The Effects of Adding Expiratory Muscle Strength Training in Voice Therapy
赞助:
University of Miami
合作者:
信息的提供 (责任方):
Adam Lloyd,University of Miami
追踪信息 | |||
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首次提交日期 ICMJE | September 26, 2018 | ||
首次发布日期e ICMJE | October 2, 2018 | ||
最后更新发布日期 | October 2, 2018 | ||
预计研究开始日期 ICMJE | November 1, 2018 | ||
预计主要完成日期 | December 1, 2020 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Maximum expiratory pressure[ Time Frame: 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[ Time Frame: 16 weeks ] Amplitude of voice, in decibels, will be measured using handheld digital SPL meter values will be compared to gender matched normative values for normal and loud volumes. |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | The Effects of Adding Expiratory Muscle Strength Training in Voice Therapy | ||
正式标题 ICMJE | The Effects of Adding Expiratory Muscle Strength Training in Voice Therapy | ||
简要概况 | 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. |
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详细说明 | |||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Not yet recruiting | ||
预计入组 ICMJE |
120 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | March 1, 2021 | ||
预计主要完成日期 | December 1, 2020 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - 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 Exclusion Criteria: - 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 | ||
性别 |
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年龄 | 最小年龄:18 Years ,最大年龄:N/A | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | |||
管理信息 | 数据检测委员会 | No | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | Adam Lloyd,University of Miami | ||
研究赞助商 ICMJE | University of Miami | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | University of Miami | ||
验证日期 | September 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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