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

Not Applicable

• Conditions: Rotator Cuff Tears
• Interventions: Device: Rehabilitation using Digital Healthcare System (Uincare Homeplus); Other: Conventional Rehabilitation

• Registration Number: NCT04511377
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2020-07-30
• Study First Submitted: 2020-08-09
• Study First Submitted QC: 2020-08-11
• Study First Posted: 2020-08-13
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-04
• Last Update Posted: 2022-01-05
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 115

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital Healthcare System Rehabilitation	Rehabilitation using Digital Healthcare System (Uincare Homeplus)	Rehabilitation using Uincare Homeplus
Conventional Rehabilitation	Conventional Rehabilitation	Rehabilitation using Brochure

Primary Outcome Measures

Name	Time	Method
Change from baseline Simple Shoulder Test (SST) on the affected shoulder	Enrollment, 6-weeks, 12-weeks, 24-weeks	Simple Shoulder Test is a self-reported shoulder-specific questionnaire that measures functional limitations of the affected shoulder in patients with shoulder dysfunction. The SST consists of 12 questions with dichotomous (yes/ no) response options. score ranges from 0 to 100, higher score meaning better shoulder function.

Secondary Outcome Measures

Name	Time	Method
Manual Muscle Test (MMT) on the affected arm	Enrollment, 6-weeks, 12-weeks, 24-weeks	Evaluation of change of MMT in the affected arm from baseline to 24 weeks Upper extremities MMT ranges from 0-25, higher scoring meaning better outcome.
Shoulder Pain and Disability Index (SPADI) on the affected shoulder	Enrollment, 6-weeks, 12-weeks, 24-weeks	The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities.; Overall total scores range from 0 to 130 with higher score indicating more shoulder dysfunction.
Disabilities of the Arm, Shoulder and Hand (DASH) on the affected arm	Enrollment, 6-weeks, 12-weeks, 24-weeks	The DASH is a 30-item self-report questionnaire designed to assess musculoskeletal disorders of the upper limb. The score ranges from 0 (no disability) to 100 (most severe disability) with higher score meaning worse outcome.
Numerical Rating Scale (NRS) on the affected shoulder	Enrollment, 6-weeks, 12-weeks, 24-weeks	Evaluation of pain of the affected shoulder using numerical rating scale (0-10, with score 0 indicating no pain), higher scores mean worse outcome.
Range of Motion (ROM) on the affected shoulder	Enrollment, 6-weeks, 12-weeks, 24-weeks	Evaluation of change of ROM in the affected shoulder from baseline to 24 weeks
Quality of Life using EQ-5D-5L	Enrollment, 6-weeks, 12-weeks, 24-weeks	Evaluation of quality of life using EQ-5D-5L. This scale is numbered from -0.066 to 0.904. lower value means worse quality of life.

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of