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RECRUITING Not applicable ClinicalTrials.gov

K01 Impacts of Lingual Endurance Exercise

Sponsor: University of Cincinnati • ClinicalTrials.gov ID: NCT06072924

Registry updated: 2026-09-04
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Description

The goal of this clinical trial is to learn whether a tongue endurance exercise program can improve swallowing function in adults with dysphagia after a stroke. It also aims to explore how this exercise may affect brain structure and connectivity involved in swallowing. The main questions it aims to answer are: Primary Aim: Does lingual endurance exercise improve swallowing function compared to a sham therapy? Secondary Aim: Does lingual endurance exercise lead to changes in brain structure or neuroplasticity, as measured by MRI? Researchers will compare a group receiving tongue endurance exercises to a sham therapy group to see whether the treatment improves tongue function, swallowing. Participants will: * Complete a baseline swallowing assessment and MRI * Be randomly assigned to either the lingual exercise or sham therapy group * Complete 8 weeks of home-based tongue exercise therapy * Return for follow-up swallowing assessments * A subgroup of participants will complete a pre-treatment and post-treatment MRI.

Interventions

  • Isotonic Endurance Exercise (Behavioral)
    Pressing tongue against a pressure sensor at the set number of repetitions per session (individualized per participant) 3 times per day
  • Sham Exercise (Behavioral)
    Pressing tongue against pressure sensor at a low threshold (1-15kPa) 30x/day

Eligibility criteria

Inclusion Criteria: * 1\) 3-6 months since most recent diagnosis of ischemic, confirmed from clinical imaging) with or without small hemorrhagic transformation (HI-1) * 2\) English Speaking Exclusion Criteria: * 1\) ≤18 years of age * 2\) history of dysphagia prior to or after the stroke caused by any of the following conditions: gastrointestinal disease, traumatic brain injury, head and neck cancer, surgery involving the pharynx or larynx * 3\) history of other neurological disease (i.e. multiple sclerosis, ALS, Parkinson's, dementia). 5\) 5) History of temporomandibular joint and muscle disorders (also known as TMJ).

Conditions

Dysphagia Dysphagia, Oropharyngeal Ischemic Stroke Stroke

Locations

  • University of Cincinnati — Cincinnati, Ohio, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record