Actively Recruiting
Impact of Lingual Endurance Exercise on Rehabilitation of Swallowing Impairments After Ischemic Stroke
Led by University of Cincinnati · Updated on 2025-12-18
70
Participants Needed
1
Research Sites
52 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
Researchers are investigating whether a tongue endurance exercise program can improve swallowing function in adults who have dysphagia after a stroke. This clinical trial compares this exercise to a sham therapy to see if it improves tongue and swallowing abilities. The study also explores how tongue endurance exercises might affect brain structure and connectivity related to swallowing using MRI imaging techniques. Participants are randomly assigned to one of two groups: the lingual endurance exercise group or a sham therapy group. Those in the exercise group will perform isotonic endurance tongue exercises three times daily for eight weeks, with repetitions tailored to each participant and adjusted every two weeks. The sham group will press a tongue sensor lightly 30 times per day to avoid real exercise. Both treatments are done at home using a lingual manometer under monitored conditions. Throughout the study, participants will complete swallowing assessments and MRI scans before and after the treatment period. Researchers will measure changes in swallowing function using video-fluoroscopic studies, including the Modified Barium Swallow Impairment Profile. They will also track swallowing safety, efficiency, adherence to therapy, tongue strength, dietary intake, and food textures consumed. The study lasts for eight weeks of treatment with follow-up assessments to evaluate the effects of the exercise program and brain changes.
CONDITIONS
Brief 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 imaging, with or without small hemorrhagic transformation
- Have ongoing swallowing difficulties
- English speaking
- Adults aged 18 years or older
You will not qualify if you...
- Younger than 18 years of age
- History of swallowing difficulties 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, or dementia
- Medium to large hemorrhagic transformation shown on stroke imaging
- History of temporomandibular joint and muscle disorders (TMJ)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants perform lingual endurance exercises or sham exercises at home using a pressure sensor device to improve swallowing function after stroke.
3 training sessions per day at home, with weekly monitoring visits
Trial Site Locations
Total: 1 location
1
University of Cincinnati
Cincinnati, Ohio, United States, 45220
Actively Recruiting
Research Team
A
Anna Hopkins, MS
R
Rebecca Reinert
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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