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

Primary Purpose

Osteo Arthritis Knee

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rehabilitation using Digital Healthcare System (Uincare Homeplus)
Conventional Rehabilitation
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring Total Knee Arthroplasty, Post-Operative Rehabilitation, Digital Healthcare System

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical CenterRecruiting
  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Digital Healthcare System Rehabilitation

Conventional Rehabilitation

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Range of Motion (ROM) on the affected knee
Evaluation of change of ROM in the affected knee from baseline to 24 weeks
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.
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.
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.
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

Full Information

First Posted
August 9, 2020
Last Updated
January 4, 2022
Sponsor
Seoul National University Bundang Hospital
Collaborators
Ministry of Health, Republic of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT04513353
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
Ministry of Health, Republic of Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee
Keywords
Total Knee Arthroplasty, Post-Operative Rehabilitation, Digital Healthcare System

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Digital Healthcare System Rehabilitation
Arm Type
Experimental
Arm Title
Conventional Rehabilitation
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Rehabilitation using Digital Healthcare System (Uincare Homeplus)
Other Intervention Name(s)
Uincare Homeplus
Intervention Description
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
Other
Intervention Name(s)
Conventional Rehabilitation
Intervention Description
Home-based self-rehabilitation using brochure for 12 weeks post surgery.
Primary Outcome Measure Information:
Title
Changes from Baseline Gait Speed
Description
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.
Time Frame
Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
Secondary Outcome Measure Information:
Title
Numerical Rating Scale (NRS) on the affected knee
Description
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.
Time Frame
Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
Title
Range of Motion (ROM) on the affected knee
Description
Evaluation of change of ROM in the affected knee from baseline to 24 weeks
Time Frame
Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
Title
Manual Muscle Test (MMT) on the affected lower extremities
Description
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.
Time Frame
Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) on the affected knee
Description
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.
Time Frame
Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
Title
Berg Balance Scale (BBS)
Description
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.
Time Frame
Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks
Title
Quality of Life using EQ-5D-5L
Description
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
Time Frame
Enrollment, 3-weeks, 6-weeks, 12-weeks, 24-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jay-Young Lim, M.D., Ph. D
Phone
+82-31-787-7732
Email
drlim1@snu.ac.kr
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Gangnam-gu
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JIHYE HWANG, M.D. Ph. D.
Phone
+82-10-9933-2816
Email
jhlee.hwang@samsung.com
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Young Lim, M.D., Ph.D.
Phone
+82-10-5390-0373
Email
drlim1@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Jae-Young Lim, M.D., Ph. D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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