Effects of Behavioral Interventions Based on Sensory Cues on Freezing of Gait in Parkinson's Disease After Subthalamic Nucleus Stimulation
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Change from baseline to 4-week f/u in FOG-Q subscore (Q4+Q5+Q6)
研究概览
简要总结
The investigators aims to assess the effectiveness of behavioral interventions based on sensory cues on freezing of gait in patients with Parkinson's disease after bilateral subthalamic nucleus deep brain stimulation.
详细描述
Freezing of gait (FOG) leads to falling and is one of the major determinants of quality of life and prognosis in Parkinson's disease (PD). Previous evidence suggests that subthalamic nucleus deep brain stimulation (STN-DBS) improve off-medication FOG but not on-medication FOG in patients with PD. Furthermore, off-mediation FOG persist or even worsen after STN-DBS in some PD patients.
Although visual and auditory cues are known to improve FOG in research setting, it is unclear whether these cues are effective for FOG in real clinical setting. Most previous studies have used wearable devices to use sensory cues, but such devices are difficult to apply in clinical practice.
Therefore, this study aims to investigate the effectiveness of behavioral interventions based on visual and auditory cues in patients with PD after bilateral STN-DBS. Participants undergo clinical evaluations including the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Frontal Assessment Battery (FAB), Unified Parkinson 's Disease Rating Scale (UPDRS), Freezing of Gait-Questionnaire (FOG-Q), and the average number of falling over the last week. Then, participants receive behavior intervention training that includes how to apply visual and auditory cues to freezing of gait in real clinical practice. To investigate the education effect, FOG-Q and the average number of falling over the last week are repetitively assessed at 2-week and 4-week follow-ups using a phone call.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Parkinson's disease who are aged 30 years or older
- •Patients who underwent bilateral subthalamic nucleus deep brain stimulation
- •Patients who complain of freezing of gait
排除标准
- •Patients who have already used sensory cues for freezing of gait in clinical practice
- •Patients with MMSE scores of 18 or lower
- •Patients with Hoehn-Yahr scale 5
- •Patients who have neurological symptoms associated with neurological disorders other than Parkinson's disease
结局指标
主要结局
Change from baseline to 4-week f/u in FOG-Q subscore (Q4+Q5+Q6)
时间窗: baseline, after 4 weeks
The FOG-Q will be used to determine the efficacy of behavior intervention based on sensory cues.
Change from baseline to 4-week f/u in the number of falling
时间窗: baseline, after 4 weeks
We will ask about the average number of falling over the last week at baseline and at 4-week f/u.
次要结局
- Change from baseline to 4-week f/u in FOG-Q total score(baseline, after 4 weeks)
- Change from baseline to 2-week f/u in FOG-Q subscore (Q4+Q5+Q6)(baseline, after 2 weeks)
- Change from baseline to 2-week f/u in the number of falling(baseline, after 2 weeks)
- Change from baseline to 2-week f/u in FOG-Q(baseline, after 2 weeks)
研究者
BS Jeon
Professor
Seoul National University Hospital