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CTRI Number  CTRI/2024/02/063172 [Registered on: 26/02/2024] Trial Registered Prospectively
Last Modified On: 06/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   CORRELATION STUDY 
Study Design  Single Arm Study 
Public Title of Study   Relationship of strength of muscles of core, flexibility of the Iliopsoas(group of muscles of hip) and measure of arch height in the feet in young adults with flat feet on both sides. 
Scientific Title of Study   Assessment and relationship of core endurance, Iliopsoas flexibility with navicular drop test in young adults with bilateral flexible flat feet 
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 SWATI KUBAL 
Designation  ASSISTANT PROFESSOR(PT) 
Affiliation  Topiwala National Medical College and B. Y. L. Nair Charitable Hospital 
Address  OPD 24,PT School and Centre, Topiwala National Medical College and Dr B.Y.L Charitable Hospital, Dr A.L, Dr Anandrao Nair Marg, Mumbai Central, Mumbai, Maharashtra Mumbai MAHARASHTRA 400008 India

Mumbai
MAHARASHTRA
400008
India 
Phone  8691948255  
Fax    
Email  swatikubal@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR SWATI KUBAL 
Designation  ASSISTANT PROFESSOR 
Affiliation  Topiwala National Medical College and B. Y. L. Nair Charitable Hospital 
Address  OPD 24, PT School and Centre, Topiwala National Medical College and Dr B.Y.L. Charitable Hospital, Dr A.L, Dr Anandrao Nair Marg, Mumbai Central, Mumbai, Maharashtra Mumbai MAHARASHTRA 400008 India

Mumbai
MAHARASHTRA
400008
India 
Phone  8691948255  
Fax    
Email  swatikubal@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  AHILYA TRIMUKHE 
Designation  POST GRADUATE STUDENT(PHYSIOTHERAPIST) 
Affiliation  Topiwala National Medical College and B. Y. L. Nair Charitable Hospital 
Address  OPD 24, PT School and Centre, Topiwala National Medical College and Dr B.Y.L. Charitable Hospital, Dr A.L, Dr Anandrao Nair Marg, Mumbai Central, Mumbai, Maharashtra Mumbai MAHARASHTRA 400008 India

Mumbai
MAHARASHTRA
400008
India 
Phone  8850138350  
Fax    
Email  ahilya.trimukhe411@gnail.com  
 
Source of Monetary or Material Support  
P.T SCHOOL AND CENTRE, TOPIWALA NATIONAL MEDICAL COLLEGE AND BYL NAIR CHARITABLE HOSPITAL 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 
DR SWATI KUBAL  PT School and Centre, Topiwala National Medical College and B. Y. L. Nair Charitable Hospital  OPD 24, PT School and Centre, Topiwala National Medical College and Dr B.Y.L.Nair Charitable Hospital, Dr A.L, Dr Anandrao Nair Marg, Mumbai Central, Mumbai, Maharashtra Mumbai MAHARASHTRA 400008 India
Mumbai
MAHARASHTRA 
08691948255

swatikubal@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE FOR ACADEMIC RESEARCH PROJECTS(ECARP) PG ACADEMIC COMMITTEE TNMC AND BYL NAIR CH HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  young adults with bilateral flat feet 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1) Individuals in the age group of 18 to 25 years
2) Individuals with bilateral flexible flat feet
(navicular drop test more than 10mm)
3) Individuals willing to participate 
 
ExclusionCriteria 
Details  1) Individuals having rigid flat foot
2) Individuals having congenital deformities
3) Individuals who underwent surgery around lower
limb or trunk
4) Individuals having recent injuries around lower
limb or trunk 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
navicular drop test  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
mc gill core endurance test
bubble inclinometer 
6 months 
 
Target Sample Size   Total Sample Size="47"
Sample Size from India="47" 
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)   26/02/2024 
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="0"
Months="6"
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  

Collapse of medial longitudinal arch is known as flat foot. If the arch collapses in weight bearing position it is called and flexible flat feet. In weight bearing activities, excessive foot pronation can occur. Iliopsoas is positioned anteriorly to the hip which is a flexor of hip which pulls femur towards pelvis or pelvis towards femur. when latter movement, iliopsoas can cause anterior tilt resulting in increased lordosis. in weight bearing position in flexible flat feet, subtalar hyper pronation occurs which leads to internal rotation of tibia and femur which contributes to anterior pelvic tilt which is associated with tightness of iliopsoas muscle. Bilateral flat feet also results in more proximal lower limb dysfunctions which affects core stability.

Therefore, weakness or imbalance in these muscles may contribute to collapse of medial longitudinal arch of foot and development of flexible flat feet. It is crucial to understand the relationship between core endurance, iliopsoas flexibility and navicular drop test in individuals with bilateral flat feet to develop effective preventive and therapeutic interventions. 

The aim is the study evaluation and relationship of core endurance, iliopsoas flexibility, and the navicular drop test in young adults with bilateral flat feet. The objectives of the study are to: 1) To assess navicular drop in young adults with bilateral flexible flat feet using navicular drop test. 2) To assess iliopsoas flexibility in young adults with bilateral flexible flat feet using Thomas test. 3) To assess core endurance in young adults with bilateral flexible flat feet using Mc gill core endurance test. 4) To compare iliopsoas flexibility and core endurance in young adults with bilateral flexible flat feet using Mc gill core endurance test. 5) Determine the relationship between core endurance, iliopsoas flexibility, and the navicular drop test in young adults with bilateral flexible flat feet. Outcome measures used will be Navicular drop test for assessing flexible flat feet, Iliopsoas tightness using Thomas test and muscle length using bubble inclinometer, Core endurance will be measured using Mc gill core endurance test. All the data obtained from the participants will be kept confidential. The data will be stored in excel sheets for analysis. Graph pad or SPSS software will be used for analysis. If data passes normality, parametric (spearman correlation) test will be used. If data does not pass normality, non-parametric (Pearson correlation coefficient) test will be used.


 
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