An Open Label Study to Assess the Efficacy of Visual Cues in the Form of the Laser Cane or the U-Step Walker With Laser Accessory in Parkinson's Disease Patients Who Experience Freezing of Gait.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Mean Change From Baseline (Visit 1 Until Visit 2) to Endpoint (After Visit 2 Until Visit 3) in the Freezing of Gait Questionnaire Score.
研究概览
简要总结
The purpose of this study is to gather data to see if the Laser Cane and/or U-Step Walker with laser accessory is more effective in aiding with gait freezing than a regular cane/U-Step Walker in patients who have idiopathic Parkinson's disease.
详细描述
Freezing of gait is a significant clinical problem in Parkinson's disease (PD). It interferes with daily functioning and quality of life and often results in falls that potentially can inflict serious injury. In recent years, much more attention has been focused on the clinical characteristics of gait freezing, the severity of falls that can result, and the use of visual cues as a possible treatment in order to understand the implications of episodic freezing. Few clinical studies have been done to confirm the clinical observations to date. The laser cane is a device that has been used and prescribed in movement disorder centers as the only form of treatment for freezing of gait. Although it has been shown to be effective in many cases, there is no published data to support what has been observed in the clinic. The proposed study seeks to clarify unanswered questions regarding the laser cane and its efficacy in aiding with episodic gait freezing and falls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects or a designated proxy have given informed consent
- •Subject has been diagnosed with idiopathic Parkinson's disease
- •Subject is ambulatory. If a wheelchair is used part-time, it must be used for less than 50% of the time
- •Positive assessment for Questionnaire Used to Identify Freezing of Gait in PD Patients at subject's best "on"
排除标准
- •Presence of atypical features suggestive of MSA, PSP, ataxia, unexplained or prominent pyramidal signs, and/or autonomic dysfunction
- •Subjects who are non-ambulatory more than 50% of the time
- •Subjects who have had a history of syncope in the 6 months prior to screening
- •Subjects with moderate or advanced dementia
研究组 & 干预措施
1 mo baseline
1 mo baseline before visual cue: Cane or walker, no laserlight visual cue x 1 mo; + laserlight visual cue for 2nd mo
干预措施: 1 mo baseline before visual cue (Device)
2 month baseline
Cane or walker, no laserlight visual cue x 2 mo, + laserlight visual cue for 3rd mo
结局指标
主要结局
Mean Change From Baseline (Visit 1 Until Visit 2) to Endpoint (After Visit 2 Until Visit 3) in the Freezing of Gait Questionnaire Score.
时间窗: 2-3 months
The FOGQ has a minimum of 0 and max of 4 for each question, with 4 representing more severe freezing of gait. There are 6 questions, so the total score ranges from 0 to 24. It was pre-specified that all 26 subjects were treated as a single group with respect to the primary outcome measure regardless of whether or not they had a 1 month or 2 month baseline period.
次要结局
- Mean Change in Time to Perform the Timed Gait Test With vs Without the Laser Feature(2-3 months)
- Mean Change in Number of Falls Without Versus With the Laserlight Visual Cue.(2-3 months)
- Percentage Change in Falls(1 to 2 months)
研究者
David K. Simon
Associate Professor of Neurology
Beth Israel Deaconess Medical Center