Investigating the Efficacy of Vocal Function Exercises in the Treatment of Voice Problems in Adults Treated With Radiation Therapy for Laryngeal Cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Voice production
研究概览
简要总结
The purpose of this study is to determine if the systematic practice of Vocal Function Exercises (VFE) improves selected measures of voice production in participants who have previously been irradiated for early glottic cancers compared to participants who receive the present standard of care, namely, vocal hygiene counseling. It is hypothesized that a prescriptive vocal exercise program (VFE) will improve the voice production of individuals who have been previously treated for laryngeal cancers when compared to participants who receive vocal hygiene alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (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
- •Hearing level and cognitive ability to follow test directions
- •Laryngeal cancer
- •Radiation Therapy completed >= 6 months
- •Deemed disease free by the treating physician
- •Subjects have to be willing to attend weekly voice therapy sessions
排除标准
- •Adjuvant treatment: laser or any surgical intervention
- •Neurological or cognitive impairment
- •Hearing levels that interfere with following test instruction
- •Vocal fold paralysis
研究组 & 干预措施
Vocal Function Exercises
Vocal Function Exercises
干预措施: Vocal Function Exercises (Procedure)
Vocal hygiene
Vocal hygiene
干预措施: Vocal Hygiene (Procedure)
结局指标
主要结局
Voice production
时间窗: 6 weeks
Voice Handicap Index, a validated self- assessment tool was used as the primary outcome measure. A score of 0 indicates no handicap, and a score of 120 indicates complete impairment. Data will be presented as pre and post treatment score (pre and post 6 weeks of therapy).
次要结局
未报告次要终点
研究者
Vrushali Angadi
Principal Investigator
University of Kentucky