- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06503926
Impact of COVID-19 Vaccination on Balance Function Among Adolescents: A Long-Term Perspective
July 12, 2025 updated by: Alaa Noureldeen Kora, Sinai University
Long term impact of COVID 19 vaccination on dizziness-related disability and balance in adolescence
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
270
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ismailia, Egypt, 11749
- Sinai university
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
- Adolescence age range 10-17
- Vaccinated by any available SARS -COV-2 Vaccinations
Description
Inclusion Criteria:
- Adolescence age range 10-17
- received a dose or more of an approved COVID-19 vaccine at least one year before the study enrollment.
the ability to complete all assessment measures independently.
Exclusion Criteria:
- vestibular or neurological disorders diagnosed before vaccination.
- mixed COVID-19 vaccine types.
- a history of traumatic brain injury.
- current use of medications that affect balance.
- documented COVID-19 infection within three months of assessment.
- physical limitations that prevented them from completing balance testing.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Disability
Time Frame: Through study completion, an average of 1 day - 1 year after taking the vaccine
|
The Dizziness Handicap Inventory is used to assess functional disability related to dizziness
|
Through study completion, an average of 1 day - 1 year after taking the vaccine
|
|
Impact on Balance
Time Frame: Through study completion, an average of 1 day - 1 year after taking the vaccine
|
The pediatric balance scale is used to assess balance (Lowest score =0 " worst"- Maximum score is 56 " Perfect Balance"
|
Through study completion, an average of 1 day - 1 year after taking the vaccine
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotional Disability
Time Frame: Through study completion, an average of 1 day - 1 year after taking the vaccine
|
The Dizziness Handicap Inventory is used to assess emotional disability related to dizziness
|
Through study completion, an average of 1 day - 1 year after taking the vaccine
|
|
Physical Disability
Time Frame: Through study completion, an average of 1 day - 1 year after taking the vaccine
|
The Dizziness Handicap Inventory is used to assess physical disability related to dizziness
|
Through study completion, an average of 1 day - 1 year after taking the vaccine
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 6, 2023
Primary Completion (Actual)
April 30, 2024
Study Completion (Actual)
July 1, 2024
Study Registration Dates
First Submitted
August 11, 2023
First Submitted That Met QC Criteria
July 12, 2024
First Posted (Actual)
July 16, 2024
Study Record Updates
Last Update Posted (Actual)
July 16, 2025
Last Update Submitted That Met QC Criteria
July 12, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- P.T.REC/012/005002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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