DysphagiaNCT05708898
External Pharyngeal Exerciser and Dysphagia
A study testing Pharyngeal exerciser in people with Dysphagia, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dysphagia
- What is being tested?
- Pharyngeal exerciser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2015to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with dysphagia characterized by persistent pharyngeal residue on fluoroscopic study undergoing rehabilitative intervention (e.g.: exercises, maneuvers or dietary modification) for improving swallowing and preventing aspiration
- Healthy elderly adult (≥65 years of age).
Who cannot join
- Patients younger than 18 years of age.
- Patients with recent head and neck cancer (<1 month post-surgery or <3 months post-chemo radiation.
- Patients suffering from muscle diseases like muscular dystrophies, myopathies.
- Patients with neuro-muscular junction disorders myasthenia gravis, Eaton-Lambert disorders
- Patients having history of allergy to lidocaine or barium.
- Patients who are pregnant or lactating.
Show all 9Show fewer
- Patients who are medically unstable.
- Patients who are unable to apply the exerciser independently or with the help of a caregiver.
- Patients who lack cognition.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53086
About this study
Official title: Effect of Pharyngeal Exerciser in Rehabilitation of Pharyngeal Phase of Swallowing in Patients With 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 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
Read the detailed description
All the patients will be reviewed for inclusion and exclusion of the study in detailed manner using medical evaluation form. The physical examination part of the medical evaluation form will be filled out by one of our designated physician investigators. A urine pregnancy test will be administered if necessary at this time.
The patient's neck physical dimensions and device's physical dimensions will be measured and recorded using the Biometric form.
A baseline functional outcome assessment of swallowing (FOAMS) will be performed for each patient.
Patients will be sitting in an upright position with the head held in neutral position at Fluoroscopy lab and acclimatized for 10 minutes before proceeding.
Patient's anatomic structure and landmarks are identified in both lateral and anteroposterior (AP) views with fluoroscopy.
A 4 mm diameter catheter with 3 markers 3 cm apart will be placed on the skin in the pharyngo-UES region for the purpose of calibration and nullify the error from magnification during videorecording.
Patient will be asked to swallow barium suspension at incremental volumes of 1, 3 and 5 ml; however, if the patient develops aspiration or doesn't tolerate barium suspension higher volumes will not be administered. Following are test swallows under fluoroscopy:
1 ml- 40% weight/volume barium suspension at room temperature x 3 times each. 3 ml- 40% weight/volume barium suspension at room temperature x 3 times each. 5 ml- 40% weight/volume barium suspension at room temperature x 3 times each. The fluoroscopy machine will be turned "on" for 5 seconds ONLY during each swallow. Rest of the time fluoroscopy machine will be turned "off".
Fluoroscopic recordings were obtained at 90 kilo-electron-volt (KeV), using a 9-inch image-intensifier mode and appropriate collimation so that an image was obtained of the posterior mouth, pharynx, and pharyngoesophageal region. Fluoroscopic recordings will be timed using a specially designed timer.
After the baseline fluoroscopic study, each patient will be randomized to receive either the sham exerciser (i.e. device with no pressure) or pharyngeal exerciser (i.e. device with graded pressure).
Study Groups:
Pharyngeal exerciser group: In this group, the device will be placed around the neck overlying the laryngeal cartilage. The device will be in contact with the skin without any underlying pressure using the Velcro fastening in the back of neck. The externally applied pressure will be measured by means of the pressure gauge included in the device (see figure). 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.
Sham exerciser group: 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.
All the exercise instructions and log record will be given to each of the patient in both study groups at the time of randomization. The exerciser (sham or pharyngeal) will be worn only at the time of exercises.
Weekly telephone interviews will be conducted to assess their progress and address their concerns in both study groups.
Patients in both study groups are required to make follow up visits every 2 weeks. During the follow up visits, patients will be reviewed for symptom severity and resistance of the device. This information is documented in patient progress sheet and follow up visit form. All the adverse events during the study or from the device will be documented in the adverse and serious adverse events form. The compliance with the device will be evaluated by examining the exercise log sheet.
After 6 weeks, the device (sham exerciser or pharyngeal exerciser) will be returned to the study team and patients will be asked to complete functional outcome assessment of swallowing (FOAMS).
Each patient will undergo follow up fluoroscopic study with the same test swallows as the baseline swallows, looking for pharyngeal residue and aspiration (repeat steps: 4 to 9).
All the fluoroscopic images will be recorded and stored in digitalized format at 30 frames (60 fields/second) in a secure location at the research lab (locked in safe location and accessible only to the investigators). These the fluoroscopic studies will be analyzed for the study parameters as mentioned below by two individuals in a blinded fashion.
At the end of study period, each of the patients in sham group will be given an option to undergo another 6 weeks of pharyngeal exercise using pharyngeal exerciser. If they consent again(using informed consent form) to participate, they would be following above exercise protocol(30 swallows against 20 mm Hg of resistance with pharyngeal exerciser three times a day for 2 weeks; followed by swallowing exercise with incremental resistance of 30 and 40 mm Hg for 2 weeks each). At of 6 weeks, they would undergo repeat fluoroscopy study to check for improvement in pharyngeal residue (repeat steps: 4 to 9).
The participants will be followed after completion of the exercise regimen for a total of 12 months. At 3 months after the completion of initial exercise study, the participant will be contacted and informed about the follow up portion of the study. If they are in agreement, the participant will be asked to come to the lab to be reconsented and complete an EAT-10 form. At this time, the participant will be asked questions such as current diet consistency, evidence of cough with eating, additional time needed during meals, etc to determine FOAMS score. The patient will only be interviewed after consent is obtained. At 6 months, the subjects will undergo repeat fluoroscopy for an objective measure of their swallowing. At this visit they will also be asked to complete an EAT-10 form and a FOAMS score will again be determined. At 12 months, the participant will not be required to return to the lab. They will also be mailed a swallowing assessment form (EAT-10) to be filled out and returned at 12 months (subjects will be asked to complete the paper form for consistency). The participant will also be contacted for a telephone interview to be asked questions such as current diet consistency, evidence of cough with eating, additional time needed during meals, etc to determine FOAMS score. For those subjects who are newly enrolled, re-consent will not occur since there is only one consent form which includes the follow-up information. Newly enrolled subjects will be presented with the follow-up information at the time of initial consent.
During the entire study period, the participant will be instructed to continue their standard of medical care (medications, diet, physical therapy and activity) as suggested by their personnel physician.
All the fluoroscopic studies will be analyzed by two individuals in a blinded fashion.
After the completion of the study, individuals in the sham exerciser group will be given the option of doing exercises using pharyngeal exerciser. If they are interested, consent will be obtained using new consent form before re-enrolling into the study.
- Conditions
- Dysphagia
- Being tested
- Pharyngeal exerciser, sham pharyngeal exerciser
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharyngeal exerciserDevice
sham pharyngeal exerciserDevice
| Study group | Role | What they receive |
|---|---|---|
| Pharyngeal exerciser group | Experimental | 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. Receives: Device: Pharyngeal exerciser |
| Sham exerciser group | Sham comparator | 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. Receives: Device: sham pharyngeal exerciser |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum anterior hyoid excursion
deglutitive maximum anterior hyoid excursion from resting position measured from fluoroscopic images
Measured: Before six weeks exerciser regimen
maximum anterior hyoid excursion
deglutitive maximum anterior hyoid excursion from resting position measured from fluoroscopic images
Measured: after six weeks exerciser regimen
maximum superior hyoid excursion
deglutitive maximum superior hyoid excursion from resting position measured from fluoroscopic images
Measured: Before six weeks exerciser regimen
maximum superior hyoid excursion
deglutitive maximum superior hyoid excursion from resting position measured from fluoroscopic images
Measured: after six weeks exerciser regimen
maximum anterior laryngeal excursion
deglutitive maximum anterior laryngeal excursion from resting position measured from fluoroscopic images
Measured: Before six weeks exerciser regimen
maximum anterior laryngeal excursion
deglutitive maximum anterior laryngeal excursion from resting position measured from fluoroscopic images
Measured: after six weeks exerciser regimen
maximum superior laryngeal excursion
deglutitive maximum superior laryngeal excursion from resting position measured from fluoroscopic images
Measured: before six weeks exerciser regimen
maximum superior laryngeal excursion
deglutitive maximum superior laryngeal excursion from resting position measured from fluoroscopic images
Measured: after six weeks exerciser regimen
maximum upper esophageal sphincter (UES) anterior-posterior opening
deglutitive maximum UES diameter measured from fluoroscopic images
Measured: Before six weeks exerciser regimen
maximum upper esophageal sphincter (UES) anterior-posterior opening
deglutitive maximum UES diameter measured from fluoroscopic images
Measured: after six weeks exerciser regimen
pyriform sinus residue
area (height x width) of pyriform sinus residue measure from fluoroscopic images
Measured: Before six weeks exerciser regimen
pyriform sinus residue
area (height x width) of pyriform sinus residue measure from fluoroscopic images
Measured: after six weeks exerciser regimen
Secondary outcomes (2)
Penetration and aspiration analyses
Reduction of aspiration and penetration measured by Rosenbek's penetration-aspiration scale
Measured: Before six weeks exerciser regimen
Penetration and aspiration analyses
Reduction of aspiration and penetration measured by Rosenbek's penetration-aspiration scale
Measured: after six weeks exerciser regimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start9 Jun 2015
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pharyngeal exerciser group: In this group, the device will be placed around the neck overlying the laryngeal cartilage using the Velcro fastening in the back of neck. The externally applied pressure will be measured via the pressure gauge included in the device (see figure). 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. Sham exerciser group: 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reza Shaker, MD, Medical College of Wisconsin
- Investigators
- Reza Shaker, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708898
- Sponsor's protocol ID
- PRO00023967
- Status last verified
- Feb 2026
- First submitted
- 13 Jan 2023
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Cabre M, Serra-Prat M, Palomera E, Almirall J, Pallares R, Clave P. Prevalence and prognostic implications of dysphagia in elderly patients with pneumonia. Age Ageing. 2010 Jan;39(1):39-45. doi: 10.1093/ageing/afp100. Epub 2009 Jun 26.
PubMed 19561160Turley R, Cohen S. Impact of voice and swallowing problems in the elderly. Otolaryngol Head Neck Surg. 2009 Jan;140(1):33-6. doi: 10.1016/j.otohns.2008.10.010.
PubMed 19130958Bonilha HS, Simpson AN, Ellis C, Mauldin P, Martin-Harris B, Simpson K. The one-year attributable cost of post-stroke dysphagia. Dysphagia. 2014 Oct;29(5):545-52. doi: 10.1007/s00455-014-9543-8. Epub 2014 Jun 20.
PubMed 24948438Altman KW, Yu GP, Schaefer SD. Consequence of dysphagia in the hospitalized patient: impact on prognosis and hospital resources. Arch Otolaryngol Head Neck Surg. 2010 Aug;136(8):784-9. doi: 10.1001/archoto.2010.129.
PubMed 20713754Locke GR 3rd, Talley NJ, Fett SL, Zinsmeister AR, Melton LJ 3rd. Prevalence and clinical spectrum of gastroesophageal reflux: a population-based study in Olmsted County, Minnesota. Gastroenterology. 1997 May;112(5):1448-56. doi: 10.1016/s0016-5085(97)70025-8.
PubMed 9136821Altman KW, Schaefer SD, Yu GP, Hertegard S, Lundy DS, Blumin JH, Maronian NC, Heman-Ackah YD, Abitbol J, Casiano RR; Neurolaryngology Subcommittee of the American Academy of Otolaryngology-Head and Neck Surgery. The voice and laryngeal dysfunction in stroke: a report from the Neurolaryngology Subcommittee of the American Academy of Otolaryngology-Head and Neck Surgery. Otolaryngol Head Neck Surg. 2007 Jun;136(6):873-81. doi: 10.1016/j.otohns.2007.02.032.
PubMed 17547973Hamdy S, Aziz Q, Rothwell JC, Crone R, Hughes D, Tallis RC, Thompson DG. Explaining oropharyngeal dysphagia after unilateral hemispheric stroke. Lancet. 1997 Sep 6;350(9079):686-92. doi: 10.1016/S0140-6736(97)02068-0.
PubMed 9291902Martino R, Foley N, Bhogal S, Diamant N, Speechley M, Teasell R. Dysphagia after stroke: incidence, diagnosis, and pulmonary complications. Stroke. 2005 Dec;36(12):2756-63. doi: 10.1161/01.STR.0000190056.76543.eb. Epub 2005 Nov 3.
PubMed 16269630Smithard DG, O'Neill PA, Parks C, Morris J. Complications and outcome after acute stroke. Does dysphagia matter? Stroke. 1996 Jul;27(7):1200-4. doi: 10.1161/01.str.27.7.1200.
PubMed 8685928Shaker R, Easterling C, Kern M, Nitschke T, Massey B, Daniels S, Grande B, Kazandjian M, Dikeman K. Rehabilitation of swallowing by exercise in tube-fed patients with pharyngeal dysphagia secondary to abnormal UES opening. Gastroenterology. 2002 May;122(5):1314-21. doi: 10.1053/gast.2002.32999.
PubMed 11984518Shaker R, Kern M, Bardan E, Taylor A, Stewart ET, Hoffmann RG, Arndorfer RC, Hofmann C, Bonnevier J. Augmentation of deglutitive upper esophageal sphincter opening in the elderly by exercise. Am J Physiol. 1997 Jun;272(6 Pt 1):G1518-22. doi: 10.1152/ajpgi.1997.272.6.G1518.
PubMed 9227489Logemann JA. Treatment of oral and pharyngeal dysphagia. Phys Med Rehabil Clin N Am. 2008 Nov;19(4):803-16, ix. doi: 10.1016/j.pmr.2008.06.003.
PubMed 18940642Shaker R, Geenen JE. Management of Dysphagia in stroke patients. Gastroenterol Hepatol (N Y). 2011 May;7(5):308-32. No abstract available.
PubMed 21857832Easterling C, Grande B, Kern M, Sears K, Shaker R. Attaining and maintaining isometric and isokinetic goals of the Shaker exercise. Dysphagia. 2005 Spring;20(2):133-8. doi: 10.1007/s00455-005-0004-2.
PubMed 16172822Logemann JA, Rademaker A, Pauloski BR, Kelly A, Stangl-McBreen C, Antinoja J, Grande B, Farquharson J, Kern M, Easterling C, Shaker R. A randomized study comparing the Shaker exercise with traditional therapy: a preliminary study. Dysphagia. 2009 Dec;24(4):403-11. doi: 10.1007/s00455-009-9217-0. Epub 2009 May 27.
PubMed 19472007
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pharyngeal Exerciser in Rehabilitation of Pharyngeal Phase of Swallowing in Patients With Dysphagia
- ClinicalTrials.gov ID
- NCT05708898
- Acronym / sponsor ID
- PRO00023967
- Conditions
- Dysphagia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 9 Jun 2015 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
All the patients will be reviewed for inclusion and exclusion of the study in detailed manner using medical evaluation form. The physical examination part of the medical evaluation form will be filled out by one of our designated physician investigators. A urine pregnancy test will be administered if necessary at this time.
The patient's neck physical dimensions and device's physical dimensions will be measured and recorded using the Biometric form.
A baseline functional outcome assessment of swallowing (FOAMS) will be performed for each patient.
Patients will be sitting in an upright position with the head held in neutral position at Fluoroscopy lab and acclimatized for 10 minutes before proceeding.
Patient's anatomic structure and landmarks are identified in both lateral and anteroposterior (AP) views with fluoroscopy.
A 4 mm diameter catheter with 3 markers 3 cm apart will be placed on the skin in the pharyngo-UES region for the purpose of calibration and nullify the error from magnification during videorecording.
Patient will be asked to swallow barium suspension at incremental volumes of 1, 3 and 5 ml; however, if the patient develops aspiration or doesn't tolerate barium suspension higher volumes will not be administered. Following are test swallows under fluoroscopy:
1 ml- 40% weight/volume barium suspension at room temperature x 3 times each. 3 ml- 40% weight/volume barium suspension at room temperature x 3 times each. 5 ml- 40% weight/volume barium suspension at room temperature x 3 times each. The fluoroscopy machine will be turned "on" for 5 seconds ONLY during each swallow. Rest of the time fluoroscopy machine will be turned "off".
Fluoroscopic recordings were obtained at 90 kilo-electron-volt (KeV), using a 9-inch image-intensifier mode and appropriate collimation so that an image was obtained of the posterior mouth, pharynx, and pharyngoesophageal region. Fluoroscopic recordings will be timed using a specially designed timer.
After the baseline fluoroscopic study, each patient will be randomized to receive either the sham exerciser (i.e. device with no pressure) or pharyngeal exerciser (i.e. device with graded pressure).
Study Groups:
Pharyngeal exerciser group: In this group, the device will be placed around the neck overlying the laryngeal cartilage. The device will be in contact with the skin without any underlying pressure using the Velcro fastening in the back of neck. The externally applied pressure will be measured by means of the pressure gauge included in the device (see figure). 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.
Sham exerciser group: 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.
All the exercise instructions and log record will be given to each of the patient in both study groups at the time of randomization. The exerciser (sham or pharyngeal) will be worn only at the time of exercises.
Weekly telephone interviews will be conducted to assess their progress and address their concerns in both study groups.
Patients in both study groups are required to make follow up visits every 2 weeks. During the follow up visits, patients will be reviewed for symptom severity and resistance of the device. This information is documented in patient progress sheet and follow up visit form. All the adverse events during the study or from the device will be documented in the adverse and serious adverse events form. The compliance with the device will be evaluated by examining the exercise log sheet.
After 6 weeks, the device (sham exerciser or pharyngeal exerciser) will be returned to the study team and patients will be asked to complete functional outcome assessment of swallowing (FOAMS).
Each patient will undergo follow up fluoroscopic study with the same test swallows as the baseline swallows, looking for pharyngeal residue and aspiration (repeat steps: 4 to 9).
All the fluoroscopic images will be recorded and stored in digitalized format at 30 frames (60 fields/second) in a secure location at the research lab (locked in safe location and accessible only to the investigators). These the fluoroscopic studies will be analyzed for the study parameters as mentioned below by two individuals in a blinded fashion.
At the end of study period, each of the patients in sham group will be given an option to undergo another 6 weeks of pharyngeal exercise using pharyngeal exerciser. If they consent again(using informed consent form) to participate, they would be following above exercise protocol(30 swallows against 20 mm Hg of resistance with pharyngeal exerciser three times a day for 2 weeks; followed by swallowing exercise with incremental resistance of 30 and 40 mm Hg for 2 weeks each). At of 6 weeks, they would undergo repeat fluoroscopy study to check for improvement in pharyngeal residue (repeat steps: 4 to 9).
The participants will be followed after completion of the exercise regimen for a total of 12 months. At 3 months after the completion of initial exercise study, the participant will be contacted and informed about the follow up portion of the study. If they are in agreement, the participant will be asked to come to the lab to be reconsented and complete an EAT-10 form. At this time, the participant will be asked questions such as current diet consistency, evidence of cough with eating, additional time needed during meals, etc to determine FOAMS score. The patient will only be interviewed after consent is obtained. At 6 months, the subjects will undergo repeat fluoroscopy for an objective measure of their swallowing. At this visit they will also be asked to complete an EAT-10 form and a FOAMS score will again be determined. At 12 months, the participant will not be required to return to the lab. They will also be mailed a swallowing assessment form (EAT-10) to be filled out and returned at 12 months (subjects will be asked to complete the paper form for consistency). The participant will also be contacted for a telephone interview to be asked questions such as current diet consistency, evidence of cough with eating, additional time needed during meals, etc to determine FOAMS score. For those subjects who are newly enrolled, re-consent will not occur since there is only one consent form which includes the follow-up information. Newly enrolled subjects will be presented with the follow-up information at the time of initial consent.
During the entire study period, the participant will be instructed to continue their standard of medical care (medications, diet, physical therapy and activity) as suggested by their personnel physician.
