跳至主要内容
临床试验/NCT00322426
NCT00322426Unknown不适用

Effect of Randomized Patient-Triggered Sensory Cues for Freezing of Gait in Parkinson's Disease

Austin Health2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2006年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
Austin Health
入组人数
20
试验地点
2
主要终点
Total walking time

研究概览

简要总结

The purpose of this study is (1) to determine if patient triggered sensory(auditory, visual and tactile) cues can help treat freezing of gait in Parkinson's disease, and (2) to assess if unexpected (randomized) cues are more effective than anticipated ones.

详细描述

Freezing of gait (FOG) is defined as a transient halt in motor activity, wherein the patient appears "as if nailed to the floor." It is a common phenomenon in Parkinson's disease (PD), both when medications are at their peak ("on state") and at their lowest effectiveness ("off state"). While "off" FOG often responds to dopaminergic medications, "on" FOG is a difficult to treat, causing significant distress for the patient, and elevating risk of falls and morbidity.

A few small studies have suggested that auditory and visual sensory cues, in the form of continuous stimuli such as a clicking metronome, music, or horizontal lines drawn the floor, may help patients with gait freezing. In this study, we aim to: (1) evaluate if stimuli (including visual, auditory as well as tactile cues) which are present only on patient triggering are effective for FOG in PD; (2) investigate if presentation of unexpected cues, in the form of randomized sensory stimuli, are more effective that anticipated cues.

Participants will include patients diagnosed with PD, stabilized on drug therapy, with adequate vision, hearing, and mentation to respond to cuing, and experiencing "on" FOG. Patients will be evaluated during a single session. A small device which we have developed will be placed around the neck, and emit either repetitive beeping, a flashing line on the floor, or a slight vibration felt over the neck when the patient presses a button on the front panel in response to FOG. Participants will be videotaped walking a 15 m strip with: (1) no cues; (2) auditory cues only; (3) visual cues only; (4) tactile cues only; and (5) randomized cues. The order in which patients receive the cues will be randomized.

A reviewer will watch the videotape with sound off so that they will be blinded to the cues. The Total Time, Freezing Time (duration of walk in which patient experiences freezing, Walking Time (duration of walk during which patient is not experiencing freezing), and Average Duration of Freeze will be recorded for each walk.

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
Single

入排标准

年龄范围
40 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Currently living in Melbourne, Australia (note that we cannot respond to enquiries from outside of this area)
  • Confirmed diagnosis of Parkinson's disease
  • Stabilized drug therapy for at least 1 month prior to the study and during
  • Hearing and vision - Able to identify lines on floor, hear metronome
  • MMSE >24
  • Able to walk independently (with or without a mechanical aid)
  • Able to give informed consent

排除标准

  • Severe comorbidity (joint problems, neuromuscular disorder affecting mobility)
  • Severe dyskinesias

结局指标

主要结局

Total walking time

Number of freezes

Freeze time - duration of walk in which patient experiences freezing

Walking time - duration of walk during which patient is not experiencing freezing

Average duration of freeze

次要结局

未报告次要终点

研究者

发起方
Austin Health
申办方类型
Other Gov

研究点 (2)

Loading locations...

相似试验