Clinical trial NCT04513327: Rehabilitation Exercise Using Digital Healthcare System in Patients With Anterior Cruciate Ligament Reconstruction
Official title: New Model of Short-term Rehabilitation Exercise Training Using Digital Healthcare System in Patients With Anterior Cruciate Ligament Reconstruction; Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Keywords: Anterior Cruciate Ligament Reconstruction
Post-Operative Rehabilitation
Digital Healthcare System
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Republic of Korea
First posted: 2020-08-14
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes from baseline Limb Symmetry Index (LSI) of lower extremities
timeFrame: Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks
Secondary outcomes:
measure: Numerical Rating Scale (NRS) on the affected knee
timeFrame: Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks
measure: Range of Motion (ROM) on the affected knee
timeFrame: Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks
measure: Manual Muscle Test (MMT) on the affected lower extremities
timeFrame: Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks
measure: International Knee Documentation Committee (IKDC) score on the affected knee
timeFrame: Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks
measure: Quality of Life using EQ-5D-5L
timeFrame: Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-gu
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References: