K01 Impacts of Lingual Endurance Exercise

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Ischemic Stroke; Dysphagia; Dysphagia, Oropharyngeal
• Intervention / Treatment: Behavioral: Isotonic Endurance Exercise; Behavioral: Sham Exercise

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Hopkins, MS; Phone Number: +1 513 558 4152; Email: hopkiak@ucmail.uc.edu
• Study Contact Backup: Name: Rebecca Reinert; Phone Number: +1 513 558 1719; Email: gibsonrk@ucmail.uc.edu

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Recruiting
      • University of Cincinnati
      • Principal Investigator: Brittany Krekeler, PhD
      • Contact: Anna Hopkins, MS; Phone Number: +1 513 558 4152; Email: hopkiak@ucmail.uc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lingual Endurance Exercise; The experimental exercise group will participate in 3 training sessions per day for 8 weeks. Endurance exercise will include completing isotonic endurance repetitions 3 times a day. Number of repetitions per session will be determined during baseline testing, and re-evaluated every 2 weeks, for each participant.	Behavioral: Isotonic Endurance Exercise; Pressing tongue against a pressure sensor at the set number of repetitions per session (individualized per participant) 3 times per day
Sham Comparator: Sham Exercise; The sham control group will be instructed to press the lingual sensor 30 times at a very low-pressure threshold (approximately 1-15 kPa), which will be monitored weekly via device output sent to the study team to avoid use of excessive force that would qualify as exercise.	Behavioral: Sham Exercise; Pressing tongue against pressure sensor at a low threshold (1-15kPa) 30x/day; Other Names: Learning group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from Baseline (at the end of 8 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	number of repetitions attempted/total number of repetitions prescribed	At the end of 8 weeks
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.	Change from Baseline (at the end of 8 weeks)
Penetration Aspiration Scale (PAS) Scores	8-point rating scale that is used to capture both degree and sensation of penetration and aspiration.	Change from Baseline (at the end of 8 weeks)
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.	Change from Baseline (at the end of 8 weeks)
Maximum Isometric Pressure imaging with video-fluoroscopy	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.	Change from Baseline (at the end of 8 weeks)
Dietary Intake (Average Daily Calorie Intake) Outcome	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	Change from Baseline (at the end of 8 weeks)
Food Textures Consumed Outcome	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	Change from Baseline (at the end of 8 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from Baseline (at the end of 8 weeks)
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.	Change from Baseline (at the end of 8 weeks)

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH); TriHealth Inc.
• Investigators: Principal Investigator: Brittany N Krekeler, PhD, University of Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: October 2, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: difficulty swallowing; swallowing trouble; swallow rehab
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Ischemic Stroke; Stroke; Deglutition Disorders
• Other Study ID Numbers: 2023-0582 Lingual Endurance; 1K01HD111680-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan currently to share IPD with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No