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临床试验/NCT05865769
NCT05865769尚未招募不适用

Impact of Pulmonary Function on Vestibular System in Children

Kafrelsheikh University0 个研究点目标入组 50 人开始时间: 2023年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
Frequency of swaying in X,Y,Z

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
6 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children will be recruited from Future Academy School. Children will be included in the current study if their age is between 4 and 10 years old, also all children are free of asthma and other respiratory diseases.

排除标准

  • They were excluded if they had surgery or previous trauma over the chest.

结局指标

主要结局

Frequency of swaying in X,Y,Z

时间窗: 2 weeks

Hz

Root Mean Square (RMS) swaying of COG in X,Y,Z

时间窗: 2 weeks

mm

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Ali Mohammed Torad

Lecturer

Kafrelsheikh University

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