NCT05865769

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 19, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

December 20, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

May 19, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

April 20, 2023

Last Update Submit

May 9, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

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

    mm

    2 weeks

  • Frequency of swaying in X,Y,Z

    Hz

    2 weeks

Study Arms (2)

Normal children

Have FEV1 higher than median on their class

Other: Balance

subclinical pulmonary impairment

Have FEV1 lower than median on their class

Other: Balance

Interventions

BalanceOTHER

measuring pulmonary and vestibular functions in all subjects

Normal childrensubclinical pulmonary impairment

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children were recruited from Future Academy School. Children were 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. They were excluded if they had surgery or previous trauma over the chest. 62 children were recruited at the start of the current study; 5 children are older than the proposed sample while the parents of the other 5 refused to enter the study then the sample was classified according to FEV1 into 2 equal number classes (Low and high FEV1) according to median also 4 records were excluded as they are so extreme then the Mini-SITCIB test was used to measure balance in 4 conditions to test vision, proprioception and vestibular systems.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vestibular DiseasesLung Diseases

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 20, 2023

First Posted

May 19, 2023

Study Start

December 20, 2023

Primary Completion

December 20, 2024

Study Completion

December 20, 2024

Last Updated

May 19, 2023

Record last verified: 2023-05