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CTRI Number  CTRI/2024/11/077195 [Registered on: 21/11/2024] Trial Registered Prospectively
Last Modified On: 20/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   IMPLICATION OF STATIC LOWER EXTREMITY KINETIC CHAIN ANGULATIONS ON FOOT POSTURE AND ARCH INDEX IN CHILDREN  
Scientific Title of Study   RAMIFICATION OF STATIC BIOMECHANICAL VARIABLES ON PLANTAR PARAMETERS IN PAEDIATRIC POPULATION  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Payal Mehta 
Designation  PG Student 
Affiliation  MMIPR Mullana Ambala 
Address  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation Maharishi Markandeshwar Deemed to be University Mullana Ambala
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation Maharishi Markandeshwar Deemed to be University Mullana Ambala
Ambala
HARYANA
133207
India 
Phone  9998356065  
Fax    
Email  payalmehta0112@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Payal Mehta 
Designation  PG Student 
Affiliation  MMIPR Mullana Ambala 
Address  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation Maharishi Markandeshwar Deemed to be University Mullana Ambala
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation Maharishi Markandeshwar Deemed to be University Mullana Ambala
Ambala
HARYANA
133207
India 
Phone  9998356065  
Fax    
Email  payalmehta0112@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shweta Sharma 
Designation  Assistant Professor 
Affiliation  MMIPR Mullana Ambala 
Address  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation Maharishi Markandeshwar Deemed to be University Mullana Ambala
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation Maharishi Markandeshwar Deemed to be University Mullana Ambala
Ambala
HARYANA
133207
India 
Phone  8860405721  
Fax    
Email  shwetasharmampth27@gmail.com  
 
Source of Monetary or Material Support  
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation Maharishi Markandeshwar Deemed to be University Mullana Ambala 
 
Primary Sponsor  
Name  Payal Mehta  
Address  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation Maharishi Markandeshwar Deemed to be University Mullana Ambala 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Shweta Sharma  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation Maharishi Markandeshwar Deemed to be University Mullana Ambala 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Payal Mehta  Maharishi Markandeshwar International School  Room No 1 D Block Sports Complex Maharishi Markandeshwar International School
Ambala
HARYANA 
9998356065

payalmehta0112@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee MM Institute of Medical Sciences and Research Mullana Ambala  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy school going children  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ramification of static biomechanical variables on plantar parameters in paediatric population  A correlational study looking the implication of hip and knee biomechanical variables on arcgh index in children 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  The study will include a sample of 184 healthy asymptomatic subjects aged 5 to 15 years with diverse BMI compositions 
 
ExclusionCriteria 
Details  Participants will be excluded if they have any pathological conditions such as sports injuries or recent fractures or any other conditions that could affect bone alignment 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Static biomechanical variables like Hip Rotation that is Hip External and Hip Internal Range of Motion and Q Angle  Static biomechanical variables like Hip Rotation that is Hip External and Hip Internal Range of Motion and Q Angle measured in degrees using Universal Goniometer 
 
Secondary Outcome  
Outcome  TimePoints 
Plantar parameters like arch index & plantar pressure distribution will be calculated from foot prints taken using Harris Mat & scanned with PodiaScan Software  no unit 
 
Target Sample Size   Total Sample Size="184"
Sample Size from India="184" 
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)   02/12/2024 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Purpose: The lower extremities’ biomechanics are crucial to a child’s development mainly because alignment issues might possess a consequential effect on joint mechanics and exacerbate musculoskeletal abnormalities. The purpose of this study is to investigate how children’s foot posture and plantar parameters are modulated by static biomechanical variables such as hip range of motion (ROM) and quadriceps angle (Q-angle). The research also delves into how age and body mass index (BMI) affect these factors, especially in children who are asymptomatic and between the ages of 5 and 15.

Basic Procedures: Quota sampling will be utilized to gather 110 children between the ages of 5 and 15 for this correlational investigation. Anthropometric measures of the participants will be assessed. Biomechanical variables including hip internal and external range of motion, Q-angle measurements with a goniometer, assessment of foot posture using the Foot Posture Index-6 (FPI-6), and determination of the Arch Index based on footprint measurements will be assessed.  The BMI will be computed and how it affects these biomechanical factors will be evaluated.

Main findings: Significant associations between plantar factors (Foot Posture, Arch Index) and static biomechanical variables (Hip ROM, Q-angle) are expected. Furthermore, it is anticipated that age and BMI will have a major impact on these variables.

Principal Conclusions: The research will shed light on the biomechanical interactions between foot posture and lower extremity alignment, highlighting the significance of detecting misalignment problems in children at an early age.

Keywords: Arch Index, Biomechanics, Foot Posture, Lower extremity, Range Of Motion.

 
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