GaitNCT04944342
Breathing After COVID-19
An observational study of Gait and Covid19, run by Trakya University.
Trial summary
This research; It will be done to perform thoracic movement analysis of young adult individuals who have survived COVID-19 and to compare them with those without a history of COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Gait, Covid19, Thorax Anomalies
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 25 Jun 2021to 30 Jul 2021
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy individuals who have a COVID-19 illness history or have no COVID-19 history will be the participants of the study.
Who may be able to join
- to be voluntary.
- have COVID-19 illness history.
- No COVID-19 illness history.
- treated by a standard medical treatment (vitamins, blood thinners, anti-viral drugs)
Who cannot join
- have another chronic disease such as systemic, orthopedic or neurologic.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Thoracal Motion After COVID-19 Disease
This research; It will be done to perform thoracic movement analysis of young adult individuals who have survived COVID-19 and to compare them with those without a history of COVID-19.
Read the detailed description
This research; It will be done to perform thoracic movement analysis of young adult individuals who have survived COVID-19 and to compare them with those without a history of COVID-19.
Individuals' sternal movements using motion analysis sensors; will be recorded in sitting position, standing, and walking. Sternal movement of the person; It will be recorded during relaxed breathing and deep breathing. They will also be asked to walk on the treadmill in such a way as to collect at least 500 steps.
- Conditions
- Gait, Covid19, Thorax Anomalies
- Being tested
- No intervention.
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention.Other
No intervention.
| Study group | Role | What they receive |
|---|---|---|
| Individuals who have had COVID-19. | Individuals who have had COVID-19 and who treated by a standart medical treatment at home. Receives: Other: No intervention. | |
| Individuals who have not a COVID-19 illness history. | Individuals who have not a COVID-19 illness history. Receives: Other: No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thoracal motion while normal breathing at sitting.
Sensor - based thoracal motion assesment while normal breathing at sitting will be utilized.
Measured: At first day.
Thoracal motion while normal breathing at standing.
Sensor - based thoracal motion assesment while normal breathing at standing will be utilized.
Measured: At first day.
Thoracal motion while deep breathing at sitting.
Sensor - based thoracal motion assesment while normal breathing at sitting will be utilized.
Measured: At first day.
Thoracal motion while deep breathing at standing.
Sensor - based thoracal motion assesment while deep breathing at standing will be utilized.
Measured: At first day.
Thoracal motion at walk.
Sensor - based thoracal motion assesment at walk will be utilized.
Measured: At first day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start25 Jun 2021 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GaitStudies 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
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal Hotaman, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944342
- Sponsor's protocol ID
- 2021/64
- Status last verified
- Jun 2021
- First submitted
- 16 Jun 2021
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracal Motion After COVID-19 Disease
- ClinicalTrials.gov ID
- NCT04944342
- Acronym / sponsor ID
- 2021/64
- Conditions
- Gait, Covid19, Thorax Anomalies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 25 Jun 2021 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 29 Jun 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.
This research; It will be done to perform thoracic movement analysis of young adult individuals who have survived COVID-19 and to compare them with those without a history of COVID-19.
Detailed description
This research; It will be done to perform thoracic movement analysis of young adult individuals who have survived COVID-19 and to compare them with those without a history of COVID-19.
Individuals' sternal movements using motion analysis sensors; will be recorded in sitting position, standing, and walking. Sternal movement of the person; It will be recorded during relaxed breathing and deep breathing. They will also be asked to walk on the treadmill in such a way as to collect at least 500 steps.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals who have had COVID-19. | – | Other: No intervention.Individuals who have had COVID-19 and who treated by a standart medical treatment at home. |
| Individuals who have not a COVID-19 illness history. | – | Other: No intervention.Individuals who have not a COVID-19 illness history. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy individuals who have a COVID-19 illness history or have no COVID-19 history will be the participants of the study.
Key inclusion criteria (4 listed)
- to be voluntary.
- have COVID-19 illness history.
- No COVID-19 illness history.
- treated by a standard medical treatment (vitamins, blood thinners, anti-viral drugs)
Key exclusion criteria (1 listed)
- have another chronic disease such as systemic, orthopedic or neurologic.
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 |
|---|---|---|
| No intervention.No intervention. | Other | Individuals who have had COVID-19., Individuals who have not a COVID-19 illness history. |
Primary outcome
Thoracal motion while normal breathing at sitting.
Time frame: At first day.
Sensor - based thoracal motion assesment while normal breathing at sitting will be utilized.
Thoracal motion while normal breathing at standing.
Time frame: At first day.
Sensor - based thoracal motion assesment while normal breathing at standing will be utilized.
Thoracal motion while deep breathing at sitting.
Time frame: At first day.
Sensor - based thoracal motion assesment while normal breathing at sitting will be utilized.
Thoracal motion while deep breathing at standing.
Time frame: At first day.
Sensor - based thoracal motion assesment while deep breathing at standing will be utilized.
Thoracal motion at walk.
Time frame: At first day.
Sensor - based thoracal motion assesment at walk will be utilized.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Gait and Covid19, run by Trakya University.
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: status not confirmed, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hilal Keklicek, PhD (00902842133042, hhotaman23@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thoracal motion while normal breathing at sitting. (time frame: At first day.). The study lists 5 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 29 Jun 2021.