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

Trial Summary

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 data supports the effectiveness of the treatment Expiratory Muscle Strength Training (EMST) and Standard of Care Voice Therapy for Vocal Cord Paralysis?

Research on vocal rehabilitation for paralytic dysphonia shows that voice therapy can significantly improve voice quality, pitch, and breath support, with excellent results in most patients. This suggests that combining voice therapy with Expiratory Muscle Strength Training could be beneficial for vocal cord paralysis. ^{1 2 3 4 5}

Is Expiratory Muscle Strength Training (EMST) safe for humans?

Expiratory Muscle Strength Training (EMST) has been used safely in various populations, including those with multiple sclerosis, spinal cord injury, and Parkinson's disease, without reports of harmful effects. It is generally considered safe for improving muscle strength and function. ^{1 6 7 8 9}

How does Expiratory Muscle Strength Training + Voice Therapy differ from other treatments for vocal cord paralysis?

This treatment is unique because it combines expiratory muscle strength training (EMST), which is a simple, home-based exercise therapy, with standard voice therapy to potentially enhance voice and swallowing function. EMST has been shown to be effective in other voice and swallowing disorders, making it a novel addition to traditional voice therapy for vocal cord paralysis. ^{1 10 11 12 13}

What is the purpose of this trial?

This trial tests if adding breathing muscle exercises to regular voice therapy helps people with voice problems due to vocal cords not closing properly. The goal is to see if it improves their breath control, speaking ability, and overall voice quality.

Research Team

Adam T Lloyd, SLP-D, MM, MA

Principal Investigator

University of Miami

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Combining voice therapy and physical therapy: A novel approach to treating muscle tension dysphonia. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Physical Therapy for Muscle Tension Dysphonia with Cervicalgia. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Maximum vocal intensity as a primary outcome measure in unilateral vocal fold paralysis patients. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Bi-Weekly Voice Therapy Versus Weekly Voice Therapy for Muscle Tension Dysphonia. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Rehabilitation of paralytic dysphonia. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Intensive Voice Therapy Versus Weekly Therapy for Muscle Tension Dysphonia: A Noninferiority Randomised Controlled Trial With Nested Focus Group. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Respiratory muscle strength training: functional outcomes versus plasticity. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Expiratory muscle strength training: speech production outcomes in patients with multiple sclerosis. [2007]

9. United States pubmed.ncbi.nlm.nih.gov

Cough and Swallowing Therapy and Their Effects on Vocal Fold Bowing and Laryngeal Lesions. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Laryngeal movements during inspiratory muscle training in healthy subjects. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

The Safety and Efficacy of Expiratory Muscle Strength Training for Rehabilitation After Supracricoid Partial Laryngectomy: A Pilot Investigation. [2022]

12. England pubmed.ncbi.nlm.nih.gov

A mixed-method feasibility study of the use of the Complete Vocal Technique (CVT), a pedagogic method to improve the voice and vocal function in singers and actors, in the treatment of patients with muscle tension dysphonia: a study protocol. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Expiratory muscle strength training for radiation-associated aspiration after head and neck cancer: A case series. [2019]