New Model of Short-term Rehabilitation Exercise Training Using Digital Healthcare System in Patients With Rotator Cuff Repair; Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Change from baseline Simple Shoulder Test (SST) on the affected shoulder
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 rotator cuff repair surgery. 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. Simple Shoulder Test (SST), Pain (using Numerical rating scale), shoulder range of motion (ROM), Disability of Arm, Shoulder and Hand (DASH), Shoulder Pain and Disability Index (SPADI), quality of life using EQ-5D will be evaluation on enrollment, 6-weeks, 12-weeks and 24-weeks after enrollment.
详细描述
Rotator cuff tear is one of the most common disorders affecting shoulder pain and disabilities of daily life. It is a disorder that can be caused by trauma, overuse, inappropriate usage of shoulder as well as degenerative change, which is increasing due to enlarged geriatric population. 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 aimed 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 rotator cuff repair surgery
- •Patient who is discharged to home after surgery
排除标准
- •Patient who has previous history of shoulder surgery on the affected shoulder
- •Patient who has severe neurological deficit or infection on the affected shoulder
- •Patient who has severe comorbidities (Ex: uncontrolled diabetes mellitus or rheumatoid arthritis) that inhibit affected shoulder rehabilitation
- •Patient who cannot participate rehabilitation program
结局指标
主要结局
Change from baseline Simple Shoulder Test (SST) on the affected shoulder
时间窗: Enrollment, 6-weeks, 12-weeks, 24-weeks
Simple Shoulder Test is a self-reported shoulder-specific questionnaire that measures functional limitations of the affected shoulder in patients with shoulder dysfunction. The SST consists of 12 questions with dichotomous (yes/ no) response options. score ranges from 0 to 100, higher score meaning better shoulder function.
次要结局
- Manual Muscle Test (MMT) on the affected arm(Enrollment, 6-weeks, 12-weeks, 24-weeks)
- Shoulder Pain and Disability Index (SPADI) on the affected shoulder(Enrollment, 6-weeks, 12-weeks, 24-weeks)
- Disabilities of the Arm, Shoulder and Hand (DASH) on the affected arm(Enrollment, 6-weeks, 12-weeks, 24-weeks)
- Numerical Rating Scale (NRS) on the affected shoulder(Enrollment, 6-weeks, 12-weeks, 24-weeks)
- Range of Motion (ROM) on the affected shoulder(Enrollment, 6-weeks, 12-weeks, 24-weeks)
- Quality of Life using EQ-5D-5L(Enrollment, 6-weeks, 12-weeks, 24-weeks)
研究者
Jae-Young Lim
Professor
Seoul National University Bundang Hospital