Lingual Endurance Exercise in Treating Post-Stroke Dysphagia

April 21, 2025 updated by: Brittany Krekeler, University of Cincinnati

Effects of Lingual Endurance Exercise on Rehabilitation of Swallowing Impairment After Ischemic Stroke

Aim 1: Determine feasibility of lingual endurance training for individuals with persistent dysphagia after ischemic stroke. Primary outcome measures: % patient adherence (# of attempted repetitions/# prescribed repetitions) and % dose delivery (# of repetitions meeting goal/# prescribed repetitions). Aim 2: Determine preliminary efficacy of lingual endurance training on improving critical aspects of oropharyngeal swallowing (physiologic impairments, clearance of oropharyngeal residue, airway protection), functional oral intake, and patient reported swallowing quality of life in individuals with persistent dysphagia after ischemic stroke. Primary outcome measures: improvement on videofluoroscopic assessment of swallowing function using the gold standard Modified Barium Swallowing Impairment Profile (MBSImP) Overall Impression (OI) score and Functional Oral Intake Scale (FOIS) score. Secondary outcome measures: Analysis of Swallow Physiology, Events, Timing and Kinematics (ASPEKT); airway invasion - Penetration Aspiration Scale (PAS). Patient reported outcome measures: EAT-10 (Eating Assessment Tool) and the Swallowing Quality of Life Questionnaire (SWAL-QoL).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Implications of Post-Stroke Dysphagia Dysphagia (swallowing impairment) after stroke is common, estimated to affect 78% of patients.1 Dysphagia results in additional negative consequences that complicate patient recovery and increase the risk of developing pulmonary complications (aspiration pneumonia) and may result in suboptimal nutrition. These comorbidities increase cost of care, up to $6,243 on average per patient, placing a burden not only on the individual, but also the healthcare system at large. The effects of dysphagia post-stroke extend beyond physical health concerns and increase the risk of depression, with devastating impacts on quality of life. Given these undesirable and dangerous health consequences, adequate assessment and treatment of swallowing impairments after stroke is a critical component of rehabilitation for this patient population.

Limitations to Current Treatment Approaches Current treatment approaches to alleviate dysphagia after stroke, especially in acute and sub-acute phases, have primarily focused on diet modification, compensatory posturing, and providing alternate access to hydration and nutrition. While the goal of these strategies is to improve swallow safety and avoid negative consequences of airway invasion, these techniques can be burdensome to the patient if implemented long-term. Additionally, these approaches do not target rehabilitation of swallowing function, but rather provide a somewhat temporary solution to what is, for many patients, a life-long issue. Available rehabilitative approaches to target improvements in function of oropharyngeal musculature during swallowing include both swallowing exercises (task-specific) and non-swallowing exercises (e.g. tongue exercise), which rely on the principles of transference to improve swallowing function. However, evidence is inconsistent regarding efficacy of these "exercise-based" interventions that target the oropharyngeal musculature, and the scientific validity of these trials varies greatly. Of these non-swallowing exercise approaches, lingual (tongue) exercise has been frequently studied and can be facilitated by medical devices which provide bio-feedback of lingual pressure generative capabilities to the patient and clinician. However, there is little to no evidence that lingual strengthening improves swallow physiology or functional outcomes in post-stroke dysphagia, and a majority of these previous studies lack use of standardized outcomes or randomized controlled trial procedures. Also, lingual strengthening may not induce biological changes to tongue muscle fiber size, as would be expected with a resistance-based exercise program. Despite these mixed findings, lingual strengthening is still routinely to treat post-stroke dysphagia. A major limitation of these current approaches is a sole focus on increasing muscular strength alone without consideration for other aspects of muscle physiology necessary for swallowing, such as endurance.

Lingual Endurance Training as an Alternative Approach In this preliminary study, we have proposed to examine the effects of lingual endurance training in individuals with dysphagia after stroke, as an alternative approach to traditional progressive lingual strength training, because this patient group is known to have specific deficits in lingual function after stroke. Both oral and pharyngeal tongue movements are essential for safe and efficient swallowing. Thus, exercise of the lingual musculature is a reasonable goal. However, swallowing is an endurance task; lingual pressures required for swallowing are submaximal, requiring repeated and sustained contraction over the course of a meal. Thus, targeting improvement in lingual endurance over strength alone may provide greater transferrable benefit to daily swallowing tasks. However, there are currently no randomized controlled trials investigating efficacy of lingual endurance training as a treatment for dysphagia in any patient population. As such, this proposed preliminary trial is essential to gathering the necessary pilot evidence regarding whether lingual endurance training is feasible and effective as an alternative approach to dysphagia rehabilitation for individuals with swallowing impairments after stroke. The long-term goal of this proposed work is to develop improved, evidence-based protocols for lingual exercise training for individuals with dysphagia after stroke. Ultimately, the results of this proposed pilot will be highly significant in creating movement towards more specific and evidence-based approaches for this unique patient group, who currently have very few rehabilitative options available. In this initial trial, we will assess if lingual endurance training will be feasible (Aim 1) and effective (Aim 2) for improving swallowing function in post-stroke dysphagia.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Medical Sciences Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥3 months since initial diagnosis ischemic, non-hemorrhagic stroke occurring in areas involving anterior or posterior circulation and affecting underlying cortical or subcortical structures (including brainstem)
  • are safe to tolerate some oral intake required for assessment of swallowing function via Modified Barium Swallow Study
  • able to follow 2-step commands
  • English speaking. Participants will not be considered for inclusion if they meet any of the following screening exclusion criteria

