- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04513353
Rehabilitation Exercise Using Digital Healthcare System in Patients With Total Knee Arthroplasty
New Model of Short-term Rehabilitation Exercise Training Using Digital Healthcare System in Patients With Total Knee Arthroplasty; Randomized Controlled Study
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gangnam-gu
-
Seoul, Gangnam-gu, Korea, Republic of, 06351
- Recruiting
- Samsung Medical Center
-
-
Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
- Recruiting
- Seoul National University Bundang Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient who had total knee arthroplasty
- Patient who is discharged to home after surgery
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Conventional Rehabilitation
|
Home-based self-rehabilitation using brochure for 12 weeks post surgery.
|
EXPERIMENTAL: Digital Healthcare System Rehabilitation
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numerical Rating Scale (NRS) on the affected knee
Time Frame: Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
|
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.
|
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
|
Evaluation of change of ROM in the affected knee from baseline to 24 weeks
|
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
|
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.
|
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
|
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.
|
Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
|
Berg Balance Scale (BBS)
Time Frame: Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
|
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.
|
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
|
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
|
Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-2005/612-001(2)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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