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NCT Number: NCT06072924

K01 Impacts of Lingual Endurance Exercise

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.

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Key information

Conditions

Dysphagia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Deglutition Disorders Digestive System Diseases Dysphagia, Oropharyngeal Esophageal Diseases Gastrointestinal Diseases Ischemic Stroke Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cincinnati

Cincinnati, Ohio, 45220, United States

Location status: Recruiting

Location contact

Anna Hopkins, MS

CONTACT

[email protected]

+1 513 558 4152

Brittany Krekeler, PhD

PRINCIPAL_INVESTIGATOR

About this study

This randomized, controlled clinical trial investigates the efficacy of a 8-week lingual endurance exercise program in adults with dysphagia following stroke. The study uses a two-arm, parallel-group design with participants randomized to either a lingual endurance exercise group or a sham therapy control group. Both interventions are delivered using a lingual manometer, which participants use at home under monitored conditions.

The primary aim is to evaluate changes in oral-phase swallowing physiology using the Modified Barium Swallow Impairment Profile (MBSImP) Oral Total Score, as assessed through video-fluoroscopic swallowing study (VFSS).

An exploratory aim will assess potential neuroplasticity associated with lingual endurance exercise using multimodal neuroimaging. Participants who meet MRI eligibility criteria undergo pre- and post-intervention imaging, including diffusion tensor imaging (DTI) to assess white matter integrity, high-resolution structural imaging for cortical thickness estimation, and functional MRI (task-based and resting state). Data will be used to evaluate intervention-related changes in regions associated with swallowing motor control and sensory integration.

This study also supports the investigator's training in clinical trial methodology, swallowing outcomes analysis, and neuroimaging techniques, and will inform a future, fully powered efficacy trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Isotonic Endurance Exercise

Behavioral

Pressing tongue against a pressure sensor at the set number of repetitions per session (individualized per participant) 3 times per day

Sham Exercise

Behavioral

Pressing tongue against pressure sensor at a low threshold (1-15kPa) 30x/day

Other names: Learning group

Primary outcomes

  1. Modified Barium Swallow Study Impairment Profile Oral Total (MBSImP OT Score)

    Time frame: Change from Baseline (at the end of 8 weeks)

    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.

Secondary outcomes

  1. Pharyngeal Swallow Efficiency

    Time frame: Change from Baseline (at the end of 8 weeks)

    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.

  2. Penetration Aspiration Scale (PAS) Scores

    Time frame: Change from Baseline (at the end of 8 weeks)

    8-point rating scale that is used to capture both degree and sensation of penetration and aspiration.

  3. Adherence

    Time frame: At the end of 8 weeks

    number of repetitions attempted/total number of repetitions prescribed

  4. Pharyngeal Swallow Safety

    Time frame: Change from Baseline (at the end of 8 weeks)

    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.

  5. Maximum Isometric Pressure imaging with video-fluoroscopy

    Time frame: Change from Baseline (at the end of 8 weeks)

    Maximum isometric press will be recorded in kPa and with recorded imaging using video-fluoroscopy. This will be collected pre- and post-therapy to determine any changes in oropharyngeal movements with a lingual press.

  6. Dietary Intake (Average Daily Calorie Intake) Outcome

    Time frame: Change from Baseline (at the end of 8 weeks)

    A pre treatment and post treatment 24 hour dietary recall will be collected in a subset or participants. This information will be used for estimating nutrient and food group intake to characterize usual diet and to assess changes over time. Nutrition Data Systems for Research (NDSR) (Nutrition Coordinating Center, University of Minnesota, Minneapolis, MN) software and foods database will be used to assess average daily energy (kJ) intake over 3 days

  7. Food Textures Consumed Outcome

    Time frame: Change from Baseline (at the end of 8 weeks)

    A pre treatment and post treatment 24 hour dietary recall will be collected in a subset or participants. This information will be used for estimating nutrient and food group intake to characterize usual diet and to assess changes over time. Nutrition Data Systems for Research (NDSR) (Nutrition Coordinating Center, University of Minnesota, Minneapolis, MN) software and foods database will be used to assess the relative percentage (%) of dry texture food intake, on average, across three days

Other outcomes

  1. Change in fractional anisotropy (FA)

    Time frame: Change from Baseline (at the end of 8 weeks)

    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.

  2. Change in cortical thickness

    Time frame: Change from Baseline (at the end of 8 weeks)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Hopkins, MS

CONTACT

[email protected]

+1 513 558 4152

Rebecca Reinert

CONTACT

[email protected]

+1 513 558 1719

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institutes of Health (NIH)
  • TriHealth Inc.

Registry information

Official study title

Impact of Lingual Endurance Exercise on Rehabilitation of Swallowing Impairments After Ischemic Stroke

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Oct 10, 2023
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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