StrokeSOMADC-CCNCT07737873
Examining Relationships Between Musculoskeletal Function Measurements of Movement Efficiency and Nervous System Function After Chronic Stroke
An observational study of Stroke and Osteopathic Medicine, run by University of California, Davis at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Osteopathic Medicine, Physical Examination
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 30 Jun 2028
- How long will I take part?
- 1 Day
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive outpatient ischemic stroke patients seen at the UC Davis Stroke Center.
Who may be able to join
- • 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
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California Davis
Sacramento, California, 95817
Alan Yee, D.O., ahyee@ucdavis.edu
About this study
Official title: 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.
- Conditions
- Stroke, Osteopathic Medicine, Physical Examination, Heart Rate Variability (HRV), Energy Expenditure, Patient Reported Outcome (PRO)
- Keywords
- stroke, osteopathic medicine, patient reported outcome, heart rate variability, physical examination
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
6 Minute Walk Test
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.
Measured: 6 minute duration to be performed a single time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan Yee, D.O., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737873
- Sponsor's protocol ID
- 2374498-1
- Other IDs
- 26151929
- Acronym
- SOMADC-CC
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yee AH, Brooks WJ, Palchik GA, Akers B, Li Y, Dossett ML. Examiner reliability of a systematic osteopathic musculoskeletal examination model in patients with stroke: results from the SOMADC-AC study. J Osteopath Med. 2025 Dec 4;126(7):329-337. doi: 10.1515/jom-2025-0084. eCollection 2026 Jul 1.
PubMed 41343705