Hospital-home Linkage Short-term Rehabilitation Therapy Using Real-time Interactive Digital Healthcare System in Frozen Shoulder; Randomized Controlled Trial, Assessor Blinding, Multi-center Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Range of motion (ROM) in affected shoulder
研究概览
简要总结
This study aims to examine the effect of hospital-home linkage short-term rehabilitation therapy using real-time interactive digital healthcare system (Uincare Homeplus) in frozen shoulder. This is prospective randomized controlled trial and multi-center study. 100 frozen shoulder who diagnosed with limited range of motion in 2 more plane of flexion, abduction, external rotation of affected shoulder. Shoulder range of motion (ROM), Shoulder Pain and Disability Index (SPADI), pain evaluation with Numeral Rating Scale (NRS), quality of life evaluation with Short Form (SF)-36 Health Survey and EQ-5D-5L, activity daily living (ADL) evaluation with Canadian Occupational Performance Measure (COPM) will be evaluated on enrollment, 4-week, 8-week, 12-weeks, 18-weeks, and 24 weeks after enrollment.
详细描述
The frozen shoulder is a disease in which severe pain and limited range of motion of the shoulder occur as an inflammatory change occurs in the articular capsular surrounding the shoulder joint. As a result, it has caused limitation in daily life movement.
Uincare Homeplus is software manufactured in Korea, which uses infrared, kinect camera and motion capture technology to track 3D motion of the patients' articulation. Using this technology, the patients can receive feedback of their motion immediately.
The objective of the study is to examine the effect of hospital-home linkage short-term rehabilitation therapy using real-time interactive digital healthcare system (Uincare Homeplus) in frozen shoulder.
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
Range of motion
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Limited passive range of motion of the affected shoulder in 2 more plane (flexion < 150˚, abduction <150˚, external rotation < 60˚)
排除标准
- •Bilateral frozen shoulder
- •Secondary frozen shoulder caused by trauma (shoulder fracture, dislocation), or/and inflammatory disease(rheumatoid arthritis)
- •Those unable to perform exercise due to general deconditioning
- •Those with communication difficulty
结局指标
主要结局
Range of motion (ROM) in affected shoulder
时间窗: Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks
Evaluation of change of ROM in the affected shoulder from baseline to 12 weeks
次要结局
- Numerical rating scale (NRS) of affected shoulder(Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks)
- Quality of life in the patients with frozen shoulder using EQ-5D-5L(Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks)
- Quality of life in the patients with frozen shoulder using Short form -36 (SF36)(Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks)
- Functional outcome in patients with frozen shoulder using Shoulder Pain and Disability Index (SPADI)(Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks)
- Activities of Daily Living of the patients with frozen shoulder using Canadian Occupational Performance Measure (COPM)(Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks)
研究者
JiHye Hwang
Professor
Samsung Medical Center