Armeo® Versus Standard Physiotherapy for Upper Limb Rehabilitation in Patients With Acquired Brain Lesions
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 4
- 主要终点
- Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke
研究概览
简要总结
The Armeo Spring has proven its effectiveness in the rehabilitation of acute stroke patients. It neutralizes limb weight, enabling patients to use residual control in both arm and hand and to follow exercises guided by simulations of real-life challenges. The Armeo Spring incorporates wrist pronation and supination, allowing patients to enhance functional reaching patterns.
Aim of the study is to compare the Armeo device with standard physiotherapy in chronic patients with acquired brain lesions.
The result of the trial should show which treatment is more effective in the clinical practice. A significant better outcome of one arm should suggest to follow one treatment strategy more than the other.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6 month after the onset of disease
- •acquired brain lesions in adults with upper limb hemiparesis
- •modified Ashworth <= 3
- •muscular strength MRC =>1 mano; MRC =>2 elbow e shoulder
- •Fugl Meyer => 18
排除标准
- •NYHA >III
- •MMSE (mini mental status examination test) < 24
- •muscular strength (MRC) < 1
- •Dystonia, spasticity (Ashworth => 3)
- •articular contractions in the upper limb
- •previous upper limb lesions
- •cognitive/language impairment likely to influence assessments
- •any diagnosis likely to interfere with rehabilitation
结局指标
主要结局
Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke
时间窗: 12 weeks
次要结局
- Upper Extremity Motor Activity Log for measuring real use of the upper limb(12 weeks)
- Wolf Motor Function Test for measurement of timed joint-segment movements(12 weeks)
- Clinical Global Impression Score for the measurement of change over time of the illness' severity(12 weeks)