Covid19 Epidemic Lockdown ImpactNCT04761718
Covid-19 Epidemic Lockdown Impact on Psychomotor Performance
An observational study of Covid19 Epidemic Lockdown Impact, run by Delta University for Science and Technology at 1 site in Egypt.
Trial summary
PURPOSE: To detect the Covid-19 Epidemic Lockdown impact on Psychomotor performance in Egyptian Children. BACKGROUND: The corona virus disease (COVID-19) affected virtually all countries including Egypt as records showed 156,397 subjects including all age groups, Adolescents and children represent sector in the… Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19 Epidemic Lockdown Impact
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Oct 2021to 30 Jun 2022
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Participants will be randomly selected from all provinces in Egypt.
Who may be able to join
- 100 participants will be chosen according to the following criteria : subject in both sexes and their age will ranged between
- 6-9 years.
- 10-13 years.
- 14-18 years All subjects should be clinically and medically stable
Who cannot join
- Subjects with psychological or Motor impairment will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Covid-19 Epidemic Lockdown Impact on Psychomotor Performance in Egyptian Children
PURPOSE:
To detect the Covid-19 Epidemic Lockdown impact on Psychomotor performance in Egyptian Children.
Read more
BACKGROUND:
The corona virus disease (COVID-19) affected virtually all countries including Egypt as records showed 156,397 subjects including all age groups, Adolescents and children represent sector in the records, lockdown can contribute to widespread psychological distress and an increased risk of physical inactivity consequences shortly. Psychomotor disorders are expected during and aftermath of the pandemic. Validated Questionnaires are tools to assess the psychomotor condition during and after pandemic lockdown as safe and valid assessment tool.
HYPOTHESES:
Covid-19 Epidemic Lockdown has an impact on Psychomotor performance in Egyptian Children.
RESEARCH QUESTION:
Does Covid-19 Epidemic Lockdown impact on Psychomotor performance in Egyptian Children?
- Conditions
- Covid19 Epidemic Lockdown Impact
What is being measured
The primary outcome is the main question the study is designed to answer.
pre lockdown assessment for physical activity
Google form questionnaires include the physical activity questionnaire.
Measured: up to 24 weeks
post lockdown assessment for physical activity
Google form questionnaires include the physical activity questionnaire.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start29 Oct 2021
- Primary completion25 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19 Epidemic Lockdown ImpactStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Hussin Hussin Mohammed, Delta University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761718
- Sponsor's protocol ID
- Covid-19 Epidemic impact
- Status last verified
- Jan 2024
- First submitted
- 17 Feb 2021
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covid-19 Epidemic Lockdown Impact on Psychomotor Performance in Egyptian Children
- ClinicalTrials.gov ID
- NCT04761718
- Acronym / sponsor ID
- Covid-19 Epidemic impact
- Conditions
- Covid19 Epidemic Lockdown Impact
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 29 Oct 2021 (actual)
- Primary completion
- 25 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 21 Feb 2021 (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.
PURPOSE:
To detect the Covid-19 Epidemic Lockdown impact on Psychomotor performance in Egyptian Children.
BACKGROUND:
The corona virus disease (COVID-19) affected virtually all countries including Egypt as records showed 156,397 subjects including all age groups, Adolescents and children represent sector in the records, lockdown can contribute to widespread psychological distress and an increased risk of physical inactivity consequences shortly. Psychomotor disorders are expected during and aftermath of the pandemic. Validated Questionnaires are tools to assess the psychomotor condition during and after pandemic lockdown as safe and valid assessment tool.
HYPOTHESES:
Covid-19 Epidemic Lockdown has an impact on Psychomotor performance in Egyptian Children.
RESEARCH QUESTION:
Does Covid-19 Epidemic Lockdown impact on Psychomotor performance in Egyptian Children?
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants will be randomly selected from all provinces in Egypt.
Key inclusion criteria (4 listed)
- 100 participants will be chosen according to the following criteria : subject in both sexes and their age will ranged between
- 6-9 years.
- 10-13 years.
- 14-18 years All subjects should be clinically and medically stable
Key exclusion criteria (1 listed)
- Subjects with psychological or Motor impairment will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pre lockdown assessment for physical activity
Time frame: up to 24 weeks
Google form questionnaires include the physical activity questionnaire.
post lockdown assessment for physical activity
Time frame: up to 24 weeks
Google form questionnaires include the physical activity questionnaire.
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 23 Jan 2024.
- Individual participant dataSharing planned: Yes
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 Covid19 Epidemic Lockdown Impact, run by Delta University for Science and Technology 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 4 inclusion and 1 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 23 Jan 2024. 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?
pre lockdown assessment for physical activity (time frame: up to 24 weeks). 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 23 Jan 2024.