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Anterior Cruciate Ligament InjuriesNCT04513327

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

A study testing Rehabilitation using Digital Healthcare System (Uincare Homeplus) and Conventional Rehabilitation in people with Anterior Cruciate Ligament Injuries, run by Seoul National University Bundang Hospital at 2 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 anterior cruciate ligament reconstruction. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Anterior Cruciate Ligament Injuries
What is being tested?
Rehabilitation using Digital Healthcare System (Uincare Homeplus) and Conventional Rehabilitation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesSouth Korea
Study dates
30 Jul 2020to 31 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

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

+82-31-787-7732

drlim1@snu.ac.kr

South Korea2 sites, 2 recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

    Jae-Young Lim, M.D., Ph.D., +82-10-5390-0373, drlim1@snu.ac.kr

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

    Recruiting

  • Samsung Medical Center

    Seoul, Gangnam-gu, 06351

    JIHYE HWANG, M.D. Ph. D., +82-10-9933-2816, jhlee.hwang@samsung.com

    Recruiting

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Being tested
Rehabilitation using Digital Healthcare System (Uincare Homeplus), Conventional Rehabilitation
Keywords
Anterior Cruciate Ligament Reconstruction, Post-Operative Rehabilitation, Digital Healthcare System
Medical subject headings
Anterior Cruciate Ligament Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rehabilitation using Digital Healthcare System (Uincare Homeplus)Device

    Also called 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.

  • Conventional RehabilitationOther

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

Study groups in NCT04513327
Study groupRoleWhat they receive
Digital Healthcare System RehabilitationExperimentalNot described
Receives: Device: Rehabilitation using Digital Healthcare System (Uincare Homeplus)
Conventional RehabilitationActive comparatorNot described
Receives: Other: Conventional Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes from baseline Limb Symmetry Index (LSI) of lower extremities

    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.

    Measured: Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks

Secondary outcomes (5)

  1. 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). Higher score meaning worse pain.

    Measured: Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks

  2. Range of Motion (ROM) on the affected knee

    Evaluation of change of ROM in the affected knee from baseline to 24 weeks

    Measured: Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks

  3. 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 extremity MMT ranges from 0-25 with higher score meaning better motor power.

    Measured: Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks

  4. International Knee Documentation Committee (IKDC) score on the affected knee

    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.

    Measured: Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks

  5. 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.

    Measured: Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2020
  2. Study start30 Jul 2020
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Mar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04513327
Sponsor's protocol ID
B-2005/612-001(3)
Status last verified
Jan 2022
First submitted
9 Aug 2020
Last updated
5 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lim JY, Yu HJ, Kim SH, Lee JI, Lim JY, Wang JH, Hwang JH. Effectiveness of In-Home, Augmented Reality-Based Telerehabilitation After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial. Orthop J Sports Med. 2024 Oct 15;12(10):23259671241271729. doi: 10.1177/23259671241271729. eCollection 2024 Oct.

    PubMed 39415796

Questions about this trial

What is this clinical trial studying?

A study testing Rehabilitation using Digital Healthcare System (Uincare Homeplus) and Conventional Rehabilitation in people with Anterior Cruciate Ligament Injuries, run by Seoul National University Bundang Hospital at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jay-Young Lim, M.D., Ph. D (+82-31-787-7732, drlim1@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes from baseline Limb Symmetry Index (LSI) of lower extremities (time frame: Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04513327, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2022.

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