Validation of Wearable Sensors to Monitor Tissue Hydration and Stiffness in Patients With Lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Tissue Hydration Score Recorded from the Tissue Hydration Sensor
研究概览
简要总结
The goal of this clinical trial in adult patients diagnosed with upper extremity lymphedema is to test the safety and effectiveness of small, wearable sensors that may be able to measure lymphedema. The main questions this study aims to answer are:
- Do these sensors detect lymphedema?
- If so, how accurate are these wearable sensors?
Participants will complete one in-person measurement session and one phone call with study staff 14 days after the measurement session to check-in on the participant's well-being.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of unilateral lymphedema that affects the upper extremity (UE).
- •Patients previously diagnosed with non-metastatic cancer.
- •Adults 18 years of age and older.
排除标准
- •Patients with history of lymphatic surgery.
- •Patients with implantable devices (e.g., pacemaker, pacemaker/defibrillator, intrathecal pump, joint replacements, etc.) or any other device deemed unsafe by the treating investigator.
- •Patients with an amputation involving the upper extremity.
- •Patients with known allergies to adhesives - including silicone adhesives.
- •Patients with the following comorbidities: diabetes, congestive heart failure, peripheral vascular disease, irradiated upper extremity skin, psoriasis, atopic dermatitis, open wounds/skin breakdown.
结局指标
主要结局
Tissue Hydration Score Recorded from the Tissue Hydration Sensor
时间窗: From enrollment to the end of the measurement session (appx. 3 hours)
This score will determine whether or not fluid associated with lymphedema is detected when compared to previously validated measures (bioimpedance spectroscopy and tissue dielectric constant). This is a continuous ratio level of measurement.
Tissue Stiffness Score from the Tissue Stiffness Sensor
时间窗: From enrollment to the end of the measurement session (appx. 3 hours)
This score will determine whether or not tissue affected by lymphedema can yield is detected when compared to a comparable clinical measurement device using Young's Modulus. This is a continuous ratio level of measurement.
次要结局
- Bioimpedance spectroscopy (BIS) L-Dex score(Three hours)
- Tissue Dielectric Constant (TDC)(From enrollment to the end of the measurement session (appx. 3 hours))
- Volume of the Upper Extremities(Three hours)
研究者
Ann Marie Flores
Associate Professor at Northwestern University, Department of Physical Therapy and Human Movement Sciences, Director of Cancer Rehabilitation Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Director of Cancer Rehabilitation Stud
Northwestern University