RecruitingNot ApplicableNCT07110142

Tongue Proactive Strengthening Exercise Program Following Partial/Hemi Glossectomy and Reconstruction

Impact of Tongue Proactive Strengthening Exercise Program on Speech and Swallowing Outcomes Following Partial/Hemiglossectomy and Reconstruction


Sponsor

Case Comprehensive Cancer Center

Enrollment

40 participants

Start Date

Dec 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is being done to determine whether adding a proactive tongue strengthening exercise program using a biofeedback device (the Tongueometer) improves speech and swallowing outcomes after surgery for tongue cancer. Patients who undergo partial or hemiglossectomy often experience difficulties with speech and swallowing, which can significantly impact their quality of life. While speech and swallow therapy is typically provided in response to problems, this study investigates whether introducing structured tongue strengthening exercises with biofeedback early-can lead to better long-term outcomes. This research will help establish whether this approach should become part of standard post-operative care.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • ≥18 years of age
  • No prior history of head and neck cancer
  • No prior history of radiation
  • Planned to undergo resection of ≤50% of the native tongue (partial/hemiglossectomy) with immediate reconstruction, including free flap reconstruction, and with or without neck dissection
  • Sufficiently fluent in written English, French, Spanish or Simplified Chinese to complete the study outcomes questionnaires

Exclusion Criteria4

  • Distant metastasis at enrollment
  • Previously seen and treated by speech and language pathologist for dysphagia or dysarthria for non-head and neck cancer causes
  • Prior head and neck radiation
  • Requires mandibulectomy or \>50% resection of native tongue

Interventions

OTHERTongueometer

The Tongueometer device features an air-filled bulb that is placed against the roof of the mouth by the tongue for resistance training. This setup allows for an initial measurement of the patient's maximum tongue strength and endurance, which helps establish goals that are specific to each patient. The device connects to a mobile application that provides visual biofeedback, ensuring consistent monitoring as the patient completes exercises using the tongue bulb for resistance. Once the patient's goals are set based on their initial measurements, the app offers two exercise modules designed to improve both tongue strength and endurance.


Locations(1)

Case Comprehensive Cancer Center, Cleveland Clinic Foundation

Cleveland, Ohio, United States

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NCT07110142


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