FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/02/063391 [Registered on: 29/02/2024] Trial Registered Prospectively
Last Modified On: 16/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Intrarater Reliability of Chest Expansion in Healthy Children Between 5–12 years of Age Group 
Scientific Title of Study   Intrarater Reliability of Chest Expansion in Healthy Children Between 5–12 years of Age Group 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ADITI L SOMAN 
Designation  assistant professor, Department of Kinesiotherapy 
Affiliation  DECCAN EDUCATION SOCIETYS BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY, PUNE 
Address  DECCAN EDUCATION SOCIETYS BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY, FERGUSSON COLLEGE CAMPUS Department of Kinesiotherapy

Pune
MAHARASHTRA
411004
India 
Phone  08788123192  
Fax    
Email  aditi.soman@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ishani Kulkarni 
Designation  Student 
Affiliation  DECCAN EDUCATION SOCIETYS BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY, PUNE 
Address  DECCAN EDUCATION SOCIETYS,BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY, FERGUSSON COLLEGE CAMPUS, DEPARTMENT OF KINESIOTHERAPY

Pune
MAHARASHTRA
411004
India 
Phone  9145342209  
Fax    
Email  ishanikulkarni01@gmail.com  
 
Details of Contact Person
Public Query
 
Name  ADITI L SOMAN 
Designation  assistant professor, Department of Kinesiotherapy 
Affiliation  DECCAN EDUCATION SOCIETYS BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY, PUNE 
Address  DECCAN EDUCATION SOCIETYS BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY, FERGUSSON COLLEGE CAMPUS, DEPARTMENT OF KINESIOTHERAPY

Pune
MAHARASHTRA
411004
India 
Phone  08788123192  
Fax    
Email  aditi.soman@despune.org  
 
Source of Monetary or Material Support  
self funded The data will be collected from M.S. Golwalkar Guruji School, Pune the expenses for required stationery for data collection will be born by PI and evaluator 
 
Primary Sponsor  
Name  NIL 
Address  self funded 
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 Aditi L Soman  DECCAN EDUCATION SOCIETYS BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY  DEPARTMENT OF PHYSIOTHERAPY, DECCAN EDUCATION SOCIETYS BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY, FERGUSSON COLLEGE CAMPUS,
Pune
MAHARASHTRA 
08788123192

aditi.soman@despune.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DECCAN EDUCATION SOCIETYS BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy childern between 5-12 years of age with Normal BMI 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Healthy Children between 5-12 years of age with normal BMI.

Normal BMI for Boys:
5 years 13.8 – 16.8
10 years 14.2 – 19.4
15 years 16.5 – 23.4



Normal BMI for Girls:
5 years 13.6 – 16.7
10 years 14 – 19.5
15 years 16.3 - 24
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
CHEST EXPANSION ASSESSMENTAT 2ND 4TH AND 6TH INTERCOSTAL SPACE   DAY 1 AND DAY 7 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="385"
Sample Size from India="385" 
Final Enrollment numbers achieved (Total)= "385"
Final Enrollment numbers achieved (India)="385" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/03/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  08/03/2024 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="1" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
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  

               Chest expansion is a respiratory system assessment technique which is easy to use and gives an idea about the chest mobility and the capacity of lung to expand. There is a difference between the normal adult and paediatric respiratory system with respect to the anatomical and physiological development of lungs.

               The cross-sectional shape of infant thorax is cylindrical and not elliptical as in adolescents or adults. Cartilaginous and extremely compliant chest wall of new-born allows necessary distortion of the infant’s thorax to travel through the birth canal. The rib cage of an infant has more horizontal alignment of ribs compared to the oblique configuration of ribs seen in adults giving rise to a variation in the biomechanics.

               Normally, the process of inspiration is active and that of expiration is passive. This occurs as the pump handle movement is seen in upper thorax while the bucket handle movement seen in lower thorax. With inspiration there is pump handle movement which causes increase in the anteroposterior diameter of thorax, while in the bucket handle movement there is an increase in the transverse diameter of lower thorax. Movement of the ribs occur at the costotransverse and costovertebral joints. Orientation of these joints varies in the upper and lower joints. The transverse diameter is greater than the anteroposterior diameter giving it an ellipsoid shape with the ratio 7:5.

               The development of alveoli in lung continues and is completed by 10yrs of age, most of which occurs in first 6 months of life. The number of alveoli increases with increase in height.

Normal chest wall mobility is important for effective lung expansion and subsequent ventilation. Respiratory evaluation is an integral part of Chest Physiotherapy. Hence, normative values of chest expansion in paediatrics and adults are different. Therefore, there is a need to study paediatric respiratory system separately.

                 Normative values of chest expansion among healthy young individuals of the age group 5 – 12 years are known but there is no evidence of its intrarater reliability. Hence to check this intrarater reliability, the individuals from 5 – 12 years age group have been chosen.

                 Intrarater reliability is defined as the consistency of data recorded by one rater over several trials. It is a diagnostic tool used to check the test validity. The intrarater reliability studies will help to check the reliability of the normative values.

                As chest expansion is a non-invasive method of lung function and chest mobility, aim of the study is to check the reliability of the chest expansion in paediatric age group – in 5-12 years in Pune City.

 
Close