Cognitive-Sensorimotor Function in Long-COVID
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
Growing evidence indicates that many people who have chronic post-acute sequelae of SARS-CoV-2 infection (PASC) will experience ongoing neurological and musculoskeletal impairment that can affect gait and balance. Identifying the factors contributing to these impairments and how they influence functional mobility is the first step towards creating effective evaluation and treatment protocols. In this study the investigators will examine cognition, vision, proprioception, muscle strength, gait and balance in persons with and without PASC to understand how PASC may impact functional mobility through a cognitive-sensorimotor lens. Gait and balance will be studied in environments that stress cognitive and sensory abilities. Study outcomes will be critical for the development of evidence-based Veteran Health Administration diagnostic and standard-of-care protocols to address gait and balance dysfunction in Veterans with PASC for restoring their functional mobility and independence.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Older than 18 years of age
Positive PCR or Rapid COVID-19 test in the past
Onset of COVID-19 illness greater than 3 months prior to their participation in the study
Self-reported ability to walk 10 meters with or without external assistance prior to COVID-19 illness
Disqualifiers
Presence of severe cardiovascular and pulmonary disease and/or neurological and musculoskeletal disorders unrelated to COVID-19 (e.g., amputation, stroke, spinal cord injury)
Cognitive impairments precluding ability to provide informed consent.
Severe acute COVID-19 infection requiring hospitalization or diagnosed post-intensive care syndrome.
Presence of musculoskeletal, inflammatory, or neurological conditions mimicking Long COVID-19 symptoms (e.g., concussion within last 5 years, Chronic fibromyalgia, Myofascial pain syndrome, etc.)
Trial population
Adults who previously contracted Covid-19 and do or do not have Long-COVID.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
136 Participants
are grouped into 2 trial groupsGroup A: Control
Group B: Experimental
Trial outcomes
Primary outcomes
1
NIH Toolbox Cognition Battery
The NIH Toolbox Cognition Battery to assess working memory and attention cognitive function. Working memory and attention cognitive function are quantified through performance on the List Sorting Working Memory Test and Flanker Inhibitory Control and Attention Test, respectively, administered via tablet. Raw scores from these measures can be converted to normally distributed standard (scaled) scores adjusted for age, education, sex, and/or race/ethnicity (T-Scores), as appropriate. A higher score means better performance.
Time frame
During single session of two hours2
Joint position sense proprioception
Joint position sense is measured by participants' ability to accurately extend the knee joint to a target reference angle. Participants will be seated and perform nine trials where they have to replicate guided knee joint angle position of 30, 45, or 60°. The difference between guided and replicated position is recorded as the angle error, where greater error means worse proprioception.
Time frame
During single session of two hours3
King-Devick Test
The King-Devick Test assesses ocular-motor function. Participants are asked to accurately and rapidly read rows of single-digit numbers displayed on a tablet. The test score is calculated as the total time required to read three test cards (each test card is approximately a full page of numbers), where faster is better.
Time frame
During single session of two hours4
Maximum voluntary muscle strength
Participants will be seated and isokinetic maximum voluntary contraction is measured with a dynamometer, normalized by participant height and body mass (N-m/kg-m). Greater values mean better strength.
Time frame
During single session of two hoursSecondary outcomes
1
Mini-Balance Evaluation Systems Test
The Mini-Balance Evaluation Systems Test is a performance-based clinical outcome measure to assess dynamic balance, including 14 items scored on a 3-level ordinal scale (total score of 28). The test assesses anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. A higher summary score means better performance.
Time frame
During single session of two hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
VA Office of Research and Development
Lead sponsor
Edward Hines Jr. VA Hospital
Collaborator
Source ClinicalTrials.gov