Rehabilitation Exercise Using Digital Healthcare System in Patients With Total Knee Arthroplasty

Osteo Arthritis Knee Clinical Trial

Official title:

New Model of Short-term Rehabilitation Exercise Training Using Digital Healthcare System in Patients With Total Knee Arthroplasty; Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04513353
• Other study ID #: B-2005/612-001(2)
• Status: Recruiting
• Phase: N/A
• Start date: July 30, 2020
• Est. completion date: March 31, 2023

Study information

• Verified date: January 2022
• Source: Seoul National University Bundang Hospital
• Contact: Jay-Young Lim, M.D., Ph. D
• Phone: +82-31-787-7732
• Email: drlim1[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Rehabilitation 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.

Other:
• Conventional Rehabilitation
Home-based self-rehabilitation using brochure for 12 weeks post surgery.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Samsung Medical Center	Seoul	Gangnam-gu

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Ministry of Health, Republic of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
Secondary	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.	Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
Secondary	Range of Motion (ROM) on the affected knee	Evaluation of change of ROM in the affected knee from baseline to 24 weeks	Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
Secondary	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.	Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
Secondary	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.	Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
Secondary	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.	Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
Secondary	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	Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks