Covid19NCT04934085
COVID-19 Versus Neurological Impairment, Physical Activity, Social Contacts and Education
An observational study of Covid19 and Neurological Disorder, run by University of Rzeszow at 1 site in Poland.
Trial summary
The research will make it possible to assess patients who recovered from COVID-19 for the incidence of neurological problems (impaired balance, gait, coordination, concentration and attention), and changes in the quality of life, physical activity, social contacts and education. Read more about this study
- Who is it for?
- Ages 19 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, Neurological Disorder, Balance; Distorted
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 30 Jun 2021to 30 Aug 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 19 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study will be conducted in the population of people living in south-eastern Poland.
Who may be able to join
- Informed consent to participate in the study.
- Experienced infection with SARS-COV-2.
- Age 19 - 26 years
- No injuries to lower limbs in the period of 12 months preceding the date of enrolment into the study
- No orthopaedic disorders affecting the lower limbs (including decreased length of the lower limbs)
- No diagnosed neurological diseases or disorders (including labyrinth dysfunction)
- No diagnosed impairment of concentration and attention
Who cannot join
- Lack of informed consent to participate in the study
- No experience of infection with SARS-COV-2
- Age outside the range of 19 and 27 years
- Confirmed injuries to lower limbs in the period of 12 months preceding the date of enrolment into the study
- Confirmed neurological diseases or disorders, such as impaired balance, concentration and attention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Earlier Infection With SARS-COV-2 on Neurological Impairments, Quality of Life, Physical Activity, Social Contacts and Education
The research will make it possible to assess patients who recovered from COVID-19 for the incidence of neurological problems (impaired balance, gait, coordination, concentration and attention), and changes in the quality of life, physical activity, social contacts and education.
Read the detailed description
The intended size of group - 100 subjects (50 subjects - study group, 50 subjects - control group). The above population was determined based on sample size calculator, with the following parameters: fraction size of 0.9, Confidence Interval of 95%, maximum error of 9%. The proper study will be preceded with a pilot study involving a smaller group of subjects (in order to standardise the surveys, and minimise the relationship between the results of the survey and side-effect factors). After inclusion and exclusion criteria are considered, the subjects will be allocated into two groups:
- study group (subjects who had tested positive and recovered from COVID-19)
- control group (healthy subjects who did not have COVID-19). The controls will be matched to the study group for gender and age.
The examination will be performed once, at the premises of the University of Rzeszów. The participants' condition will be assessed using the following measures:
- static and dynamic balance and risk of falls (force plate and computerised posturography, clinical tests)
- activity in the cerebral cortex of the frontal lobe during focused performance of a task (Hemoencephalography HEG-System)
- concentration and attention, memory and cognitive functions (Bourdon-Wiersma test and Auditory-Verbal Learning Test)
- gait velocity and efficiency (10-meter walk test and 6-minute walk test)
- physical activity (International Physical Activity Questionnaire IPAQ), as well as education, mood, and social contacts (specially designed questionnaire)
- quality of life (SF-36 questionnaire)
- Conditions
- Covid19, Neurological Disorder, Balance; Distorted, Gait Disorders, Neurologic, Activity, Motor, Social Isolation
- Medical subject headings
- COVID-19, Nervous System Diseases, Gait Disorders, Neurologic, Motor Activity, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | subjects who had tested positive and recovered from COVID-19 | |
| Control group | healthy subjects who did not have COVID-19, the controls will be matched to the study group for gender and age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static balance
measurements to be performed with a force plate. Centre of Foot Pressure (COP) movements will be assessed in the frontal and sagittal plane (95% confidence ellipse area (COP-area mm2), medium antero-posterior and lateral sway COP (mm), COP average velocity (mm/sec). Stabilographic measurements, each continued for 60 seconds, will be carried out during the following trials: standing on stable ground with eyes open and with eyes closed; standing on unstable ground with eyes open and with eyes closed.
Measured: up to 1 month
Dynamic balance
measurements to be performed using computerised dynamic posturography. The assessment will be performed using Smart EquiTest System from Neurocom. The assessment with take into account delay in response to a destabilising stimulus of mild, moderate and high strength (motor control test - one of the available standard research protocols). The assessment will take into account: Latency - time lapse (in milliseconds) between the onset of support surface translation and the participant's active force response, measured for each limb independently; and Amplitude scaling (or Relative response strength) - strength of the participant's active force response to arrest the angular momentum imparted to the body during the backwards and forwards translations. The response strength will be measured for each leg independently in units of angular momentum (degrees/second) and normalized to body height and weight.
