Clinical trial NCT04934085: COVID-19 Versus Neurological Impairment, Physical Activity, Social Contacts and Education
Official title: Impact of Earlier Infection With SARS-COV-2 on Neurological Impairments, Quality of Life, Physical Activity, Social Contacts and Education
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Neurological Disorder
Balance; Distorted
Gait Disorders, Neurologic
Activity, Motor
Social Isolation
Educational Problems
Quality of Life
Lead sponsor: University of Rzeszow
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted in the population of people living in south-eastern Poland.

Brief 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.

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Static balance
timeFrame: up to 1 month
measure: Dynamic balance
timeFrame: up to 1 month
measure: Activity in the cerebral cortex of the frontal lobe
timeFrame: up to 1 month
Secondary outcomes:
measure: Concentration and attention
timeFrame: up to 1 month
measure: Memory and cognitive functions
timeFrame: up to 1 month
measure: Walking speed
timeFrame: up to 1 month
measure: Walking distance
timeFrame: up to 1 month
measure: Self-reliant mobility
timeFrame: up to 1 month
measure: Balance
timeFrame: up to 1 month
measure: Balance and lower limbs muscle strength
timeFrame: up to 1 month
measure: Health-related quality of life
timeFrame: up to 1 month
measure: Physical activity level
timeFrame: up to 1 month
measure: education, mood, physical activity and social contacts
timeFrame: up to 1 month
Other outcomes:
Locations:
city: Rzeszów
country: Poland
facility: University of Rzeszów
state: Podkarpackie
Study officials:
affiliation: University of Rzeszow
name: Agnieszka Guzik, PhD
role: STUDY_CHAIR
References: