Covid19 Clinical Trial - COVID-19 Versus Neurological Impairment, Physical

Status Completed

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04934085
Study type	Observational
Source	University of Rzeszow
Contact
Status	Completed
Phase
Start date	June 30, 2021
Completion date	August 30, 2021

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

COVID-19 Versus Neurological Impairment, Physical Activity, Social Contacts and Education

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms