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Real-time Interactive Digital Healthcare System in Post Operation Patients With Breast Cancer; Pilot Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04152590
Enrollment
20
Registered
2019-11-05
Start date
2019-10-21
Completion date
2020-04-27
Last updated
2020-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Rehabilitation

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.

Interventions

DEVICEUincare

Interactive digital healthcare system

Sponsors

JongIn Lee
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Range of motion of affected shoulderEnrollment, 4 week, 8 week, 12 weekEvaluation of change of range of motion of the affected shoulder from baseline to 12 weeks

Secondary

MeasureTime frameDescription
Numerical rating scale of affected shoulderEnrollment, 4 week, 8 week, 12 weekEvaluation of pain of the affected shoulder using numerical rating scale (0-10, with score 0 indicating no pain)
Functional outcomeEnrollment, 4 week, 8 week, 12 weekEvaluation of shoulder function using Quick DASH
Quality of life of the patient with breast cancerEnrollment, 4 week, 8 week, 12 weekEvaluation of quality of life using FACT-B
Quality of life of the patientEnrollment, 4 week, 8 week, 12 weekEvaluation of quality of life using EQ-5D

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026