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Clinical Trials/NCT04152590
NCT04152590CompletedNot Applicable

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 site in 1 country20 target enrollmentStarted: October 21, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
Range of motion of affected shoulder

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
30 Years to 70 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Range of motion of affected shoulder

Time Frame: Enrollment, 4 week, 8 week, 12 week

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

Secondary Outcomes

  • 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)

Investigators

Sponsor
JongIn Lee
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

JongIn Lee

professor

Seoul St. Mary's Hospital

Study Sites (1)

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