New Model of Short-term Rehabilitation Exercise Training Using Digital Healthcare System in Patients With Rotator Cuff Repair; Randomized Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rotator Cuff Tears
- Sponsor
- Seoul National University Bundang Hospital
- Enrollment
- 115
- Locations
- 1
- Primary Endpoint
- Change from baseline Simple Shoulder Test (SST) on the affected shoulder
- Last Updated
- 4 years ago
Overview
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.
Investigators
Jae-Young Lim
Professor
Seoul National University Bundang Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change from baseline Simple Shoulder Test (SST) on the affected shoulder
Time Frame: 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 Outcomes
- Manual Muscle Test (MMT) on the affected arm(Enrollment, 6-weeks, 12-weeks, 24-weeks)
- Shoulder Pain and Disability Index (SPADI) on the affected shoulder(Enrollment, 6-weeks, 12-weeks, 24-weeks)
- Disabilities of the Arm, Shoulder and Hand (DASH) on the affected arm(Enrollment, 6-weeks, 12-weeks, 24-weeks)
- Numerical Rating Scale (NRS) on the affected shoulder(Enrollment, 6-weeks, 12-weeks, 24-weeks)
- Range of Motion (ROM) on the affected shoulder(Enrollment, 6-weeks, 12-weeks, 24-weeks)
- Quality of Life using EQ-5D-5L(Enrollment, 6-weeks, 12-weeks, 24-weeks)