| 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
|
|
|
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. |