Covid19NCT04734717
Coordination and Locomotor Problems in Patients With Covid-19 Virus
A study testing Neurology test in people with Covid19 and Motility Disorder, run by Somogy Megyei Kaposi Mór Teaching Hospital at 1 site in Hungary.
Trial summary
Coordination and Locomotor Problems in Patients With Covid-19 Virus Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, Motility Disorder, Balance
- What is being tested?
- Neurology test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteHungary
- Study dates
- 12 Jan 2021to 12 Apr 2021
- Phase
- Interventional
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- COVID 19 diagnosis
Who cannot join
- Severe heart problems
- severe demeanor
- alcoholism
- drug problems
Trial locations and contacts
1 site in 1 country.
About this study
Coordination and Locomotor Problems in Patients With Covid-19 Virus
- Conditions
- Covid19, Motility Disorder, Balance
- Being tested
- Neurology test
- Keywords
- 6MWT, Berg balance, Beam Walking
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurology testDiagnostic test
movement examination of patients with covid19 disease
| Study group | Role | What they receive |
|---|---|---|
| COVID19 | Experimental | Not described Receives: Diagnostic Test: Neurology test |
| Controll | Experimental | Not described Receives: Diagnostic Test: Neurology test |
What is being measured
The primary outcome is the main question the study is designed to answer.
EQ5D-5L
Questionnaire
Measured: 5 weeks-long
Berg test
Fatigue questionnaire
Measured: 5 weeks-long
SPPB test (gait, balance, leg stregth)
Walking and balance testing
Measured: 5 weeks-long
6MWT
Walking test
Measured: 5 weeks-long
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start12 Jan 2021
- Primary completion12 Apr 2021 (estimated)
- Study completion12 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Somogy Megyei Kaposi Mór Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tollár József, Somogy Megyei Kaposi Mór Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734717
- Sponsor's protocol ID
- IKEB2021/02
- Status last verified
- Feb 2021
- First submitted
- 1 Feb 2021
- Last updated
- 2 Feb 2021
- 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 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coordination and Locomotor Problems in Patients With Covid-19 Virus
- ClinicalTrials.gov ID
- NCT04734717
- Acronym / sponsor ID
- IKEB2021/02
- Conditions
- Covid19, Motility Disorder, Balance
- Keywords
- 6MWT, Berg balance, Beam Walking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Somogy Megyei Kaposi Mór Teaching HospitalUniversity, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 12 Apr 2021 (estimated)
- Study completion
- 12 Apr 2021 (estimated)
- First posted
- 2 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.
Coordination and Locomotor Problems in Patients With Covid-19 Virus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID19 | Experimental | Diagnostic Test: Neurology test |
| Controll | Experimental | Diagnostic Test: Neurology test |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- COVID 19 diagnosis
Key exclusion criteria (4 listed)
- Severe heart problems
- severe demeanor
- alcoholism
- drug problems
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 |
|---|---|---|
| Neurology testmovement examination of patients with covid19 disease | Diagnostic test | COVID19, Controll |
Primary outcome
EQ5D-5L
Time frame: 5 weeks-long
Questionnaire
Berg test
Time frame: 5 weeks-long
Fatigue questionnaire
SPPB test (gait, balance, leg stregth)
Time frame: 5 weeks-long
Walking and balance testing
6MWT
Time frame: 5 weeks-long
Walking test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Related InfoLink provided by the sponsor.
- 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?
A study testing Neurology test in people with Covid19 and Motility Disorder, run by Somogy Megyei Kaposi Mór Teaching Hospital at 1 site in Hungary.
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 4 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 2 Feb 2021. 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 Hungary. 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?
Results are not available in the source record.
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?
EQ5D-5L (time frame: 5 weeks-long). The study lists 4 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 2 Feb 2021.