NCT06605014 Somatic Dysfunction in Patients With Acute Cerebrovascular Disease
| NCT ID | NCT06605014 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Davis |
| Condition | Stroke, Acute |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2023-09-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goals of this observational study are to test the reliability of a new, standardized physical examination method to identify motion problems within joints or groups of joints among adult asymptomatic volunteers and in patients hospitalized with stroke or stroke-like episodes (e.g., transient ischemic attack, TIA). The main questions this investigation aims to answer are: * Can different, independent providers reliability quantify motion pattern problems using a systematic approach called, The Functional Pathology of the Musculoskeletal System (FPMSS) model? * Are there differences in joint(s) motion patterns among asymptomatic volunteers, patients with TIA (people with brain disease without new neurologic disability), and recent ischemic stroke (patients with new stroke-related-disability, e.g., paralysis)? * Is there an association between joint(s) motion impairment severity and stroke survivor outcomes? Participants (asymptomatic and those with stroke) will undergo a set of repeated paired, musculoskeletal physical exams by independent providers blinded to each other's assessments and patient information. Researchers will compare the severity, location, and quantity of joint(s) motion impairment between these three groups with the physical examination methodology (FPMSS). Clinical information (e.g., test results, diagnoses, brain imaging, medical history) will be collected from patients admitted for TIA and stroke. Enrolled participants with recent stroke will complete a survey three months after hospitalization to determine their self-perceived quality-of-life.
Eligibility Criteria
Inclusion Criteria: * adults ≥18 years Admission diagnosis: * 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 Criteria: * 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
Contact & Investigator
Alan Yee, D.O.
PRINCIPAL INVESTIGATOR
University of California, Davis
Frequently Asked Questions
Who can join the NCT06605014 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06605014 currently recruiting?
Yes, NCT06605014 is actively recruiting participants. Contact the research team at ahyee@ucdavis.edu for enrollment information.
Where is the NCT06605014 trial being conducted?
This trial is being conducted at Sacramento, United States.
Who is sponsoring the NCT06605014 clinical trial?
NCT06605014 is sponsored by University of California, Davis. The principal investigator is Alan Yee, D.O. at University of California, Davis. The trial plans to enroll 120 participants.
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