NCT03692494撤回不适用
The Effects of Adding Expiratory Muscle Strength Training in Voice Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Maximum expiratory pressure
研究概览
简要总结
Evaluate if adding expiratory muscle strength training to traditional voice therapy for individuals with dysphonia due to glottal insufficiency improves maximal expiratory pressure, acoustic and aerodynamic measures (i.e. amplitude, maximum phonation time, peak expiratory flow), and voice related quality of life.
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
- Double (Participant, Outcomes Assessor)
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
- •Individuals with glottic insufficiency.
- •Adequate cognition evidenced by score of 24 or higher on the Mini-Mental State Examination (MMSE) survey to determine if the subject has the mental capacity to participate in therapy
- •Completed voice combination evaluation with speech pathologists and otolaryngologist.
- •Individuals 18 years of age or older
排除标准
- •Adults unable to consent
- •Non English or Spanish speakers
- •Pregnant women
- •Prisoners
- •Individuals with significant uncontrolled chronic and progressive respiratory diseases including COPD, interstitial lung disease, and cystic fibrosis.
- •Individuals with uncontrolled blood pressure.
- •Individuals with significant GI disease and/or gastroesophageal surgery with the exception of well-controlled GERD.
- •Individuals with a history of abdominal hernia.
- •Individuals with difficulty complying due to neuropsychological dysfunction (e.g., severe depression, psychosis).
- •Individuals with other neurological disorders and/or neuromuscular disease other than Parkinson's Disease
结局指标
主要结局
Maximum expiratory pressure
时间窗: 16 weeks
Maximum expiratory pressure, in cm of H2O, will be measured to evaluate how much pressure a participant can blow into a respiratory pressure meter.
Amplitude
时间窗: 16 weeks
Amplitude of voice, in decibels, will be measured using Voice Range Profile on Kay Pentax CSL and will be compared to gender matched normative values for normal and loud volumes.
次要结局
- Dynamic pitch range(16 weeks)
- Voice Handicap Index(16 weeks)
- Peak expiratory flow rate(16 weeks)
- Cepstral Peak Prominence (CPP)(16 weeks)
- Cepstral spectral index of dysphonia (CSID)(16 weeks)
- Fundamental frequency(16 weeks)
- Maximum phonation time(16 weeks)
研究者
Adam Lloyd
Speech Pathologist
University of Miami
研究点 (2)
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