Clinical trial NCT06605014: Somatic Dysfunction in Patients With Acute Cerebrovascular Disease
Official title: Characterization of Somatic Dysfunction in Patients With Acute Cerebrovascular Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke, Acute
TIA
Reproducibility of Results
Osteopathic Manipulation
Health-Related Quality-of-Life
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: American Osteopathic Association
First posted: 2024-09-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 Asymptomatic adult volunteers (e.g., medical center employees) will be recruited to undergo paired, repeated osteopathic physical examinations and serve as controls.

20 disease controls (TIA) will undergo a single paired assessment by two independent raters

80 patients recently admitted with acute ischemic stroke will undergo repeated paired independent rater assessments throughout hospitalization.

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

Primary outcomes:
measure: Examiner Rater-Reliability
timeFrame: 3 to 14 days
measure: Functional Pathology of the Musculoskeletal System
timeFrame: 3-14 days
measure: National Institutes of Health Neuro-Quality of Life (QoL) survey
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Alan Yee, D.O.
role: PRINCIPAL_INVESTIGATOR
References: