Expiratory Muscle Strength Training for Hypernasal Speech in Children

Study Overview
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Brief Summary
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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
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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 (3-6 or 7+) to Expiratory Muscle Strength Training for 6 to 8 weeks or no exercises. Patients with reductions in PWSS during this time will be further randomized to EMST maintenance training for 6 months or no exercises.

Official Title
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Expiratory Muscle Strength Training as a Non-surgical Option for Velopharyngeal Dysfunction: A Randomized-controlled Trial

Conditions
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Velopharyngeal Insufficiency, Velopharyngeal Incompetence Due to Cleft Palate, Inadequate Velopharyngeal Closure, Palatopharyngeal Incompetence, Hypernasality

Intervention / Treatment
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* Device: Expiratory Muscle Strength Training
* Device: Maintenance Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pittsburgh weighted speech scores of 3 or greater Ages 5-17 years Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Expiratory Muscle Strength Training + No Maintenance Training<br>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. | Device: Expiratory Muscle Strength Training<br>* At visit 1, participants will be block randomized based on PWSS score (3-6 or 7+) to Expiratory Muscle Strength Training (EMST) for 6 to 8 weeks or no exercises. Participants in the EMST-150 group will perform 5 sets of 5 resistive expirations once a day with a 10-15 second rest between each repetition and a 1-2 minute rest between each set of 5 repetitions.<br>* Other names: EMST-150;|
| No Intervention: No Exercises<br>These participants were initially randomized to 6-8 weeks of no exercises. They ended active study participation after the initial 6-8 weeks of no exercises. They were not eligible to be randomized to maintenance training or no maintenance training. | |
| Experimental: Expiratory Muscle Strength Training + Maintenance Training<br>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. | Device: Expiratory Muscle Strength Training<br>* At visit 1, participants will be block randomized based on PWSS score (3-6 or 7+) to Expiratory Muscle Strength Training (EMST) for 6 to 8 weeks or no exercises. Participants in the EMST-150 group will perform 5 sets of 5 resistive expirations once a day with a 10-15 second rest between each repetition and a 1-2 minute rest between each set of 5 repetitions.<br>* Other names: EMST-150;Device: Maintenance Training<br>* At visit 2, participants with improved (decreased) PWSS of 2 or more points, for whom the family and/or surgeon is not currently considering surgical intervention for VPI, will be further randomized to continue maintenance EMST exercises or no exercises for 6 months. Participants in the maintenance group will complete 3-5 sessions exercise sessions each week (rather than daily training), with 2 sets of 5 resistive expirations (rather than 5 sets)<br>|
| Experimental: Expiratory Muscle Strength Training<br>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. | Device: Expiratory Muscle Strength Training<br>* At visit 1, participants will be block randomized based on PWSS score (3-6 or 7+) to Expiratory Muscle Strength Training (EMST) for 6 to 8 weeks or no exercises. Participants in the EMST-150 group will perform 5 sets of 5 resistive expirations once a day with a 10-15 second rest between each repetition and a 1-2 minute rest between each set of 5 repetitions.<br>* Other names: EMST-150;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in nasalance scores after 6-8 weeks of exercises compared with baseline | Percent change in nasalance measured during nasometry | Baseline and 6-8 weeks | 
| Change in perceptual speech symptoms of velopharyngeal dysfunction following 6-8 weeks of exercises compared with baseline | Perceptual symptoms of velopharyngeal incompetence measured using the Pittsburgh Weighted Speech Score, on a scale of 0-23, with ≥7 indicating likely velopharyngeal incompetence | Baseline and 6-8 weeks | 
| Change in oral pressure following 6-8 weeks of exercises compared with baseline | Percent change in oral pressure achieved when blowing through the EMST-150 | Baseline and 6-8 weeks | 
| Change in velopharyngeal flutter following 6-8 weeks of exercises compared with baseline | Change in percentage of participants with oscillating oral pressure when blowing through the EMST-150 | Baseline and 6-8 weeks | 
| Change in oral pressure decay following 6-8 weeks of exercises compared with baseline | Ratio of the magnitude of oral pressure decay when blowing through the EMST-150 | Baseline and 6-8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in VELO questionnaire scores following 6-8 weeks of exercises compared with baseline | Percent change in Velopharyngeal Insufficiency (VPI) Effects on Life Outcomes (VELO) scores. Scores range from 0 - 100, with 100 representing the highest QOL | Baseline and 6-8 weeks | 
| Resolution of type B tympanogram following 6-8 weeks of exercises compared with baseline. | Percentage of participants with a change in tympanogram type from type B (flat) to type A (normal middle ear function). | Baseline and 6-8 weeks | 
| Resolution of type C tympanogram following 6-8 weeks of exercises compared with baseline. | Percentage of participants with a change in tympanogram type from type C (negative pressure) to type A (normal middle ear function). | Baseline and 6-8 weeks | 
| Resolution of effusion following 6-8 weeks of exercises compared with baseline. | Percentage of participants with resolution of middle ear effusion based on otoscopy. | Baseline and 6-8 weeks | 
| Resolution of retraction following 6-8 weeks of exercises compared with baseline. | Percentage of participants with resolution of tympanic membrane retraction based on otoscopy | Baseline and 6-8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cleft Palate, Speech Intelligibility