Clinical trial NCT04511377: Rehabilitation Exercise Using Digital Healthcare System in Patients With Rotator Cuff Repair
Official title: New Model of Short-term Rehabilitation Exercise Training Using Digital Healthcare System in Patients With Rotator Cuff Repair; Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rotator Cuff Tears
Keywords: Rotator Cuff Repair
Post-Operative Rehabilitation
Digital Healthcare System
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Republic of Korea
First posted: 2020-08-13
Enrollment: 115
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline Simple Shoulder Test (SST) on the affected shoulder
timeFrame: Enrollment, 6-weeks, 12-weeks, 24-weeks
Secondary outcomes:
measure: Numerical Rating Scale (NRS) on the affected shoulder
timeFrame: Enrollment, 6-weeks, 12-weeks, 24-weeks
measure: Range of Motion (ROM) on the affected shoulder
timeFrame: Enrollment, 6-weeks, 12-weeks, 24-weeks
measure: Manual Muscle Test (MMT) on the affected arm
timeFrame: Enrollment, 6-weeks, 12-weeks, 24-weeks
measure: Disabilities of the Arm, Shoulder and Hand (DASH) on the affected arm
timeFrame: Enrollment, 6-weeks, 12-weeks, 24-weeks
measure: Shoulder Pain and Disability Index (SPADI) on the affected shoulder
timeFrame: Enrollment, 6-weeks, 12-weeks, 24-weeks
measure: Quality of Life using EQ-5D-5L
timeFrame: Enrollment, 6-weeks, 12-weeks, 24-weeks
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References:
citation: Chang WK, Lee JI, Hwang JH, Lim JY. Post-operative rehabilitation using a digital healthcare system in patients who had undergone rotator cuff repair: protocol for a single-center randomized controlled trial. Trials. 2022 Aug 17;23(1):667. doi: 10.1186/s13063-022-06648-4.