Yi Jin Jing Tiger Roaring Speech Rehabilitation With Real-Time Feedback Technique for Treatment of Speech Disorders in Parkinson's Disease: A Perspective Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Differences in Voice Handicap Index (VHI) between treatment conditions in the on- and off- medication states
研究概览
简要总结
Speech disorders affect more than 90% of patients with Parkinson's disease (PD). Neither of conventional drugs nor surgery can effectively improve speech function. Western speech rehabilitation is effective for speech disorders, but the domestic use of those methods used is limited. Our preliminary results revealed that traditional Chinese Yi jin jing tiger roaring speech rehabilitation is effectively in the treatment of speech disorders in PD, however, high-quality clinical evidence is still scarce. In order to solve this problem, we will conduct a prospective cohort study to explore the effects of Yi Jin Jing tiger roaring speech rehabilitation with real-time feedback technique on speech disorders in PD patients. This study will help to establish a set of Chinese Medicine treatment and objective evaluation methods for PD speech disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with idiopathic Parkinson's disease
- •Native language is Chinese
- •VHI-10 score more than 10
- •informed consent
排除标准
- •Previous or concurrent medical history affecting swallowing function (laryngeal diseases such as vocal nodules, gastroesophageal reflux, and laryngeal cancer).
- •History of serious psychosis
- •Diagnosed by the investigators that patients with severe cardiac, liver and kidney diseases, or other serious health conditions
- •Dementia (A Mini-Mental State Examination (MMSE) score of < 24), inability to comprehend the experimental protocol or voluntarily provide informed consent
- •Lack of cooperation
- •Additional reasons for exclusion at the discretion of the clinical investigator
结局指标
主要结局
Differences in Voice Handicap Index (VHI) between treatment conditions in the on- and off- medication states
时间窗: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
The Voice Handicap Index is a self-administered instrument, comprising 30 items on voice-related dysfunction. VHI has a range of 0 (normal voice function) to 120 (severe voice dysfunction).
次要结局
- Differences in voice parameters between treatment conditions in the on- and off- medication states(Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks)
- Differences in Burg Balance Scale (BBS) scores between two treatment conditions in the on- and off- medication states.(Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks)
- Differences in Beck Depression Inventory (BDI) scores between Treatment conditions.(Baseline, 4 weeks)
- Differences in Beck Anxiety Inventory (BAI) scores between treatment conditions.(Baseline, 4 weeks)
- Differences in Swallowing Disturbance Questionnaire (SDQ) scores between treatment conditions in the on- and off- medication states.(Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks)
- Differences in Water Swallow Test (WST) scores between treatment conditions in the on- and off- medication states.(Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks)
- Differences in 8-item Parkinson's Disease Questionnaire (PDQ-8) scores between treatment conditions.(Baseline, 4 weeks)