Rotator Cuff TearsNCT04511377
Rehabilitation Exercise Using Digital Healthcare System in Patients With Rotator Cuff Repair
A study testing Rehabilitation using Digital Healthcare System (Uincare Homeplus) and Conventional Rehabilitation in people with Rotator Cuff Tears, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Rehabilitation using Digital Healthcare System (Uincare Homeplus) and Conventional Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jul 2020to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who had rotator cuff repair surgery
- Patient who is discharged to home after surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Jae-Young Lim, M.D., Ph.D., +82-10-5390-0373, drlim1@snu.ac.kr
Jae-Young Lim, M.D., Ph. D.
About this study
Official title: 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.
Read the 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.
- Conditions
- Rotator Cuff Tears
- Being tested
- Rehabilitation using Digital Healthcare System (Uincare Homeplus), Conventional Rehabilitation
- Keywords
- Rotator Cuff Repair, Post-Operative Rehabilitation, Digital Healthcare System
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation using Digital Healthcare System (Uincare Homeplus)Device
Also called 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.
Conventional RehabilitationOther
Home-based self-rehabilitation using brochure for 12 weeks post surgery.
| Study group | Role | What they receive |
|---|---|---|
| Digital Healthcare System Rehabilitation | Experimental | Rehabilitation using Uincare Homeplus Receives: Device: Rehabilitation using Digital Healthcare System (Uincare Homeplus) |
| Conventional Rehabilitation | Active comparator | Rehabilitation using Brochure Receives: Other: Conventional Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Enrollment, 6-weeks, 12-weeks, 24-weeks
Secondary outcomes (6)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Enrollment, 6-weeks, 12-weeks, 24-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start30 Jul 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Republic of Korea
- Responsible party
- Principal investigator, Jae-Young Lim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511377
- Sponsor's protocol ID
- B-2005/612-001
- Status last verified
- Jan 2022
- First submitted
- 9 Aug 2020
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 35978437
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Model of Short-term Rehabilitation Exercise Training Using Digital Healthcare System in Patients With Rotator Cuff Repair; Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04511377
- Acronym / sponsor ID
- B-2005/612-001
- Conditions
- Rotator Cuff Tears
- Keywords
- Rotator Cuff Repair, Post-Operative Rehabilitation, Digital Healthcare System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, Republic of Korea
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Healthcare System Rehabilitation | Experimental | Device: Rehabilitation using Digital Healthcare System (Uincare Homeplus)Rehabilitation using Uincare Homeplus |
| Conventional Rehabilitation | Active comparator | Other: Conventional RehabilitationRehabilitation using Brochure |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient who had rotator cuff repair surgery
- Patient who is discharged to home after surgery
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation using Digital Healthcare System (Uincare Homeplus)Also: Uincare HomeplusUincare 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. | Device | Digital Healthcare System Rehabilitation |
| Conventional RehabilitationHome-based self-rehabilitation using brochure for 12 weeks post surgery. | Other | Conventional Rehabilitation |
Primary outcome
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.
6 secondary outcomes
Numerical Rating Scale (NRS) on the affected shoulder
Time frame: Enrollment, 6-weeks, 12-weeks, 24-weeks
Range of Motion (ROM) on the affected shoulder
Time frame: Enrollment, 6-weeks, 12-weeks, 24-weeks
Manual Muscle Test (MMT) on the affected arm
Time frame: Enrollment, 6-weeks, 12-weeks, 24-weeks
Disabilities of the Arm, Shoulder and Hand (DASH) on the affected arm
Time frame: Enrollment, 6-weeks, 12-weeks, 24-weeks
Shoulder Pain and Disability Index (SPADI) on the affected shoulder
Time frame: Enrollment, 6-weeks, 12-weeks, 24-weeks
Quality of Life using EQ-5D-5L
Time frame: Enrollment, 6-weeks, 12-weeks, 24-weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Derived from this study: PubMed 35978437Chang 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.
- Individual participant dataSharing planned: Undecided
Related trials for Rotator Cuff Tears
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Not yet recruiting
Voll Non-Degradable Shoulder Spacer FIH Study
Massive Rotator Cuff Tears, Massive Rotator Cuff Tear
Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Orthopedics, Traumatology
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation using Digital Healthcare System (Uincare Homeplus) and Conventional Rehabilitation in people with Rotator Cuff Tears, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jay-Young Lim, M.D., Ph. D (+82-31-787-7732, drlim1@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Simple Shoulder Test (SST) on the affected shoulder (time frame: Enrollment, 6-weeks, 12-weeks, 24-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04511377, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2022.