Somatic Dysfunction in Patients With Acute Cerebrovascular Disease

NCT ID: NCT06605014

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2026-08-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

SOMADC-AC Cohort

1. Asymptomatic adult volunteers

2. Patients admitted with TIA

3. Patients admitted with acute ischemic stroke

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Osteopathic Association

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alan Yee, D.O.

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California Davis Medical Center

Sacramento, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alan Yee, D.O.

Role: CONTACT

ahyee@ucdavis.edu

916-734-3588

Facility Contacts

Alan Yee, D.O.

Role: primary

Other Identifiers

23151879

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1901775

Identifier Type: -

Identifier Source: org_study_id