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临床试验/NCT04152590
NCT04152590已完成不适用

Hospital-home Linkage Short-term Rehabilitation Therapy Using Real-time Interactive Digital Healthcare System in Post Operation Patients With Breast Cancer; Pilot Study

JongIn Lee1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年10月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Range of motion of 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 pilot study. 20 breast cancer patients who underwent wide local excision-axillary lymph node diessection or modified radical 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 suffer difficulty in 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
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients who underwent breast cancer surgery (wide local excision-axillary lymph node dissection or modified radical 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 of 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 of affected shoulder

时间窗: Enrollment, 4 week, 8 week, 12 week

Evaluation of change of range of motion of the affected shoulder from baseline to 12 weeks

次要结局

  • Functional outcome(Enrollment, 4 week, 8 week, 12 week)
  • Quality of life of the patient with breast cancer(Enrollment, 4 week, 8 week, 12 week)
  • Quality of life of the patient(Enrollment, 4 week, 8 week, 12 week)
  • Numerical rating scale of affected shoulder(Enrollment, 4 week, 8 week, 12 week)

研究者

发起方
JongIn Lee
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

JongIn Lee

professor

Seoul St. Mary's Hospital

研究点 (1)

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