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临床试验/NCT02356536
NCT02356536已完成1 期

The Effect of a Wearable Cueing Device on Freezing of Gait in Parkinson's Disease

The University of Queensland2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年10月最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
20
试验地点
2
主要终点
Total seconds of FOG

研究概览

简要总结

The CuePeD trial is an intervention trial measuring the effectiveness of a novel treatment for Freezing of Gait (FOG) in Parkinson's disease (PD). The primary intervention is the use of a wearable cueing device (WCD), which detects and responds to FOG and extinguishes on the resumption of normal walking. It is designed for use in PD patients with FOG, in their home environment where FOG is most severe. Kinematic data will be logged by a memory card in the belt worn device recording FOG, and falls. The device will be used on 3 different settings in a gait laboratory environment, and then for 2 weeks in the patient's own home using the same 3 settings. A battery of psychometric instruments will be administered before and after the trial

详细描述

The CuePeD trial primarily involves the use of a WCD ( pictured on website www.brightdevices.com.au). This is a belt worn device, with a co-location of motion sensor input and cueing output. The input is mediated by miniaturized accelerometers and gyroscopes and utilizes software algorithms which have been developed to detect FOG. The cueing output is mediated by a laser light which shines on the floor in front of the user as a continuous visual signal. The cue is produced because of the device's ability to recognize FOG in the user. The laser is produced for a predetermined period of time or until normal gait is recommenced, at which time it extinguishes until the next freezing episode.

This study plans to examine the effectiveness of the WCD for the problem of FOG in PD 'in vivo', that is, in a community setting.

FOG has been defined narrowly as 'the sudden inability to initiate or sustain locomotion'. It includes 'start', 'turn' and 'destination' hesitation. A broader definition accepted at the 2010 workshop of clinicians and scientists interested in FOG was " brief, episodic absence or marked reduction of forward progression of the feet despite the intention to walk" . It generally occurs several years after the onset of PD and has been recognized as a significant source of morbidity in PD patients. Cueing represents one of the more promising treatments, but the demonstration of in vivo effectiveness of this intervention to date, are modest.

Falls, while often multifactorial in a general population, in PD are often attributable to FOG.

Unfortunately, current treatments for FOG are largely ineffective, and the evidence for their use limited.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Parkinson's Disease, clinically significant freezing of gait, no significant medical comorbidities

排除标准

  • Non-english speaking, dementia, wheelchair or mobility aid dependent

研究组 & 干预措施

Experimental

Experimental

干预措施: Agilitas (Device)

结局指标

主要结局

Total seconds of FOG

时间窗: 2 weeks

duration of freezing with device on versus During the 2 week home trial, Kinematic data to capture FOG duration will be logged on the device during the same time period each day with the device on different settings. Fall data will collected from 6am to 10pm. FOG episodes on all 3 settings of the device will be recorded. The primary outcome measure will be the total seconds of FOG when the device is simply recording compared with the total FOG seconds when a FOG dependent ( or continuous FOG independent) cue is provided by the device. This will be recorded by means of a microSD card within the device. The data will be downloaded once the device is returned

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

rodney marsh

Dr

The University of Queensland

研究点 (2)

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