Measured: up to 1 month
Activity in the cerebral cortex of the frontal lobe
measurements to be performed with Hemoencephalography HEG - a system for imaging of cerebral blood oxygenation as well as brain activity. During the examination HEG headset will be placed on the subject's forehead, and any external light stimuli, which could affect the results, will be eliminated. The subject will be required to fully focus on the image displayed on a screen. The examination will comprise a 10-minute session, preceded with one minute test trial during which the indicators will be normalised and the subjects will be prepared for the task. The assessment will take into account HEG ratio mean, max and min. The HEG ratio is: red light (nm) / infrared light (nm)
Measured: up to 1 month
Secondary outcomes (10)
Concentration and attention
measurements to be performed with Bourdon-Wiersma test. During the trial the subject is shown a sheet with a sequence of various letters and digits and he/she is asked to cancel specific letters, e.g., e and r in three minutes. The score reflects the total number of accurately cancelled letters, and a total number of letters omitted or cancelled inaccurately.
Measured: up to 1 month
Memory and cognitive functions
measurements to be performed with Auditory-Verbal Learning Test (AVLT). During the trial the subject is asked to repeat a list of 15 words.
Measured: up to 1 month
Walking speed
measurements to be performed with a 10-meter walk test. During the trials assessing gait velocity (m/s) over a distance of 10 metres, the subjects walk at a self-selected speed.
Measured: up to 1 month
Walking distance
measurements to be performed with a 6-minute walk test. During the trial, the subjects walk at a self-selected speed for 6 minutes.
Measured: up to 1 month
Self-reliant mobility
measurements to be performed with the Timed Up and Go Test. During the trial, the subjects are instructed to get up from a chair with a standard-height backrest and to walk 3 metres, turn round at a specified location, return to the chair and resume the sitting position unassisted
Measured: up to 1 month
Balance
measurements to be performed with Tandem Tests and with a 15-second step test. During Tandem test trials subjects are asked to assume a "tip-top" balance position - the heel of a dominant foot touches the toe of the other with each step. The tasks are used to assess coordination, static and dynamic balance in order to determine the risk of falls. During the 15-second step test, the subject should make as many steps as possible and descend with the entire foot from a 7.5 cm high bench.
Measured: up to 1 month
Balance and lower limbs muscle strength
Measurements to be performed with a sit-to-stand test. During the trial, the subject should perform as many repetitions of standing up and sitting down from a 43.2 cm tall chair in 30 seconds.
Measured: up to 1 month
Health-related quality of life
Measurements to be performed with 20-Item Short Form Survey (SF-20). This questionnaire is a short multi-dimensional instrument that measures six aspects of health status: physical functioning (6 items), role functioning (2 items), social functioning (1 item), mental health (5 items), general health perceptions (5 items), and pain (1 item).
Measured: up to 1 month
Physical activity level
Measurements to be performed with International Physical Activity Questionnaire Short Form (IPAQ-SF). The short form records the "last 7 days recall" activity of four intensity levels: vigorous-intensity activity, moderate-intensity activity, walking, and sitting. Single examination
Measured: up to 1 month
education, mood, physical activity and social contacts
measurements to be performed with a specially designed questionnaire. The self-authored questionnaire consists of questions assessing the impact of Covid-19 pandemic and the related restrictions on the quality of education, knowledge acquisition, frequency and form of physical activity performed, as well as mental state, mood, and changes in social contacts.
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start30 Jun 2021
- Primary completion30 Jul 2021
- Study completion30 Aug 2021
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rzeszow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnieszka Guzik, PhD, University of Rzeszow
- Investigators
- Agnieszka Guzik, PhD, Study chair, University of Rzeszow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934085
- Sponsor's protocol ID
- COVID-19
- Status last verified
- Sep 2021
- First submitted
- 18 Jun 2021
- Last updated
- 9 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Earlier Infection With SARS-COV-2 on Neurological Impairments, Quality of Life, Physical Activity, Social Contacts and Education
- ClinicalTrials.gov ID
- NCT04934085
- Acronym / sponsor ID
- COVID-19
- Conditions
- Covid19, Neurological Disorder, Balance; Distorted, Gait Disorders, Neurologic, Activity, Motor, Social Isolation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of RzeszowUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 22 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.
The research will make it possible to assess patients who recovered from COVID-19 for the incidence of neurological problems (impaired balance, gait, coordination, concentration and attention), and changes in the quality of life, physical activity, social contacts and education.
