Throat Exerciser for Swallowing Disorders

Overseen By Mark Kern

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Head/neck cancer, Muscle diseases, Pregnancy, others

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

Compensation: Varies

Number of Visits: 5

Duration: 6 weeks

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Pharyngeal Exerciser can assist individuals with swallowing problems, known as dysphagia. It examines whether using this device can improve swallowing and reduce the need for additional treatments like special diets or exercises. Participants will use the device daily for six weeks and undergo swallowing tests before and after. Individuals experiencing persistent swallowing issues, such as food or liquid getting stuck in the throat, and who are already trying various rehabilitation methods, might be suitable candidates. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future treatment options for dysphagia.

Will I have to stop taking my current medications?

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 this pharyngeal exerciser is safe for patients with dysphagia?

Research has shown that using a throat exerciser, which gently presses on the throat, is generally safe for improving swallowing. One study found that repeatedly swallowing against light resistance safely caused normal tiredness in the throat muscles, akin to a workout for the throat. This indicates the device is well-tolerated and does not cause harm.

Another study on healthy individuals examined the device's effect on swallowing pressure. The results showed no negative side effects, suggesting the treatment is safe. Additionally, a similar exercise method proved safe for stroke patients with swallowing difficulties, with no pain reported during exercises.

Overall, these findings suggest that using a throat exerciser for swallowing issues is safe, with no significant adverse effects reported in past studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the pharyngeal exerciser for swallowing disorders because it introduces a new way to strengthen the muscles involved in swallowing. Unlike traditional treatments that might involve dietary changes or medication, this device directly targets the laryngeal area by applying external resistance to encourage muscle strengthening through repetitive swallowing exercises. By gradually increasing resistance, the exerciser aims to build muscle strength over time, which could improve swallowing function more effectively than current options. This hands-on approach offers a promising alternative for those who haven't found success with standard treatments.

What evidence suggests that the pharyngeal exerciser is effective for swallowing disorders?

Research shows that a throat exerciser can improve swallowing by strengthening and coordinating throat muscles. In this trial, participants in the pharyngeal exerciser group will use a device that applies resistance to throat muscles. Studies have found that this can safely tire these muscles, potentially leading to stronger and more effective swallowing over time. Tests with both young and older individuals have shown that this exerciser affects throat pressure, which is crucial for swallowing. These early results suggest that the throat exerciser could help those with swallowing problems, possibly reducing the need for other treatments like dietary changes or additional exercises. Participants in the sham exerciser group will use a device without applied resistance, serving as a comparator to evaluate the pharyngeal exerciser's effectiveness. ^{1 2 4 5 6}

Who Is on the Research Team?

Reza Shaker, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for healthy adults over 65 with swallowing difficulties, who have pharyngeal residue seen on a fluoroscopic study and are undergoing treatment to improve swallowing. It's not for those with cognitive impairments, muscle diseases, allergies to lidocaine or barium, neuro-muscular junction disorders, pregnant or lactating women, anyone unable to use the device independently or under 18.

Inclusion Criteria

You have difficulty swallowing which can be seen during a special X-ray test and are currently receiving treatment to improve your ability to swallow and prevent food or liquid from entering your lungs.

Healthy elderly adult (≥65 years of age).

Exclusion Criteria

Patients who lack cognition.

You have a muscle disease such as muscular dystrophy or myopathy.

You have had an allergic reaction to lidocaine or barium in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Baseline functional outcome assessment of swallowing (FOAMS) and fluoroscopic barium swallow study

1 week

1 visit (in-person)

Treatment

Participants perform thrice daily sessions of swallowing with an external, laryngeal restriction device over a six-week period

6 weeks

Bi-weekly visits (in-person), weekly telephone interviews

Follow-up

Participants are monitored for safety and effectiveness after treatment, including follow-up fluoroscopic study and functional outcome assessment

12 months

3-month and 6-month visits (in-person), 12-month telephone interview

Open-label extension (optional)

Participants in the sham group may opt into another 6 weeks of pharyngeal exercise using the pharyngeal exerciser

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pharyngeal Exerciser
• Sham Pharyngeal Exerciser

Trial Overview The trial tests if using a pharyngeal exerciser can help in rehabilitating the swallowing process in patients with dysphagia. Participants will use an external laryngeal restriction device three times daily for six weeks and undergo fluoroscopic barium swallow studies before and after this period.

How Is the Trial Designed?

Group I: Pharyngeal exerciser group Experimental Treatment 1 Intervention

In this group, the device will be placed around the neck overlying the laryngeal cartilage. Patients are asked to follow exercise regimen: to perform 30 swallows at 15 seconds interval against minimal resistance of 20 mm Hg applied by pharyngeal exerciser over larynx during the first 2 weeks. This is repeated 3 times per day and the external resistance is increased every 2 weeks from 20 to 30 mm Hg and subsequently from 30 to 40 mm Hg in another 2 weeks.

Group II: Sham exerciser group Placebo Group 1 Intervention

In this group, sham device will be placed around the neck overlying the laryngeal cartilage. No external pressure will be applied during exercise. These patients will be asked to follow the exercise regimen: to perform repetitive tongue protrusion for 5 times without any pressure. This will be repeated 3 times a day for 6 weeks.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

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 study involving 20 healthy participants, a fully immersive virtual reality game (VRPhysio) successfully prompted neck movements that were identified by physiotherapists as appropriate rehabilitation exercises.

