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

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. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Pharyngeal Exerciser for swallowing disorders?

The research on virtual reality rehabilitation and gamification for physical therapy suggests that engaging and motivating treatment methods can improve patient adherence and outcomes, which may indirectly support the use of innovative devices like the Pharyngeal Exerciser for swallowing disorders. ^{1 2 3 4 5}

Is the Throat Exerciser for Swallowing Disorders safe for humans?

Research on devices like the Throat Exerciser, which apply resistance to swallowing, has been conducted on healthy adults and elderly individuals. These studies did not report any safety concerns, suggesting that such exercises are generally safe for human use. ^{6 7 8 9 10}

How is the Pharyngeal Exerciser treatment different from other treatments for swallowing disorders?

The Pharyngeal Exerciser is unique because it focuses on strengthening the muscles involved in swallowing through a specific exercise device, which is different from other treatments that may involve general exercises or medications. This device targets the pharyngeal muscles directly, potentially offering a more targeted approach to improving swallowing function. ^{6 8 9 10 11}

What is the purpose of this trial?

The goal of this a clinical trial is to test the effect of a pharyngeal exerciser in rehabilitation of pharyngeal phase of swallowing in patients with dysphagia. The main question it aims to answer is: •Does application of pharyngeal exerciser improve swallowing as evidenced by need for prescribed intervention for dysphagia (maneuvers, exercises or dietary modification to prevent aspiration). Participants will: * Perform barium swallows in lateral view fluoroscopy * Over a six-week period, perform thrice daily sessions of swallowing with an external, laryngeal restriction device covering the larynx * Return for another fluoroscopic barium swallow study

Research Team

Reza Shaker, MD

Principal Investigator

Medical College of Wisconsin

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. Spain pubmed.ncbi.nlm.nih.gov

[Guided home-based vestibular rehabilitation assisted by audiovisual media]. [2010]

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

Virtual reality rehabilitation as a treatment approach for older women with mixed urinary incontinence: a feasibility study. [2019]

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

Gamification of Cervical Spine Physiotherapy by Virtual Reality Software: Is This Real Rehabilitation? [2023]

4. Netherlands 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. [2008]

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

Physical and occupational therapy in inpatient stroke rehabilitation: the contribution of therapy extenders. [2019]

6. Japan pubmed.ncbi.nlm.nih.gov

Effects of bedside self-exercise on oropharyngeal swallowing function in stroke patients with dysphagia: a pilot study. [2020]

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

Effects of laryngeal restriction on pharyngeal peristalsis and biomechanics: Clinical implications. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Swallow strength training exercise for elderly: A health maintenance need. [2019]

9. Japan pubmed.ncbi.nlm.nih.gov

Proposal for a Modified Jaw Opening Exercise for Dysphagia: A Randomized, Controlled Trial. [2017]

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

Standardized instrument for lingual pressure measurement. [2018]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of tongue pressing effortful swallow in older healthy individuals. [2019]