Effect of Comprehensive Swallowing Rehabilitation in Patients With Multiple System Atrophy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Penetration-Aspiration Scale
研究概览
简要总结
The purpose of this study is to investigate the effect of comprehensive swallowing rehabilitation in patients with multiple system atrophy.
详细描述
Multiple system atrophy (MSA) is a rapidly progressive neurodegenerative disease characterized by parkinsonism, cerebellar syndrome, and autonomic failure. Dysphagia is a clinically significant symptom leading to pneumonia that causes death in patients with MSA. Although the symptoms of dysphagia in the two subtypes of MSA-the parkinsonian variant and the cerebellar variant- are different, there is no significant difference in the latency to onset of tube feeding. Therefore, effective intervention is needed to improve the safety and efficiency of swallowing regardless of the subtypes of MSA.
Although swallowing rehabilitation has been widely applied for swallowing disorders in patients with MSA, few studies have reported the clinical effect of applying swallowing therapy. Comprehensive swallowing rehabilitation has focused on functional muscle training, compensatory swallowing maneuvers, and thermal-tactile stimulation, which is used to treat dysphagia from stroke, Parkinson's disease, and head and neck cancer. Therefore, this study aims to investigate the effect of comprehensive swallowing rehabilitation in patients with MSA.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >19 years
- •Clinically diagnosed with MSA according to the guidelines of the 2nd consensus of the Gilman criteria
- •Clinically diagnosed to have dysphagia by a physiatrist
- •Two or more points on the Penetration-aspiration scale (PAS) from the Videofluoroscopic swallowing study (VFSS) conducted within 3 months
排除标准
- •Moderate to severe cognitive dysfunction with Mini-mental State Examination score < 19
- •Comorbidities or structural abnormalities that may affect swallowing function
- •Other comorbidities that make it difficult to participate in the study
研究组 & 干预措施
Comprehensive swallowing rehabilitation
干预措施: Comprehensive swallowing rehabilitation (Other)
Swallowing education
干预措施: Swallowing education (Other)
结局指标
主要结局
Penetration-Aspiration Scale
时间窗: at 6 weeks
Videofluoroscopic dysphagia scale
时间窗: at 6 weeks
次要结局
- Penetration-Aspiration Scale(at 12 weeks)
- Videofluoroscopic dysphagia scale(at 12 weeks)
- Peak Cough Flow(at 6 weeks, at 12 weeks)
- Maximal Inspiratory Pressure(at 6 weeks, at 12 weeks)
- Swallowing disturbance questionnaire(at 6 weeks, at 12 weeks)
- Maximal Expiratory Pressure(at 6 weeks, at 12 weeks)
- Forced vital capacity(at 6 weeks, at 12 weeks)
- Forced expiratory volume(at 6 weeks, at 12 weeks)
- Maximal phonation time(at 6 weeks, at 12 weeks)
- Swallowing Quality of Life questionnaire(at 6 weeks, at 12 weeks)
研究者
Han Gil Seo
Associate Professor
Seoul National University Hospital