Actively Recruiting
K01 Impacts of Lingual Endurance Exercise
Led by University of Cincinnati · Updated on 2025-12-18
70
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
U
University of Cincinnati
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
K01 Impacts of Lingual Endurance Exercise
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 3 to 6 months since most recent ischemic stroke diagnosis confirmed by clinical imaging, with or without small hemorrhagic transformation (HI-1)
- Have some ongoing swallowing difficulties
- Speak English
You will not qualify if you...
- Younger than 18 years of age
- History of dysphagia before or after stroke caused by gastrointestinal disease, traumatic brain injury, head and neck cancer, or surgery involving the pharynx or larynx
- History of other neurological diseases such as multiple sclerosis, ALS, Parkinson's disease, or dementia
- Medium to large hemorrhagic stroke involvement on clinical imaging
- History of temporomandibular joint and muscle disorders (TMJ disorders)
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Cincinnati
Cincinnati, Ohio, United States, 45220
Actively Recruiting
Research Team
A
Anna Hopkins, MS
CONTACT
R
Rebecca Reinert
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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