Clinical trial NCT04513353: Rehabilitation Exercise Using Digital Healthcare System in Patients With Total Knee Arthroplasty
Official title: New Model of Short-term Rehabilitation Exercise Training Using Digital Healthcare System in Patients With Total Knee Arthroplasty; Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteo Arthritis Knee
Keywords: Total Knee Arthroplasty
Post-Operative Rehabilitation
Digital Healthcare System
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Republic of Korea
First posted: 2020-08-14
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes from Baseline Gait Speed
timeFrame: Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
Secondary outcomes:
measure: Numerical Rating Scale (NRS) on the affected knee
timeFrame: Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
measure: Range of Motion (ROM) on the affected knee
timeFrame: Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
measure: Manual Muscle Test (MMT) on the affected lower extremities
timeFrame: Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) on the affected knee
timeFrame: Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
measure: Berg Balance Scale (BBS)
timeFrame: Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
measure: Quality of Life using EQ-5D-5L
timeFrame: Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-gu
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References: