Clinical trial NCT06850350: Cognitive-Sensorimotor Function in Long-COVID
Official title: Enhancing Veterans Long-COVID Care: A Cognitive-Sensorimotor Framework to Understand Gait and Balance Dysfunction
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Post-acute Sequelae of SARS-CoV-2 Infection
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Edward Hines Jr. VA Hospital
First posted: 2025-02-27
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults who previously contracted COVID-19 and do or do not have Long-COVID.

Brief summary: 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.

Detailed description: As many as one in seven COVID-19 survivors will experience symptoms that persist more than two months after their acute illness has resolved. Growing evidence estimates that up to 30% of people who experience this chronic post-COVID disorder (aka post-acute sequelae of SARS-CoV-2 infection (PASC)) will exhibit gait and balance dysfunction. The consequences of impaired mobility are of considerable concern for the Veterans Health Administration (VHA) given that mobility is closely related to quality of life for older adults and almost half of Veterans are 65 years or older. There currently is no established VHA standard-of-care for PASC. The critical first step towards development of comprehensive clinical protocols to identify and treat PASC-related gait and balance dysfunction is understanding the contributing factors. PASC is characterized by diverse multi-organ system effects that has made it difficult to identify the causes of dysfunction. However, new data suggests frequently reported neurologic issues related to cognitive and sensorimotor impairment may be potential contributors to gait and balance dysfunction. While cognition, sensation, and muscle function can be measured in isolation, the effects of cognitive and sensory impairment on gait and balance are best detected using dual task tests (e.g., count backward by 7's while walking) that pair cognitive and motor function or tasks performed in complex environments that limit sensory feedback and/or stress sensory-motor integration (e.g., maintaining standing balance with eyes closed). However, such assessments are not included in the current recommended PASC gait and balance screening guidelines, thereby leaving a clinical gap in knowledge when evaluating and treating Veterans and non-Veterans with PASC-related gait and balance dysfunction.

Therefore, the proposed project will evaluate the effect of PASC on isolated cognitive-sensorimotor function (Aim 1), and cognitive-sensorimotor contributions to gait (Aim 2) and balance (Aim 3) dysfunction in COVID-19 survivors through an observational cross-sectional study design. Aim 1 will assess cognition, vision, proprioception, and muscle strength independent of functional task in COVID-19 survivors with and without PASC using established methods. Aim 2 will perform an instrumented assessment of gait performance of participants under a dual task scenario to stress cognition. Aim 3 will perform an instrumented assessment of postural balance under different conditions that challenge sensorimotor integration by compromising certain sensory modalities (vision, vestibular, somatosensory). A non-instrumented clinical outcome measure will also be performed as a secondary measure to evaluate a potential clinical screening tool. Based on emerging evidence, the investigators hypothesize that COVID-19 survivors with PASC will exhibit worse cognitive-sensorimotor function, dual task gait performance, and sensory-interaction balance performance than those without PASC when accounting for age, sex, and time since acute infection. PASC-induced gait and balance dysfunction has significant clinical implications as it could compromise mobility, long-term health, and quality of life of Veterans if left unaddressed. Outcomes from this study will generate new knowledge on PASC-induced gait and balance dysfunction as related to cognitive-sensorimotor impairment, This information is critical for informing VHA PASC standard-of-cares that are currently being developed to ensure inclusion of appropriate gait and

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.)

Primary outcomes:
measure: NIH Toolbox Cognition Battery
timeFrame: During single session of two hours
measure: Joint position sense proprioception
timeFrame: During single session of two hours
measure: King-Devick Test
timeFrame: During single session of two hours
measure: Maximum voluntary muscle strength
timeFrame: During single session of two hours
measure: Dual task gait cost
timeFrame: During single session of two hours
measure: Modified Clinical Test of Sensory Interaction on Balance
timeFrame: During single session of two hours
Secondary outcomes:
measure: Mini-Balance Evaluation Systems Test
timeFrame: During single session of two hours
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center, Chicago, IL
state: Illinois
Study officials:
affiliation: Jesse Brown VA Medical Center, Chicago, IL
name: Matthew J. Major, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Edward Hines Jr. VA Hospital, Hines, IL
name: Keith Edward Gordon, PhD
role: PRINCIPAL_INVESTIGATOR
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