NCT04513353

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 30, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 14, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

January 5, 2022

Status Verified

January 1, 2022

Enrollment Period

2.4 years

First QC Date

August 9, 2020

Last Update Submit

January 4, 2022

Conditions

Osteo Arthritis Knee

Keywords

Total Knee ArthroplastyPost-Operative RehabilitationDigital Healthcare System

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Numerical Rating Scale (NRS) on the affected knee

    Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks

  • Range of Motion (ROM) on the affected knee

    Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks

  • Manual Muscle Test (MMT) on the affected lower extremities

    Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) on the affected knee

    Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks

  • Berg Balance Scale (BBS)

    Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks

  • +1 more secondary outcomes

Study Arms (2)

Digital Healthcare System Rehabilitation

EXPERIMENTAL
Device: Rehabilitation using Digital Healthcare System (Uincare Homeplus)

Conventional Rehabilitation

ACTIVE COMPARATOR
Other: Conventional Rehabilitation

Interventions

Rehabilitation using Digital Healthcare System (Uincare Homeplus)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.

Also known as: Uincare Homeplus
Digital Healthcare System Rehabilitation
Conventional RehabilitationOTHER

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

Conventional Rehabilitation

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient who had total knee arthroplasty
  • Patient who is discharged to home after surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37129691DERIVED

Central Study Contacts

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

CONTACT

+82-31-787-7732drlim1@snu.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 9, 2020

First Posted

August 14, 2020

Study Start

July 30, 2020

Primary Completion

December 31, 2022

Study Completion

March 31, 2023

Last Updated

January 5, 2022

Record last verified: 2022-01

Locations

KR(2)