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NCT06072924
K01 Impacts of Lingual Endurance Exercise
Conditions: Dysphagia, Dysphagia, Oropharyngeal, Ischemic Stroke, Stroke
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 70
Sponsor: University of Cincinnati
Location: University of Cincinnati Cincinnati Ohio
Summary
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.
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).
Source: ClinicalTrials.gov (NCT06072924). StuddyBuddy aggregates publicly available trial information.