NCT Number: NCT05608824
Primary Objective:
To explore changes in shear wave elastography (SWE) and microvascular flow imaging (MFI) measurements from time of injury through the recovery phase of lower extremity musculoskeletal injuries to determine if a correlation exists with functional impairment.
Secondary Objective:
To develop a deep learning AI system for automated region of interest (ROI) determination for measurement of average SWE and MFI.
Methodology:
Eligible subjects with lower extremity injuries will undergo SWE and MFI measurements and complete the Lower Extremity Functional Scale questionnaire at each study visit. Clinical data related to the evaluation of the injury acquired during standard medical care of the injury will be collected from the patients' medical record such as CT or MRI scans, X-rays, physical exams and tests as well as laboratory measurements. Subjects will undergo serial SWE and MFI imaging throughout their rehabilitation episode of care to assess changes over time, status in rehabilitation and comparison to the contralateral extremity.
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Notify Me18 year–89 year
All sexes
Interventional
Not applicable
University of Oregon, Eugene, Oregon, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will undergo serial SWE and MFI imaging throughout their rehabilitation episode of care to assess changes over time, status in rehabilitation and comparison to the contralateral extremity.
Time frame: Within 48 hours
Tissue stiffness measured by shear wave elastography
Time frame: 5 days post injury (+/- 2 days)
Tissue stiffness measured by shear wave elastography
Time frame: 6 weeks post injury (+/- 1 week)
Tissue stiffness measured by shear wave elastography
Time frame: 12 weeks post injury (+/- 1 week)
Tissue stiffness measured by shear wave elastography
Time frame: 24 weeks post injury (+/- 1 week)
Tissue stiffness measured by shear wave elastography
Time frame: Within 48 hours
Measured by microvascular flow imaging
Time frame: 5 days post injury (+/- 2 days)
Measured by microvascular flow imaging
Time frame: 6 weeks post injury (+/- 1 week)
Measured by microvascular flow imaging
Time frame: 12 weeks post injury (+/- 1 week)
Measured by microvascular flow imaging
Time frame: 24 weeks post injury (+/- 1 week)
Measured by microvascular flow imaging
Oregon Health and Science University
Other
Evaluation of Lower Extremity Athletic Injuries and Response to Treatment Using Shear Wave Elastography and Micro-vascular Flow Imaging
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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