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 (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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
At visit 1, participants will be block randomized based on PWSS score (5-6 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) CAPS-A hypernasality rating of 1 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)
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
RECRUITINGChange in nasalance scores after 6-8 weeks of exercises compared with baseline
Percent change in nasalance measured during nasometry
Time frame: 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 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and 6-8 weeks
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
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: Baseline and 6-8 weeks
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