Expiratory Muscle Strength Training as a Non-surgical Option for Velopharyngeal Dysfunction: A Randomized-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in oral pressure decay following 6-8 weeks of exercises compared with baseline
研究概览
简要总结
When the soft palate does not move enough because of a cleft palate or for unknown reasons, this can lead to a speech difference called velopharyngeal insufficiency. The purpose of this research study is to test if soft palate exercises using a hand help breathing device will help improve the ability of the soft palate to close the area between the throat and nose and help improve speech.
详细描述
The objective of this study is to examine the feasibility and efficacy of expiratory muscle strength training to improve velopharyngeal closure in patients with velopharyngeal dysfunction and nasal air emissions. A single-arm trial will be conducted at a cleft craniofacial center at a tertiary children's hospital. Patients will perform Expiratory Muscle Strength Training for 6 to 8 weeks. Patients with reductions in nasal resonance during this time will be further randomized to EMST maintenance training for 6 months or no exercises.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Score of 2 or greater on the nasality/resonance domain of the Pittsburgh Weighted Speech Scale
- •Ages 5-17 years
排除标准
- •CAPS-A-AM hypernasality score <2
- •Previous speech surgery (e.g. palatoplasty or pharyngeal flap for speech)
- •Speech surgery scheduled within the next 56 days
- •Unable or unwilling to perform the tests and exercises outlined in the study
研究组 & 干预措施
Expiratory Muscle Strength Training + No Maintenance Training
These participants completed 6-8 weeks of exercises with EMST-150. They had improvement in their CAPS-A hypernasality rating of 1 point or more and were randomized to complete 6 months of no maintenance training.
干预措施: Expiratory Muscle Strength Training (Device)
Expiratory Muscle Strength Training + Maintenance Training
These participants completed 6-8 weeks of exercises with EMST-150. They had improvement in their CAPS-A hypernasality rating of 1 point or more and were randomized to complete 6 months of maintenance training.
干预措施: Maintenance Training (Device)
Expiratory Muscle Strength Training + Maintenance Training
These participants completed 6-8 weeks of exercises with EMST-150. They had improvement in their CAPS-A hypernasality rating of 1 point or more and were randomized to complete 6 months of maintenance training.
干预措施: Expiratory Muscle Strength Training (Device)
Expiratory Muscle Strength Training
These participants completed 6-8 weeks of exercises with EMST-150. They did not have improvement in their CAPS-A hypernasality rating of 1 point or more and ended active study participation after the initial 6-8 weeks of exercises.
干预措施: Expiratory Muscle Strength Training (Device)
结局指标
主要结局
Change in oral pressure decay following 6-8 weeks of exercises compared with baseline
时间窗: Baseline and 6-8 weeks
Ratio of the magnitude of oral pressure decay when blowing through the EMST-150
Change in nasalance scores after 6-8 weeks of exercises compared with baseline
时间窗: Baseline and 6-8 weeks
Percent change in nasalance measured during nasometry
Change in oral pressure following 6-8 weeks of exercises compared with baseline
时间窗: Baseline and 6-8 weeks
Percent change in oral pressure achieved when blowing through the EMST-150
Change in perceptual speech symptoms of velopharyngeal dysfunction following 6-8 weeks of exercises compared with baseline
时间窗: Baseline and 6-8 weeks
Perceptual symptoms of velopharyngeal incompetence measured using the CAPS-A-AM hypernasality score, on a scale of 0-4. 0 indicates nasality that is normal for the region, 1 (borderline/minimal) suggests a minimal or inconsistent increase in nasal resonance, 2 (mild) implies hypernasality that is evident on vowels with a high tongue posture, 3 (moderate) indicates hypernasality that is perceived across all vowels, and 4 (severe) signifies that hypernasality is evident in voiced consonants and all vowels.
Change in velopharyngeal flutter following 6-8 weeks of exercises compared with baseline
时间窗: Baseline and 6-8 weeks
Change in percentage of participants with oscillating oral pressure when blowing through the EMST-150
次要结局
- Resolution of type B tympanogram following 6-8 weeks of exercises compared with baseline.(Baseline and 6-8 weeks)
- Change in VELO questionnaire scores following 6-8 weeks of exercises compared with baseline(Baseline and 6-8 weeks)
- Resolution of type C tympanogram following 6-8 weeks of exercises compared with baseline.(Baseline and 6-8 weeks)
- Resolution of effusion following 6-8 weeks of exercises compared with baseline.(Baseline and 6-8 weeks)
- Resolution of retraction following 6-8 weeks of exercises compared with baseline.(Baseline and 6-8 weeks)
研究者
Noel Jabbour
Associate Professor
University of Pittsburgh