Evaluation of Lower Extremity Athletic Injuries and Response to Treatment Using Shear Wave Elastography and Micro-vascular Flow Imaging
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 9
- 试验地点
- 4
- 主要终点
- kPa
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
All SWE and MFI images are evaluated for quality and analyzed by qualified study physicians that are blinded to the clinical data. The analysis includes but is not limited to reading images, identifying the regions of interest, and making measurements. Clinical data will then be reviewed to validate the clinical diagnosis.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects age 18 - 89 years;
- •Able to sign an informed consent document;
- •Suspected MSK injury of the lower extremity (i.e. hamstring injuries and soft tissue injuries involving the ankle).
排除标准
- •Prior fasciotomy of same limb;
- •Hemodialysis grafts of involved extremity;
- •Extremity wounds preventing ultrasound imaging.
结局指标
主要结局
kPa
时间窗: 24 weeks post injury (+/- 1 week)
Tissue stiffness measured by shear wave elastography
Presence of blood flow
时间窗: 24 weeks post injury (+/- 1 week)
Measured by microvascular flow imaging
次要结局
未报告次要终点
研究者
Kenton W. Gregory
Principal Investigator
Oregon Health and Science University