COVID-19NCT05299320
Postural Control in Covid-19
An observational study of COVID-19 and Performance, run by Karamanoğlu Mehmetbey University at 2 sites in Turkey (Türkiye).
Trial summary
This study was planned to investigate how much the anaerobic performance of individuals who experienced fatigue with Want (Wingate) affected their postural sway parameters. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Performance
- What is being tested?
- Neuromuscular fatigue and postural sway evaluation
- How many people
- 56 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 2 Mar 2022to 20 Jun 2022
- How long will I take part?
- 3 Months
- 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
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients with covid-19 and Have not had covid 19 before
Who may be able to join
- Being between the ages of 18-30, - Being a volunteer - Having had Covid 19 in the last 3 month
Who cannot join
- Presence of neurologic and oncologic disease - Presence of orthopedic surgery - Presence of active Covid 19 disease - Any cardiopulmonary disease
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Karamanoglu Mehmetbey University
Karaman
Karamanoğlu Mehmetbey University
Karaman
About this study
Official title: Covid 19 and Postural Sway: A Comprasion of SARS-CoV-2 and Healthy Sedentary Women
This study was planned to investigate how much the anaerobic performance of individuals who experienced fatigue with Want (Wingate) affected their postural sway parameters.
Read the detailed description
The postural sway parameters of the individuals will be evaluated using the "Kistler Force Plate" and the anaerobic values will be evaluated using the Wingate Anaerobic Strength Test and the "Excalibur Sport Ergometer" device. The data obtained will be compared with the data of patients with and without Covid-19 disease using appropriate statistical methods.
- Conditions
- COVID-19, Performance
- Being tested
- Neuromuscular fatigue and postural sway evaluation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular fatigue and postural sway evaluationDiagnostic test
Also called Postural sway, Postural sway evaluation
Neuromuscular fatigue will be established by using the Excalibur Sport Ergometer device and the Wingate Anaerobic Strength Test. Postural sway will be evaluated with Cyst Force Plate Balance device. This device is a precision device that provides objective measurable data.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Post-Covid | Being between the ages of 18-30, - Being a volunteer - Having had Covid-19 in the last 3 month Exclusion Criteria - Presence of neurologic and oncologic disease - Presence of orthopedic surgery - Presence of active Covid-19 disease - Any cardiopulmonary disease Receives: Diagnostic Test: Neuromuscular fatigue and postural sway evaluation | |
| Healthy Person | Being between the ages of 18-30, Being a volunteer, not having Covid-19 before Receives: Diagnostic Test: Neuromuscular fatigue and postural sway evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural Sway
Postural sway will be evaluated with Cyst Force Plate Balance device. This device is a precision device that provides objectively measurable data. Thanks to its movable platform, it can measure in all directions. Participants will be asked to stand on the platform assessing their body oscillations. They will be asked to look at a still picture on the wall with their arms at the iliac and eyes directly opposite them. Individuals will be asked to keep their designated positions for 30 seconds. At the end of the specified period, the data obtained from the device will be saved. Before and after the neuromuscular fatigue test postural sway will be evaluated.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start2 Mar 2022
- Primary completion10 Jun 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hikmet Kocaman, Karamanoğlu Mehmetbey University
- Investigators
- Ayşenur Gökşen, PhD, Study chair, Tarsus Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299320
- Sponsor's protocol ID
- 12-2022/15
- Status last verified
- Jul 2022
- First submitted
- 25 Mar 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sudre CH, Murray B, Varsavsky T, Graham MS, Penfold RS, Bowyer RC, Pujol JC, Klaser K, Antonelli M, Canas LS, Molteni E, Modat M, Jorge Cardoso M, May A, Ganesh S, Davies R, Nguyen LH, Drew DA, Astley CM, Joshi AD, Merino J, Tsereteli N, Fall T, Gomez MF, Duncan EL, Menni C, Williams FMK, Franks PW, Chan AT, Wolf J, Ourselin S, Spector T, Steves CJ. Attributes and predictors of long COVID. Nat Med. 2021 Apr;27(4):626-631. doi: 10.1038/s41591-021-01292-y. Epub 2021 Mar 10.
