NCT01815281终止不适用
Foot Mechanical Stimulation for Treatment of Gait and Gait Related Disorders in Parkinson's Disease
IRCCS San Raffaele Roma5 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 5
- 主要终点
- Timed Up and Go.
研究概览
简要总结
The purpose of this research study is to evaluate safety and effectiveness of Foot Mechanical stimulation to improving Gait and Gait Related Disorders in Parkinson Disease and Progressive Supranuclear Palsy both stable and with motor fluctuation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of idiopathic PD or PSP by UK Brain Bank criteria,
- •Able to walk 25 feet unassisted or with minimal assistance;
- •On stable doses of Parkinson's medications for at least 2 weeks prior to study onset;
- •Endurance sufficient to stand at least 20 minutes unassisted per patient report.
排除标准
- •Other significant neurological or orthopedic problems.
结局指标
主要结局
Timed Up and Go.
时间窗: Change from Baseline in Timed Up and Go test at 1 month follow up.
Time Up and Go test will be collected in OFF state 4 hour after oral assumption of levodopa at baseline (inclusion) (T0), before (T1-T3-T5-T7-T9-T11) and after all stimulation (T2-T4-T6-T8-T10) and endpoint (after 6 stimulation) (T12) at the follow-up examination after 1 months from the treatments conclusion (T13).
次要结局
- FREEZING OF GAIT QUESTIONNAIRES(Change from Baseline in FREEZING OF GAIT QUESTIONNAIRES at 1 month follow up.)
- 6 minuts walking test.(Change from Baseline in gait speed at 1 month follow up)
- Gait Parameters(Change from Baseline in Gait Parameters at 1 month follow up)
- THE PARKINSON'S DISEASE QUESTIONNAIRE (PDQ-39)(Change from Baseline in PDQ-39 at 1 month follow up)
研究者
研究点 (5)
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