Parkinsonics: A Controlled Study of Group Singing for Quality of Life and Voice Outcomes in Parkinson Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Parkinson Disease Quality of Life Questionnaire (PDQ)-39 scores
研究概览
简要总结
The overall objective of this study is to observe the effect of group Vocal performance training and performance experience on patients' reported symptoms and quality of life. The effectiveness of PD medications varies significantly in different patients depending on their symptoms. By using music-based interventions to improve symptoms that may be inadequately treated by medications, the investigators hope to improve quality of life in PD patients. "Parkinsonics: A controlled study of group singing for quality of life and voice outcomes in Parkinson disease" (PD) is a controlled crossover behavioral intervention study of once weekly choral classes for patients with idiopathic PD (progressing toward a group performance) and once weekly discussion/support group meetings.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic PD based on UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria for PD (Hughes et al. 1992).
排除标准
- •Patients unable to consent to the study.
- •Patients unable or unwilling to participate in weekly singing classes for 12 weeks, or unwilling to perform in a concert setting.
- •Patients with active psychiatric disturbances (agitation, active hallucinations).
结局指标
主要结局
Parkinson Disease Quality of Life Questionnaire (PDQ)-39 scores
时间窗: Change from baseline scores at 30 weeks
Validated 39-item questionnaire
次要结局
- Voice-Related Quality of Life(Change from baseline scores at 30 weeks)
- Movement Disorder Society-Unified Parkinson Disease Rating Scale Motor scores(Change from baseline scores at 30 weeks)
- Montreal Cognitive Assessment(Change from baseline scores at 30 weeks)
- Geriatric Depression Scale-15(Change from baseline scores at 30 weeks)
- Lorig Self-efficacy scale(Change from baseline scores at 30 weeks)
- Short Form-36(Change from baseline scores at 30 weeks)
- Sound pressure level (decibels)(Change from baseline levels at 30 weeks)
- Voice jitter(Change from baseline values at 30 weeks)
- Voice shimmer(Change from baseline values at 30 weeks)
- Harmonic to noise ratio(Change from baseline values at 30 weeks)
研究者
Alex Pantelyat
Assistant Professor of Neurology
Johns Hopkins University