Expiratory Muscle Strength Training for Hypernasal Speech in Children
- Conditions
- Inadequate Velopharyngeal ClosurePalatopharyngeal IncompetenceHypernasalityVelopharyngeal InsufficiencyVelopharyngeal Incompetence Due to Cleft Palate
- Interventions
- Device: Expiratory Muscle Strength TrainingDevice: Maintenance Training
- Registration Number
- NCT05492266
- Lead Sponsor
- Noel Jabbour
- Brief Summary
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.
- Detailed Description
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 randomized, controlled trial will be conducted at a cleft craniofacial center at a tertiary children's hospital. Patients will be block randomized based on Pittsburgh Weighted Speech Scale (PWSS) score (5-6 or 7+) to Expiratory Muscle Strength Training for 6 to 8 weeks or no exercises. Patients with reductions in nasal resonance during this time will be further randomized to EMST maintenance training for 6 months or no exercises.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Pittsburgh weighted speech scores of 5 or greater
- Ages 5-17 years
- CAPS-A-AM hypernasality score <2
- Previous speech surgery (e.g. palatoplasty or pharyngeal flap)
- Speech surgery scheduled within the next 56 days
- Unable or unwilling to perform the tests and exercises outlined in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Expiratory Muscle Strength Training + Maintenance Training Expiratory Muscle Strength Training These participants were initially randomized to complete 6-8 weeks of exercises with EMST-150. They had improvement in their speech score of 2 points or more and were randomized to complete 6 months of maintenance training. Expiratory Muscle Strength Training + Maintenance Training Maintenance Training These participants were initially randomized to complete 6-8 weeks of exercises with EMST-150. They had improvement in their speech score of 2 points or more and were randomized to complete 6 months of maintenance training. Expiratory Muscle Strength Training + No Maintenance Training Expiratory Muscle Strength Training These participants were initially randomized to complete 6-8 weeks of exercises with EMST-150. They had improvement in their speech score of 2 points or more and were randomized to complete 6 months of no maintenance training. Expiratory Muscle Strength Training Expiratory Muscle Strength Training These participants were initially randomized to complete 6-8 weeks of exercises with EMST-150. They did not have improvement in their speech score of 2 points or more and ended active study participation after the initial 6-8 weeks of exercises.
- Primary Outcome Measures
Name Time Method Change in nasalance scores after 6-8 weeks of exercises compared with baseline 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 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 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 Baseline and 6-8 weeks Change in percentage of participants with oscillating oral pressure when blowing through the EMST-150
Change in oral pressure decay following 6-8 weeks of exercises compared with baseline Baseline and 6-8 weeks Ratio of the magnitude of oral pressure decay when blowing through the EMST-150
- Secondary Outcome Measures
Name Time Method Resolution of type B tympanogram following 6-8 weeks of exercises compared with baseline. Baseline and 6-8 weeks Percentage of participants with a change in tympanogram type from type B (flat) to type A (normal middle ear function).
Change in VELO questionnaire scores following 6-8 weeks of exercises compared with baseline Baseline and 6-8 weeks Percent change in Velopharyngeal Insufficiency (VPI) Effects on Life Outcomes (VELO) scores. Scores range from 0 - 100, with 100 representing the highest QOL
Resolution of type C tympanogram following 6-8 weeks of exercises compared with baseline. Baseline and 6-8 weeks Percentage of participants with a change in tympanogram type from type C (negative pressure) to type A (normal middle ear function).
Resolution of effusion following 6-8 weeks of exercises compared with baseline. Baseline and 6-8 weeks Percentage of participants with resolution of middle ear effusion based on otoscopy.
Resolution of retraction following 6-8 weeks of exercises compared with baseline. Baseline and 6-8 weeks Percentage of participants with resolution of tympanic membrane retraction based on otoscopy
Trial Locations
- Locations (1)
UPMC Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States