Pilot Efficacy Study of the Stendo Pulsating Suit in Patient With Leg Lymphoedema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- volume of the most affected leg
研究概览
简要总结
This study aims at evaluating the efficacy of the Stendo pulsating suit in patients with a leg lymphedema hospitalized for intensive Complex Decongestive Physiotherapy (CDP).
This study is a pilot controlled randomized study with two arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient with a primary or secondary lympedema clinically diagnosed (Stemmer Sign) of one or two legs.
- •Patient with a lympedema stage II (persistent) or III according to the classification of the International Society of Lymphoedema (ISL)
- •Patient aged 18 or more
排除标准
- •Patient with a severe heart, kidney or liver failure,
- •Patient with an advanced obstructive arterial disease
- •Patient with a recent and progressive deep venous thrombosis
研究组 & 干预措施
Standard intensive CDP
This arm is the controlled group ; patients in that group will undergo a current practice performed in the lymphology unit.
干预措施: Current intensive CDP (Other)
Stendo group
This arm contitutes the group where the Stendo pulsating suit sessions are investigated in the frame of the CDP in replacement of the pressotherapy sessions.
干预措施: intensive CDP where Stendo pulsating suit replaces pressotherapy (Other)
结局指标
主要结局
volume of the most affected leg
时间窗: baseline ; after 5 days intensive CDP
Change in % of the volume of the most affected leg according to disk model method
次要结局
- Quality of Life(baseline ; after 5 days intensive CDP)