No adverse events were reported during the session, suggesting that VR gamification could be a safe and effective method for encouraging adherence to neck rehabilitation exercises, warranting further evaluation in randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gamification of Cervical Spine Physiotherapy by Virtual Reality Software: Is This Real Rehabilitation? Gavish, L., Weissberger, O., Barzilay, Y.[2023]

The tongue pressing effortful swallow (TPES) exercise program, performed by 27 older individuals over 4 weeks, significantly increased maximum tongue pressure, which is important for swallowing function.

While TPES improved tongue strength, it did not affect the peak amplitude of submental muscle activity, suggesting that while it enhances one aspect of swallowing, further research is needed to explore its full benefits, especially for those with swallowing disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of tongue pressing effortful swallow in older healthy individuals. Park, T., Kim, Y.[2019]

The study involving 24 older women (average age 70.5 years) demonstrated that a combined pelvic floor muscle exercises and virtual reality rehabilitation (PFM/VRR) program is feasible, with high participation and adherence rates (91% and 92% respectively).

Post-treatment results showed significant improvements in urinary incontinence symptoms and quality of life, with 91% of participants reporting high satisfaction with the program, indicating its potential as an effective treatment option for mixed urinary incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality rehabilitation as a treatment approach for older women with mixed urinary incontinence: a feasibility study. Elliott, V., de Bruin, ED., Dumoulin, C.[2019]

The Madison Oral Strengthening Therapeutic (MOST) device was developed to improve tongue muscle strength and address swallowing difficulties, showing promise in both treatment and prevention of muscle atrophy.

The study compared the MOST device to the Iowa Oral Performance Instrument (IOPI) and aimed to determine the best sampling rate for measuring tongue pressure during exercises, highlighting its potential for broader use in healthy aging adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardized instrument for lingual pressure measurement. Hewitt, A., Hind, J., Kays, S., et al.[2018]

A novel resistance exercise program called Swallowing Against Laryngeal Restriction (SALR) significantly improved key swallowing mechanics in healthy elderly participants, including increased upper esophageal sphincter opening and laryngeal movement after 6 weeks of training.

In contrast, a sham exercise did not produce any significant changes, highlighting the efficacy of the SALR program in enhancing the pharyngeal phase of swallowing, which could lead to better swallow health maintenance in the elderly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Swallow strength training exercise for elderly: A health maintenance need. Agrawal, D., Kern, M., Edeani, F., et al.[2019]

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]

A new audiovisual support model for guided home-based vestibular rehabilitation programs was developed and validated, showing high adherence rates (only 5.6% abandonment) among 89 patients.

Patients experienced significant improvements in their dizziness symptoms, with an average decrease of 33.14 points in the Dizziness Handicap Inventory score and a reduction in dynamic visual acuity test lines lost from 4.24 to 1.52 by the end of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Guided home-based vestibular rehabilitation assisted by audiovisual media]. Trinidad Ruiz, G., Domínguez Pedroso, M., Cruz de la Piedad, E., et al.[2010]

A study involving 30 healthy subjects demonstrated that applying resistance during swallowing can effectively overload and fatigue the pharyngeal muscles, which is crucial for developing rehabilitative exercises.

The results showed significant reductions in pharyngeal contractile pressure and laryngeal excursion during repeated swallowing against resistance, indicating that this method could strengthen pharyngeal muscle function safely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of laryngeal restriction on pharyngeal peristalsis and biomechanics: Clinical implications. Shaker, R., Sanvanson, P., Balasubramanian, G., et al.[2019]

In a study of 51 patients with chronic peripheral vestibular disease, those who performed Cawthorne & Cooksey exercises supplemented with breathing rhythm training showed a significant reduction in self-reported disability, with 94% experiencing a decrease in their Dizziness Handicap Inventory scores.

Proprioception exercises also improved postural control, as evidenced by a significant reduction in oscillation during static posturography tests, highlighting the potential benefits of both interventions in vestibular rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of vestibular rehabilitation supplemented by training of the breathing rhythm or proprioception exercises, in patients with chronic peripheral vestibular disease. Jáuregui-Renaud, K., Villanueva Padrón, LA., Cruz Gómez, NS.[2008]

In a study of 298 patients with moderate stroke and 284 with severe stroke across 5 rehabilitation facilities, occupational therapists and assistants provided the majority of therapy hours, with therapists focusing on advanced activities and assistants handling more basic tasks.

The use of therapy extenders varies by therapy type and patient severity, suggesting that the effectiveness of stroke rehabilitation may depend on how therapy is structured and delivered, highlighting the need for further research on their impact on patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical and occupational therapy in inpatient stroke rehabilitation: the contribution of therapy extenders. Hsieh, CH., Putman, K., Nichols, D., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4935483/

Effects of laryngeal restriction on pharyngeal peristalsis ... Repeated swallows against a resistive load induced by restricting the anterosuperior excursion of the larynx safely induces fatigue in pharyngeal peristalsis.

2. withpower.com withpower.com/trial/phase-deglutition-disorders-8-2014-0a54d

Pharyngeal Exerciser for Swallowing Disorders This study of healthy young and elderly individuals is intended to assess the effects of pharyngeal exerciser on pharyngeal pressure phenomenon during ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05708911

NCT05708911 | External Pharyngeal Exerciser and ... This study of healthy young and elderly individuals is intended to assess the effects of pharyngeal exerciser on pharyngeal pressure phenomenon during ...

4. 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 ...

5. journals.physiology.org journals.physiology.org/doi/10.1152/japplphysiol.00516.2024

Pharyngeal electrical stimulation favorably modifies ... Pharyngeal electrical stimulation (PES) positively influences clinical swallow-outcomes in patients with neurogenic dysphagia. Its effect on the underlying ...

6. 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 ...