K01 Impacts of Lingual Endurance Exercise
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Cincinnati
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Isotonic Endurance Exercise
BehavioralPressing tongue against a pressure sensor at the set number of repetitions per session (individualized per participant) 3 times per day
Sham Exercise
BehavioralPressing tongue against pressure sensor at a low threshold (1-15kPa) 30x/day
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Lingual Endurance ExerciseExperimental treatment 1 intervention
Group B: Sham ExerciseSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Modified Barium Swallow Study Impairment Profile Oral Total (MBSImP OT Score)
MBSImP is a validated, standardized tool for assessing oral, pharyngeal, and esophageal swallowing function. We will be using change in OT score (sum of components 1-6) as our primary outcome measure.
Time frame
Change from Baseline (at the end of 8 weeks)Secondary outcomes
1
Pharyngeal Swallow Efficiency
Measurements via the ASPEKT method (Analysis of Swallowing Physiology: Events, Kinematics, and Timing) will be analyzed to compared pre and post treatment swallow efficiency. The amount will be presented as a percent of anatomical C2-C4 Scalar. Higher percentile, in general indicated greater impairment, however these will be compared to published normative data for reference.
Time frame
Change from Baseline (at the end of 8 weeks)2
Penetration Aspiration Scale (PAS) Scores
8-point rating scale that is used to capture both degree and sensation of penetration and aspiration.
Time frame
Change from Baseline (at the end of 8 weeks)3
Adherence
number of repetitions attempted/total number of repetitions prescribed
Time frame
At the end of 8 weeks4
Pharyngeal Swallow Safety
Closure above the airway must be achieved for swallowing safety and in a timely manner. The ASPEKT method (Analysis of Swallow Physiology: Events, Kinematics and Timing) will be used to analyze changes of laryngeal vestibule closure pre and post treatment.
Time frame
Change from Baseline (at the end of 8 weeks)Other outcomes
1
Change in fractional anisotropy (FA)
Diffusion Tensor Imaging (DTI) has been the most common analysis framework that is used to analyze the signal from diffusion MRI (dMRI) to gather information about the properties of the underlying white matter.
Time frame
Change from Baseline (at the end of 8 weeks)2
Change in cortical thickness
Diffusion Tensor Imaging (DTI) has been the most common analysis framework that is used to analyze the signal from diffusion MRI (dMRI) to gather information about the properties of the underlying white matter.
Time frame
Change from Baseline (at the end of 8 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Cincinnati
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
TriHealth Inc.
Collaborator
Source ClinicalTrials.gov