Frozen ShoulderNCT04316130
Real-time Interactive Digital Healthcare System in Frozen Shoulder; Randomized Controlled Trial
A study testing Uincare Homeplus and Brochure in people with Frozen Shoulder, run by Samsung Medical Center at 2 sites in South Korea.
Trial summary
This study aims to examine the effect of hospital-home linkage short-term rehabilitation therapy using real-time interactive digital healthcare system (Uincare Homeplus) in frozen shoulder. This is prospective randomized controlled trial and multi-center study. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- Uincare Homeplus and Brochure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 1 Mar 2020to 31 Dec 2021
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Limited passive range of motion of the affected shoulder in 2 more plane (flexion < 150˚, abduction <150˚, external rotation < 60˚)
Who cannot join
- Bilateral frozen shoulder
- Secondary frozen shoulder caused by trauma (shoulder fracture, dislocation), or/and inflammatory disease(rheumatoid arthritis)
- Those unable to perform exercise due to general deconditioning
- Those with communication difficulty
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Samsung Medical Center
Seoul, Gangnam-gu, 06351
Department of rehabilitation, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea
Seoul, Seocho-gu, 06591
About this study
Official title: Hospital-home Linkage Short-term Rehabilitation Therapy Using Real-time Interactive Digital Healthcare System in Frozen Shoulder; Randomized Controlled Trial, Assessor Blinding, Multi-center Study
This study aims to examine the effect of hospital-home linkage short-term rehabilitation therapy using real-time interactive digital healthcare system (Uincare Homeplus) in frozen shoulder. This is prospective randomized controlled trial and multi-center study. 100 frozen shoulder who diagnosed with limited range of motion in 2 more plane of flexion, abduction, external rotation of affected shoulder. Shoulder range of motion (ROM), Shoulder Pain and Disability Index (SPADI), pain evaluation with Numeral Rating Scale (NRS), quality of life evaluation with Short Form (SF)-36 Health Survey and EQ-5D-5L, activity daily living (ADL) evaluation with Canadian Occupational Performance Measure (COPM) will be evaluated on enrollment, 4-week, 8-week, 12-weeks, 18-weeks, and 24 weeks after enrollment.
Read the detailed description
The frozen shoulder is a disease in which severe pain and limited range of motion of the shoulder occur as an inflammatory change occurs in the articular capsular surrounding the shoulder joint. As a result, it has caused limitation in daily life movement.
Uincare Homeplus is software manufactured in Korea, which uses infrared, kinect camera and motion capture technology to track 3D motion of the patients' articulation. Using this technology, the patients can receive feedback of their motion immediately.
The objective of the study is to examine the effect of hospital-home linkage short-term rehabilitation therapy using real-time interactive digital healthcare system (Uincare Homeplus) in frozen shoulder.
- Conditions
- Frozen Shoulder
- Being tested
- Uincare Homeplus, Brochure
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uincare HomeplusDevice
Also called digital healthcare
Interactive digital healthcare system
BrochureOther
Brochure
| Study group | Role | What they receive |
|---|---|---|
| Exercise using Uincare Homeplus | Experimental | Uincare Homeplus Receives: Device: Uincare Homeplus |
| Exercise using brochure | Active comparator | brochure Receives: Other: Brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion (ROM) in affected shoulder
Evaluation of change of ROM in the affected shoulder from baseline to 12 weeks
Measured: Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks
Secondary outcomes (5)
Functional outcome in patients with frozen shoulder using Shoulder Pain and Disability Index (SPADI)
Evaluation of shoulder function (pain and disability) using SPADI. Overall total scores range from 0 to 130 with a percentage score of 0 indicating less shoulder disability and 100 indicating more shoulder dysfunction.
Measured: Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks
Numerical rating scale (NRS) of affected shoulder
Evaluation of pain of the affected shoulder using numerical rating scale (0-10, with score 0 indicating no pain) minimum ~ maximum value: 0 ~ 10, higher scores mean worse outcome.
Measured: Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks
Quality of life in the patients with frozen shoulder using Short form -36 (SF36)
Evaluation of quality of life using SF36. Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Measured: Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks
Quality of life in the patients with frozen shoulder 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 the worst quality of life you can imagine.
Measured: Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks
Activities of Daily Living of the patients with frozen shoulder using Canadian Occupational Performance Measure (COPM)
Evaluation of quality of life using COPM PERFORMANCE and SATISFACTION scores can be generated for up to 5 individual occupational performance problems. Average PERFORMANCE and SATISFACTION scores can be calculated by summing individual problem scores and dividing by the number of problems. Change scores for both PERFORMANCE and SATISFACTION can be calculated after a reassessment interval.
Measured: Enrollment, 4 week, 8 week, 12 week, 18 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 posted20 Mar 2020
- Study start1 Mar 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Frozen ShoulderStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Republic of Korea
- Responsible party
- Principal investigator, JiHye Hwang, Samsung Medical Center
- Investigators
- JIHYE HWANG, Professor, Study chair, Physical & Rehabilitation Medicine Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316130
- Sponsor's protocol ID
- SMC-2019-05-021
- Status last verified
- Jan 2022
- First submitted
- 18 Mar 2020
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yeo SM, Lim JY, Kim S, Park HY, Lim JY, Do JG, Lee JI, Hwang JH. Effects of augmented reality-based telerehabilitation in adhesive capsulitis of the shoulder: a randomized controlled trial. Ann Phys Rehabil Med. 2025 Jun;68(5):101956. doi: 10.1016/j.rehab.2025.101956. Epub 2025 Jun 27.
