Osteo Arthritis KneeNCT04513353
Rehabilitation Exercise Using Digital Healthcare System in Patients With Total Knee Arthroplasty
A study testing Rehabilitation using Digital Healthcare System (Uincare Homeplus) and Conventional Rehabilitation in people with Osteo Arthritis Knee, run by Seoul National University Bundang Hospital at 2 sites 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 total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteo Arthritis Knee
- 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
- 60 participants
- Where
- 2 sitesSouth 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 total knee arthroplasty
- Patient who is discharged to home after surgery
Who cannot join
- Patient who had previous history of high tibial osteotomy on the affected lower extremities.
- Patient who had history of lower extremities joint revision arthroplasty in the past 6 months.
- Patient who has severe comorbidity that inhibits exercise.
- Patient who has major neurological deficits on the lower extremities.
- Patient who cannot participate in post surgery rehabilitation
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 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.
- Recruiting
Samsung Medical Center
Seoul, Gangnam-gu, 06351
JIHYE HWANG, M.D. Ph. D., +82-10-9933-2816, jhlee.hwang@samsung.com
About this study
Official title: New Model of Short-term Rehabilitation Exercise Training Using Digital Healthcare System in Patients With Total Knee Arthroplasty; 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 total knee arthroplasty. 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. Gait speed (4-meter), Pain (using Numerical rating scale), knee joint range of motion (ROM), lower extremities motor power (using Manual muscle test), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Berg Balance Scale (BBS) and quality of life using EQ-5D-5L will be evaluation on enrollment, 3-weeks, 6-weeks, 12-weeks and 24-weeks after enrollment.
Read the detailed description
Total knee arthroplasty is treatment of choice for knee degenerative arthritis patients who are unresponsive to non-operative management including medications and physical therapies. Total knee arthroplasty is an effective treatment enhancing the joint range of motion as well as reducing pain and correcting deformities which leads to better patient function with better quality of life. 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 aim to compare the efficacy of the newly-developed digital healthcare system with conventional rehabilitation program.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Rehabilitation using Digital Healthcare System (Uincare Homeplus), Conventional Rehabilitation
- Keywords
- Total Knee Arthroplasty, Post-Operative Rehabilitation, Digital Healthcare System
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 total knee arthroplasty post-op rehabilitation at home.
Home-based self-rehabilitation using brochure for 3 weeks post surgery (same as the active comparator)
Home-based self-rehabilitation using digital healthcare system(Uincare Homeplus) for 3 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 | Not described Receives: Device: Rehabilitation using Digital Healthcare System (Uincare Homeplus) |
| Conventional Rehabilitation | Active comparator | Not described Receives: Other: Conventional Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Baseline Gait Speed
Gait Speed is measured by the time required to walk 4-meters in plain indoor. Shorter time required to complete 4-meter walk means better gait function.
Measured: Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
Secondary outcomes (6)
Numerical Rating Scale (NRS) on the affected knee
Evaluation of pain of the affected shoulder using numerical rating scale (0-10, with score 0 indicating no pain). the higher score means worse pain.
Measured: Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
Range of Motion (ROM) on the affected knee
Evaluation of change of ROM in the affected knee from baseline to 24 weeks
Measured: Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
Manual Muscle Test (MMT) on the affected lower extremities
Evaluation of change of MMT in the affected lower extremities from baseline to 24 weeks. affected lower extremities MMT scales from 0-25, higher score meaning better outcome.
Measured: Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) on the affected knee
The WOMAC is a self-administered questionnaire used in the evaluation of knee osteoarthritis. It is consisted with 24 items divided into 3 subscales; Pain, Stiffness and Physical function. WOMAC score ranges from 0-96 with higher score meaning worse pain, stiffness and function.
Measured: Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
Berg Balance Scale (BBS)
BBS is a 14-item objective measure that assess static balance and fall risk in adults. BBS score ranges from 0-56, with higher score meaning better balance.
Measured: Enrollment, 3-weeks, 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, 3-weeks, 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 posted14 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 Osteo Arthritis KneeStudies 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
- 60 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
- NCT04513353
- Sponsor's protocol ID
- B-2005/612-001(2)
- 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
Shim GY, Kim EH, Lee SJ, Chang CB, Lee YS, Lee JI, Hwang JH, Lim JY. Postoperative rehabilitation using a digital healthcare system in patients with total knee arthroplasty: a randomized controlled trial. Arch Orthop Trauma Surg. 2023 Oct;143(10):6361-6370. doi: 10.1007/s00402-023-04894-y. Epub 2023 May 2.
PubMed 37129691
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 Total Knee Arthroplasty; Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04513353
- Acronym / sponsor ID
- B-2005/612-001(2)
- Conditions
- Osteo Arthritis Knee
- Keywords
- Total Knee Arthroplasty, Post-Operative Rehabilitation, Digital Healthcare System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 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
- 14 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 total knee arthroplasty. 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. Gait speed (4-meter), Pain (using Numerical rating scale), knee joint range of motion (ROM), lower extremities motor power (using Manual muscle test), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Berg Balance Scale (BBS) and quality of life using EQ-5D-5L will be evaluation on enrollment, 3-weeks, 6-weeks, 12-weeks and 24-weeks after enrollment.
Detailed description
Total knee arthroplasty is treatment of choice for knee degenerative arthritis patients who are unresponsive to non-operative management including medications and physical therapies. Total knee arthroplasty is an effective treatment enhancing the joint range of motion as well as reducing pain and correcting deformities which leads to better patient function with better quality of life. 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 aim 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) |
| Conventional Rehabilitation | Active comparator | Other: Conventional Rehabilitation |
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 total knee arthroplasty
- Patient who is discharged to home after surgery
Key exclusion criteria (5 listed)
- Patient who had previous history of high tibial osteotomy on the affected lower extremities.
- Patient who had history of lower extremities joint revision arthroplasty in the past 6 months.
- Patient who has severe comorbidity that inhibits exercise.
- Patient who has major neurological deficits on the lower extremities.
- Patient who cannot participate in post surgery rehabilitation
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 total knee arthroplasty post-op rehabilitation at home. Home-based self-rehabilitation using brochure for 3 weeks post surgery (same as the active comparator) Home-based self-rehabilitation using digital healthcare system(Uincare Homeplus) for 3 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
Changes from Baseline Gait Speed
Time frame: Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
Gait Speed is measured by the time required to walk 4-meters in plain indoor. Shorter time required to complete 4-meter walk means better gait function.
6 secondary outcomes
Numerical Rating Scale (NRS) on the affected knee
Time frame: Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
Range of Motion (ROM) on the affected knee
Time frame: Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
Manual Muscle Test (MMT) on the affected lower extremities
Time frame: Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) on the affected knee
Time frame: Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
Berg Balance Scale (BBS)
Time frame: Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
Quality of Life using EQ-5D-5L
Time frame: Enrollment, 3-weeks, 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 37129691Shim GY, Kim EH, Lee SJ, Chang CB, Lee YS, Lee JI, Hwang JH, Lim JY. Postoperative rehabilitation using a digital healthcare system in patients with total knee arthroplasty: a randomized controlled trial. Arch Orthop Trauma Surg. 2023 Oct;143(10):6361-6370. doi: 10.1007/s00402-023-04894-y. Epub 2023 May 2.
- Individual participant dataSharing planned: Undecided
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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.
2 sites 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 Osteo Arthritis Knee, run by Seoul National University Bundang Hospital 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 2 inclusion and 5 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 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?
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?
Changes from Baseline Gait Speed (time frame: Enrollment, 3-weeks, 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 NCT04513353, 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.