NCT01302184Unknown2 期
Robotic Locomotor Experience Applied to Parkinson's Disease (ROLEP)
Azienda Ospedaliero Universitaria Maggiore della Carita2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2010年10月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- 6 minute walking test
研究概览
简要总结
Gait rehabilitation with treadmill has been reported to be useful in patients with Parkinson's disease. In the last years, interest in robotic devices for gait training has grew up for patients with different neurological disorders, since they minimize demands on physical therapists and may provide a more reliable and constant treatment.
The aim of this study is to evaluate if robotic gait training with Lokomat® can improve walking more than conventional gait training with treadmill in patients affected by Parkinson's disease.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients affected by PD with a disease stage < III according to Hoehn and Yahr's classification and age < 75 years;
- •absence of motor fluctuations;
- •able to ambulate independently;
- •no treadmill training for at least 6 months before the study.
排除标准
- •current levodopa therapy started more than 6 months before enrollment;
- •medical or neurological pathology that contributed significantly to gait dysfunction, as musculoskeletal disease, severe osteoarthritis, peripheral neuropathy, previous lower limb joint replacement, cardiovascular disease (recent myocardial infarct, from less than 4 weeks or uncontrolled hypertension, with blood pressure > 180/110 at rest);
- •hearth failure (NYHA >=3);
- •orthostatic hypotension;
- •body weight over 100 kg;
- •respiratory disease;
- •dementia;
- •depression;
- •uncorrected visual disturbances.
- •patients that have undergone deep brain stimulation.
结局指标
主要结局
6 minute walking test
时间窗: Enrollment, after training completion, 3 and 6 months after training completion
The subject has to walk the longest distance possible within 6 minutes.
次要结局
- 10 meter walking test(Enrollment, after training completion, 3 and 6 months after training completion)
- Time Up and Go test(Enrollment, after training completion, 3 and 6 months after training completion)
研究者
研究点 (2)
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