Effectiveness of an Interactive Virtual Telerehabilitation System in Patients After Total Knee Arthroplasty. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Active knee extension/flexion
研究概览
简要总结
The purpose of this clinical trial is to compare the effectiveness of a new interactive virtual telerehabilitation (IVT) system with the conventional program in the rehabilitation of patients after total knee arthroplasty.
详细描述
Patients are distributed into two treatment groups: 1) Group I (control): standard clinical protocol of TKA rehabilitation consisting of 1-hour sessions for 10 days; and 2) Group II (IVT): 1-hour IVT sessions for 10 days (5 sessions under a therapist's supervision to verify the absence of medical complications + 5 sessions performed at home). The IVT is an interactive virtual software-hardware platform that facilitates the development of remote rehabilitation therapy for multiple diseases. Patients receive information required to perform exercise and the therapist remotely monitors the patient's performance. For the purpose of this trial, the IVT system was designed for lower limb motor recovery in patients undergoing TKA.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post-TKA active range of motion: flexion 80º and extension -10º
- •ABsence of stiffness
- •Ability to walk with the use of a walking aid
- •Ability to read and understand Spanish
- •Ability to understand and accept the trial procedures and to sign an informed consent form in accordance with national legislation
排除标准
- •Sensory, cognitive and/or praxic impairment
- •Concomitant medical conditions that may influence the rehabilitation process
- •Discharge destination other than home
- •Patients with any local or systemic complication (e.g., surgical wound infection, suspicion of deep vein thrombosis…) in the three-month follow-up period
研究组 & 干预措施
Interactive Virtual Telerehabilitation
Rehabilitation by IVT
干预措施: Interactive Virtual Telerehabilitation (IVT) (Other)
Standard rehabilitation care
Standard care rehabilitation after total knee arthroplasty
干预措施: Standard care rehabilitation (Other)
结局指标
主要结局
Active knee extension/flexion
时间窗: Change from baseline to 2 weeks
Active knee extension/flexion measured by investigator
次要结局
- Muscle strength(Baseline to 2 weeks)
- Pain(Baseline to 2 weeks)
- Functional capacity(Baseline to 2 weeks)