Stroke, AcuteSOMADC-ACNCT06605014
Somatic Dysfunction in Patients With Acute Cerebrovascular Disease
An observational study of Stroke, Acute and TIA, run by University of California, Davis at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Acute, TIA, Reproducibility of Results
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 31 Aug 2026
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California Davis Medical Center
Sacramento, California, 95817
Alan Yee, D.O.
Alan Yee, D.O.
About this study
Official title: Characterization of Somatic Dysfunction in Patients With Acute Cerebrovascular Disease
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
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SOMADC-AC Cohort | 1. Asymptomatic adult volunteers 2. Patients admitted with TIA 3. Patients admitted with acute ischemic stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examiner Rater-Reliability
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.
Measured: 3 to 14 days
Functional Pathology of the Musculoskeletal System
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".
Measured: 3-14 days
National Institutes of Health Neuro-Quality of Life (QoL) survey
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start1 Sep 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- American Osteopathic Association
- Responsible party
- Sponsor
- Investigators
- Alan Yee, D.O., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605014
- Sponsor's protocol ID
- 1901775
- Other IDs
- 23151879
- Acronym
- SOMADC-AC
- Status last verified
- Sep 2025
- First submitted
- 25 Jul 2024
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Somatic Dysfunction in Patients With Acute Cerebrovascular Disease
- ClinicalTrials.gov ID
- NCT06605014
- Acronym / sponsor ID
- SOMADC-AC / 1901775
- Conditions
- Stroke, Acute, TIA, Reproducibility of Results, Osteopathic Manipulation, Health-Related Quality-of-Life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- American Osteopathic Association
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOMADC-AC Cohort | – | –1. Asymptomatic adult volunteers 2. Patients admitted with TIA 3. Patients admitted with acute ischemic stroke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Examiner Rater-Reliability
Time frame: 3 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 System
Time frame: 3-14 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) survey
Time frame: 90 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alan Yee, D.O. principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute and TIA, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alan Yee, D.O. (916-734-3588, ahyee@ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examiner Rater-Reliability (time frame: 3 to 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.