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Observational Study of Somatic Dysfunction in Stroke Patients

This observational study is looking at how reliably different healthcare providers can identify motion problems in joints, called "somatic dysfunction," using a new physical exam method. This method is called the Functional Pathology of the Musculoskeletal System (FPMSS) model. The study includes adults aged 18 and older who have had an ischemic stroke or a transient ischemic attack (TIA), which is like a mini-stroke. Researchers want to see if different providers get similar results when using this new exam. They will also look at how these motion problems relate to your quality of life after 90 days. The study is currently not recruiting, and no specific treatments are being tested.

Study design
This is an observational study with a planned enrollment of 120 participants. It aims to see if different providers can reliably use a new physical exam method.
What's involved
You would undergo a physical examination to assess musculoskeletal function between 3 and 14 days after your stroke or TIA. You would also complete a quality of life survey at 90 days.
Compensation
Not stated in the trial record.
Follow-up
Your quality of life will be assessed at 90 days after the initial examination.

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NCT06605014

Somatic Dysfunction in Patients With Acute Cerebrovascular Disease

Recruiting
Not specifiedAges 18+Observational
University of California, Davis
~120 participants
Updated 2025-09-26 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Examiner Rater-Reliability
Measured over 3 to 14 days
+2 more outcomes measured

Conditions

Stroke, Acute
TIA
Reproducibility of Results
Osteopathic Manipulation
Health-Related Quality-of-Life

Explore related trials

Ischemic StrokeTransient Ischemic Attack

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Alan Yee, D.O. · PRINCIPAL_INVESTIGATOR · University of California, Davis

Who to contact

Alan Yee, D.O.
[email protected]
916-734-3588
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

adults ≥18 years
ischemic stroke OR
transient ischemic attack (TIA). A prior history of TIA but without stroke may be enrolled.
Neurologic stability or lack of significant deterioration (i.e. ∆ NIHSS\<4) for at least 24 hours (defined by clinical documentation and/or communication with provider team(s)) in stroke subjects
Able to sit upright, lie supine, and when able lateral recumbent left/right positions with assist independently or with minimal person assist
Anticipated length of stay greater \> or = 2 days for ischemic stroke. TIA patients average length of stay is \< 2 days, and can be enrolled in the study.

Exclusion

Acute skeletal fracture or known dislocation; history of pathologic (osteoporotic or neoplastic) skeletal fracture of thoracic cage, hip/pelvis/sacrum, or vertebral column
Prior history of ICH, ischemic stroke, confirmed by imaging and/or clinical evaluation. Patients with imaging showing "chronic stroke" who have never received a diagnosis of stroke and/or have not been previously symptomatic may still be enrolled, based on the Investigator's clinical judgement.
Spinal column support brace (e.g. cervical collar)
Anticipated neurosurgical intervention during hospitalization: decompressive hemicraniectomy, hematoma evacuation (defined by clinical documentation and/or communication with provider team(s))
Current endotracheal intubation (\*note: extubated patients can be evaluated for eligibility)
History of spinal cord injury with residual neuromuscular or sensory disability
History of recent trauma within the past 30 days
Known ligament, musculotendinous, or bone lesion
Clinical condition that would interfere with execution of movement or palpatory diagnostic testing, e.g. chronic pain
History of spinal surgery

What this trial measures

  • Examiner Rater-Reliability3 to 14 days

    Test intra- and inter-rater reliability in identifying osteopathic somatic dysfunction (joint(s) motion impairment) among asymptomatic volunteers, patients with TIA, and recently admitted patients with stroke.

  • Functional Pathology of the Musculoskeletal System3-14 days

    A total of 80 specific musculoskeletal examination tests are performed assessing the amount of available motion in the spine, upper extremities, lower extremities, and pelvis. Navigational Motions (i.e., whole upper limb motion at shoulder) are scored on a scale of 1-4 with one representing the least loss of motion and 4 representing the most and Component Motions (i.e., motion of foot at ankle) scored on a scale of 0-3 with 0 representing "normal motion" and 3 representing "no motion".

  • National Institutes of Health Neuro-Quality of Life (QoL) survey90 days

    Quantify self-reported health-related quality-of-life (QoL) 90 days after ischemic stroke. Patient response domain scores have a normative distribution and are compared against general population means (50, with a standard deviation of 10; range 10-90). Interpreting value responses above or below means are based on the specific questions - i.e., higher scores do not uniformly reflect improvement while lower scores do not necessarily reflect poorer status. Patient will receive a digitally distributed survey inquiring about QoL domains surrounding mobility, satisfaction with and ability to participate in social roles, mood, fatigue, anxiety, cognition.