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

NCT ID: NCT04934085

Last Updated: 2021-09-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2021-08-30

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)

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Study group

subjects who had tested positive and recovered from COVID-19

No interventions assigned to this group

Control group

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

No interventions assigned to this group

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Rzeszow

OTHER

Sponsor Role: lead

Responsible Party

Agnieszka Guzik, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Agnieszka Guzik, PhD

Role: STUDY_CHAIR

University of Rzeszow

Locations

University of Rzeszów

Rzeszów, Podkarpackie Voivodeship, Poland

Countries

Poland

Other Identifiers

COVID-19

Identifier Type: -

Identifier Source: org_study_id