Exclusion Criteria:

  • a 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, or a surgical procedure involving the pharynx or larynx
  • a history of other neurological disease including traumatic brain injury, multiple sclerosis, Amyotrophic lateral sclerosis (ALS), Parkinson, or dementia
  • Pregnant women
  • Patients with a history of Temporomandibular joint dysfunction (TMJ) or Epilepsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lingual Endurance Training
Participants will complete lingual endurance training 2-3 times a day. Half of the participants will also complete a session of effortful swallows with the device.
Other: Lingual Endurance Training
Participants will participate in 3 training sessions per day for 8 weeks. Some participants will complete 3 sessions of lingual endurance exercise. For example, if the participant completed 100 repetitions during the baseline measurement, they would complete 75 repetitions during their exercise session. Other participants will complete effortful swallows during their 3rd training session. These participants will complete 30 swallows where they are instructed to press their tongue hard on the bulb and swallow their saliva.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: Assessed at 8 weeks (study completion)
% [(total number of days of attempted exercise/total number of days prescribed over 8 weeks of therapy)x100]
Assessed at 8 weeks (study completion)
Change From Baseline Modified Barium Swallowing Impairment Profile (MBSImP) Oral Total Score
Time Frame: Baseline and 8 Weeks
Improvement on Oral Total (OT) score MBSImP; OT score minimum score (best) =0; OT maximum score (worst) = 22
Baseline and 8 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Improving Worst Penetration Aspiration Scale (PAS) Score
Time Frame: Baseline and 8 Weeks
measure of airway invasion during swallowing, best score = 1, worst score = 8 Number of patients who improved worst PAS score from baseline to 8 week timepoint
Baseline and 8 Weeks
Change From Baseline in Post-swallow Residue (Solid)
Time Frame: Baseline and 8 Weeks
Analysis of Swallowing Physiology, Kinematics, Events, Timing (ASPEKT): The ASPEKT method uses ImageJ pixel based measures of post-swallow residue (Total% of C2-C4)
Baseline and 8 Weeks
Change From Baseline in Post-swallow Residue (Puree)
Time Frame: Baseline and 8 Weeks
Analysis of Swallowing Physiology, Kinematics, Events, Timing (ASPEKT): The ASPEKT method uses ImageJ pixel based measures of post-swallow residue (Total% of C2-C4)
Baseline and 8 Weeks
Change From Baseline in Post-swallow Residue (Thin Liquids)
Time Frame: Baseline and 8 Weeks
Analysis of Swallowing Physiology, Kinematics, Events, Timing (ASPEKT): The ASPEKT method uses ImageJ pixel based measures of post-swallow residue (Total% of C2-C4)
Baseline and 8 Weeks
Change From Baseline in Post-swallow Residue (Mildly Thick Liquids)
Time Frame: Baseline and 8 Weeks
Analysis of Swallowing Physiology, Kinematics, Events, Timing (ASPEKT): The ASPEKT method uses ImageJ pixel based measures of post-swallow residue (Total% of C2-C4)
Baseline and 8 Weeks
Change From Baseline in Post-swallow Residue (Moderately Thick Liquids)
Time Frame: Baseline and 8 Weeks
Analysis of Swallowing Physiology, Kinematics, Events, Timing (ASPEKT): The ASPEKT method uses ImageJ pixel based measures of post-swallow residue (Total% of C2-C4)
Baseline and 8 Weeks
Change From Baseline in Swallowing Quality of Life Questionnaire (SWAL-QoL)
Time Frame: Baseline and 8 Weeks
Patient reported outcome measure of swallowing quality of life, 0 = best score; 100 = worst score
Baseline and 8 Weeks
Change From Baseline Eating Assessment Tool (EAT-10) Score
Time Frame: Baseline and 8 Weeks
patient reported outcome tool; 0 = best score, 50 = worst score
Baseline and 8 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Brittany Krekeler, PhD, University of Cincinnati, Department of Otolaryngology-Head and Neck Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2022

Primary Completion (Actual)

November 28, 2023

Study Completion (Actual)

November 28, 2023

Study Registration Dates

First Submitted

August 25, 2022

First Submitted That Met QC Criteria

August 30, 2022

First Posted (Actual)

September 1, 2022

Study Record Updates

Last Update Posted (Actual)

May 7, 2025

Last Update Submitted That Met QC Criteria

April 21, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-0218
  • P2CHD101899 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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