Post-acute Sequelae of SARS-CoV-2 InfectionNCT06850350
Cognitive-Sensorimotor Function in Long-COVID
An observational study of Post-acute Sequelae of SARS-CoV-2 Infection, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-acute Sequelae of SARS-CoV-2 Infection
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults who previously contracted Covid-19 and do or do not have Long-COVID.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, 60612
Matthew J Major, PhD, 312-569-6166, Matthew.Major2@va.gov
Karen M Lenehan, (312) 569-6343, Karen.Lenehan@va.gov
About this study
Official title: Enhancing Veterans Long-COVID Care: A Cognitive-Sensorimotor Framework to Understand Gait and Balance Dysfunction
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.
Read the 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.
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Adults who previously contracted Covid-19 but do not have Long-COVID. | |
| Experimental | Adults who previously contracted Covid-19 and have Long-COVID. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During single session of two hours
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.
Measured: During single session of two hours
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.
Measured: During single session of two hours
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.
Measured: During single session of two hours
Dual task gait cost
Participants will walk at their self-selected speed for 10 laps back and forth along a 10-m straight walkway with wide turns, once without a cognitive task (single task) and once with a cognitive task that stresses working memory (dual task). Difference in gait speed (m/s) is the dual task gait cost, in which higher values mean worse performance.
Measured: During single session of two hours
Modified Clinical Test of Sensory Interaction on Balance
Participants stand on a force plate and perform four balance tasks for which participants are instructed to maintain quiet upright balance: 1) eyes open on a firm surface while focusing straight ahead (access to all three modalities), 2) eyes closed on a firm surface (compromised visual), 3) eyes open on a foam surface while focusing straight ahead (compromised somatosensory), and 4) eyes closed on a foam surface (compromised visual and somatosensory). Total CoP distance travelled (mm) of the four specific balance tasks is measured, with greater distance meaning worse performance.
Measured: During single session of two hours
Secondary 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.
Measured: During single session of two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Apr 2026
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-acute Sequelae of SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Edward Hines Jr. VA Hospital
- Responsible party
- Sponsor
- Investigators
- Matthew J. Major, PhD, Principal investigator, Jesse Brown VA Medical Center, Chicago, ILKeith Edward Gordon, PhD, Principal investigator, Edward Hines Jr. VA Hospital, Hines, IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850350
- Sponsor's protocol ID
- F5372-R
- Other IDs
- RX005372
- Status last verified
- May 2026
- First submitted
- 26 Feb 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Veterans Long-COVID Care: A Cognitive-Sensorimotor Framework to Understand Gait and Balance Dysfunction
- ClinicalTrials.gov ID
- NCT06850350
- Acronym / sponsor ID
- F5372-R
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Edward Hines Jr. VA Hospital
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Adults who previously contracted Covid-19 but do not have Long-COVID. |
| Experimental | – | –Adults who previously contracted Covid-19 and have Long-COVID. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who previously contracted Covid-19 and do or do not have Long-COVID.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
NIH Toolbox Cognition Battery
Time frame: During single session of two hours
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.
Joint position sense proprioception
Time frame: During single session of two hours
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.
King-Devick Test
Time frame: During single session of two hours
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.
Maximum voluntary muscle strength
Time frame: During single session of two hours
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.
Dual task gait cost
Time frame: During single session of two hours
Participants will walk at their self-selected speed for 10 laps back and forth along a 10-m straight walkway with wide turns, once without a cognitive task (single task) and once with a cognitive task that stresses working memory (dual task). Difference in gait speed (m/s) is the dual task gait cost, in which higher values mean worse performance.
Modified Clinical Test of Sensory Interaction on Balance
Time frame: During single session of two hours
Participants stand on a force plate and perform four balance tasks for which participants are instructed to maintain quiet upright balance: 1) eyes open on a firm surface while focusing straight ahead (access to all three modalities), 2) eyes closed on a firm surface (compromised visual), 3) eyes open on a foam surface while focusing straight ahead (compromised somatosensory), and 4) eyes closed on a foam surface (compromised visual and somatosensory). Total CoP distance travelled (mm) of the four specific balance tasks is measured, with greater distance meaning worse performance.
1 secondary outcome
Mini-Balance Evaluation Systems Test
Time frame: During single session of two hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew J. Major, PhD principal investigator
Jesse Brown VA Medical Center, Chicago, IL
Keith Edward Gordon, PhD principal investigator
Edward Hines Jr. VA Hospital, Hines, IL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-acute Sequelae of SARS-CoV-2 Infection, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew J Major, PhD ((312) 569-6166, Matthew.Major2@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIH Toolbox Cognition Battery (time frame: During single session of two hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.