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NCT07737873 · University of California, Davis

Examining Relationships Between Musculoskeletal Function Measurements of Movement Efficiency and Nervous System Function After Chronic Stroke

(SOMADC-CC)

What this study is about

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.

View original scientific description

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.

Primary outcome measures

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.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

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.

Where

  • Sacramento, California

Related conditions & keywords

StrokeOsteopathic MedicinePhysical ExaminationHeart Rate Variability (HRV)Energy ExpenditurePatient Reported Outcome (PRO)patient reported outcomeheart rate variability

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Jul 30, 2026 · Source of record for eligibility and locations

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1 of 100 participants interested
1% interest

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Study locations

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RECRUITING

Sacramento

California

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What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Stroke Treatment in Sacramento?

Join others in California exploring innovative treatment options through clinical research

Stroke Treatment Options in Sacramento, California

If you're searching for Stroke treatment in Sacramento, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Sacramento and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Stroke. All study-related care is provided at no cost to participants.

Local Sites
1 locations in California
Now Enrolling
Up to 100 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Stroke?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Stroke

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Stroke Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07737873. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.