All the fluoroscopic studies will be analyzed by two individuals in a blinded fashion.
After the completion of the study, individuals in the sham exerciser group will be given the option of doing exercises using pharyngeal exerciser. If they are interested, consent will be obtained using new consent form before re-enrolling into the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Pharyngeal exerciser group: In this group, the device will be placed around the neck overlying the laryngeal cartilage using the Velcro fastening in the back of neck. The externally applied pressure will be measured via the pressure gauge included in the device (see figure). 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. Sham exerciser group: 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.
| Arm | Type | Receives |
|---|---|---|
| Pharyngeal exerciser group | Experimental | Device: Pharyngeal exerciserIn 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. |
| Sham exerciser group | Sham comparator | Device: sham pharyngeal exerciserIn 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with dysphagia characterized by persistent pharyngeal residue on fluoroscopic study undergoing rehabilitative intervention (e.g.: exercises, maneuvers or dietary modification) for improving swallowing and preventing aspiration
- Healthy elderly adult (≥65 years of age).
Key exclusion criteria (9 listed)
- Patients younger than 18 years of age.
- Patients with recent head and neck cancer (<1 month post-surgery or <3 months post-chemo radiation.
- Patients suffering from muscle diseases like muscular dystrophies, myopathies.
- Patients with neuro-muscular junction disorders myasthenia gravis, Eaton-Lambert disorders
- Patients having history of allergy to lidocaine or barium.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharyngeal exerciser | Device | Pharyngeal exerciser group |
| sham pharyngeal exerciser | Device | Sham exerciser group |
Primary outcome
maximum anterior hyoid excursion
Time frame: Before six weeks exerciser regimen
deglutitive maximum anterior hyoid excursion from resting position measured from fluoroscopic images
maximum anterior hyoid excursion
Time frame: after six weeks exerciser regimen
deglutitive maximum anterior hyoid excursion from resting position measured from fluoroscopic images
maximum superior hyoid excursion
Time frame: Before six weeks exerciser regimen
deglutitive maximum superior hyoid excursion from resting position measured from fluoroscopic images
maximum superior hyoid excursion
Time frame: after six weeks exerciser regimen
deglutitive maximum superior hyoid excursion from resting position measured from fluoroscopic images
maximum anterior laryngeal excursion
Time frame: Before six weeks exerciser regimen
deglutitive maximum anterior laryngeal excursion from resting position measured from fluoroscopic images
maximum anterior laryngeal excursion
Time frame: after six weeks exerciser regimen
deglutitive maximum anterior laryngeal excursion from resting position measured from fluoroscopic images
maximum superior laryngeal excursion
Time frame: before six weeks exerciser regimen
deglutitive maximum superior laryngeal excursion from resting position measured from fluoroscopic images
maximum superior laryngeal excursion
Time frame: after six weeks exerciser regimen
deglutitive maximum superior laryngeal excursion from resting position measured from fluoroscopic images
maximum upper esophageal sphincter (UES) anterior-posterior opening
Time frame: Before six weeks exerciser regimen
deglutitive maximum UES diameter measured from fluoroscopic images
maximum upper esophageal sphincter (UES) anterior-posterior opening
Time frame: after six weeks exerciser regimen
deglutitive maximum UES diameter measured from fluoroscopic images
pyriform sinus residue
Time frame: Before six weeks exerciser regimen
area (height x width) of pyriform sinus residue measure from fluoroscopic images
pyriform sinus residue
Time frame: after six weeks exerciser regimen
area (height x width) of pyriform sinus residue measure from fluoroscopic images
2 secondary outcomes
Penetration and aspiration analyses
Time frame: Before six weeks exerciser regimen
Penetration and aspiration analyses
Time frame: after six weeks exerciser regimen
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Background: PubMed 19561160Cabre M, Serra-Prat M, Palomera E, Almirall J, Pallares R, Clave P. Prevalence and prognostic implications of dysphagia in elderly patients with pneumonia. Age Ageing. 2010 Jan;39(1):39-45. doi: 10.1093/ageing/afp100. Epub 2009 Jun 26.
