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临床试验/NCT02098707
NCT02098707Unknown不适用

Effects of a Multidisciplinary Intensive Rehabilitation Treatment (MIRT) on Balance in Patients With Parkinson's Disease Evaluated With a Stabilometric Platform

Ospedale Generale Di Zona Moriggia-Pelascini1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
Standard deviation (SD) of trunk sway

研究概览

简要总结

Pharmacotherapy with dopaminergic medications and deep brain stimulation cannot provide significant improvements in postural instability in Parkinson's disease, whereas previous reports of physical interventions have suggested promising results. The investigators want to study the effects of the multidisciplinary intensive rehabilitation treatment (MIRT) on balance disorders in Parkinson Disease (PD).

详细描述

Pharmacotherapy with dopaminergic medications and deep brain stimulation cannot provide significant improvements in postural instability in Parkinson's disease, whereas previous reports of physical interventions have suggested promising results. The investigators want to study the effects of our multidisciplinary intensive rehabilitation treatment (MIRT) on balance disorders in PD.

PD patients in stage 3 of Hoen & Yahr will undergo clinical and instrumental evaluations at the beginning (T0) and at the end (T1) of the MIRT. Berg Balance Scale (BBS) will be performed to assess static and dynamic balance abilities. In order to determine some variables as index of postural stability, the investigators will use a stabilometric platform. With respect to the average centre of gravity the standard deviation (SD) of trunk sway will be calculated: total, in antero-posterior (AP) and in medio-lateral (ML) direction. The investigators can obtain a statokinesigram, that is the layout of a line connecting the successive positions of the center of pressure during the recording, and the area of the ellipse containing 90% of the sampled positions of the center of pressure. These measurements will be calculated with open eyes (OE), and while the patient was performing a cognitive task (open eyes counting [OEC]).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
58 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients diagnosed with PD in stage 3 of Hoen & Yahr according to the United Kingdom Brain Bank criteria.
  • Exclusion criteria:
  • Atypical parkinsonisms, patients with osteoarticular and muscular pathologies, PD patients with Mini Mental State Examination < 26, patients with other disorders of balance.

排除标准

  • 未提供

结局指标

主要结局

Standard deviation (SD) of trunk sway

时间窗: up to 4 weeks

With respect to the average centre of gravity the standard deviation (SD) of trunk sway will be calculated: total, in antero-posterior \[AP\] and in medio-lateral \[ML\] direction. We will also calculate a statokinesigram, that is the layout of a line connecting the successive positions of the center of pressure during the recording, and the area of the ellipse containing 90% of the sampled positions of the center of pressure. These measurements will be calculated with open eyes (OE), and while the patient was performing a cognitive task (counting, \[OEC\]). All physical measurements will be obtained during the ON phase of levodopa medication and at the same time of the day to reduce the influence of medication fluctuations. Statistical analysis with Wilcoxon signed rank test for non parametric data will be performed to analyze differences between T0 and T1 values of all variables. Results will be considered statistically significant for p \< 0.05.

次要结局

  • BBS scale(up to 4 weeks)

研究者

发起方
Ospedale Generale Di Zona Moriggia-Pelascini
申办方类型
Other
责任方
Sponsor

研究点 (1)

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