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临床试验/NCT02051556
NCT02051556Unknown不适用

Working on Asymmetry in Parkinson's Disease: a Double Blind, Randomized, Controlled Rehabilitation Trial.

Neuromed IRCCS2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2014年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
42
试验地点
2
主要终点
Motor Symptoms

研究概览

简要总结

Freezing of gait (FOG) is a disabling episodic gait disturbance that is common among patients with Parkinson's disease (PD). The symptoms of PD generally show an asymmetric onset and progression.

In particular, impairments in rhythmicity, symmetry, and bilateral coordination have been reported to be associated with FOG episodes. As the maintenance of gait depends on the precise alternating movements of both legs, irregularities in rhythm, symmetry, and bilateral coordination may impair gait sequence, potentially causing freezing.

Results of recent studies strongly suggest that bilateral uncoordinated gait and marked gait asymmetry are associated with FOG. Moreover, it has recently been hypothesized that this may lead to a degree of asymmetric motor function, and that FOG in parkinsonian patients is triggered by a breakdown in the bilateral co-ordination underlying the normal timing of gait. Aim of the study was to evaluate how the modulation of asymmetry through physical therapy might improve gait and FOG.

详细描述

The patients will be'blind' to the study protocol and will be randomly assigned to one of the three study arms: 1) physiotherapy aimed to potentiate the more affected body side (worst side improvement, WSI); 2) physiotherapy aimed to potentiate the less affected body side (best side improvement, BSI); 3) physiotherapy aimed to potentiate both sides equally (standard treatment, ST). Each group will be undergo physiotherapy twice a week for three months. Each session will have duration of one hour and include a first part of warming up, a final part of cooling down (these two parts are the same for all the groups) and an active part (which is different from group to group). The active part includes exercises which are alike for all the groups but with a number of repetitions different from group to group according to the aim of potentiating the most affected side (WSI) or the least affected side (BSI) or both sides equally (in this case the number of repetitions was the same for both sides; ST). Medical treatment will be kept stable through all the study duration; medications are expressed as levodopa daily dose equivalent (LEDD).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
55 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Parkinson's disease, freezing of gait history, informed consent

排除标准

  • depression, severe orthopedic diseases

结局指标

主要结局

Motor Symptoms

时间窗: 24 weeks

次要结局

  • Freezing of gait(24 weeks)

研究者

发起方
Neuromed IRCCS
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicola Modugno

MD, PhD

Neuromed IRCCS

研究点 (2)

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