跳至主要内容
临床试验/NCT06538909
NCT06538909尚未招募不适用

Steps Against the Burden of Parkinson's Disease - StepuP

Tel-Aviv Sourasky Medical Center0 个研究点目标入组 21 人开始时间: 2024年9月最近更新:
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:

  1. 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;
  2. To assess to what extent improvements in walking due to treadmill training, as measured in the laboratory, transfer to improvements in daily life mobility;
  3. To understand the mechanisms underlying the transfer from improvements in walking to improvements in mobility in daily life in people with PD;
  4. 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

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

申办方类型
Other Gov
责任方
Sponsor

相似试验