- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04934085
COVID-19 Versus Neurological Impairment, Physical Activity, Social Contacts and Education
Impact of Earlier Infection With SARS-COV-2 on Neurological Impairments, Quality of Life, Physical Activity, Social Contacts and Education
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Podkarpackie
-
Rzeszów, Podkarpackie, Poland, 35-959
- University of Rzeszow
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
up to 1 month
|
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.
|
up to 1 month
|
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)
|
up to 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentration and attention
Time Frame: up to 1 month
|
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.
|
up to 1 month
|
Memory and cognitive functions
Time Frame: up to 1 month
|
measurements to be performed with Auditory-Verbal Learning Test (AVLT).
During the trial the subject is asked to repeat a list of 15 words.
|
up to 1 month
|
Walking speed
Time Frame: up to 1 month
|
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.
|
up to 1 month
|
Walking distance
Time Frame: up to 1 month
|
measurements to be performed with a 6-minute walk test.
During the trial, the subjects walk at a self-selected speed for 6 minutes.
|
up to 1 month
|
Self-reliant mobility
Time Frame: up to 1 month
|
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
|
up to 1 month
|
Balance
Time Frame: up to 1 month
|
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.
|
up to 1 month
|
Balance and lower limbs muscle strength
Time Frame: up to 1 month
|
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.
|
up to 1 month
|
Health-related quality of life
Time Frame: up to 1 month
|
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).
|
up to 1 month
|
Physical activity level
Time Frame: up to 1 month
|
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
|
up to 1 month
|
education, mood, physical activity and social contacts
Time Frame: up to 1 month
|
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.
|
up to 1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Agnieszka Guzik, PhD, University of Rzeszow
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Neurologic Manifestations
- COVID-19
- Disease
- Nervous System Diseases
- Gait Disorders, Neurologic
Other Study ID Numbers
- COVID-19
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Quality of Life
-
Children's National Research InstituteRecruitingProfessional Quality of LifeUnited States
-
Istituto Ortopedico RizzoliUniversity of BolognaRecruitingImprove Quality of LifeItaly
-
B. Braun Medical SAUnknownQuality of Life of Colostomized Patient
-
Assiut UniversityUnknownImproving Quality of LifeEgypt
-
Linkoeping UniversityRecruiting
-
South Valley UniversityActive, not recruitingDeterminants of Health-related Quality of Life for Patients After Renal Lithotripsy: PNL Versus RIRSHealth Related Quality of LifeEgypt
-
Region VästmanlandUnknownHealth Related Quality of Life
-
Ain Shams UniversityCompletedHealth Related Quality of LifeEgypt
-
Institute of Oncology LjubljanaUnknownHealth-related Quality of LifeSlovenia
-
Oslo University HospitalNorwegian Fund for Postgraduate Training in PhysiotherapyCompletedHealth-Related Quality of LifeNorway