Examining Relationships Between Musculoskeletal Function Measurements of Movement Efficiency and Nervous System Function After Chronic Stroke (SOMADC-CC)

July 27, 2026 updated by: University of California, Davis

SOMADC-CC (SOMAtic Dysfunction Characterization Following Chronic Cerebrovascular Disease): Biomarker Study

Stroke remains the leading cause of severe disability, and survivors frequently have incomplete recovery. More than half of older survivors have impaired mobility which contributes to poorer quality-of-life (QoL) and suffering. The annual rate of disability compared to myocardial infarction triples, and stroke accelerates natural age-related functional decline. Somatic dysfunction (SD) is impaired function of the body framework identified by physical examination. Few studies have rigorously studied SD among stroke survivors. We recently demonstrated the reliability of a novel, more construct valid osteopathic examination methodology [called the Functional Pathology of the Musculoskeletal System (FPMSS) model] to quantify SD among asymptomatic participants and patients with acute cerebral ischemia. The preliminary findings suggest that dysfunction may develop within the first week after acute ischemic stroke (IS) and be more severe among those with paralysis compared to healthy volunteers. The precise pathophysiologic mechanism underlying SD remains unknown.

The objective of this proposal is to establish the relationship between SD severity during chronic stroke recovery and physiologic biomarkers. The central hypothesis is that SD is quantifiable, correlates with biomarkers that reflect functional status, and is associated with QoL among chronic stroke survivors. There are currently no biomarkers that correlate with SD severity after IS. Establishing valid biomarkers associated with physiologic processes that are otherwise inferred by physical examination would allow for quantification of changes in response to treatment (e.g., osteopathic manipulative treatment; OMT) aimed at restoring economical biomechanical function. Testing this hypothesis will address several fundamental gaps in knowledge about osteopathic palpatory diagnosis, physiologic processes associated with SD, and its association with survivor outcomes. Until these knowledge gaps are filled, optimal strategies to complement stroke recovery in patients with neurological disability cannot fully be determined. The project specific aims are to quantify the association between SD among chronic (>3 months) IS survivors and measured (1) energy expenditure, (2) heart rate variability (HRV), and (3) patient-reported outcome (PRO) health domains.

The proposed research is significant because it will establish a novel osteopathic approach that determines the impact of whole musculoskeletal system (MSS) health on QoL among stroke survivors living with chronic disability and correlate physiologic properties related to SD. This approach will allow us to quantify SD and show meaningful associations with autonomic function, biomechanical economy, and QoL after chronic stroke. These new metrics would then be derived in stroke patients to determine SD and physiologic thresholds for those that would benefit most from OMT in a future trial. This proposal is innovative in that it seeks to shift current research and practice paradigms by re-appraising the impact of whole musculoskeletal functional economy on patient-centered outcomes among stroke survivors. Methodologically, use of the FPMSS model represents a novel, more construct valid, diagnostic paradigm to reliably identify SD and establish an osteopathic, cross-disciplinary approach to the field of stroke research. The model examines the MSS as integrated, highlighting proportionate, not merely symmetrical, posture and motion among survivors with chronic disability. Similarly, PROs have been used to quantify health status after stroke, but have not been used to study the relationship between chronic neurologic impairment and SD. Integrating contemporary patient-centered stroke outcomes, rigorous osteopathic assessment, and analysis of physiologic processes will advance our understanding of how musculoskeletal dysfunction impacts QoL after stroke.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Davis
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive outpatient ischemic stroke patients seen at the UC Davis Stroke Center.

Description

Inclusion Criteria:

  • • UC Davis Stroke Clinic outpatient patients >3 months from previous stroke

    • Adults ≥18 years

    • Previous admission diagnosis or referral indication:

      o Ischemic stroke (prior history of)

    • Able to sit upright, lie supine, and lie lateral recumbent left/right positions
    • Must be able to walk independently with/without walking aids.
    • Participants must have the capacity to consent to study participation themselves or have a Legally Authorized Representative (LAR) available.
    • Willingness to receive SMS (text) messages and/or email to complete REDCap QoL survey

Exclusion Criteria:

  • • Acute skeletal fracture or known dislocation; history of pathologic (osteoporotic or neoplastic) skeletal fracture of thoracic cage, hip/pelvis/sacrum, or vertebral column

    • Spinal column support brace (e.g. cervical collar)
    • History of spinal cord injury with residual neuromuscular or sensory disability
    • Clinical condition that would interfere with execution of movement or palpatory diagnostic testing, e.g. prohibitive chronic pain
    • Participants who have received either OMT or chiropractic manipulation following their stroke and prior to enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Ambulatory post-ischemic stroke patients (> 3 months after stroke)

Adult patients who have a history of ischemic stroke more than 3 months prior to study enrollment are eligible. Ambulatory patients seen at the UC Davis Stroke Center will be screened for eligibility.

Participants must be have the ability to sit upright, lie supine, and lie lateral recumbent to undergo musculoskeletal examination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 Minute Walk Test
Time Frame: 6 minute duration to be performed a single time.
Participants will walk for 6 consecutive minutes, be allowed to rest and wear support devices as needed, and have their heart rate and waling speed quantified.
6 minute duration to be performed a single time.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Somatic dysfunction
Time Frame: 15-25 minutes, single instance
participants will undergo osteopathic musculoskeletal examination based on applying Functional Pathology of the Musculoskeletal System (FPMSS) criteria to quantify somatic dysfunction --defined as proportionate loss of range of motion during passive testing
15-25 minutes, single instance
Physiologic Cost Index
Time Frame: 6 minute duration of walking, single instance
Quantify energy expense of ambulation among chronic stroke survivors
6 minute duration of walking, single instance
Heart Rate Variability
Time Frame: 5 minutes, single instance
Examine resting heart rate variability among chronic stroke survivors
5 minutes, single instance

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: Alan Yee, D.O., University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

July 27, 2026

First Submitted That Met QC Criteria

July 27, 2026

First Posted (Actual)

July 30, 2026

Study Record Updates

Last Update Posted (Actual)

July 30, 2026

Last Update Submitted That Met QC Criteria

July 27, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2374498-1
  • 26151929 (Other Grant/Funding Number: American Osteopathic Association)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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