No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
100 (estimated)
Sponsor
University of California, Davis · Other
Who this trial is looking for
This trial is looking for adults who have had a stroke more than 3 months ago. Participants will help researchers understand relationships between physical function, nervous system function, and quality of life after stroke.
Are You a Good Fit for This Trial?
You may be able to join if
I am an adult aged 18 or older.
I have had a stroke more than 3 months ago.
I can sit upright and lie down in different positions.
I can walk independently, with or without help.
I can give my consent for the study or have someone who can.
I am willing to receive text messages or emails for surveys.
You may not be able to join if
I have a recent bone fracture or dislocation.
I use a brace or cervical collar for my spine.
I have a history of spinal cord injury with lasting disability.
I have a condition that makes movement or testing too painful.
I have received osteopathic or chiropractic treatment since my stroke.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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Eligibility Criteria
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 posit…
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.
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