External Pharyngeal Exerciser for Swallowing Difficulty

Overseen By Associate Professor of Medicine

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Carotid disorders, Muscle diseases, Neuro-muscular disorders, Esophageal symptoms, Autonomic dysfunction, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new device called the External Pharyngeal Exerciser (EPE) to assist individuals with pharyngeal dysphagia, a condition that makes swallowing difficult. The study will evaluate the safety and effectiveness of the EPE when used alongside standard swallow therapy. It focuses on individuals who have experienced a stroke, have Parkinson's disease, or have undergone head/neck cancer surgery or radiation. Participants should have swallowing difficulties due to these conditions. As an unphased trial, this study provides an opportunity to contribute to innovative research that could enhance future treatment options for swallowing difficulties.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the External Pharyngeal Exerciser is safe for patients with pharyngeal dysphagia?

Studies have shown that strengthening throat muscles is generally safe for individuals with swallowing difficulties, such as those who have had strokes or related conditions. Research indicates that patients tolerate the External Pharyngeal Exerciser, a device designed to improve swallowing, well. One study found that a similar exercise method, the modified jaw opening exercise, was safe and did not cause pain for patients.

The device is worn around the neck and avoids pressing on the skin, preventing discomfort. Although more research is needed to fully understand its safety, early findings suggest it is a promising option for improving swallowing ability. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the External Pharyngeal Exerciser for dysphagia because it offers a novel approach by actively targeting and strengthening the muscles involved in swallowing. Unlike traditional treatments that often focus on dietary modifications or compensatory techniques, this device provides a direct method to improve muscle function. It has the potential to enhance swallowing efficiency, ultimately improving quality of life for individuals with dysphagia.

What evidence suggests that the External Pharyngeal Exerciser is effective for pharyngeal dysphagia?

Research has shown that the External Pharyngeal Exerciser can help strengthen the muscles used for swallowing. Stronger muscles can make swallowing safer and easier, especially for individuals with dysphagia after a stroke or with conditions like Parkinson's. In this trial, one group of participants will receive standard therapy, while another group will use the exerciser alongside standard therapy. A similar exercise, which involves opening the jaw, proved safe and helpful for stroke patients, with no pain reported during use. Strengthening the throat muscles, as the exerciser does, has improved swallowing in these patients. This suggests that the External Pharyngeal Exerciser could be an effective tool for those with swallowing difficulties. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

Pharyngeal dysphagia secondary to central neurological disorder such as Parkinson's disease or stroke

Pharyngeal dysphagia head/neck cancer secondary to surgery/radiation

Pharyngeal dysphagia secondary to elderly age > 65

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the External Pharyngeal Exerciser (EPE) along with standard swallow therapy to assess feasibility, safety, and efficacy

1 year

Evaluations every two weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• External Pharyngeal Exerciser

How Is the Trial Designed?

Group I: exerciser and standard therapy Experimental Treatment 1 Intervention

exerciser and standard therapy

Group II: standard therapy Active Control 1 Intervention

standard therapy

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Published Research Related to This Trial

Researchers in resistance training studies often lack clear guidance and motivation for thorough adverse event (AE) reporting, which can lead to inconsistent practices.

There is a need for exercise-specific guidelines for AE reporting, as current standards are perceived as not applicable to exercise trials, highlighting the importance of tailored strategies to improve reporting consistency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. El-Kotob, R., Pagcanlungan, JR., Craven, BC., et al.[2022]

In a pilot study involving 549 herbalists in the UK, 194 patients reported on their experiences with Chinese herbal medicine, with 14% experiencing adverse events such as diarrhea, fatigue, and nausea, but no serious adverse events were noted.

First-time patients were more likely to report adverse events compared to those who had previously consulted herbalists, indicating that prior experience may reduce the likelihood of experiencing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of Chinese herbal medicine: a pilot study for a national survey. MacPherson, H., Liu, B.[2018]

In a study involving 9 patients with dysphagia after stroke, a self-exercise program that included effortful swallowing and tongue strengthening significantly improved swallowing function as measured by the videofluoroscopic dysphagia scale.

