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

Seoul National University logo

Seoul National University

Status

Unknown

Conditions

Anterior Cruciate Ligament Injuries

Treatments

Other: Conventional Rehabilitation
Device: Rehabilitation using Digital Healthcare System (Uincare Homeplus)

Study type

Interventional

Funder types

Other

Identifiers

NCT04513327
B-2005/612-001(3)

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Digital Healthcare System Rehabilitation
Experimental group
Treatment:
Device: Rehabilitation using Digital Healthcare System (Uincare Homeplus)
Conventional Rehabilitation
Active Comparator group
Treatment:
Other: Conventional Rehabilitation

Trial contacts and locations

2

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Central trial contact

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

Data sourced from clinicaltrials.gov

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