Lingual Strengthening Exercises for Swallowing Difficulty

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byTimothy M. McCulloch, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Trial Summary

What is the purpose of this trial?

This multi-site trial will follow a cohort of Veterans with dysphagia for 8 weeks as they undergo clinically guided oropharyngeal exercises with oropharyngeal strengthening as the primary goal. Veterans with dysphagia will be assessed at three time points: baseline, 4 weeks after treatment initiation, and 8 weeks after treatment initiation. A non-dysphagic Veteran control group will also undergo data collection at parallel time points, without completion of a treatment paradigm. The investigators will then compare patients to non-dysphagic controls using manometry, videofluoroscopy, diet assessment, functional reserve tests, and patient-reported outcome measures. The investigators aim to 1) quantify change in pressure measures of swallowing function resulting from dysphagia treatment; 2) determine which combination of standard of care and/or pressure-based metrics best track with outcome measures; and 3) develop multimodal prognostic algorithms that predict treatment success. This research will establish a precise outcome measurement paradigm suitable for dysphagia clinical care and research, thus improving clinical confidence and paving the way for a personalized medicine approach for dysphagia rehabilitation in Veterans.

Research Team

Timothy M. McCulloch, MD

Principal Investigator

William S. Middleton Memorial Veterans Hospital, Madison, WI

Eligibility Criteria

This trial is for Veterans who have difficulty swallowing (dysphagia) and are undergoing treatment to strengthen their throat muscles. They must be able to speak English, consent to participate, and have been diagnosed with dysphagia by a speech-language pathologist. Those allergic to barium or topical anesthetics cannot join.

Inclusion Criteria

English speaking

I am following a plan to strengthen my throat muscles due to swallowing difficulties.

Signed an informed consent form

See 1 more

Exclusion Criteria

You have had an allergic reaction to barium before.

You have had an allergic reaction to numbing creams used on the skin.

Treatment Details

Interventions

Standard of Care Lingual Strengthening (Behavioural Intervention)

Trial OverviewThe study tests the effectiveness of standard care exercises aimed at strengthening throat muscles in Veterans with dysphagia over 8 weeks. It compares changes in swallowing function against non-dysphagic controls using various assessments and aims to develop predictive algorithms for treatment success.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Patient groupExperimental Treatment1 Intervention

lingual strengthening

Group II: ControlsActive Control1 Intervention

No history of dysphagia (swallowing disorder) or minimal to mild dysphagia not requiring a strengthening program