Expiratory Muscle Strength Training for Hypernasal Speech in Children

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

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.

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.

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

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.

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.

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.

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.

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.

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)

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

Change in percentage of participants with oscillating oral pressure when blowing through the EMST-150

Percent change in Velopharyngeal Insufficiency (VPI) Effects on Life Outcomes (VELO) scores. Scores range from 0 - 100, with 100 representing the highest QOL

Percentage of participants with a change in tympanogram type from type B (flat) to type A (normal middle ear function).

Percentage of participants with a change in tympanogram type from type C (negative pressure) to type A (normal middle ear function).

Change in nasalance scores after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises

Change in perceptual speech symptoms of velopharyngeal dysfunction after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises

Perceptual symptoms of velopharyngeal incompetence measured using the Pittsburgh Weighted Speech Score, on a scale of 0-23, with ≥7 indicating likely velopharyngeal incompetence

Change in oral pressure after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises

Change in velopharyngeal flutter after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises

Change in percentage of participants with oscillating oral pressure when blowing through the EMST-150

Change in oral pressure decay after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises

Percentage of patients undergoing surgical intervention for speech symptoms within the 1 year following enrollment

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

Individual participant data (IPD) that underlie the results reported in a publication may be shared, after de-identification.

IPD will be shared with researchers who provide a methodologically sound proposal. IPD to be shared will include that necessary to achieve the aims in the approved proposal. Proposals should be directed to shafferad@upmc.edu. To gain access, data requestors will need to sign data access agreement.