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

NCT ID: NCT04513353

Last Updated: 2022-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-30

Study Completion Date

2023-03-31

Brief Summary

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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

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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

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Osteo Arthritis Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Digital Healthcare System Rehabilitation

Group Type EXPERIMENTAL

Rehabilitation using Digital Healthcare System (Uincare Homeplus)

Intervention Type DEVICE

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.

Conventional Rehabilitation

Group Type ACTIVE_COMPARATOR

Conventional Rehabilitation

Intervention Type OTHER

Home-based self-rehabilitation using brochure for 12 weeks post surgery.

Interventions

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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.

Intervention Type DEVICE

Conventional Rehabilitation

Home-based self-rehabilitation using brochure for 12 weeks post surgery.

Intervention Type OTHER

Other Intervention Names

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Uincare Homeplus

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Republic of Korea

OTHER_GOV

Sponsor Role collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jae-Young Lim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung Medical Center

Seoul, Gangnam-gu, South Korea

Site Status RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jay-Young Lim, M.D., Ph. D

Role: CONTACT

+82-31-787-7732

Facility Contacts

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JIHYE HWANG, M.D. Ph. D.

Role: primary

+82-10-9933-2816

Jae-Young Lim, M.D., Ph.D.

Role: primary

+82-10-5390-0373

References

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Shim GY, Kim EH, Lee SJ, Chang CB, Lee YS, Lee JI, Hwang JH, Lim JY. Postoperative rehabilitation using a digital healthcare system in patients with total knee arthroplasty: a randomized controlled trial. Arch Orthop Trauma Surg. 2023 Oct;143(10):6361-6370. doi: 10.1007/s00402-023-04894-y. Epub 2023 May 2.

Reference Type DERIVED
PMID: 37129691 (View on PubMed)

Other Identifiers

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B-2005/612-001(2)

Identifier Type: -

Identifier Source: org_study_id

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