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临床试验/NCT04194762
NCT04194762Unknown不适用

Treadmill vs Cycling in Parkinson´s Disease Rehabilitation. Non-pharmacological, Randomized, Blind Rater, Clinical Trial for the Definition of the Most Effective Model in Gait Reeducation

Puerta de Hierro University Hospital2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2019年9月9日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
48
试验地点
2
主要终点
Changes in step length after treadmill training or cycling.

研究概览

简要总结

PARK-FIT Treadmill vs Cycling in Parkinson´s Disease Rehabilitation. Non-pharmacological Clinical Trial for the Definition of the Most Effective Model in Gait Reeducation.

详细描述

Treadmill vs Cycling in Parkinson´s Disease Rehabilitation. Non-pharmacological Clinical Trial for the Definition of the Most Effective Model in Gait Reeducation.

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
Double (Investigator, Outcomes Assessor)

盲法说明

Intervention arm for each patient is masked for the raters

入排标准

性别
All
接受健康志愿者

入选标准

  • Patient is diagnosed with idiopathic Parkinson's disease according to criteria from the United Kingdom Parkinson's Disease Society Brain Bank (UK-PDSBB)
  • H&Y less than or equal to 2
  • Stable drug treatment in the six weeks prior to the start of training and during the study.
  • Signature of informed consent.

排除标准

  • Diagnosis of other neuro-degenerative disease
  • Cardiovascular disease or other systemic condition that contraindicates the moderate physical exercise
  • Need for ambulation support
  • Frequent freezing of gait events.
  • Mni- Mental State Examination (MMSE) <26

结局指标

主要结局

Changes in step length after treadmill training or cycling.

时间窗: Ten months

Highlight changes in the length of the step after training in treadmill or cycling in patients with Parkinson´s disease.

Changes in step length after treadmill training. Discussion of its specificity to Parkinson´s disease

时间窗: Ten months

A description of step length and cadence for different velocities of gait after treadmill training.

次要结局

  • Rating Scale for Gait Evaluation in Parkinson's disease ( RSGE- PD scale )(Ten months)

研究者

发起方
Puerta de Hierro University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sabela Novo Ponte

Principal Investigator

Puerta de Hierro University Hospital

研究点 (2)

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