DysphagiaNCT06072924
K01 Impacts of Lingual Endurance Exercise
A study testing Isotonic Endurance Exercise in people with Dysphagia and Dysphagia, Oropharyngeal, run by University of Cincinnati at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia, Dysphagia, Oropharyngeal, Ischemic Stroke
- What is being tested?
- Isotonic Endurance Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
- 5) 5) History of temporomandibular joint and muscle disorders (also known as TMJ).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45220
Anna Hopkins, MS, +1 513 558 4152, hopkiak@ucmail.uc.edu
Brittany Krekeler, PhD
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Dysphagia, Dysphagia, Oropharyngeal, Ischemic Stroke, Stroke
- Being tested
- Isotonic Endurance Exercise, Sham Exercise
- Keywords
- swallowing trouble, difficulty swallowing, swallow rehab
- Medical subject headings
- Deglutition Disorders, Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isotonic Endurance ExerciseBehavioural
Pressing tongue against a pressure sensor at the set number of repetitions per session (individualized per participant) 3 times per day
Sham ExerciseBehavioural
Also called Learning group
Pressing tongue against pressure sensor at a low threshold (1-15kPa) 30x/day
| Study group | Role | What they receive |
|---|---|---|
| Lingual Endurance Exercise | Experimental | 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. Receives: Behavioral: Isotonic Endurance Exercise |
| Sham Exercise | Sham comparator | 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. Receives: Behavioral: Sham Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline (at the end of 8 weeks)
Secondary outcomes (5)
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.
Measured: 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.
Measured: Change from Baseline (at the end of 8 weeks)
Adherence
number of repetitions attempted/total number of repetitions prescribed
Measured: 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.
Measured: 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.
Measured: Change from Baseline (at the end of 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Sep 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Sham Controlled
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), TriHealth Inc.
- Responsible party
- Principal investigator, Brittany Krekeler, University of Cincinnati
- Investigators
- Brittany N Krekeler, PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072924
- Sponsor's protocol ID
- 2023-0582 Lingual Endurance
- Other IDs
- 1K01HD111680-01
- Status last verified
- Dec 2025
- First submitted
- 19 Sep 2023
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan currently to share IPD with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Lingual Endurance Exercise on Rehabilitation of Swallowing Impairments After Ischemic Stroke
- ClinicalTrials.gov ID
- NCT06072924
- Acronym / sponsor ID
- 2023-0582 Lingual Endurance
- Conditions
- Dysphagia, Dysphagia, Oropharyngeal, Ischemic Stroke, Stroke
- Keywords
- swallowing trouble, difficulty swallowing, swallow rehab
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), TriHealth Inc.
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Sham Controlled
| Arm | Type | Receives |
|---|---|---|
| Lingual Endurance Exercise | Experimental | Behavioral: Isotonic Endurance ExerciseThe 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. |
| Sham Exercise | Sham comparator | Behavioral: Sham ExerciseThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
- 5) 5) History of temporomandibular joint and muscle disorders (also known as TMJ).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isotonic Endurance ExercisePressing tongue against a pressure sensor at the set number of repetitions per session (individualized per participant) 3 times per day | Behavioural | Lingual Endurance Exercise |
| Sham ExerciseAlso: Learning groupPressing tongue against pressure sensor at a low threshold (1-15kPa) 30x/day | Behavioural | Sham Exercise |
Primary outcome
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.
5 secondary outcomes
Pharyngeal Swallow Efficiency
Time frame: Change from Baseline (at the end of 8 weeks)
Penetration Aspiration Scale (PAS) Scores
Time frame: Change from Baseline (at the end of 8 weeks)
Adherence
Time frame: At the end of 8 weeks
Pharyngeal Swallow Safety
Time frame: Change from Baseline (at the end of 8 weeks)
Maximum Isometric Pressure imaging with video-fluoroscopy
Time frame: Change from Baseline (at the end of 8 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No. There is not a plan currently to share IPD with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brittany N Krekeler, PhD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isotonic Endurance Exercise in people with Dysphagia and Dysphagia, Oropharyngeal, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Hopkins, MS (+1 513 558 4152, hopkiak@ucmail.uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Barium Swallow Study Impairment Profile Oral Total (MBSImP OT Score) (time frame: Change from Baseline (at the end of 8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.