Home-based Rehabilitation Using Smart Wearable Knee Exercise Device With Electrical Stimulation After Anterior Cruciate Ligament Reconstruction: A Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Quadriceps muscle strength using dynamometry
研究概览
简要总结
The purpose of this study is to develop and apply a rehabilitation program for patients who are discharged after ACL reconstruction using a wearable joint rehabilitation exercise device (exoRehab).
详细描述
This randomized, single-blind, controlled trial included 40 patients who are discharged after ACL reconstruction.
The intervention group(n=20) was instructed and educated about 6 week home rehabilitation program using a wearable device(exoRehab)
The controls(n=20) was instructed and educated about 6 week conventional home rehabilitation program
Two weeks after surgery and six weeks after discharge, evaluation is performed.
The purpose of this study is to develop and apply a rehabilitation program for patients who are discharged after ACL reconstruction using a wearable joint rehabilitation exercise device (exoRehab).
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with anterior cruciate ligament reconstruction
- •Patients who are older than 19 years of age
排除标准
- •History of surgery or traumatic injury to the uninvolved lower extremity
- •Complication after ACL reconstruction surgery
- •Dermatological conditions affecting the thigh
- •Body mass index (BMI) greater than 40 kg/m2
- •Implanted pacemakers or defibrillators
- •Significant neurologic impairments
- •Other unstable lower-extremity orthopedic conditions
- •Initiated rehabilitation at another facility prior to their first physical therapy session at our facility
- •Other lower limb impairment affecting function
- •More than one surgery for a tear of the ACL
结局指标
主要结局
Quadriceps muscle strength using dynamometry
时间窗: Baseline and 6 weeks
Change from baseline quadriceps muscle strength at 6 weeks
次要结局
- Active range of motion of knee(Baseline, 2 weeks and 6 weeks)
- Lysholm score(Baseline, 2 weeks and 6 weeks)
- Knee Outcome Survey-Activities of Daily Living Scale(Baseline, 2 weeks and 6 weeks)
- International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score(Baseline, 2 weeks and 6 weeks)
- Visual Analogue Scale for pain(Baseline, 2 weeks and 6 weeks)
- Passive range of motion of knee(Baseline, 2 weeks and 6 weeks)
- Root mean square of surface electromyography of quadriceps muscle(Baseline, 2 weeks and 6 weeks)
- EQ-5D-3L Scores(Baseline, 2 weeks and 6 weeks)
研究者
Nam-Jong Paik
Professor
Seoul National University Bundang Hospital