Evaluation of Safety and Efficacy of ReHub in Patients Who Underwent Primary Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change in Active Knee Range of Motion (º)
研究概览
简要总结
This is a randomized, non-blinded, parallel assignment, clinical trial for the evaluation of safety and efficacy of ReHub, a telerehabilitation system made up of a cloud platform and an exercise kit with smart sensors, for performing rehabilitation exercises after a primary Total Knee Arthroplasty.
Primary TKA patients are allocated randomly to the control arm or the experimental arm with a 1:1 ratio. Both arms follow the usual rapid recovery protocol for TKA surgeries at Hospital Clínic de Barcelona, which includes discharge after 2-3 days from the surgery, the prescription of a daily plan of 5 exercises for autonomous rehabilitation and domiciliary visits by a physiotherapist starting approximately 2 weeks after the surgery. The experimental arm participants use ReHub to do their exercises instead of working independently and physiotherapists monitor their performance and adherence remotely.
Outcomes assessment is performed at hospital discharge (baseline), at stitch removal (2 weeks after baseline) and 2 weeks after stitch removal (4 weeks after baseline).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidates to primary TKA
- •Age from 18 to 75 years old
- •Ability to understand and accept the clinical study procedure and to sign an informed consent form
- •Good predisposition to the use of technology or cohabitation with someone that can give them technological support
- •Availability to attend the Hospital for control visits
- •Patient resides in the area of influence of Hospital Clínic de Barcelona
排除标准
- •Reluctance or inability to use technology
- •Any type of disability that could alter the homogeneity of the study
- •Sensory and/or cognitive impairment
- •Concomitant medical conditions that may influence the rehabilitation process
- •Any local or systemic complications after TKA surgery (e.g. surgical wound infection, suspicious of deep vein thrombosis)
结局指标
主要结局
Change in Active Knee Range of Motion (º)
时间窗: Baseline, 2 weeks and 4 weeks after discharge
Range of motion of the replaced knee without the aid of the outcomes assessor will be measured with a conventional goniometer.
次要结局
- Change in EuroQol-5D-5L (EQ-5D-5L) score(Baseline, 2 weeks and 4 weeks after discharge)
- Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score(Baseline, 2 weeks and 4 weeks after discharge)
- Change in the Timed Up-and-Go test score (s)(Baseline, 2 weeks and 4 weeks after discharge)
- Change in Quadriceps Strength (kg)(Baseline, 2 weeks and 4 weeks after discharge)
- Change in Hamstring Strength (kg)(Baseline, 2 weeks and 4 weeks after discharge)
- Change in Self-Reported Pain Level: Visual Analogue Scale(Baseline, 2 weeks and 4 weeks after discharge)
- Change in Passive Knee Range of Motion (º)(Baseline, 2 weeks and 4 weeks after discharge)
- Satisfaction with ReHub: System Usability Scale(4 weeks after discharge)