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临床试验/NCT04181918
NCT04181918Unknown不适用

Action Observation Treatment and Motor Imagery as Rehabilitation Tools in Parkinson's Disease Patients

Fondazione Don Carlo Gnocchi Onlus2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年3月26日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
change in Parkinson disease motor symptoms

研究概览

简要总结

The aim of the study is to assess the role of Action Observation Treatment (AOT) and Motor Imagery (MI) in the rehabilitation of Parkinson's disease patients, as compared to a control condition. Main outcome measures will be the results in two functional scales (FIM, UPDRS) and kinematics parameters obtained from gait analysis. Data at two months and six months follow up, respectively, will be also collected.

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 (Participant, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Parkinson disease patients on Hoehn and Yahr 3-4

排除标准

  • Mini-Mental State Examination < 24
  • Fluent aphasic patients
  • major neuropsychiatric disorders

结局指标

主要结局

change in Parkinson disease motor symptoms

时间窗: Before treatment, within one week after treatment, two months' follow up

to assess the change in motor status of the patient, the Unified Parkinson's Disease Rating Scale (UPDRS) will be used, and it consists in a 5-point scale (0 = no signs; 4 = severe). UPDRS will be administered before treatment, within one week after the end of the treatment (after treatment) and two months' follow up.

change in the functional status of the patient

时间窗: Before treatment, within one week after treatment, two months' follow up

to assess the change in the functional status of the patient, the Functional Independence Measure (FIM) will be used. FIM consists in a 7-point scale (1 = \<25% independence; total assistance required, 7 = 100% independence), and it can detect changes in the patient's status in 18 categories, focusing on motor and cognitive function. Functional patients' status will assess before treatment, within one week after the end of the treatment (after treatment) and two months' follow up.

change in kinematic parameters of the gait (velocity, footing, pace, step length)

时间窗: Before treatment, within one week after treatment, two months' follow up

to assess the change of patient's gait parameters, the kinematic analysis will be used (i.e. gait analysis). The gait analysis allows to detect fine-grain changes in kinematic parameters of the movement, through a non-invasive methodology. Gait analysis will be performed before treatment, within one week after the end of the treatment (after treatment) and two months' follow up.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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