Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05865769 |
| Other study ID # |
P.T/PED/2/2023/41 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 20, 2023 |
| Est. completion date |
December 20, 2024 |
Study information
| Verified date |
May 2023 |
| Source |
Kafrelsheikh University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The vestibular system and the pulmonary system are two critical components of the human body
that are involved in maintaining balance, coordination, and the exchange of oxygen and carbon
dioxide This study aim to investigate the impact of pulmonary function on the vestibular
system in children.
Children aged 4 to 10 years will be recruited from Future Academy School in March 2023.
Pulmonary function will be measured using digital spirometry, and balance will be evaluated
using the Mini-SITCIB test, which tested vision, proprioception, and the vestibular system
using mobile sensors fixed near the center of gravity. Features from the sensor data will be
extracted using Python 3.10 code, and the SPSS program will used to compare these features
between the two groups.
Description:
The procedures of the current study will be explained to the children and their parents then
parents read and sign an informed consent form.
Spirometry (spirOx plus, MEDITECH, China) will be used in the current study; Hand-held lung
function test equipment uses infrared signal acquisition methods to measure the forced vital
capacity-related items. It has a compact design, is lightweight and is convenient to carry
and use; also, it uses low power consumption and can store up to 200 test cases. It can
measure forced vital capacity (FVC), forced expiratory volume in the first second (FEV1),
peak expiratory flow (PEF) and PEF in 25%, 50%, and 75% also the device may provide
percentages like FEV1/FVC, and FEP25/75. This device has proven to be valid and reliable to
measure spirometry functions.
Phyphox application will be used(physical phone experiment, version 1.1.7), a free program
with at least 30 functions for proceeding with physics experiments. The application is named
phyphox (an acronym for physical phone experiments) and bosom on Google's Play Store and
Apple's App Store in September 2016. To buttress users about the world, an accompanying
website was created at http://phyphox.org, which offers itemized instructions, demonstration
videos and technical information in English and German. The app itself is presently being
translated into additional languages by volunteers from all around the world. The application
can use the remote access option to transfer the screen to another monitor wirelessly; also,
the app can measure acceleration, gyroscope, linear acceleration, and magnetometer readings.
Also exporting the results is available on the wireless screen. This application is proven to
be valid and reliable to measure the sensor's readings.
After obtaining the consent form, some demographic data like gender, age, weight, height and
BMI were collected then each child was asked to take a deep breath and then expire for 6 sec
at the spirometer.
The mobile application will be opened, and a new experiment will be created with the
following criteria: sensors are acceleration, gyroscope, linear acceleration and
magnetometer, the sampling rate is 800 Hz, the Experiment time is 30 sec with a 3-sec delay,
then the remote access option will be enabled so that the screen appears on laptop screen
wirelessly.
Abdominal support will be modified so it contains a pocket in its centre so the mobile can
fit onto it. Then the mobile phone with the application opened on its screen will be fitted
in the pocket in the modified belt, so when the belt is attached the mobile sensors will be
very close to the centre of gravity of the participant. After wrapping the belt, participants
will be asked to conduct a mini-SITCIB test. For each condition, they will be asked to stand
as the condition states for 30 sec and start counting when the application starts recording
the sensors data, the conditions are as follows: opened eye with the fixed surface, the
closed eye with the fixed surface, opened eye with movable surface and closed eye with the
movable surface. Finally, the data will be extracted and stored anonymously on the hard drive
as CSV files. The condition test is over when (a) the participant opens his/her eyes in an
eyes-closed condition, (b) raises arms from sides, (c) loses balance and requires manual
assistance to prevent a fall.
