
Dr. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY, ORTHOPAEDIC PHYSIOTHERAPY DEPARTMENT, PRAVARA INSTITUTE OF MEDICAL SCIENCES TAL:RAHATA, LONI
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9638299273  
Fax    
Email  pablasukhpreet27@gmail.com  
 
Details of Contact Person
Public Query  
Name  TEJASHWINI SHINDE 
Designation  MUSCULOSKELETAL PHYSIOTHERAPY RESIDENT 
Affiliation  Dr. BALASAHEB VIKHE PATIL RUURAL MEDICAL COLLEGE 
Address  Dr. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY, ORTHOPAEDIC PHYSIOTHERAPY DEPARTMENT, PRAVARA INSTITUTE OF MEDICAL SCIENCES TAL:RAHATA, LONI

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  8379936345  
Fax    
Email  tejashvini20@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY 
Address  Dr. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY,ORTHOPAEDIC PHYSIOTHERAPY DEPARTMENT,PRAVARA INSTITUTE OF MEDICAL SCIENCES TAL:RAHATA, DISTRICT:AHEMDNAGAR, LONI MAHARASTRA PIN:413736 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
TEJASHWINI SHINDE  Dr APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY  HALL NO 403 DEPARTMENT OF ORTHOPAEDIC PHYSIOTHERAPY TALAUKA RAHATA
Ahmadnagar
MAHARASHTRA 		 8379936345
2422271426
tejashvini20@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group  Foot Intrinsic Muscle Strengthening Training 
Intervention  Experimental Group  Selected Tibialis Posterior Muscle Strengthening Training 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1. Both Males and females.
2. Adults aged 18 to 25 years
3. Asymptomatic bilateral flexible flatfoot
4. Navicular drop (ND) greater than 10 mm
5. MMT for Intrinsic and Extrinsic Muscle
 
 
ExclusionCriteria 
Details  1. Patient with any other Orthopaedic conditions of Lower Extremity.
2. Patients with any other lower extremity deformity
3. Patients with neurological conditions
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Navicular Drop measured with Navicular Drop Test
Arch Measured with Arch Height Index
Strength-Manual Muscle Testing (Grade 3 )
Plantar Pressure with Diapodo Care Software.

 		 All outcomes measured at baseline and after 6 weeks

 
 
Secondary Outcome  
Outcome  TimePoints 
Navicular Drop measured with Navicular Drop Test
Arch Measured with Arch Height Index
Strength-Manual Muscle Testing (Grade 3 )
Plantar Pressure with Diapodo Care Software.

 		 All outcomes measured at baseline and after 6 weeks

 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   23/08/2025 
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="2"
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  

PROJECT TITLE: EFFECT OF FOOT INTRINSIC VS TIBIALIS POSTERIOR STRENGHTHENING EXERCISES ON PLANTAR PRESSURE IN ADULTS WITH FLATFOOT: A RANDOMIZED CONTROL TRIAL

Dr. Tejashwini Shinde1 Musculoskeletal Physiotherapy Resident, Dr. APJ Abdul Kalam College of Physiotherapy, Loni, Maharashtra, India, Email-tejashvini20@gmail.com

Dr. Sukhpreet Pabla2 Associate Professor, Department of Orthopaedic Physiotherapy, Dr. APJ Abdul Kalam College of Physiotherapy, Loni, Maharashtra, India, Email-pablasukhpreet27@gmail.com

AIMS AND OBJECTIVES

AIM:

To find the efficacy of Intrinsic vs Tibilias Posterior Strengthening Exercise on Plantar pressure in adults with Flatfoot. 

OBJECTIVES:

To find the effect of Intrinsic vs Tibilias Posterior Strengthening Exercise on Plantar pressure by

1.       Navicular Drop Test

2.       Arch Height Index (In weight bearing position)

3.       Manual Muscle Testing (Strength) (Grade 3)in adults with Flatfoot.

SELECTION CRITERIA:

Inclusion criteria-

1.       Both Males and females.

2.       Adults aged 18 to 25 years

3.       Asymptomatic bilateral flexible flatfoot

4.       Navicular drop (ND) greater than 10 mm 

5.       MMT for Intrinsic and Extrinsic Muscle       

  Exclusion criteria-

1.       Patient with any other Orthopaedic conditions of Lower Extremity.

2.       Patients with any other lower extremity deformity

3.       Patients with neurological conditions

METHODOLOGY

Source of Data: Department of Orthopedics, Dr. APJ Abdul Kalam College of Physiotherapy, Loni.

Method of collection of data: Primary

Type of Study: Experimental study

Study Design: Single Blinded, Randomized Control Trail.

Study Setting: This study will be conducted in the OPD of Orthopaedic Physiotherapy Department, Dr. APJAK College of Physiotherapy.

Sample size: A total 90 = 86±4

Study population: Patients with Flatfoot.

Sampling Method: Simple Random Sampling- Lottery Method

Study Duration: 2 Years

Materials: Resistance band (used in ascending order), Towel, Chair with armrest, Stepper

OUTCOME MEASURES

1.       Navicular Drop measured with Navicular Drop Test

2.       Strength-Manual Muscle Testing (Grade 3)

3.       Plantar Pressure with Diapodo Care Software

4.       Arch Height Index in weight bearing position

PROCEDURE- After receiving ethical clearance by the Institutional Ethical Committee of Dr. A.P.J Abdul Kalam College of Physiotherapy, PIMS-DU. Participants were selected from Orthopaedic OPD at Dr. A.P.J Abdul Kalam College of Physiotherapy, PIMS-DU. The participants were selected on the basis of lottery method according to the inclusion and exclusion criteria mentioned above. The consent of the participants will be taken, the ones willing to participate in the project will be selected. All information, procedure of the study, how it will be beneficial to the participants will be explained. Patient with Flatfoot aged

The participants will be randomly distributed into two exercise groups: Group A- 43±2 - Intrinsic Muscle Strengthening Exercise Group B- 43±2 - Tibilias Posterior Muscle Strengthening Exercise All groups received strengthening training for 30 minutes five times a week for six weeks

STUDY VARIABLES

NAME OF VARIABLE

MEASUREMENT SCALE

MEASUREMENT METHOD

Age

Nominal

Verbally/Interview

Gender

Nominal

Observation

Plantar Pressure 

Interval

Record

Navicular drop

Interval

Ruler

Strength

Interval

MMT                                                

Arch height index

Interval

Footprint Method

 STATISICAL ANALYSIS

Statistical Analysis will be done using appropriate test

 
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