Rehabilitation Exercise Using Digital Healthcare System in Patients With Rotator Cuff Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-30

Study Completion Date

2023-03-31

Brief Summary

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The study aims to examine the effect of short-term rehabilitation exercise support using digital healthcare system (Uincare homeplus) in the patients with rotator cuff repair surgery. The study is a two-arm prospective randomized controlled study comparing the effect of rehabilitation exercise digital healthcare system at home with conventional brochure-based home exercise. Simple Shoulder Test (SST), Pain (using Numerical rating scale), shoulder range of motion (ROM), Disability of Arm, Shoulder and Hand (DASH), Shoulder Pain and Disability Index (SPADI), quality of life using EQ-5D will be evaluation on enrollment, 6-weeks, 12-weeks and 24-weeks after enrollment.

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Detailed Description

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Rotator cuff tear is one of the most common disorders affecting shoulder pain and disabilities of daily life. It is a disorder that can be caused by trauma, overuse, inappropriate usage of shoulder as well as degenerative change, which is increasing due to enlarged geriatric population. Current method of post-operative rehabilitation is home-based self rehabilitation using brochure, combined with one or two times of education at the hospital before discharge. Patients often find difficulty in doing rehabilitation by themselves at home without supervision which resulted in decreased compliance.

With development of technologies using multi-motion sensor and AR(augmented-reality) system, the investigators have developed a digital healthcare system(Uincare Homeplus) which can supplement patients' rehabilitation at home by giving them proper instructions as well as feedback.

In this prospective randomized controlled study, the investigators aimed to compare the efficacy of the newly-developed digital healthcare system with conventional rehabilitation program.

Conditions

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Rotator Cuff Tears

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Digital Healthcare System Rehabilitation

Rehabilitation using Uincare Homeplus

Group Type EXPERIMENTAL

Rehabilitation using Digital Healthcare System (Uincare Homeplus)

Intervention Type DEVICE

Uincare Homeplus is a device using infrared, kinect camera and motion capture technology to track 3D motion of the patients' posture and joint articulations. It also has embedded exercise training software dedicated to rotator cuff repair post-op rehabilitation at home.

Home-based self-rehabilitation using brochure for 6 weeks post surgery (same as the active comparator)

Home-based self-rehabilitation using digital healthcare system(Uincare Homeplus) for 6 to 12 weeks post surgery.

Conventional Rehabilitation

Rehabilitation using Brochure

Group Type ACTIVE_COMPARATOR

Conventional Rehabilitation

Intervention Type OTHER

Home-based self-rehabilitation using brochure for 12 weeks post surgery.

Interventions

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Rehabilitation using Digital Healthcare System (Uincare Homeplus)

Uincare Homeplus is a device using infrared, kinect camera and motion capture technology to track 3D motion of the patients' posture and joint articulations. It also has embedded exercise training software dedicated to rotator cuff repair post-op rehabilitation at home.

Home-based self-rehabilitation using brochure for 6 weeks post surgery (same as the active comparator)

Home-based self-rehabilitation using digital healthcare system(Uincare Homeplus) for 6 to 12 weeks post surgery.

Intervention Type DEVICE

Conventional Rehabilitation

Home-based self-rehabilitation using brochure for 12 weeks post surgery.

Intervention Type OTHER

Other Intervention Names

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Uincare Homeplus

Eligibility Criteria

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Inclusion Criteria

* Patient who had rotator cuff repair surgery
* Patient who is discharged to home after surgery

Exclusion Criteria

* Patient who has previous history of shoulder surgery on the affected shoulder
* Patient who has severe neurological deficit or infection on the affected shoulder
* Patient who has severe comorbidities (Ex: uncontrolled diabetes mellitus or rheumatoid arthritis) that inhibit affected shoulder rehabilitation
* Patient who cannot participate rehabilitation program

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No