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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT07110142
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tongueometer — OTHER
    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.

Study Details

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.

Key Dates

Start date
Dec 10, 2025
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Arm 1 - Standard of Care(SOC)
    Standard of Care (SOC): Standard post-operative care with additional intervention if dysarthria or dysphagia symptoms are not improving as expected
  • Experimental: Arm 2 - SOC + Interventional Group
    SOC + Interventional Group: Standard post-operative care with biofeedback-driven prophylactic tongue strengthening exercise program using the Tongueometer and the routine interventions if dysarthria or dysphagia symptoms are not improving appropriately

Primary Outcome Measure

Quality of life patient report outcome (PRO) as assessed by Speech Handicap Index(SHI) [ Time Frame: 6 months post-treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Case Comprehensive Cancer Center, Cleveland Clinic FoundationClevelandOhio44195
Jamie Ku, MD, FACS
[email protected]
216-445-6594

Find similar trials in Cleveland, OH

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Case Comprehensive Cancer Center, Cleveland Clinic Foundation· Cleveland, OH

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