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

Covid19 Clinical Trial

Official title:

Impact of Earlier Infection With SARS-COV-2 on Neurological Impairments, Quality of Life, Physical Activity, Social Contacts and Education

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04934085
• Other study ID #: COVID-19
• Status: Completed
• Start date: June 30, 2021
• Est. completion date: August 30, 2021

Study information

• Verified date: September 2021
• Source: University of Rzeszow
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 26 Years

Eligibility

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.

Related Conditions & MeSH terms

• Activity, Motor
• Balance; Distorted
• Covid19
• Disease
• Educational Problems
• Gait Disorders, Neurologic
• Nervous System Diseases
• Neurological Disorder
• Quality of Life
• Social Isolation

Locations

Country	Name	City	State
Poland	University of Rzeszów	Rzeszów	Podkarpackie

Sponsors (1)

Lead Sponsor	Collaborator
University of Rzeszow

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Static balance	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
Primary	Dynamic balance	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
Primary	Activity in the cerebral cortex of the frontal lobe	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	Concentration and attention	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
Secondary	Memory and cognitive functions	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
Secondary	Walking speed	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
Secondary	Walking distance	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
Secondary	Self-reliant mobility	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
Secondary	Balance	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
Secondary	Balance and lower limbs muscle strength	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
Secondary	Health-related quality of life	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
Secondary	Physical activity level	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
Secondary	education, mood, physical activity and social contacts	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