- Background: PubMed 19130958Turley R, Cohen S. Impact of voice and swallowing problems in the elderly. Otolaryngol Head Neck Surg. 2009 Jan;140(1):33-6. doi: 10.1016/j.otohns.2008.10.010.
- Background: PubMed 24948438Bonilha HS, Simpson AN, Ellis C, Mauldin P, Martin-Harris B, Simpson K. The one-year attributable cost of post-stroke dysphagia. Dysphagia. 2014 Oct;29(5):545-52. doi: 10.1007/s00455-014-9543-8. Epub 2014 Jun 20.
- Background: PubMed 20713754Altman KW, Yu GP, Schaefer SD. Consequence of dysphagia in the hospitalized patient: impact on prognosis and hospital resources. Arch Otolaryngol Head Neck Surg. 2010 Aug;136(8):784-9. doi: 10.1001/archoto.2010.129.
- Background: PubMed 9136821Locke GR 3rd, Talley NJ, Fett SL, Zinsmeister AR, Melton LJ 3rd. Prevalence and clinical spectrum of gastroesophageal reflux: a population-based study in Olmsted County, Minnesota. Gastroenterology. 1997 May;112(5):1448-56. doi: 10.1016/s0016-5085(97)70025-8.
- Background: PubMed 17547973Altman KW, Schaefer SD, Yu GP, Hertegard S, Lundy DS, Blumin JH, Maronian NC, Heman-Ackah YD, Abitbol J, Casiano RR; Neurolaryngology Subcommittee of the American Academy of Otolaryngology-Head and Neck Surgery. The voice and laryngeal dysfunction in stroke: a report from the Neurolaryngology Subcommittee of the American Academy of Otolaryngology-Head and Neck Surgery. Otolaryngol Head Neck Surg. 2007 Jun;136(6):873-81. doi: 10.1016/j.otohns.2007.02.032.
- Background: PubMed 9291902Hamdy S, Aziz Q, Rothwell JC, Crone R, Hughes D, Tallis RC, Thompson DG. Explaining oropharyngeal dysphagia after unilateral hemispheric stroke. Lancet. 1997 Sep 6;350(9079):686-92. doi: 10.1016/S0140-6736(97)02068-0.
- Background: PubMed 16269630Martino R, Foley N, Bhogal S, Diamant N, Speechley M, Teasell R. Dysphagia after stroke: incidence, diagnosis, and pulmonary complications. Stroke. 2005 Dec;36(12):2756-63. doi: 10.1161/01.STR.0000190056.76543.eb. Epub 2005 Nov 3.
- Background: PubMed 8685928Smithard DG, O'Neill PA, Parks C, Morris J. Complications and outcome after acute stroke. Does dysphagia matter? Stroke. 1996 Jul;27(7):1200-4. doi: 10.1161/01.str.27.7.1200.
- Background: PubMed 11984518Shaker R, Easterling C, Kern M, Nitschke T, Massey B, Daniels S, Grande B, Kazandjian M, Dikeman K. Rehabilitation of swallowing by exercise in tube-fed patients with pharyngeal dysphagia secondary to abnormal UES opening. Gastroenterology. 2002 May;122(5):1314-21. doi: 10.1053/gast.2002.32999.
- Background: PubMed 9227489Shaker R, Kern M, Bardan E, Taylor A, Stewart ET, Hoffmann RG, Arndorfer RC, Hofmann C, Bonnevier J. Augmentation of deglutitive upper esophageal sphincter opening in the elderly by exercise. Am J Physiol. 1997 Jun;272(6 Pt 1):G1518-22. doi: 10.1152/ajpgi.1997.272.6.G1518.
- Background: PubMed 18940642Logemann JA. Treatment of oral and pharyngeal dysphagia. Phys Med Rehabil Clin N Am. 2008 Nov;19(4):803-16, ix. doi: 10.1016/j.pmr.2008.06.003.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reza Shaker, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharyngeal exerciser in people with Dysphagia, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reza Shaker, MD (4149556840, rshaker@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum anterior hyoid excursion (time frame: Before six weeks exerciser regimen). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05708898, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.