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
1 other identifier
interventional
115
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 30, 2020
CompletedFirst Submitted
Initial submission to the registry
August 9, 2020
CompletedFirst Posted
Study publicly available on registry
August 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedJanuary 5, 2022
January 1, 2022
2.4 years
August 9, 2020
January 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
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
Manual Muscle Test (MMT) on the affected arm
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
Shoulder Pain and Disability Index (SPADI) on the affected shoulder
Enrollment, 6-weeks, 12-weeks, 24-weeks
- +1 more secondary outcomes
Study Arms (2)
Digital Healthcare System Rehabilitation
EXPERIMENTALRehabilitation using Uincare Homeplus
Conventional Rehabilitation
ACTIVE COMPARATORRehabilitation using Brochure
Interventions
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.
Home-based self-rehabilitation using brochure for 12 weeks post surgery.
Eligibility Criteria
You may qualify if:
- Patient who had rotator cuff repair surgery
- Patient who is discharged to home after surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Related Publications (1)
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.
PMID: 35978437DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 9, 2020
First Posted
August 13, 2020
Study Start
July 30, 2020
Primary Completion
December 31, 2022
Study Completion
March 31, 2023
Last Updated
January 5, 2022
Record last verified: 2022-01