interACTION: A Portable Joint Function Monitoring and Training System for Remote Rehabilitation 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
- 38
- 试验地点
- 2
- 主要终点
- Value Was Evaluated as the Ratio of Change in the Activities of Daily Living Scale Score to the Costs of Rehabilitation.
研究概览
简要总结
The purpose of this study is to determine if home-based therapy with monitoring via telemedicine can overcome many barriers to compliance and improve rehabilitation. Patients undergoing total knee arthroplasty will be followed for 10 weeks during their outpatient physical therapy course. Subjects will undergo standard physical therapy or physical therapy paired with InterACTION for 10 weeks.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between ages 40 to 80 years of age;
- •Have undergone primary unilateral total knee arthroplasty;
- •Being referred for post-operative outpatient physical therapy;
- •Agree to and able to perform pre-defined exercises that they would normally perform in a physical rehabilitation program.
排除标准
- •Patients with BMI >40 at the time of surgery;
- •Individuals who are not free of any other co-disability or comorbidity that would specifically impede disallow or otherwise hinder performance of rehabilitation exercises;
- •Individuals who cannot physically receive or understand audio and visual feedback from the joint motion tracking system during or after performance of rehabilitation exercises;
- •Individuals who are discharged post-operatively to a skilled nursing facility instead of to their residence;
研究组 & 干预措施
Rehabilitation with InterACTION
After total knee arthroplasty, subjects will undergo physical therapy 1 time per week supplemented by home exercise program with InterACTION device.
干预措施: InterACTION (Device)
Standard Physical Therapy
After total knee arthroplasty, subjects will undergo standard of care physical therapy 2 times per week with standard home exercise program.
干预措施: Standard of Care Physical Therapy (Other)
结局指标
主要结局
Value Was Evaluated as the Ratio of Change in the Activities of Daily Living Scale Score to the Costs of Rehabilitation.
时间窗: 10 weeks
The value was calculated the ratio of the difference between the 10 week and baseline Activities of Daily Living Scale (ADLS) of the Knee Outcome Survey divided by the total charges for the physical therapy treatment sessions. The ADLS is a 14-item measure of symptoms and activity limitations for individuals with a variety of knee impairments. Items are scored from 0 to 4, and the total score is the sum of all the items divided by 70 and multiplied by 100. The ADLS score ranges from 0 to 100 with higher scores representing less symptoms and greater levels of activity. Higher ratio of the change in the ADLS score to the costs for rehabilitation represents greater value.
次要结局
- Number of Participants That Complied With Rehabilitation Program(10 weeks)
- Number of Subjects Satisfied With InterACTION Device(10 weeks)
- Performance Based Outcome Measures(10 weeks)
- Range of Motion (Extension)(baseline and 10 weeks)
- Range of Motion (Flexion)(baseline and 10 weeks)
研究者
James J. Irrgang
PhD, PT
University of Pittsburgh