NCT06538909尚未招募不适用
Steps Against the Burden of Parkinson's Disease - StepuP
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 21
- 主要终点
- motion capture
研究概览
简要总结
The goals of our StepuP project are:
- To understand the kinematic and neural mechanisms underlying walking improvements due to treadmill training with and without VR-enabled gait adaptations in people with PD;
- To assess to what extent improvements in walking due to treadmill training, as measured in the laboratory, transfer to improvements in daily life mobility;
- To understand the mechanisms underlying the transfer from improvements in walking to improvements in mobility in daily life in people with PD;
- To understand for whom treadmill training improves walking characteristics in the laboratory and for whom it does not, and to understand for whom treadmill training improves mobility in daily life and for whom it does not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Specific criteria for Parkinson's disease - PD
- •Diagnosis of Parkinson's disease according to the MDS World Movement Disorders Society criteria Disease severity H&Y I-III
- •Score section 3.10 (ability to walk) MDS-UPDRS 3.10 ≥ 1
- •MoCA cognitive assessment > 15
- •Stable cardiovascular condition, ability to perform aerobic activity at low to moderate intensity
- •Without orthopedic diseases and other diseases that affect the quality of walking, at the decision of the researcher.
排除标准
- •Moderate or severe depression (BDI-II ≥18)
- •Orthopedic diseases and other diseases that affect the quality of walking, at the decision of the researcher
结局指标
主要结局
motion capture
时间窗: 13 months
Kinematic data will be collected using a Qualisys or Vicon motion capture system at a sampling frequency of 100 Hz.
describe muscles activity by EMG electrodes
时间窗: 13 months
Bipolar EMG electrodes will be placed on the leg muscles. EMG data will be recorded at a sample frequency available for each system around 2000 Hz.
describe brain activity by EEG cap
时间窗: 13 months
EEG recordings will be made using a 64-channel or 128 channel EEG cap
次要结局
- clinical trial MiniBESTest(13 months)
- mGES questionnaire(13 months)
- Frailty questionnaire(13 months)
- MDS-UPDRS test(13 months)
- Fracture history questionnaire(13 months)
- clinical trial TUG(13 months)
- clinical trial walk test(13 months)
- FES-i questionnaire(13 months)
- FACIT-F questionnaire(13 months)
- EQ-5D questionnaire(13 months)
- cognition questionnaires(13 months)
- NFOGQ questionnaires(13 months)
- Demographics questionnaire ( descriptive measures)(13 months)
- Fall questionnaires(13 months)
- aids questionnaires(13 months)
研究者
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