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临床试验/NCT02438124
NCT02438124Unknown不适用

Rhythmic Auditory Stimulation Optimalization for Gait Improvement in Parkinson's

University Hospital, Montpellier3 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2014年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
80
试验地点
3
主要终点
gait velocity

研究概览

简要总结

The beneficial effects of rhythmical auditory stimulation (RAS) on spatio-temporal gait characteristics in Parkinson's disease (PD) are attested by clinical research.

Nonetheless, it is still unclear which auditory information parameters (i.e. complexity, temporal regularity or adaptability to gait) maximize the effectiveness of RAS.

Objectives: To evaluate the beneficial effects of RAS on spatio-temporal gait characteristics in PD patients with gait disorders according to:

  • RAS complexity (i.e. metronome, amplitude modulated noise, music)
  • RAS variability (i.e fixed, random, semi-random)
  • RAS adapted in real-time to gait

Variability study:

To study the impact of RAS variability (i.e fixed, random, semi-random) in 20 PD patients and 20 healthy controls on spatio-temporal gait characteristics with metronome, amplitude noise and music.

Adaptability studyTo study the impact of RAS adaptability (i.e fixed, random, adapted in real-time to gait) in 20 PD patients and 20 healthy controls on spatio-temporal gait characteristics with metronome, amplitude noise and music.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •to be able to understand the study aims and to agree to participate
  • •to have signed the consent form
  • •to be registered to social security system
  • •to reach the diagnosis criteria of idiopathic PD (Queen Square Brain Bank)
  • •gait disorder clinically observable

排除标准

  • •pregnant or lactating woman
  • •high probability of non-compliance
  • •curators , authorship or advisers to person of full age Specific exclusion criteria for PD patients
  • •clinical signs of parkinsonian syndrome
  • •Mini Mental State Examination < 24/30 Specific exclusion criteria for controls
  • •neurological disease
  • •gait disorder

研究组 & 干预措施

Patient

Experimental

Patient with Parkinson's Disease with walking test and neuropsychological evaluation

干预措施: Neuropsychological evaluation (Behavioral)

Contrôle

Experimental

normal control with walking test and neuropsychological evaluation

干预措施: Neuropsychological evaluation (Behavioral)

结局指标

主要结局

gait velocity

时间窗: 2 days

evaluation of walking speed between the different conditions

次要结局

  • spatio-temporal gait characteristics(2 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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