Rehabilitation Exercise Using Digital Healthcare System in Patients With Anterior Cruciate Ligament Reconstruction

January 4, 2022 updated by: Jae-Young Lim, Seoul National University Bundang Hospital

New Model of Short-term Rehabilitation Exercise Training Using Digital Healthcare System in Patients With Anterior Cruciate Ligament Reconstruction; Randomized Controlled Study

The study aims to examine the effect of short-term rehabilitation exercise support using digital healthcare system (Uincare homeplus) in the patients with anterior cruciate ligament reconstruction. 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. Limb Symmetry Index (LSI), Pain (using Numerical rating scale), knee joint range of motion (ROM), lower extremities motor power (using Manual muscle test), International Knee Documentation Committee (IKDC) and quality of life using EQ-5D-5L will be evaluation on enrollment, 2-weeks, 6-weeks, 12-weeks and 24-weeks after enrollment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Anterior cruciate ligament(ACL) is a vital structure in the knee maintaining the stability and due to increased population engaging in sports activities, the ACL injury is becoming more prevalent among young adults. Rehabilitation after ACL reconstruction is essential to restore knee function and many factors including age, degree of sports activities engagement, weight bearing should be considered when organizing rehabilitation programs. Knee joint stiffness and weakness of knee flexor/extensor muscles are common problems following the surgery which are related to improper rehabilitation after ACL reconstructions.

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 newlydeveloped digital healthcare system with conventional rehabilitation program.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gangnam-gu
      • Seoul, Gangnam-gu, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient who had anterior cruciate ligament reconstruction surgery
  • Patient who is discharged to home after surgery

Exclusion Criteria:

  • Patient who had previous history of anterior cruciate ligament reconstruction surgery in the past 6 months.
  • Patient who had undergone bilateral anterior cruciate ligament reconstruction surgery.
  • Patient who has knee joint disorders (rheumatoid arthritis, osteoarthritis) other than anterior cruciate ligament injury.
  • Patient who has neurological deficit or infection in the affected knee joint.
  • Patient who has severe comorbidity that inhibits exercise.
  • Patient who cannot participate in post surgery rehabilitation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Digital Healthcare System Rehabilitation
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 anterior cruciate ligament reconstruction post-op rehabilitation at home.

Home-based self-rehabilitation using brochure for 2 weeks post surgery (same as the active comparator)

Home-based self-rehabilitation using digital healthcare system(Uincare Homeplus) for 2 to 12 weeks post surgery.

Other Names:
  • Uincare Homeplus
Active Comparator: Conventional Rehabilitation
Other: Conventional Rehabilitation
Home-based self-rehabilitation using brochure for 12 weeks post surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline Limb Symmetry Index (LSI) of lower extremities
Time Frame: Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks
LSI(%) = (involved limb knee flexor and extensor manual muscle test score / uninvolved limb knee flexor and extensor manual muscle test score * 100). LSI ranges from 0-100 with higher score meaning better limb symmetry.
Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical Rating Scale (NRS) on the affected knee
Time Frame: Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks
Evaluation of pain of the affected shoulder using numerical rating scale (0-10, with score 0 indicating no pain). Higher score meaning worse pain.
Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks
Range of Motion (ROM) on the affected knee
Time Frame: Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks
Evaluation of change of ROM in the affected knee from baseline to 24 weeks
Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks
Manual Muscle Test (MMT) on the affected lower extremities
Time Frame: Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks
Evaluation of change of MMT in the affected lower extremities from baseline to 24 weeks. Affected lower extremity MMT ranges from 0-25 with higher score meaning better motor power.
Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks
International Knee Documentation Committee (IKDC) score on the affected knee
Time Frame: Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks
IKDC score is a self-reported measure, 18 items (7 on symptoms, 1 on participation in sports, 9 on daily activities, and 1 on current knee function). IKDC score ranges from 0-100, with higher score meaning better function.
Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks
Quality of Life using EQ-5D-5L
Time Frame: Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks
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, 2-weeks, 6-weeks, 12-weeks, 24-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Collaborators

Ministry of Health, Republic of Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2020

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

March 31, 2023

Study Registration Dates

First Submitted

August 9, 2020

First Submitted That Met QC Criteria

August 11, 2020

First Posted (Actual)

August 14, 2020

Study Record Updates

Last Update Posted (Actual)

January 5, 2022

Last Update Submitted That Met QC Criteria

January 4, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-2005/612-001(3)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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