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

Seoul National University

Status: Unknown

Conditions: Rotator Cuff Tears

Treatments: Device: Rehabilitation using Digital Healthcare System (Uincare Homeplus); Other: Conventional Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04511377

B-2005/612-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 115 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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115 participants in 2 patient groups

Digital Healthcare System Rehabilitation

Experimental group

Description:

Rehabilitation using Uincare Homeplus

Treatment:

Device: Rehabilitation using Digital Healthcare System (Uincare Homeplus)

Conventional Rehabilitation

Active Comparator group

Description:

Rehabilitation using Brochure

Treatment:

Other: Conventional Rehabilitation