NCT02962453已完成不适用
Multi-Modalities Evaluation of Gait Rehabilitation Robot of an End-Effector on Neuro-Muscular Pathway of the Proximal Muscles in Patients After Total Knee Arthroplasty
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change of Isometric muscle strength
研究概览
简要总结
The aim of this study is to determine the clinical efficacy of gait rehabilitation robot through cortico-spinal-muscular pathway activation of the muscles remotely located from the end-effecter in patients after total knee arthroplasty.
详细描述
pre-interventional evaluation; within 1 day of intervention start primary end point; 3 days after intervention start secondary end point; 5 days after intervention start
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients after Unilateral Total Knee Arthroplasty
排除标准
- •brain disease, spinal cord injury, peripheral neuropathy, myopathy
- •Inability to ambulate fully due to muscukoskeletal disorders
- •history of arthroplasty surgery on either of legs
- •Cardiac pacemaker
- •Refusal of participation
结局指标
主要结局
Change of Isometric muscle strength
时间窗: 0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)
peak torque (Nm/㎡), Maximal ratio of torque development (RTD) (degree/sec)
次要结局
- Change of Spinal Motor-neuron Excitability(0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop))
- Change of Cross-sectional area and volume of thigh muscle(0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop))
- Change of Cortico-motor Excitability(0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop))
- Change of Muscle work(0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop))
研究者
Chang Ho Hwang
Associated Professor
Ulsan University Hospital
研究点 (2)
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