Expiratory Muscle Strength Training for Hypernasal Speech in Children
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 (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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Expiratory Muscle Strength Training + 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 no maintenance training. |
Device: Expiratory Muscle Strength Training
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.
Other Names:
|
| No Intervention: No Exercises 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 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
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.
Other Names:
Device: Maintenance Training
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)
|
| Experimental: 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. |
Device: Expiratory Muscle Strength Training
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 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 Pittsburgh Weighted Speech Score, on a scale of 0-23, with ≥7 indicating likely velopharyngeal incompetence
- 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 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
- 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 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).
- 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
Other Outcome Measures
- Change in nasalance scores after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises [6-8 weeks and 8 months]
Percent change in nasalance measured during nasometry
- Change in perceptual speech symptoms of velopharyngeal dysfunction after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises [6-8 weeks and 8 months]
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 [6-8 weeks and 8 months]
Percent change in pressure achieved when blowing through the EMST-150
- Change in velopharyngeal flutter after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises [6-8 weeks and 8 months]
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 [6-8 weeks and 8 months]
Ratio of the magnitude of oral pressure decay when blowing through the EMST-150
- Prevalence of surgical intervention [1 year]
Percentage of patients undergoing surgical intervention for speech symptoms within the 1 year following enrollment
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | United States | 15224 |
Sponsors and Collaborators
- Noel Jabbour
- National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
- Principal Investigator: Noel Jabbour, MD, University of Pittsburgh
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY21120032
- 5R21DC017553-03