Expiratory Muscle Strength Training + Voice Therapy for Vocal Cord Paralysis

Overseen By Costanza Pelusso, FMG, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: COPD, Cystic fibrosis, Uncontrolled hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding expiratory muscle strength training (EMST) can improve outcomes for individuals with vocal cord paralysis who are already receiving standard voice therapy. Researchers seek to assess whether EMST enhances breathing strength, voice quality, and overall voice-related quality of life. The trial includes different groups, such as those with vocal cord paralysis and Parkinson’s disease, to evaluate the effectiveness of the combination. Individuals with vocal problems who have completed a voice evaluation might be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance treatment options for vocal cord paralysis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have uncontrolled chronic respiratory diseases or blood pressure, you may not be eligible to participate.

What prior data suggests that this protocol is safe for individuals with vocal cord paralysis?

Research has shown that expiratory muscle strength training (EMST) is well-tolerated. Participants improved their ability to exhale forcefully by 57%, as measured by maximal expiratory pressure (MEP). This improvement indicates the treatment's safety and effectiveness.

Another study found that participants could hold a sound longer and scored better on symptom questionnaires. These results suggest that EMST can be safe and beneficial for voice and breathing exercises.

No serious safety issues have been reported in these studies, which is encouraging. While EMST is not a new treatment, its use with voice therapy remains under study. Past research has shown positive results, indicating that it is generally safe, especially under medical supervision. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines expiratory muscle strength training (EMST) with traditional voice therapy to tackle vocal cord paralysis, including cases related to Parkinson's disease. Standard voice therapy typically involves exercises for better breath control and vocal techniques, but adding EMST brings a fresh approach. EMST helps strengthen the muscles used in breathing by having participants blow into a specialized device that increases resistance as they get stronger. This novel combination aims to enhance voice therapy's effectiveness by not only improving vocal function but also potentially accelerating recovery time.

What evidence suggests that this trial's treatments could be effective for vocal cord paralysis?

Research has shown that expiratory muscle strength training (EMST) can improve voice and breathing. For example, studies have found a 57% increase in breathing muscle strength and safer swallowing after eight weeks of EMST. Another study demonstrated significant improvement in the ability to hold a voiceless "S" sound and in symptom scores with EMST. This training strengthens breathing muscles, enhancing voice control and quality. In this trial, some participants will receive standard voice therapy combined with EMST, which may help individuals with vocal cord paralysis speak more clearly and easily. ^{1 2 5 6 7}

Who Is on the Research Team?

Adam T Lloyd, SLP-D, MM, MA

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults over 18 with glottal insufficiency, who've seen a speech pathologist and otolaryngologist. They must score at least 24 on the MMSE, showing they can follow therapy instructions. It's not for those unable to consent, non-English/Spanish speakers, pregnant women, prisoners, or people with certain medical conditions like uncontrolled blood pressure or chronic respiratory diseases.

Inclusion Criteria

My mental ability to participate in therapy is confirmed by a test score.

You have a problem with the opening of your vocal cords.

I have completed a voice check with speech and throat specialists.

Exclusion Criteria

My blood pressure is not under control.

I have a stable stomach condition, except for well-managed acid reflux.

You have trouble following instructions because of a severe mental health condition like depression or psychosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard voice therapy with or without expiratory muscle strength training (EMST) for individuals with dysphonia due to glottal insufficiency

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Expiratory Muscle Strength Training (EMST)
• Standard of Care Voice Therapy

Trial Overview The study tests if adding expiratory muscle strength training (EMST) to standard voice therapy improves breathing strength and voice quality in individuals with vocal cord issues. The goal is to see better maximal expiratory pressure and voice measures such as loudness and duration of sound.

How Is the Trial Designed?

Group I: Unilateral vocal fold paralysis standard of care voice therapy Experimental Treatment 1 Intervention

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.

Group II: Unilateral paralysis standard of care voice therapy plus EMST Experimental Treatment 2 Interventions

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.

Group III: Parkinson's disease standard of care voice therapy plus EMST Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Published Research Related to This Trial

A study of 178 patients with muscle tension dysphonia (MTD) and cervicalgia showed that a specialized manual physical therapy (PT) program significantly improved voice quality, as measured by the Voice Handicap Index-10 (VHI-10).

