The Effects of Adding Expiratory Muscle Strength Training in Voice Therapy

Study Overview
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Brief Summary
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Evaluate if adding expiratory muscle strength training to traditional voice therapy for individuals with dysphonia due to glottal insufficiency improves maximal expiratory pressure, acoustic and aerodynamic measures (i.e. amplitude, maximum phonation time, peak expiratory flow), and voice related quality of life.

Official Title
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The Effects of Adding Expiratory Muscle Strength Training in Voice Therapy

Conditions
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Dysphonia, Unilateral Vocal Cord Paralysis

Intervention / Treatment
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* Other: Standard of care voice therapy
* Other: Expiratory muscle strength training (EMST)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals with glottic insufficiency. Adequate cognition evidenced by score of 24 or higher on the Mini-Mental State Examination (MMSE) survey to determine if the subject has the mental capacity to participate in therapy Completed voice combination evaluation with speech pathologists and otolaryngologist. Individuals 18 years of age or older Exclusion Criteria: Adults unable to consent Non English or Spanish speakers Pregnant women Prisoners Individuals with significant uncontrolled chronic and progressive respiratory diseases including COPD, interstitial lung disease, and cystic fibrosis. Individuals with uncontrolled blood pressure. Individuals with significant GI disease and/or gastroesophageal surgery with the exception of well-controlled GERD. Individuals with a history of abdominal hernia. Individuals with difficulty complying due to neuropsychological dysfunction (e.g., severe depression, psychosis). Individuals with other neurological disorders and/or neuromuscular disease other than Parkinson's Disease

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unilateral vocal fold paralysis standard of care voice therapy<br>The participants will receive the standard of voice therapy including improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relations techniques. | Other: Standard of care voice therapy<br>* Exercises will include improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relaxation techniques to the neck and shoulder<br>|
| Experimental: Unilateral paralysis standard of care voice therapy plus EMST<br>The participants will receive the standard of voice therapy including improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relations techniques. EMST consists of blowing into respiratory device at a measure threshold pressure. As strength improves threshold resistance will be increased. | Other: Standard of care voice therapy<br>* Exercises will include improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relaxation techniques to the neck and shoulder<br>Other: Expiratory muscle strength training (EMST)<br>* EMST150 used at 75% of their maximum expiratory pressure. Participants will be directed to perform 5 sets of 5 breaths, 5 days per week, for 5 weeks, at the pressure threshold established in therapy. Maximum expiratory pressure will then be determined at the beginning of each therapy session and recalibration of the device will be performed if indicated.<br>|
| Experimental: Parkinson's disease standard of care voice therapy plus EMST<br>The participants will receive the standard of voice therapy including improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relations techniques. EMST consists of blowing into respiratory device at a measure threshold pressure. As strength improves threshold resistance will be increased. | Other: Standard of care voice therapy<br>* Exercises will include improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relaxation techniques to the neck and shoulder<br>Other: Expiratory muscle strength training (EMST)<br>* EMST150 used at 75% of their maximum expiratory pressure. Participants will be directed to perform 5 sets of 5 breaths, 5 days per week, for 5 weeks, at the pressure threshold established in therapy. Maximum expiratory pressure will then be determined at the beginning of each therapy session and recalibration of the device will be performed if indicated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum expiratory pressure | Maximum expiratory pressure, in cm of H2O, will be measured to evaluate how much pressure a participant can blow into a respiratory pressure meter. | 16 weeks | 
| Amplitude | Amplitude of voice, in decibels, will be measured using Voice Range Profile on Kay Pentax CSL and will be compared to gender matched normative values for normal and loud volumes. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fundamental frequency | Fundamental frequency, measured in herz, will be obtained using the Analysis of Dysphonia in Speech and Voice on Kay Pentax Computerized Speech Lab. | 16 weeks | 
| Dynamic pitch range | Dynamic pitch range will be measured using Voice Range Profile on Kay Pentax Computerized Speech Lab. | 16 weeks | 
| Cepstral Peak Prominence (CPP) | Cepstral Peak Prominence will be obtained using the Analysis of Dysphonia in Speech and Voice on Kay Pentax Computerized Speech Lab. | 16 weeks | 
| Cepstral spectral index of dysphonia (CSID) | Cepstral spectral index of dysphonia, will be obtained using the Analysis of Dysphonia in Speech and Voice on Kay Pentax Computerized Speech Lab. | 16 weeks | 
| Voice Handicap Index | This is quality of life assessment tool quantifying perception of the impact of their vocal disorder on various aspects of lifestyle. It is 30-questions in length and is divided into 3 subscales including emotional, physical, and functional, divided into 10 questions each. Each question scored from 0-4. Total score range from 0-120. Higher score indicates increased handicap. | 16 weeks | 
| Maximum phonation time | The patient will be asked to inhale deeply and sustain the vowel /a/ at a comfortable loudness level for a many seconds as possible. | 16 weeks | 
| Peak expiratory flow rate | Peak expiratory flow rate, measured in units of liters per minute, will be measured for purposes of measuring cough function. | 16 weeks |