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

University of Rzeszow

Status: Completed

Conditions: Balance; Distorted; Gait Disorders, Neurologic; Quality of Life; Neurological Disorder; Activity, Motor; Covid19; Educational Problems; Social Isolation

Study type: Observational

Funder types: Other

Identifiers

NCT04934085

COVID-19

Details and patient eligibility

About

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.

Full 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)

Enrollment: 100 patients

Sex: All

Ages: 19 to 26 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

Study group

Description:

subjects who had tested positive and recovered from COVID-19

Control group

Description:

healthy subjects who did not have COVID-19, the controls will be matched to the study group for gender and age