Patients receiving concurrent PT and voice therapy (VT) experienced the greatest improvement, but PT alone also provided substantial benefits, suggesting that PT can be an effective complementary treatment for MTD patients with cervicalgia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Therapy for Muscle Tension Dysphonia with Cervicalgia. Tate, AD., Tomlinson, CA., Francis, DO., et al.[2021]

In a study of 64 head and neck cancer survivors with chronic aspiration issues, 91% had reduced maximum expiratory pressures (MEPs), indicating a need for targeted therapy.

After 8 weeks of expiratory muscle strength training (EMST), participants showed a significant 57% improvement in MEPs and enhanced swallowing safety, suggesting EMST could be an effective intervention for improving airway protection in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expiratory muscle strength training for radiation-associated aspiration after head and neck cancer: A case series. Hutcheson, KA., Barrow, MP., Plowman, EK., et al.[2019]

Expiratory muscle strength training (EMST) is a safe and effective home-based intervention for individuals with voice and swallowing disorders, showing positive results in a pilot study with 6 participants who had undergone supracricoid partial laryngectomy (SCPL).

Participants experienced a significant 21% increase in peak cough flow and a 38% reduction in dyspnea symptoms after a 4-week EMST program, indicating its potential benefits for respiratory function post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety and Efficacy of Expiratory Muscle Strength Training for Rehabilitation After Supracricoid Partial Laryngectomy: A Pilot Investigation. Palmer, AD., Bolognone, RK., Thomsen, S., et al.[2022]

In a study involving 56 participants with Parkinson's Disease, neither expiratory muscle strength training (EMST) nor sensorimotor training of airway protection (smTAP) showed significant changes in vocal fold bowing or the presence of vocal fold lesions, indicating that these treatments do not negatively impact vocal fold health.

Both EMST and smTAP were found to be safe interventions, as they did not lead to the development of vocal fold lesions despite involving forceful exhalation and repetitive coughing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cough and Swallowing Therapy and Their Effects on Vocal Fold Bowing and Laryngeal Lesions. Doruk, C., Curtis, JA., Dakin, AE., et al.[2023]

A 4-week expiratory muscle strength training program, using a pressure threshold device, showed up to a 50% improvement in respiratory muscle strength among healthy individuals and those with conditions like multiple sclerosis and spinal cord injury.

The training protocol, which involves 15-20 minutes of daily exercises five times a week, is designed to enhance expiratory muscle strength and may also positively impact functional outcomes and brain plasticity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory muscle strength training: functional outcomes versus plasticity. Sapienza, CM., Wheeler, K.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/18475074/

Respiratory Muscle Strength Training Applications Case study results of Lance Adams syndrome indicated a positive outcome for maximum phonation time and improved intelligibility ratings and communication ...

2. withpower.com withpower.com/trial/phase-dysphonia-2022-538f7

Expiratory Muscle Strength Training + Voice Therapy for ... After 8 weeks of expiratory muscle strength training (EMST), participants showed a significant 57% improvement in MEPs and enhanced swallowing safety, ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0892199718305502

The Impact of Respiratory Exercises on Voice Outcomes A study comparing singers' performances with and without voluntarily engaging respiratory support revealed an increase in acoustic power and a decrease in ...

4. emst150.com emst150.com/wp-content/uploads/2020/12/Treatment-Outcomes-for-Professional-Voice-Users.pdf

Treatment Outcomes for Professional Voice Users The use of expiratory muscle strength training (EMST) holds promise for helping profes- sional voice users to meet the increased physical demands for loudness ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26564581/

The Effects of Expiratory Muscle Strength Training on Voice ... The participants' voiceless /S/ expiratory time, symptom questionnaire scores, and MEP significantly improved after the intervention.

6. medrxiv.org medrxiv.org/content/10.1101/2020.12.20.20248589.full

Effect of Complete Respiratory Muscle Training (cRMT) on ... In this study, the overall data reveal cRMT is an effective therapy when compared to no treatment of neurogenic dysphonia following stroke.

7. pubs.asha.org pubs.asha.org/doi/10.1044/2024_AJSLP-24-00194

Voice Meets Swallowing: A Scoping Review of Therapeutic ... This scoping review aimed to explore the use of volitional voice tasks in assessing swallowing-related outcomes and to evaluate their therapeutic impact on ...