New Model of Short-term Rehabilitation Exercise Training Using Digital Healthcare System in Patients With Anterior Cruciate Ligament Reconstruction; Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Changes from baseline Limb Symmetry Index (LSI) of lower extremities
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who had anterior cruciate ligament reconstruction surgery
- •Patient who is discharged to home after surgery
排除标准
- •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
结局指标
主要结局
Changes from baseline Limb Symmetry Index (LSI) of lower extremities
时间窗: 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.
次要结局
- Range of Motion (ROM) on the affected knee(Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks)
- International Knee Documentation Committee (IKDC) score on the affected knee(Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks)
- Numerical Rating Scale (NRS) on the affected knee(Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks)
- Quality of Life using EQ-5D-5L(Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks)
- Manual Muscle Test (MMT) on the affected lower extremities(Enrollment, 2-weeks, 6-weeks, 12-weeks, 24-weeks)
研究者
Jae-Young Lim
Professor
Seoul National University Bundang Hospital