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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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.
Home-based self-rehabilitation using brochure for 12 weeks post surgery.
Samsung Medical Center
Seoul, Gangnam-gu, South Korea
RECRUITINGSeoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
RECRUITINGChanges 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.
Time frame: Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
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