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CTRI Number  CTRI/2023/11/060369 [Registered on: 30/11/2023] Trial Registered Prospectively
Last Modified On: 29/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Enhancing Foot Health in School Children: A Study on Intrinsic and Extrinsic Foot Muscle Exercises and Their Impact on Plantar Arch Development and Balance  
Scientific Title of Study   Effect of Intrinsic and Extrinsic Foot Muscles Exercise in School Children with Flat Feet: Implications for Foot Function, Development of planter arch and Balance  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prajapati Upasana Yogeshbhai 
Designation  Post Graduate Student 
Affiliation  school of physiotherapy, R K University 
Address  School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India

Rajkot
GUJARAT
360020
India 
Phone  8320443615  
Fax    
Email  uprajapati383@rku.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Amit Sharma 
Designation  Director, School of Physiotherapy 
Affiliation  School of physiotherapy, R K University 
Address  School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India

Rajkot
GUJARAT
360020
India 
Phone  9811281520  
Fax    
Email  amit.sharma@rku.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Amit Sharma 
Designation  Director, School of Physiotherapy 
Affiliation  School of physiotherapy, R K University 
Address  School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India


GUJARAT
360020
India 
Phone  9811281520  
Fax    
Email  amit.sharma@rku.ac.in  
 
Source of Monetary or Material Support  
Prajapati Upasana Yogeshbhai school of physiotherapy, R k university 
 
Primary Sponsor  
Name  Prajapati Upasana Yogeshbhai 
Address  School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
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 
Prajapati Upasana Yogeshbhai  BAPS swaminarayan vidyamandir  Opposite akshar mandir, yogiji maharaj marg, gondal, rajkot
Rajkot
GUJARAT 		 8320443615

uprajapati383@rku.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethics committee, School of Physiotherapy, R K University  Approved 
Ethics committee, school of physiotherapy, R K University   No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  FLATFEET 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intrinsic and extrinsic foot muscle exercise in school children with flatfeet  Intrinsic foot muscle exercises 1. Short foot exercise 2. Toe spread exercise 3. Hallux extension exercise 4. Lesser toe extension exercise Extrinsic foot muscle exercises 1. Ankle dorsi flexion 2. Ankle plantar flexion 3. Foot Eversion 4. Foot inversion 5. Foot supination 6. Hip abduction 7. Calf stretching These exercises will be prescribed with 3 sets of 15 repitions for 10 second hold, 3 sessions/week 6 weeks exercise protocol 
Comparator Agent  Not applicable   Not applicable  
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  1.Subjects with flexible flat feet
2.Age group of 7 years to 19 years
3.Subjects with bilateral flatfeet
 
 
ExclusionCriteria 
Details  1.Subjects with unilateral flatfeet
2.Subjects with any previous foot injury
3.Subjects with previous foot surgery
4.Subjects with any congenital deformity
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
navicular drop test  At baseline day 1 and after 6 weeks of intervention  
 
Secondary Outcome  
Outcome  TimePoints 
foot posture index  At baseline day 1 & after 6 weeks intervention  
sensamove balance system  At baseline day 1 & after 6 weeks intervention  
 
Target Sample Size   Total Sample Size="43"
Sample Size from India="43" 
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)   10/12/2023 
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   Title : Effect of Intrinsic and Extrinsic Foot Muscles Exercise in School Children with Flat Feet: Implications for Foot Function, Development of planter arch and Balance
Introduction: 30 % of children have been reported of foot problem where the most common deformities seen are flat feet out of which 13.4%-27.6% of school children have flatfeet. Normal foot function is provided by foot core which includes active, passive and neutral subsystem. Activation of foot muscles play critical role to maintain balance. Foot has a smaller base of support and it is the most distal segment of lower limb and helps to maintain balance in closed kinematic chain. Complete kinematic chain is altered by flatfeet and it is combined with altered proximal joint proprioception and it will be resulted in impaired balance. If flatfeet is left untreated, low back pain, patello-femoral pain, joint degeneration and instability and functional limitation, altered gait, abnormal balance and motor dysfunction and can continue to the adulthood.
Need of the study: In recent times, therapists are giving more importance to extrinsic foot muscles to treat flatfeet. While intrinsic foot muscles also have contributory factor for the management of flatfeet specially the role of abductor hallucis in maintaining the navicular height. There is a need of the study is to check the combined effect of strengthening exercise of intrinsic foot muscle and extrinsic foot muscle on function, development of arches and balance in school children with flatfeet.
AIM: To check the effect of intrinsic and extrinsic foot muscle exercise in school children with flatfeet.
OBJECTIVES: 1. To check the combined effect of intrinsic and extrinsic foot muscle exercise on the navicular height in school children. 2.To check the combined effect of intrinsic and extrinsic foot muscle exercise on static and dynamic balance in school children. 3.To check the combined effect of intrinsic and extrinsic foot muscle exercise on foot posture in school children.
Methodology: The population will be school children. Subjects will be screened on the basis of convenient sampling and included in the study on the basis of inclusion criteria from schools of rajkot area and written consent will be taken from parents of subjects. intrinsic and extrinsic foot muscle exercises will be prescribed to the students for 6 weeks. The intervention will be given for 6 weeks according to the protocol and post intervention assessment will be taken after 6 weeks. Pre and post data will be assessed with navicular drop test, foot posture index and sensamove balance system.

 
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