| 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
|
|
|
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
|
|
|
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 |
|
|
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.
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