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

New Model of Short-term Rehabilitation Exercise Training Using Digital Healthcare System in Patients With Rotator Cuff Repair; Randomized Controlled Study

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.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Other: Conventional Rehabilitation; Device: Rehabilitation using Digital Healthcare System (Uincare Homeplus)

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 Type: Interventional
• Enrollment (Anticipated): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Recruiting
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Digital Healthcare System Rehabilitation; Rehabilitation using Uincare Homeplus	Device: 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.; Other Names: Uincare Homeplus
ACTIVE_COMPARATOR: Conventional Rehabilitation; Rehabilitation using Brochure	Other: Conventional Rehabilitation; Home-based self-rehabilitation using brochure for 12 weeks post surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Simple Shoulder Test (SST) on the affected shoulder	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.	Enrollment, 6-weeks, 12-weeks, 24-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale (NRS) on the affected shoulder	Evaluation of pain of the affected shoulder using numerical rating scale (0-10, with score 0 indicating no pain), higher scores mean worse outcome.	Enrollment, 6-weeks, 12-weeks, 24-weeks
Range of Motion (ROM) on the affected shoulder	Evaluation of change of ROM in the affected shoulder from baseline to 24 weeks	Enrollment, 6-weeks, 12-weeks, 24-weeks
Manual Muscle Test (MMT) on the affected arm	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.	Enrollment, 6-weeks, 12-weeks, 24-weeks
Disabilities of the Arm, Shoulder and Hand (DASH) on the affected arm	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.	Enrollment, 6-weeks, 12-weeks, 24-weeks
Shoulder Pain and Disability Index (SPADI) on the affected shoulder	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.	Enrollment, 6-weeks, 12-weeks, 24-weeks
Quality of Life using EQ-5D-5L	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.	Enrollment, 6-weeks, 12-weeks, 24-weeks

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Collaborators: Ministry of Health, Republic of Korea

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 30, 2020
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): March 31, 2023

Study Registration Dates

• First Submitted: August 9, 2020
• First Submitted That Met QC Criteria: August 11, 2020
• First Posted (ACTUAL): August 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 5, 2022
• Last Update Submitted That Met QC Criteria: January 4, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Post-Operative Rehabilitation; Digital Healthcare System; Rotator Cuff Repair
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: B-2005/612-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No