Impact of Earlier Infection With SARS-COV-2 on Neurological Impairments, Quality of Life, Physical Activity, Social Contacts and Education
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Static balance
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 26 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent to participate in the study.
- •Experienced infection with SARS-COV-
- •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
排除标准
- •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.
结局指标
主要结局
Static balance
时间窗: up to 1 month
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.
Activity in the cerebral cortex of the frontal lobe
时间窗: up to 1 month
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)
Dynamic balance
时间窗: up to 1 month
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.
次要结局
- Health-related quality of life(up to 1 month)
- education, mood, physical activity and social contacts(up to 1 month)
- Walking distance(up to 1 month)
- Balance and lower limbs muscle strength(up to 1 month)
- Physical activity level(up to 1 month)
- Memory and cognitive functions(up to 1 month)
- Walking speed(up to 1 month)
- Concentration and attention(up to 1 month)
- Self-reliant mobility(up to 1 month)
- Balance(up to 1 month)
研究者
Agnieszka Guzik, PhD
Principal Investigator
University of Rzeszow