Hospital-home Linkage Short-term Rehabilitation Therapy Using Real-time Interactive Digital Healthcare System in Patients With Breast Cancer; 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 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 post-operative patients with breast cancer. This is prospective study. 100 breast cancer patients who underwent axillary lymph node diessection or breast reconstruction following mastectomy will be examined, and those with limited range of motion (ROM) of affected shoulder will be enrolled in the study. Shoulder ROM, Quick-DASH, pain evaluation with NRS, quality of life evaluation with FACT-B and EQ-5D will be evaluated on enrollment, 4-week, 8-week, and 12-weeks after enrollment.
详细描述
The limited range of motion (ROM) of the shoulder occur often after receiving breast cancer surgery, which may be due to post-operative pain, stiffness of shoulder girdle muscle, and etc. Due to this limited ROM, the patients may have difficulty with activities of daily life and quality of life may be reduced.
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 post-operative patients with breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Range of motion
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent breast cancer surgery (axillary lymph node dissection or breast reconstruction following mastectomy)
- •Limited active/passive range of motion of the affected shoulder (Flexion <160' or Abduction <160')
- •post-operative day not exceeding 8 week
- •Patients who agreed informed consent
排除标准
- •Bilateral breast cancer surgery
- •Patients with shoulder pain and limited ROM before breast cancer surgery
- •Those unable to perform exercise due to general deconditioning
- •Those with communication difficulty
结局指标
主要结局
Range of motion in affected shoulder
时间窗: Enrollment, 4 week, 8 week, 12 week
Evaluation of change in range of motion of the affected shoulder from baseline to 12 weeks
次要结局
- Quality of life in the patient with breast cancer (1)(Enrollment, 4 week, 8 week, 12 week)
- Quality of life in the patient with breast cancer (2)(Enrollment, 4 week, 8 week, 12 week)
- Functional outcome (Quick Disability of Arm, Shoulder, Hand)(Enrollment, 4 week, 8 week, 12 week)
- Numerical rating scale of affected shoulder(Enrollment, 4 week, 8 week, 12 week)
研究者
JiHye Hwang
Professor
Samsung Medical Center