Cognitive-Sensorimotor Function in Long-COVID

NCT06850350 | Recruiting

• 2 other identifiers: F5372-RRX005372
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-acute Sequelae of SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  During single session of two hours

Secondary Outcomes (1)

• Mini-Balance Evaluation Systems Test

  During single session of two hours

Study Arms (2)

Control

Adults who previously contracted Covid-19 but do not have Long-COVID.

Experimental

Adults who previously contracted Covid-19 and have Long-COVID.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults who previously contracted Covid-19 and do or do not have Long-COVID.

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Edward Hines Jr. VA Hospital: collaborator

Study Sites (1)

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew J. Major, PhD

  Jesse Brown VA Medical Center, Chicago, IL

  PRINCIPAL INVESTIGATOR

• Keith Edward Gordon, PhD

  Edward Hines Jr. VA Hospital, Hines, IL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew J Major, PhD

CONTACT

(312) 569-6166; Matthew.Major2@va.gov

Keith E Gordon, PhD

CONTACT

(708) 202-8387; Keith.Gordon2@va.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: February 27, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)