Smart Kneebrace for Continuous Monitoring of Joint Angles During Rehabilitation After Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- The change of postoperative joint angles
研究概览
简要总结
This study aims to investigate the effect of Smart Kneebrace use for osteoarthritis patients after total knee arhtroplasty (TKA) on post-operative performance.
详细描述
This is a single-center, open-label randomized controlled clinical trail. A total of 60 participants will receive total knee arthroplasty, who will be randomly assigned into experiment or control group. Smart Kneebrace will be used for the patients during the rehabilitation for the patients in experiment group, while the patients in the control group will not receive such a smart kneebrace. Postoperative joint angles as well as visual analog scale pain score, the Western Ontario and McMaster Universities Osteoarthritis Index knee society score will be estimated before operation and at 6/12 weeks after operation.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ready to receive single-side TKA
排除标准
- •contraindication of surgery
- •self-reported diseases that cause lower limb disability (for example, cerebrovascular disease especially stroke)
研究组 & 干预措施
Smart Kneebrace
Smart Kneebrace with a smart phone app will be used during the rehabilitation after surgery for three months
干预措施: Smart Kneebrace with a smart phone app (Device)
without Smart Kneebrace
regular rehabilitation procedure will be applied after surgery
干预措施: regular rehabilitation procedure (Other)
结局指标
主要结局
The change of postoperative joint angles
时间窗: before operation and 6/12 weeks after operation
Patients in both groups will wear the smart kneebrace by which the range of motion of the knee joint can be calculated.
次要结局
- The change of knee pain.(before operation and 6/12 weeks after operation)
- The change of knee symptoms.(before operation and 6/12 weeks after operation)
研究者
Yifan Chen
Clinical professor ofarthritis clinic and research center
Peking University People's Hospital