Combined Repetitive Transcranial Magnetic Stimulation and Robot-Assisted Upper Arm Training in Subacute Stroke Patients : Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Fugl-Meyer Assessment (FMA)
研究概览
简要总结
This study was designed to establish the clinical evidence for effect of Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation on upper limb function of subacute stroke patients.
- Purpose : to elucidate the effect of Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation on upper limb function of stroke patients compared to conventional occupational therapy
- Subjects : total 99 patients with stroke whose upper limb functions are impaired
- Intervention : 4 weeks of therapy (5 days per week)
- Studies : upper limb functional assessment (FMA, MFT, WMFT), computerized motion analysis
- Evaluation plan : 1) pre-intervention, 2) post-2 weeks of intervention, 3) post-4 weeks of intervention, 4) 4 weeks after end of intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Upper FMA 7-38
- •Hemiplegic patients within 6months after stroke onset
- •male or female, 20 years older
排除标准
- •Patients with cognitive impairment who are unable to comply with protocol-required procedure
- •Quadriplegic or double hemiplegic patients
- •Patients with musculoskeletal disease, peripheral nerve disease in upper extremity
- •Patients with lower motor neuron disease
- •Patients who cannot perform rTMS
- •Pregnant woman
研究组 & 干预措施
Robot and rTMS
Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation group(intervention group 1)
干预措施: Armeo and rTMS (Device)
Robot
Robot-Assisted upper arm training group(intervention group2)
干预措施: Armeo (Device)
Conventional
Conventional training group(control group)
干预措施: Control group (Other)
结局指标
主要结局
Fugl-Meyer Assessment (FMA)
时间窗: 4 weeks after the final intervention
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
次要结局
- Manual Function test(4 weeks after the final intervention)
- Wolf motor function test(4 weeks after the final intervention)
- Kinematic data of computerized 3D motion analysis(4 weeks after the final intervention)