Somatic Dysfunction in Patients With Acute Cerebrovascular Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Stroke, Acute, TIA, Reproducibility of Results, Osteopathic Manipulation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Characterization of Somatic Dysfunction in Patients With Acute Cerebrovascular Disease
Overview
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.
Primary outcome measures
- Examiner Rater-Reliability [Time frame: 3 to 14 days]
- Functional Pathology of the Musculoskeletal System [Time frame: 3-14 days]
- National Institutes of Health Neuro-Quality of Life (QoL) survey [Time frame: 90 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of California Davis Medical Center — Sacramento
Identifiers
NCT: NCT06605014 · 1901775 · 23151879