Clinical Trials Directory

Trials / Unknown

UnknownNCT04513353

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Seoul National University Bundang Hospital · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICERehabilitation using Digital Healthcare System (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.
OTHERConventional RehabilitationHome-based self-rehabilitation using brochure for 12 weeks post surgery.

Timeline

Start date
2020-07-30
Primary completion
2022-12-31
Completion
2023-03-31
First posted
2020-08-14
Last updated
2022-01-05

Locations

2 sites across 1 country: South Korea

Source: ClinicalTrials.gov record NCT04513353. Inclusion in this directory is not an endorsement.