FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/01/039461 [Registered on: 17/01/2022] Trial Registered Prospectively
Last Modified On: 14/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Cluster Randomized Trial 
Public Title of Study   Correlation of body analysis and a scale consisting of ankle and foot view in a weight bearing position 
Scientific Title of Study   THE RELATIONSHIP OF BODY COMPOSITION AND FOOT POSTURE INDEX IN YOUNG ADULTS OF THE INDIAN POPULATION 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DRISHTI B CHHEDA 
Designation  MASTER OF PHYSIOTHERAPY STUDENT 
Affiliation  Sunandan Divatia School of Science, NMIMS University 
Address  Department of Physiotherapy, Ground Floor, Nanavati Super speciality hospital, SV Road, Vile Parle (W), Mumbai

Mumbai (Suburban)
MAHARASHTRA
400056
India 
Phone  9372945935  
Fax    
Email  drishtichheda@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mansi Bhartiya 
Designation  Assistant Professor 
Affiliation  Sunandan Divatia School of Science, NMIMS University 
Address  Department of Physiotherapy, Ground Floor, Nanavati Super speciality hospital, SV Road, Vile Parle (W), Mumbai

Mumbai (Suburban)
MAHARASHTRA
400056
India 
Phone  9867512415  
Fax    
Email  mansi.bhartiya@nmims.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Mansi Bhartiya 
Designation  Assistant Professor 
Affiliation  Sunandan Divatia School of Science, NMIMS University 
Address  Department of Physiotherapy, Ground Floor, Nanavati Super speciality hospital, SV Road, Vile Parle (W), Mumbai

Nashik
MAHARASHTRA
400056
India 
Phone  9867512415  
Fax    
Email  mansi.bhartiya@nmims.edu  
 
Source of Monetary or Material Support  
Department of Physiotherapy and Sports Medicine, Nanavati Super Speciality Hospital 
 
Primary Sponsor  
Name  None 
Address  NA 
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 Ali Irani  Dr. Balabhai Nanavati Hospital  Department of Physiotherapy, Ground Floor, Nanavati Super speciality hospital, SV Road, Vile Parle (W), Mumbai
Mumbai (Suburban)
MAHARASHTRA 
02226172329

physiodept.nanavati@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, Dr. Balabhai Nanavati HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Young Adults in age group 18-35 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  THE RELATIONSHIP OF BODY COMPOSITION AND FOOT POSTURE INDEX IN YOUNG ADULTS OF THE INDIAN POPULATION  The correlation between the body composition and the foot posture index scale will be taken and noted down 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Males and females of the age group 18-35 years and of the Indian race 
 
ExclusionCriteria 
Details  Males and females having any recent (4 weeks) lower limb injuries, any pathological changes in the thoracic or lumbar spine (eg. Canal stenosis, radiating pain, etc.) any lower limb surgical history 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. FPI-6
2. BMI
3. IPAQ scale
4. BODY FAT %
5. FREE- FAT MASS
6. SKIN FOLD MEASUREMENT
7. WAIST-TO-HIP RATIO
 
At baseline
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NA 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   24/01/2022 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

THE RELATIONSHIP OF BODY COMPOSITION AND FOOT POSTURE INDEX IN YOUNG ADULTS OF THE INDIAN POPULATION

 

INTRODUCTION

The Foot Posture Index (FPI) is a validated method for quantifying standing foot posture and was developed by Redmond AC in 1998. Some studies have shown that with advancing age there is a more pronated posture and to function in a more pronated posture shows less efficiency in activities like walking. 

   The body mass index (BMI) is defined as the body mass divided by the square of the body height and is expressed in kg/m2. It is a convenient rule of thumb used to categorize a person as underweight, normal weight, overweight or obese.

 

NUTRITIONAL STATUS

BMI (kg/m2)

Underweight

< 18.5

Normal range

18.5-22.9

Overweight

23-24.9

Obese I

25-29.9

Obese II

>30

 

It has been used as a risk factor for the prevalence or for the development of various health issues. In India, more than 135 million people are affected by obesity and it varies due to age, gender, geographical environment, socio-economic status, etc. According to ICMR-INDIAB study 2015, prevalence rate of obesity and central obesity varies from 11.8%-31.3% and 16.9%-36.3% respectively. The waist-to-hip ratio is a dimensionless ratio of the waist circumference to that of the hip. Studies also show that women with abdominal type of obesity are at a greater risk for postural instability than gynoid type. Skinfolds provide an estimation of body and they can be used to evaluate the body fat distribution.

 

NEED FOR STUDY

The rate at which obesity is increasing in India is alarming. This problem of obesity can be combated through public awareness about obesity and its health consequences. Variations in foot posture, such as pes planus or pes cavus are considered to be an intrinsic risk factor for various lower limb injuries due to the altered motion. It has also been believed that even minor biomechanical changes in the foot support surface may influence strategies to maintain body standing balance in a healthy adult population. These factors become very important to teach various strategies and apply various exercises to maintain a good standing and dynamic balance. 

   Determining a relationship between these body compositions and foot posture index forms a baseline for quantifying measures to train static and dynamic balance in healthy young adults. It also gives normative values as a reference for further researches and clinical decision making.

 

AIM

To study the relationship between the body composition and foot posture index in young adults.

 

OBJECTIVES

To assess the foot posture using the foot posture index-6 (FPI-6) score.

To assess the level of activity of the individual using the International Physical Activity Questionnaire (IPAQ) score.

To assess the components of body composition such as, BMI, waist-to-hip ratio, skin fold measurements, body fat percentage and fat free mass.

To establish a relationship between the body composition and the level of activity.

To establish a relationship between body composition and FPI-6 scores.

 

OUTCOME MEASURES

FPI-6

BMI

IPAQ Scale

Body Fat %

Free- Fat Mass

Skin Fold Measurement

Waist-To-Hip Ratio

 

INCLUSION CRITERIA

Males and females of the age group 18-35 years and of the Indian race.

 

EXCLUSION CRITERIA

Males and females having any recent (4 weeks) lower limb injuries, any pathological changes in the thoracic or lumbar spine (eg. Canal stenosis, radiating pain, etc.) any lower limb surgical history.

 

INTERVENTION

Participants for the study will be selected based on the inclusion and exclusion criteria. They will be informed about the study and a written informed consent will be taken for the same. After asking for their consent, their history will be taken and the evaluation will be done.

Level of activity will be measured by the International Physical Activity Questionnaire (IPAQ) score.

It is a 27-item self-reported measure of physical activity for use with individuals aged 15-69 years. The amount of physical activity places the participant in one of the three categories:

Low/inactive- Do not meet criteria for categories 2 or 3.

Moderate- Meet one of the following:

a.   5 or more days with atleast 20 mins. of vigorous activity

b.  5 or more days with atleast 30 mins. of moderate intensity activity or walking

c.   5 or more days of any combination of walking, moderate intensity or vigorous intensity activities with atleast 600 METs-min/week.

High- Meet one of the following:

a.   3 or more days of vigorous intensity activity and atleast 1500 METs-minutes/week

7 days of any combination of walking, moderate intensity or vigorous intensities activities with atleast 3000 METs-min/week.

 Body mass index (BMI):

This will be done by dividing the body mass(kgs.) by the square of the height(cm.).

Body mass         =

Height(squared)

 

Waist-to-hip ratio:

This will be obtained by taking a ratio of waist circumference to hip circumference.

Waist measurement 

Hip measurement

Skinfold measurement:

The measurements will be taken on the right side of the body with the participant in the standing posture. Caliper will be placed directly on the skin surface, 1cm away from the thumb and finger, perpendicular to the skin fold and halfway between the crest and base of the fold. Wait 1-2 sec. to read the caliper and pinch should be maintained throughout the assessment. The sites for measurement are subscapular, triceps, suprailiac and upper thigh.

 

Foot Posture Index-6 (FPI-6):

The participant is asked to stand upright and the scoring is done based on observation and palpation by the examiner. The 6 clinical criteria in the FPI-6 are:

Talar head position

Supra and infra lateral malleolar curvatures

Calcaneal frontal plane position

Prominence in the region of talonavicular joint

Congruence of medial longitudinal arch

Abduction/adduction of forefoot on rearfoot 
Close