No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
70 (estimated)
Sponsor
University of Cincinnati · Other
Who this trial is looking for
This trial is looking for adults who have trouble swallowing after a stroke. Participants will do tongue exercises for 8 weeks and complete assessments before and after the program.
Are You a Good Fit for This Trial?
You may be able to join if
I have had a stroke in the last 3 to 6 months.
I have some ongoing swallowing issues.
I speak English.
You may not be able to join if
I am 18 years old or younger.
I had swallowing problems before my stroke.
I have a history of neurological diseases like multiple sclerosis or Parkinson's.
I have medium to large bleeding in the brain documented in imaging.
I have issues with my jaw or jaw muscles.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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Status
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\) Have some indication of on-going swallowing issues
* 3\) English Speaking
Exclusion Criteria:
* 1\) ≤18 years of age
* 2\) h…
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\) Have some indication of on-going swallowing issues
* 3\) 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).
* 4\) Medium to large hemorrhagic transformation/involvement documented on clinical stroke imaging 5) 5) History of temporomandibular joint and muscle disorders (also known as TMJ).
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