Rehabilitation Exercise Using Digital Healthcare System in Patients With Rotator Cuff Repair
Primary Purpose
Rotator Cuff Tears
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rehabilitation using Digital Healthcare System (Uincare Homeplus)
Conventional Rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tears focused on measuring Rotator Cuff Repair, Post-Operative Rehabilitation, Digital Healthcare System
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
Sites / Locations
- Seoul National University Bundang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Digital Healthcare System Rehabilitation
Conventional Rehabilitation
Arm Description
Rehabilitation using Uincare Homeplus
Rehabilitation using Brochure
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Range of Motion (ROM) on the affected shoulder
Evaluation of change of ROM in the affected shoulder from baseline to 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.
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.
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.
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.
Full Information
NCT ID
NCT04511377
First Posted
August 9, 2020
Last Updated
January 4, 2022
Sponsor
Seoul National University Bundang Hospital
Collaborators
Ministry of Health, Republic of Korea
1. Study Identification
Unique Protocol Identification Number
NCT04511377
Brief Title
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
Ministry of Health, Republic of Korea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears
Keywords
Rotator Cuff Repair, Post-Operative Rehabilitation, Digital Healthcare System
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
115 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Digital Healthcare System Rehabilitation
Arm Type
Experimental
Arm Description
Rehabilitation using Uincare Homeplus
Arm Title
Conventional Rehabilitation
Arm Type
Active Comparator
Arm Description
Rehabilitation using Brochure
Intervention Type
Device
Intervention Name(s)
Rehabilitation using Digital Healthcare System (Uincare Homeplus)
Other Intervention Name(s)
Uincare Homeplus
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Rehabilitation
Intervention Description
Home-based self-rehabilitation using brochure for 12 weeks post surgery.
Primary Outcome Measure Information:
Title
Change from baseline Simple Shoulder Test (SST) on the affected shoulder
Description
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.
Time Frame
Enrollment, 6-weeks, 12-weeks, 24-weeks
Secondary Outcome Measure Information:
Title
Numerical Rating Scale (NRS) on the affected shoulder
Description
Evaluation of pain of the affected shoulder using numerical rating scale (0-10, with score 0 indicating no pain), higher scores mean worse outcome.
Time Frame
Enrollment, 6-weeks, 12-weeks, 24-weeks
Title
Range of Motion (ROM) on the affected shoulder
Description
Evaluation of change of ROM in the affected shoulder from baseline to 24 weeks
Time Frame
Enrollment, 6-weeks, 12-weeks, 24-weeks
Title
Manual Muscle Test (MMT) on the affected arm
Description
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.
Time Frame
Enrollment, 6-weeks, 12-weeks, 24-weeks
Title
Disabilities of the Arm, Shoulder and Hand (DASH) on the affected arm
Description
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.
Time Frame
Enrollment, 6-weeks, 12-weeks, 24-weeks
Title
Shoulder Pain and Disability Index (SPADI) on the affected shoulder
Description
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.
Time Frame
Enrollment, 6-weeks, 12-weeks, 24-weeks
Title
Quality of Life using EQ-5D-5L
Description
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.
Time Frame
Enrollment, 6-weeks, 12-weeks, 24-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jay-Young Lim, M.D., Ph. D
Phone
+82-31-787-7732
Email
drlim1@snu.ac.kr
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Young Lim, M.D., Ph.D.
Phone
+82-10-5390-0373
Email
drlim1@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Jae-Young Lim, M.D., Ph. D.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35978437
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.
Results Reference
derived
Learn more about this trial
Rehabilitation Exercise Using Digital Healthcare System in Patients With Rotator Cuff Repair
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