Effectiveness of New Interventional Approaches to Improve Physical Function Following Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- range of motion
研究概览
简要总结
The purpose of the study is to determine the effectiveness of new interventional approaches in the early postoperative phase following total knee arthroplasty (TKA). It is assumed that active training programs are more effective in improving physical function than the passive standard-of-care therapy.
详细描述
The major objectives of rehabilitation after TKA are the early regain of range of motion (ROM) and mobilization of the patient. Continuous passive motion (CPM) is frequently used as part of the postoperative care regime following TKA with the aim to increase knee joint mobility and improve postoperative recovery despite little conclusive scientific evidence. Conflicting research findings have generated an ongoing debate on its usage. As the greatest loss of function occurs in the first month following TKA, it is surprising that the ROM therapy during hospital stay is still carried out passively. A passive mobilization of the knee joint with CPM does not encourage the patients to actively participate in their rehabilitation. Research on the effectiveness of active ROM exercises added to standard physiotherapy during the short in-hospital period is lacking so far.The objective of this study is to compare the passive clinical standard therapy (CPM) with different active training programs (controlled active motion, CAM). It was hypothesised that the CAM therapies are more effective in improving physical function than the CPM therapy.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with knee osteoarthritis and scheduled for primary TKA
- •age: 50-80
排除标准
- •BMI > 40
- •musculoskeletal and neurological disorders that limit physical function
- •any planned further joint surgery within 6 months
- •substantial pain or functional limitation which make the patients unable to perform study procedures
研究组 & 干预措施
continuous passive motion (CPM)
干预措施: continuous passive motion (CPM) (Other)
controlled active motion (CAM I)
干预措施: controlled active motion (CAM I) (Other)
controlled active motion (CAM II)
干预措施: controlled active motion (CAM II) (Other)
结局指标
主要结局
range of motion
时间窗: change from baseline (before surgery) to discharge (9 days post surgery)
次要结局
- cognitive functioning(change from baseline (before surgery) to discharge (9 days after surgery))
- pain(change from baseline (before surgery) to discharge (9 days after surgery))
- physical activity(change from baseline (before surgery) to discharge (9 days after surgery))
- neuromuscular function(change from baseline (before surgery) to discharge (9 days after surgery))
- joint position sense(change from baseline (before surgery) to discharge (9 days after surgery))
- motor function(change from baseline (before surgery) to discharge (9 days after surgery))
- swelling(change from baseline (before surgery) to discharge (9 days after surgery))
- length of hospital stay(change from baseline (before surgery) to discharge (9 days after surgery))
- quality of life(change from baseline (before surgery) to discharge (9 days after surgery))
研究者
Anett Mau-Moeller
M.A.
University of Rostock