Establishing Guidelines for Manual Lymphatic Drainage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change in The L-dex (Lymphedema Index).
研究概览
简要总结
The purpose of this study is to establish optimal guidelines for Manual Lymphatic Drainage in participants with lower extremity lymphedema.
详细描述
To determine if there is a difference in L-Dex Score and Segmental Limb Volume in participants with lower extremity lymphedema as measured in liters by the SOZO machine between participants who receive Manual Lymphatic Drainage (MLD) techniques utilizing light tactile pressure with 5-10 mmHg without skin stretch versus medium tactile pressure of 11-20 mmHg and medium skin stretch with therapist in a stationary position, versus firm tactile pressure (> 21 mmHg) and maximal skin stretch with therapist weight shift.
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adults between the age of 30 - 75 years
- •Lower extremity lymphedema
排除标准
- •Pregnant women
- •Participants who are unable to stand independently for up to 2 mins
- •Participants who cannot make their own decisions
- •Participants undergoing cancer treatment
- •Participants with an Infection (active cellulitis)
- •Participants with a known Iodine Allergy
- •Participants who weigh more than 375 lbs
- •Participants with cardiac arrhythmias or implanted electronic equipment
- •Participants who have undergone joint replacement in involved extremity
- •Participants with cardiac insufficiency
结局指标
主要结局
Change in The L-dex (Lymphedema Index).
时间窗: 18 months
The L-DEX score represents the difference in the amount of extracellular fluid in an at-risk limb compared to an unaffected limb.
次要结局
- Change in Basal Metabolic Rate in kg/m^2(18 months)
- Change in Skeletal Muscle Mass in lbs(18 Months)
- Change in Fat Mass in lbs(18 Months)
- Change in Total body weight in liters(18 Months)
- Change in Extracellular Fluid in liters(18 months)
- Change in Intracellular Fluid in liters(18 Months)
- Change in Free Fat Mass in lbs(18 Months)
- Change in Basal Metabolic Rate (BMR) in lbs(18 Months)