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CTRI Number  CTRI/2024/08/071804 [Registered on: 01/08/2024] Trial Registered Prospectively
Last Modified On: 18/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Effect of feet exercises and BOSU ball exercises for participants with flat feet 
Scientific Title of Study   Effectiveness of conventional therapy versus bosu ball therapy on flat feet among young adults 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Daxa Mishra  
Designation  Professor  
Affiliation  K M Patel Institute of Physiotherapy 
Address  dept no 152 K M Patel Institute of physiotherapy Bhaikaka University Karamsad Anand Gujarat India

Anand
GUJARAT
388325
India 
Phone  9913086318  
Fax    
Email  daxagm@charutarhealth.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Aishwarya Soni 
Designation  MPT 2nd year student 
Affiliation  K M Patel Institute of physiotherapy 
Address  dept no 152 K M Patel Institute of physiotherapy Bhaikaka University Karamsad Anand Gujarat 388001 India

Anand
GUJARAT
388325
India 
Phone  8849919551  
Fax    
Email  soniaishwarya936@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Aishwarya Soni 
Designation  MPT 2nd year student 
Affiliation  K M Patel Institute of physiotherapy 
Address  dept no 152 K M Patel Institute of physiotherapy Bhaikaka University Karamsad Anand Gujarat 388001 India

Anand
GUJARAT
388325
India 
Phone  8849919551  
Fax    
Email  soniaishwarya936@gmail.com  
 
Source of Monetary or Material Support  
K M Patel Institute of physiotherapy Bhaikaka University, Karamsad, Anand, Gujarat 388325 
 
Primary Sponsor  
Name  self 
Address  K M Patel Institute of Physiotherapy, Bhaikaka University Karamsad, Anand 388325 
Type of Sponsor  Other [Constituent of Bhaikaka University] 
 
Details of Secondary Sponsor  
Name  Address 
nil  NA  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Daxa Mishra  Shree Krishna Hospital   152, Department of physiotherapy, K M Patel Institute of physiotherapy, Bhaikaka University Karamsad Anand Gujarat
Anand
GUJARAT 		 9913086318

daxagm@charutarhealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  FLEXIBLE FLAT FEET 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bosu ball therapy   Bosu ball (both sides up) is a device made of inflated rubber used for balance training and strengthening. For 4 weeks, 5 day per week 
Intervention  Experimental study: Conventional and bosu ball exercises given as comparator agent using navicular drop test, foot posture index and y balance test.   Conventional therapy exercises for 5 days in a week for 4 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  26.00 Year(s)
Gender  Both 
Details  Participants with navicular drop angle more than 10 mm
Participants with foot posture index greater and eqaul than 6
Young adults age 18-26 years
Person with BMI 18.5-24.9
Participants both male and female with bilateral or unilateral non-pathological flat feet.
Person with normal BMI 18.5-24.9
 
 
ExclusionCriteria 
Details  Any foot impairment, fracture or musculoskeletal deficit
Any cardiovascular, cardiorespiratory or neurological deficit
Any congenital foot deformity or lower limb malformation
Participants wearing insoles for flat feet 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Navicular Drop Test  Pre and post treatment time of 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Foot Posture Index-6  Pre and post treatment time of 4 weeks 
Y Balance test  Pre and post treatment time of 4 weeks 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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 1/ Phase 2 
Date of First Enrollment (India)   14/08/2024 
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   This study will be beneficial for participants with flexible flat feet who have impaired Navicular drop and balance. By comparing Conventional therapy and Bosu ball therapy we will get to know which exercise training will be more effective and can be used to get effective outcome .  
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