PubMed 40580799Yeo SM, Lim JY, Do JG, Lim JY, In Lee J, Hwang JH. Effectiveness of interactive augmented reality-based telerehabilitation in patients with adhesive capsulitis: protocol for a multi-center randomized controlled trial. BMC Musculoskelet Disord. 2021 Apr 26;22(1):386. doi: 10.1186/s12891-021-04261-1.
PubMed 33902546
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital-home Linkage Short-term Rehabilitation Therapy Using Real-time Interactive Digital Healthcare System in Frozen Shoulder; Randomized Controlled Trial, Assessor Blinding, Multi-center Study
- ClinicalTrials.gov ID
- NCT04316130
- Acronym / sponsor ID
- SMC-2019-05-021
- Conditions
- Frozen Shoulder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Ministry of Health, Republic of Korea
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 20 Mar 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.
This study aims to examine the effect of hospital-home linkage short-term rehabilitation therapy using real-time interactive digital healthcare system (Uincare Homeplus) in frozen shoulder. This is prospective randomized controlled trial and multi-center study. 100 frozen shoulder who diagnosed with limited range of motion in 2 more plane of flexion, abduction, external rotation of affected shoulder. Shoulder range of motion (ROM), Shoulder Pain and Disability Index (SPADI), pain evaluation with Numeral Rating Scale (NRS), quality of life evaluation with Short Form (SF)-36 Health Survey and EQ-5D-5L, activity daily living (ADL) evaluation with Canadian Occupational Performance Measure (COPM) will be evaluated on enrollment, 4-week, 8-week, 12-weeks, 18-weeks, and 24 weeks after enrollment.
Detailed description
The frozen shoulder is a disease in which severe pain and limited range of motion of the shoulder occur as an inflammatory change occurs in the articular capsular surrounding the shoulder joint. As a result, it has caused limitation in daily life movement.
Uincare Homeplus is software manufactured in Korea, which uses infrared, kinect camera and motion capture technology to track 3D motion of the patients' articulation. Using this technology, the patients can receive feedback of their motion immediately.
The objective of the study is to examine the effect of hospital-home linkage short-term rehabilitation therapy using real-time interactive digital healthcare system (Uincare Homeplus) in frozen shoulder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise using Uincare Homeplus | Experimental | Device: Uincare HomeplusUincare Homeplus |
| Exercise using brochure | Active comparator | Other: Brochurebrochure |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Limited passive range of motion of the affected shoulder in 2 more plane (flexion < 150˚, abduction <150˚, external rotation < 60˚)
Key exclusion criteria (4 listed)
- Bilateral frozen shoulder
- Secondary frozen shoulder caused by trauma (shoulder fracture, dislocation), or/and inflammatory disease(rheumatoid arthritis)
- Those unable to perform exercise due to general deconditioning
- Those with communication difficulty
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 |
|---|---|---|
| Uincare HomeplusAlso: digital healthcareInteractive digital healthcare system | Device | Exercise using Uincare Homeplus |
| BrochureBrochure | Other | Exercise using brochure |
Primary outcome
Range of motion (ROM) in affected shoulder
Time frame: Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks
Evaluation of change of ROM in the affected shoulder from baseline to 12 weeks
5 secondary outcomes
Functional outcome in patients with frozen shoulder using Shoulder Pain and Disability Index (SPADI)
Time frame: Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks
Numerical rating scale (NRS) of affected shoulder
Time frame: Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks
Quality of life in the patients with frozen shoulder using Short form -36 (SF36)
Time frame: Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks
Quality of life in the patients with frozen shoulder using EQ-5D-5L
Time frame: Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks
Activities of Daily Living of the patients with frozen shoulder using Canadian Occupational Performance Measure (COPM)
Time frame: Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Derived from this study: PubMed 40580799Yeo SM, Lim JY, Kim S, Park HY, Lim JY, Do JG, Lee JI, Hwang JH. Effects of augmented reality-based telerehabilitation in adhesive capsulitis of the shoulder: a randomized controlled trial. Ann Phys Rehabil Med. 2025 Jun;68(5):101956. doi: 10.1016/j.rehab.2025.101956. Epub 2025 Jun 27.
- Derived from this study: PubMed 33902546Yeo SM, Lim JY, Do JG, Lim JY, In Lee J, Hwang JH. Effectiveness of interactive augmented reality-based telerehabilitation in patients with adhesive capsulitis: protocol for a multi-center randomized controlled trial. BMC Musculoskelet Disord. 2021 Apr 26;22(1):386. doi: 10.1186/s12891-021-04261-1.
- Individual participant dataSharing planned: Undecided
Related trials for Frozen Shoulder
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Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
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Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
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Effects of Posterior Capsular Stretching With and Without Dynamic Neuromuscular Stabilization Exercises in Frozen Shoulder
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RecruitingPhase 4
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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.
JIHYE HWANG, Professor study chair
Physical & Rehabilitation Medicine Samsung Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uincare Homeplus and Brochure in people with Frozen Shoulder, run by Samsung Medical Center at 2 sites 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 1 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: finished, as of the sponsor's last update on 4 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 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion (ROM) in affected shoulder (time frame: Enrollment, 4 week, 8 week, 12 week, 18 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 NCT04316130, which also lists 2 linked publications.
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 4 Jan 2022.