SARS CoV 2 VaccinationNCT06503926
Impact of COVID-19 Vaccination on Balance Function Among Adolescents: A Long-Term Perspective
An observational study of SARS CoV 2 Vaccination, run by Sinai University at 1 site in Egypt.
Trial summary
Long term impact of COVID 19 vaccination on dizziness-related disability and balance in adolescence Read more about this study
- Who is it for?
- Ages 10 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS CoV 2 Vaccination
- What is being tested?
- SARS-COV-2 vaccination
- Type of treatment
- Vaccines
- How many people
- 270 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Dec 2023to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: * Adolescence age range 10-17 * Vaccinated by any available SARS -COV-2 Vaccinations
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Long term impact of COVID 19 vaccination on dizziness-related disability and balance in adolescence
- Conditions
- SARS CoV 2 Vaccination
- Being tested
- SARS-COV-2 vaccination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-COV-2 vaccinationOther
Vaccination
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on Balance
The pediatric balance scale is used to assess balance (Lowest score =0 " worst"- Maximum score is 56 " Perfect Balance"
Measured: Through study completion, an average of 1 day - 1 year after taking the vaccine
Functional Disability
The Dizziness Handicap Inventory is used to assess functional disability related to dizziness
Measured: Through study completion, an average of 1 day - 1 year after taking the vaccine
Secondary outcomes (2)
Emotional Disability
The Dizziness Handicap Inventory is used to assess emotional disability related to dizziness
Measured: Through study completion, an average of 1 day - 1 year after taking the vaccine
Physical Disability
The Dizziness Handicap Inventory is used to assess physical disability related to dizziness
Measured: Through study completion, an average of 1 day - 1 year after taking the vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start6 Dec 2023
- Primary completion30 Apr 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV 2 VaccinationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Noureldeen Kora, Sinai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503926
- Sponsor's protocol ID
- P.T.REC/012/005002
- Status last verified
- Jul 2025
- First submitted
- 11 Aug 2023
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of COVID-19 Vaccination on Balance Function Among Adolescents: A Long-Term Perspective
- ClinicalTrials.gov ID
- NCT06503926
- Acronym / sponsor ID
- P.T.REC/012/005002
- Conditions
- SARS CoV 2 Vaccination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Sinai UniversityUniversity, hospital or other
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Long term impact of COVID 19 vaccination on dizziness-related disability and balance in adolescence
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- * Adolescence age range 10-17 * Vaccinated by any available SARS -COV-2 Vaccinations
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARS-COV-2 vaccinationVaccination | Other | – |
Primary outcome
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"
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
2 secondary outcomes
Emotional Disability
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS CoV 2 Vaccination, run by Sinai University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact on Balance (time frame: Through study completion, an average of 1 day - 1 year after taking the vaccine). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.