NCT04821440已完成不适用
A 3D Tablet Sensor Approach to the Measurement of an Upper and Lower Limb Volume in the Monitoring of a Lymphedema
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 3
- 主要终点
- Accuracy of a 3D sensor for lymphedema volumetry
研究概览
简要总结
Up to now, the diagnosis of lymphedema remains hard and delayed. It suffers from many limitations such as lack of coordination and formation of the health-care network. The diversity of used tools is another obstacle because all provided solutions on the market are either costless with poor accuracy, or highly expensive but with excellent accuracy. Therefore, we decided to evaluate an affordable and open-source 3D iPad sensor sharing the same technology used in Kinect sensors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Unilateral lymphedema
排除标准
- •Minor patient,
- •Bilateral lymphedema,
- •Trophic disorders: Acute or recent skin infection (<1 month after the end of antibiotic therapy), unhealed wounds.
- •Predictable difficulties in carrying out the measurements due to the patient's physical limitations (maintenance of orthostatic or sitting position <5 minutes)
- •Single or bilateral edema with a different etiology than lymphedema.
结局指标
主要结局
Accuracy of a 3D sensor for lymphedema volumetry
时间窗: One hour
Intra-class correlation coefficient (ICC) Mean bias and limits of agreement (LOA) derived from the Blant-Altman diagram Mean bias and limits of agreement (LOA) derived from the Blant-Altman diagram
次要结局
- Reproducibility of measurements made with a 3D sensor for lymphedema volumetry(One hour)
研究者
研究点 (3)
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