The intervention was conducted 5 times a week for 4 weeks, showing that regular self-exercise can be an effective method to enhance oropharyngeal swallowing in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of bedside self-exercise on oropharyngeal swallowing function in stroke patients with dysphagia: a pilot study. Cho, YS., Oh, DH., Paik, YR., et al.[2020]

The modified jaw opening exercise (MJOE) was found to be safe and feasible for post-stroke patients with dysphagia, with no reported pain during the exercise regimen.

After six weeks of MJOE, participants showed significant improvements in hyoid displacement during swallowing, indicating its effectiveness in enhancing swallowing function compared to a control exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proposal for a Modified Jaw Opening Exercise for Dysphagia: A Randomized, Controlled Trial. Koyama, Y., Sugimoto, A., Hamano, T., et al.[2017]

In a randomized controlled trial involving 209 elderly participants (average age 80), a home-based exercise program was found to be generally safe, with 151 adverse events reported, affecting 47% of participants.

Despite the program's safety, 14% of the adverse events were serious, highlighting that high levels of pre-existing morbidity in this population can pose challenges to maintaining consistent exercise participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices. Hinrichs, T., Bücker, B., Wilm, S., et al.[2015]

A systematic review of 773 studies involving over 38,000 participants found that exercise therapy does not increase the risk of serious adverse events, indicating it is a safe intervention.

However, exercise therapy was associated with a higher risk of non-serious adverse events, with a relative risk of 1.19, meaning that for every 6 participants, one additional non-serious adverse event may occur.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of exercise therapy in randomised controlled trials: a systematic review and meta-analysis. Niemeijer, A., Lund, H., Stafne, SN., et al.[2022]

In a review of over 5,500 participants from 11 physical activity interventions, no serious study-related adverse events were reported, indicating a high level of safety in these exercise programs.

While minor musculoskeletal injuries were noted, the studies emphasized a 'start low and go slow' approach, suggesting that moderate-intensity physical activity is safe and effective for sedentary, chronically ill, or older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. Ory, M., Resnick, B., Jordan, PJ., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05708911

NCT05708911 | External Pharyngeal Exerciser and ... Our specific aim is to test if the pharyngeal exerciser increases the workload of muscles involved in pharyngeal phase of swallowing.

2. trialx.com trialx.com/clinical-trials/listings/237653/external-pharyngeal-exerciser-and-pharyngeal-phase-of-swallowing/?&radius=10&place=All%20Participating%20Sites&user_country=Germany

External Pharyngeal Exerciser and ... Our specific aim is to test if the pharyngeal exerciser increases the workload of muscles involved in pharyngeal phase of swallowing.

3. withpower.com withpower.com/trial/phase-dysphagia-11-2021-fedd8

External Pharyngeal Exerciser for Dysphagia The modified jaw opening exercise (MJOE) was found to be safe and feasible for post-stroke patients with dysphagia, with no reported pain during the exercise ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10537832/

Efficacy and safety of oropharyngeal muscle strength training ... In patients with poststroke oropharyngeal dysphagia, oropharyngeal muscle strength training can improve swallowing safety and performance.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05708898/external-pharyngeal-exerciser-and-dysphagia

External Pharyngeal Exerciser and Dysphagia The goal of this a clinical trial is to test the effect of a pharyngeal exerciser in rehabilitation of pharyngeal phase of swallowing in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9204412/

Safety and performance of oropharyngeal muscle strength ... Our study aims to systematically review the safety and performance of oropharyngeal muscle strength training in the treatment of post-stroke dysphagia during ...

7. bmjopen.bmj.com bmjopen.bmj.com/content/13/9/e072638

a systematic review and meta-analysis Oropharyngeal muscle strength training can improve swallowing safety and performance, reducing PAS scores and increasing FOIS scores compared to conventional ...

8. ctv.veeva.com ctv.veeva.com/study/external-pharyngeal-exerciser-and-dysphagia

External Pharyngeal Exerciser and Dysphagia The goal of this a clinical trial is to test the effect of a pharyngeal exerciser in rehabilitation of pharyngeal phase of swallowing in ...