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临床试验/NCT02727257
NCT02727257已完成不适用

The Effect of a Motor-cognitive Rehabilitation on Attention in Parkinsonian Patients

Ospedale Generale Di Zona Moriggia-Pelascini2 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
103
试验地点
2
主要终点
Multiple Choice Reaction Time task

研究概览

简要总结

In this study the Investigators explore two questions: if the attentive reaction times differs in parkinsonian patients from health controls and if an intensive, focused and aerobic rehabilitation program (Multidisciplinary Intensive Rehabilitation Treatment - MIRT) tailored mainly for motor problems, could have a specific positive effect on multiple choices Reaction Times (RTs) as an indirect marker for an effect on attentional-executive frontal circuits. The hypothesis is that the MIRT could have a positive effect on the top-down control mechanisms, since the continuous feedback given by physiotherapist during exercises and the use of cues and devices (such as treadmill plus and stabilometric platform), stimulate the selective attention processes that enable goal-directed, internally-driven decision, helping the patients to overcome externally-driven decision based on stimulus salience and novelty

详细描述

Objective

To evaluate the attentive performances in Parkinsonians in comparison with healthy controls and the effect of motor-cognitive rehabilitation program on attention.

Methods: 103 Parkinsonians (stage 2,5-3 H&Y) hospitalized for a 4-week Multidisciplinary Intensive Rehabilitation Treatment and 34 healthy controls were enrolled. All subjects underwent three different attentive tasks: visual reaction times, auditory reaction times and multiple choices reaction times tasks. To evaluate the effect of rehabilitation on attention, patients performed the same battery at discharge. To investigate the effects of MIRT on motor functions and quality of life we also assessed UPDRS III, Timed Up and Go test and Parkinson's Disease Questionnaire.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
55 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • stage 2.5-3 according to the Hoehn & Yahr scale
  • pharmacological treatment for the last 8 weeks and during the hospitalization
  • Mini Mental State Examination (MMSE) ≥ 24

排除标准

  • any focal brain lesion detected in brain imaging studies (Computed Tomography or Magnetic Resonance Imaging) performed in the previous twelve months
  • disabling drug-induced dyskinesias
  • disturbing resting and/or action tremor, corresponding to scores 2 to 4 in the specific items of Unified Parkinson's Disease Rating Scale section 3 (UPDRS III)
  • behavioral disturbances (evaluated with Neuropsychiatric Inventory)
  • visual and auditory dysfunctions according to the general clinical evaluation and medical history

结局指标

主要结局

Multiple Choice Reaction Time task

时间窗: 4 weeks

The task consisted of 40 trials. The target was a number (1, 2, 3) whose presentation, on the centre of the screen, was randomized. Each number was associated to a different response buttons . In each single trial subjects had to press as quickly as possible the response button associated with the number that appeared on the screen. We evaluated the accuracy of response and recorded the time between the appearance of target and the subject's response.

次要结局

  • Simple Choice Reaction Time task(4 weeks)

研究者

发起方
Ospedale Generale Di Zona Moriggia-Pelascini
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ilaria Zivi

MD

Ospedale Generale Di Zona Moriggia-Pelascini

研究点 (2)

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