Detailed description
The intended size of group - 100 subjects (50 subjects - study group, 50 subjects - control group). The above population was determined based on sample size calculator, with the following parameters: fraction size of 0.9, Confidence Interval of 95%, maximum error of 9%. The proper study will be preceded with a pilot study involving a smaller group of subjects (in order to standardise the surveys, and minimise the relationship between the results of the survey and side-effect factors). After inclusion and exclusion criteria are considered, the subjects will be allocated into two groups:
- study group (subjects who had tested positive and recovered from COVID-19)
- control group (healthy subjects who did not have COVID-19). The controls will be matched to the study group for gender and age.
The examination will be performed once, at the premises of the University of Rzeszów. The participants' condition will be assessed using the following measures:
- static and dynamic balance and risk of falls (force plate and computerised posturography, clinical tests)
- activity in the cerebral cortex of the frontal lobe during focused performance of a task (Hemoencephalography HEG-System)
- concentration and attention, memory and cognitive functions (Bourdon-Wiersma test and Auditory-Verbal Learning Test)
- gait velocity and efficiency (10-meter walk test and 6-minute walk test)
- physical activity (International Physical Activity Questionnaire IPAQ), as well as education, mood, and social contacts (specially designed questionnaire)
- quality of life (SF-36 questionnaire)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –subjects who had tested positive and recovered from COVID-19 |
| Control group | – | –healthy subjects who did not have COVID-19, the controls will be matched to the study group for gender and age |
Who may qualify
- Ages
- 19 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will be conducted in the population of people living in south-eastern Poland.
Key inclusion criteria (7 listed)
- Informed consent to participate in the study.
- Experienced infection with SARS-COV-2.
- Age 19 - 26 years
- No injuries to lower limbs in the period of 12 months preceding the date of enrolment into the study
- No orthopaedic disorders affecting the lower limbs (including decreased length of the lower limbs)
Key exclusion criteria (5 listed)
- Lack of informed consent to participate in the study
- No experience of infection with SARS-COV-2
- Age outside the range of 19 and 27 years
- Confirmed injuries to lower limbs in the period of 12 months preceding the date of enrolment into the study
- Confirmed neurological diseases or disorders, such as impaired balance, concentration and attention.
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
Static balance
Time frame: up to 1 month
measurements to be performed with a force plate. Centre of Foot Pressure (COP) movements will be assessed in the frontal and sagittal plane (95% confidence ellipse area (COP-area mm2), medium antero-posterior and lateral sway COP (mm), COP average velocity (mm/sec). Stabilographic measurements, each continued for 60 seconds, will be carried out during the following trials: standing on stable ground with eyes open and with eyes closed; standing on unstable ground with eyes open and with eyes closed.
Dynamic balance
Time frame: up to 1 month
measurements to be performed using computerised dynamic posturography. The assessment will be performed using Smart EquiTest System from Neurocom. The assessment with take into account delay in response to a destabilising stimulus of mild, moderate and high strength (motor control test - one of the available standard research protocols). The assessment will take into account: Latency - time lapse (in milliseconds) between the onset of support surface translation and the participant's active force response, measured for each limb independently; and Amplitude scaling (or Relative response strength) - strength of the participant's active force response to arrest the angular momentum imparted to the body during the backwards and forwards translations. The response strength will be measured for each leg independently in units of angular momentum (degrees/second) and normalized to body height and weight.
Activity in the cerebral cortex of the frontal lobe
Time frame: up to 1 month
measurements to be performed with Hemoencephalography HEG - a system for imaging of cerebral blood oxygenation as well as brain activity. During the examination HEG headset will be placed on the subject's forehead, and any external light stimuli, which could affect the results, will be eliminated. The subject will be required to fully focus on the image displayed on a screen. The examination will comprise a 10-minute session, preceded with one minute test trial during which the indicators will be normalised and the subjects will be prepared for the task. The assessment will take into account HEG ratio mean, max and min. The HEG ratio is: red light (nm) / infrared light (nm)
10 secondary outcomes
Concentration and attention
Time frame: up to 1 month
Memory and cognitive functions
Time frame: up to 1 month
Walking speed
Time frame: up to 1 month
Walking distance
Time frame: up to 1 month
Self-reliant mobility
Time frame: up to 1 month
Balance
Time frame: up to 1 month
Balance and lower limbs muscle strength
Time frame: up to 1 month
Health-related quality of life
Time frame: up to 1 month
Physical activity level
Time frame: up to 1 month
education, mood, physical activity and social contacts
Time frame: up to 1 month
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 9 Sep 2021.
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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.
Agnieszka Guzik, PhD study chair
University of Rzeszow
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 and Neurological Disorder, run by University of Rzeszow at 1 site in Poland.
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 7 inclusion and 5 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 9 Sep 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 Poland. 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?
Static balance (time frame: up to 1 month). The study lists 3 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 9 Sep 2021.