Efficacy of Kinesio® Tex Taping on Edema and Early Functional Outcome of Post Total Knee Replacement Patients: a Randomized-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Knee circumference
研究概览
简要总结
This study is designed to better understand the effect of Kinesio Taping applied using the Neurotaping technique on patients who underwent total knee arthroplasty surgery. Patients will be randomized in two groups: in the first group patients will follow a protocol of usual rehabilitation, while the second group will do the same but add the Kinesio Taping application. Main outcome will be the effect on edema, secondary outcome the effect on functionality after 13 days post surgery.
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
盲法说明
Randomization list has been already generated but will not be available to the recruiters to avoid allocation bias.
Statistician that will handle the data analysis will not know which group is the interventional and which group is the control.
We were not able to mask the using of tape to the patients or the investigators because it is an evident treatment.
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Program of total knee replacement;
- •Signing and accepting informed consent.
排除标准
- •pre-operative Barthel Index score < 70;
- •program of revision of total knee replacement;
- •grade III-IV heart failure;
- •grade III-IV kidney failure;
- •hypersensitive skin or intolerance to taping;
- •Active cutaneous infection or open skin lesion on the sites of taping positioning;
- •Body Mass Index > 34,9;
- •Pregnant women;
- •Not accepting informed consent;
- •Impossibility to follow usual rehabilitation treatment.
结局指标
主要结局
Knee circumference
时间窗: pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
Difference between pre-operative knee circumference and 13th post-operative day knee circumference expressed in cm
次要结局
- 10 meters walking test(pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day)
- Thigh circumference(pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day)
- Ankle circumference(pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day)
- Timed Up and Go test(pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day)
- Barthel Index(pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day)
- R0 measured using bioimpedance(pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day)
- Functional Independence Measure(pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day)
- Knee range of motion(pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day)
- Leg circumference(pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day)
- Pain Visual Analogue Scale(pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day)