Examining Relationships Between Musculoskeletal Function Measurements of Movement Efficiency and Nervous System Function After Chronic Stroke (NCT07737873)
SOMADC-CC (SOMAtic Dysfunction Characterization Following Chronic Cerebrovascular Disease): Biomarker Study
π©Ί Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of California Davis β Sacramento, California
Age range: 18 Years
π "Do I Qualify?" β 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria β
π All Participating Trial Locations (1 Sites)
- University of California Davis β Sacramento, California
π Contact the Study Coordinator
Phone: (916) 734-3588
Email: ahyee@ucdavis.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
π° Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Determining the Optimal Dose of Reactive Balance Training After Stroke β Toronto, Ontario
- AMPLATZER PFO Occluder Post Approval Study β Birmingham, Alabama
- Reflex Excitability in Post-stroke Stiff-Knee Gait β Cleveland, Ohio
- Group Lifestyle Balanceβ’ for Individuals With Stroke (GLB-CVA) β Dallas, Texas
Explore by condition: All Stroke clinical trials
π‘ How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.