PubMed 33692530
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covid 19 and Postural Sway: A Comprasion of SARS-CoV-2 and Healthy Sedentary Women
- ClinicalTrials.gov ID
- NCT05299320
- Acronym / sponsor ID
- 12-2022/15
- Conditions
- COVID-19, Performance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 29 Mar 2022 (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 study was planned to investigate how much the anaerobic performance of individuals who experienced fatigue with Want (Wingate) affected their postural sway parameters.
Detailed description
The postural sway parameters of the individuals will be evaluated using the "Kistler Force Plate" and the anaerobic values will be evaluated using the Wingate Anaerobic Strength Test and the "Excalibur Sport Ergometer" device. The data obtained will be compared with the data of patients with and without Covid-19 disease using appropriate statistical methods.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Post-Covid | – | Diagnostic Test: Neuromuscular fatigue and postural sway evaluationBeing between the ages of 18-30, - Being a volunteer - Having had Covid-19 in the last 3 month Exclusion Criteria - Presence of neurologic and oncologic disease - Presence of orthopedic surgery - Presence of active Covid-19 disease - Any cardiopulmonary disease |
| Healthy Person | – | Diagnostic Test: Neuromuscular fatigue and postural sway evaluationBeing between the ages of 18-30, Being a volunteer, not having Covid-19 before |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with covid-19 and Have not had covid 19 before
Key inclusion criteria (1 listed)
- Being between the ages of 18-30, - Being a volunteer - Having had Covid 19 in the last 3 month
Key exclusion criteria (1 listed)
- Presence of neurologic and oncologic disease - Presence of orthopedic surgery - Presence of active Covid 19 disease - Any cardiopulmonary disease
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 |
|---|---|---|
| Neuromuscular fatigue and postural sway evaluationAlso: Postural sway, Postural sway evaluationNeuromuscular fatigue will be established by using the Excalibur Sport Ergometer device and the Wingate Anaerobic Strength Test. Postural sway will be evaluated with Cyst Force Plate Balance device. This device is a precision device that provides objective measurable data. | Diagnostic test | Healthy Person, Patients with Post-Covid |
Primary outcome
Postural Sway
Time frame: 3 months
Postural sway will be evaluated with Cyst Force Plate Balance device. This device is a precision device that provides objectively measurable data. Thanks to its movable platform, it can measure in all directions. Participants will be asked to stand on the platform assessing their body oscillations. They will be asked to look at a still picture on the wall with their arms at the iliac and eyes directly opposite them. Individuals will be asked to keep their designated positions for 30 seconds. At the end of the specified period, the data obtained from the device will be saved. Before and after the neuromuscular fatigue test postural sway will be evaluated.
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 26 Jul 2022.
- Background: PubMed 33692530Sudre CH, Murray B, Varsavsky T, Graham MS, Penfold RS, Bowyer RC, Pujol JC, Klaser K, Antonelli M, Canas LS, Molteni E, Modat M, Jorge Cardoso M, May A, Ganesh S, Davies R, Nguyen LH, Drew DA, Astley CM, Joshi AD, Merino J, Tsereteli N, Fall T, Gomez MF, Duncan EL, Menni C, Williams FMK, Franks PW, Chan AT, Wolf J, Ourselin S, Spector T, Steves CJ. Attributes and predictors of long COVID. Nat Med. 2021 Apr;27(4):626-631. doi: 10.1038/s41591-021-01292-y. Epub 2021 Mar 10.
- 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.
Ayşenur Gökşen, PhD study chair
Tarsus Universty
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Performance, run by Karamanoğlu Mehmetbey University at 2 sites in Turkey (Türkiye).
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 1 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 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Postural Sway (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05299320, which also lists 1 linked publication.
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 26 Jul 2022.