Value of Continuous Passive Motion in Rehabilitation After Total Knee Replacement - A Prospective Randomized Controlled Multicenter Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 175
- 试验地点
- 2
- 主要终点
- Staffelstein Score
研究概览
简要总结
Immediate rehabilitation after total knee arthroplasty (TKA) differs in terms of volume, intensity but also type of treatment. Continuous passive motion after TKA is so far only investigated for replacing physiotherapy. This study is conducted to investigate CPM when it partially replaces group physiotherapy in terms of functional and patient-reported outcomes.
详细描述
The aim of this study is to analyze the value (knee function, pain, and quality of life) of continuous passive motion (CPM) after total knee replacement (TKR), when it partially replaces group physiotherapy (PT) in inpatient rehabilitation to save human resources. Patients are randomized to CPM group, consisting of 3 daily sessions of 20 minutes each, or to group PT, consisting of 25 minutes physiotherapy in groups 5 days weekly. Multimodal rehabilitation does not differ for both groups throughout the 3-week rehabilitation stay.
Primary outcome is the Staffelstein Score, German standard score in rehabilitation. Secondary outcomes are Oxford Knee Score (OKS), active and passive range of motion (ROM), and pain on visual analogue scale (VAS). Return to work is assessed by post-operative days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Total knee arthroplasty because of knee osteoarthritis
- •Inpatient rehabilitation in participating clinics
排除标准
- •Pregnancy
- •Not able to give informed consent
- •Psychological disorders
- •Body weight > 150 kg
- •Hip range of motion < 50°
结局指标
主要结局
Staffelstein Score
时间窗: baseline (t0) and 3 weeks later (t1)
A maximum score of 120 points is possible including 3 sub dimensions with a maximum score of 40 points each. Sub dimensions consist of pain, activities of daily life (ADL), and ROM. The Staffelstein Score is assessed by a professional investigator. Higher scores indicated better results.
次要结局
- Visual Analogue Scale (VAS)(baseline (t0), 10 days after baseline (t1), 3 weeks after baseline (t2))
- Return to work(baseline (t0), 4 months after baseline (t3))
- Oxford Knee Score (OKS)(baseline (t0), 10 days after baseline (t1), 3 weeks after baseline (t2), 4 months after baseline (t3))
- Range of motion (ROM)(baseline (t0), 10 days after baseline (t1), 3 weeks after baseline)
研究者
Erol Gercek
Univ.-Prof. Dr. med.
Johannes Gutenberg University Mainz