临床试验/NCT00727467

NCT00727467Unknown1 期

A Randomised Controlled Trial Evaluating the Effect of an Individual Auditory Cueing Device on Freezing and Gait Speed in People With Parkinson's Disease

University of Dublin, Trinity College3 个研究点分布在 1 个国家目标入组 47 人开始时间: 2008年9月最近更新: 2008年12月31日

适应症

试验速览

阶段: 1 期
发起方: University of Dublin, Trinity College
入组人数: 47
试验地点: 3
主要终点: Freezing of Gait Questionnaire

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary aim of the study is to evaluate the effect of an IACD i.e. Apple iPod-shuffle, on freezing and gait speed in people with a diagnosis of PD through the implementation of a randomised controlled trial. A secondary aim of the study is to evaluate the impact of such a device on the quality of life of people with stroke through the administration of a self-report questionnaire. The IACD will be pre-loaded with an individualised auditory cueing frequency (metronome sound) matched to the walking speed of the individual with PD.

详细描述

The investigators calculated and pre-loaded 100 baseline frequencies (less 10%) in the sound of a metronome beat in an MP3 format (30 - 130 BPM) [38] onto a DVD-Rom. A user manual was created with a set of instructions that gives each physiotherapist a step-by-step guide on how to calculate the correct beat for their participants and how to successfully upload this beat onto the iPod. In addition physiotherapists in participating centres attended a training session on how to complete the tasks. A pack including the DVD-Rom, user manual, information leaflet and consent was sent to participating centres. Recruitment is due to commence in September 2008.

研究设计

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

入排标准

年龄范围: 18 Years 至 90 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•medically stable
•willing to give informed consent
•freeze at least once per week (minimum score of 2 on item 3 of the FOGQ) for at least 2 seconds(minimum score of 1 on item 4 of FOGQ)
•MMSE Score greater than 24

排除标准

•attending physiotherapy at time of recruitment
•unwilling to give informed consent
•not medically stable
•cognitive impairment (MMSE score less than 24)
•acure co-morbidity that prevents mobility

结局指标

主要结局

Freezing of Gait Questionnaire

时间窗: Day 8, Day 15, Day 23 and 3 month follow up

次要结局

Timed Up and Go Test(Day 8, Day 15, Day 23 and three month follow-up)
Modified Falls Efficacy Scale(Day 8, Day 15, Day 23 and three month follow-up)
10 Metre Walk Test(Day 8, Day 15, Day 23 and three month follow-up)

研究者

发起方

University of Dublin, Trinity College

申办方类型

Other

研究点 (3)

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