New Model of Short-term Rehabilitation Exercise Training Using Digital Healthcare System in Patients With Total Knee Arthroplasty; Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Changes from Baseline Gait Speed
研究概览
简要总结
The study aims to examine the effect of short-term rehabilitation exercise support using digital healthcare system (Uincare homeplus) in the patients with total knee arthroplasty. The study is a two-arm prospective randomized controlled study comparing the effect of rehabilitation exercise digital healthcare system at home with conventional brochure-based home exercise. Gait speed (4-meter), Pain (using Numerical rating scale), knee joint range of motion (ROM), lower extremities motor power (using Manual muscle test), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Berg Balance Scale (BBS) and quality of life using EQ-5D-5L will be evaluation on enrollment, 3-weeks, 6-weeks, 12-weeks and 24-weeks after enrollment.
详细描述
Total knee arthroplasty is treatment of choice for knee degenerative arthritis patients who are unresponsive to non-operative management including medications and physical therapies. Total knee arthroplasty is an effective treatment enhancing the joint range of motion as well as reducing pain and correcting deformities which leads to better patient function with better quality of life. Current method of post-operative rehabilitation is home-based self rehabilitation using brochure, combined with one or two times of education at the hospital before discharge. Patients often find difficulty in doing rehabilitation by themselves at home without supervision which resulted in decreased compliance.
With development of technologies using multi-motion sensor and AR(augmented-reality) system, the investigators have developed a digital healthcare system(Uincare Homeplus) which can supplement patients' rehabilitation at home by giving them proper instructions as well as feedback. In this prospective randomized controlled study, the investigators aim to compare the efficacy of the newly-developed digital healthcare system with conventional rehabilitation program.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who had total knee arthroplasty
- •Patient who is discharged to home after surgery
排除标准
- •Patient who had previous history of high tibial osteotomy on the affected lower extremities.
- •Patient who had history of lower extremities joint revision arthroplasty in the past 6 months.
- •Patient who has severe comorbidity that inhibits exercise.
- •Patient who has major neurological deficits on the lower extremities.
- •Patient who cannot participate in post surgery rehabilitation
结局指标
主要结局
Changes from Baseline Gait Speed
时间窗: Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
Gait Speed is measured by the time required to walk 4-meters in plain indoor. Shorter time required to complete 4-meter walk means better gait function.
次要结局
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) on the affected knee(Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks)
- Range of Motion (ROM) on the affected knee(Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks)
- Numerical Rating Scale (NRS) on the affected knee(Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks)
- Manual Muscle Test (MMT) on the affected lower extremities(Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks)
- Berg Balance Scale (BBS)(Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks)
- Quality of Life using EQ-5D-5L(Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks)
研究者
Jae-Young Lim
Professor
Seoul National University Bundang Hospital