Randomized Study of the KinexConnect Telerehabilitation System Versus Outpatient Physical Therapy After Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in the Timed up and Go (TUG) Test score
研究概览
简要总结
A randomized, single-blind study comparing telerehabilitation at home with continuous passive motion (CPM) and a tablet-based patient engagement application (KinexConnect) versus traditional outpatient physical therapy (PT) following total knee arthroplasty (TKA).
详细描述
The Randomized Study of the KinexConnect Telerehabilitation System is a 1:1 randomized, single-blind, prospective cohort study to be conducted at one investigational site in the United States. The study compares at-home telerehabilitation system versus traditional outpatient PT following total knee arthroplasty (TKA). The telerehabilitation system involves a tablet-enabled patient engagement application, the KinexConnect App, to be used in conjunction with a continuous passive motion (CPM) machine.
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)
盲法说明
All TUG and RoM assessments will be performed by trained physician assistants who will remain blinded to allocation throughout the study
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Planned for a primary unilateral TKA.
- •At least 21 years of age.
- •Capable of understanding the study requirements and giving written informed consent.
- •Willing and able to comply with either therapy program.
- •Has easy access to caregiver support.
排除标准
- •Active range-of-motion (ARoM) < 80 degrees in target knee.
- •Unable to read and write in English.
- •Lack of email capability to receive recovery trend information.
- •Previous knee intervention in target knee.
- •Previous knee joint infection in either knee.
- •Received a revision TKA (opposite knee).
- •Planned for bilateral TKA.
- •Self-reported pregnancy.
- •Reason for arthroplasty being for the treatment of fracture, infection or malignancy.
- •Other physical or mental impairments or medical conditions that may affect ability to complete therapy as prescribed.
- •Unwilling to participate.
结局指标
主要结局
Change in the Timed up and Go (TUG) Test score
时间窗: 1 year
The TUG score is the measurement of time for a person to rise from a standard armchair (seat height 46 cm), walk 3 meters, turn, walk back to the chair, and sit down as quickly as possible. The mean scores for patients in both arms are derived and compared against each other. Closer the trial arm mean is to the control arm mean, the better.
Economic Benefit
时间窗: 1 year
Expenses associated with rehabilitation after surgery will be based on costs associated with CPM rental fees and outpatient physical therapy visits. Estimates will be applied wherever actual expense data is not available.
次要结局
- Change in Passive Range of Motion (PRoM)(3 months and 6 months)
- Change in Pain as measured by the Verbal Descriptive Scale (VDS)(3 months and 1 year)
- Change in Active Range of Motion (ARoM)(3 months and 6 months)
- Change in the New Knee Society Score (NKSS) - Patient Satisfaction and Expectation(3 months and 1 year)
- Change in the Knee Osteoarthritis Outcome Score (KOOS)(3 months and 1 year)