Dysphagia, Oral PhaseNCT05523973
Lingual Endurance Exercise in Treating Post-Stroke Dysphagia
A study testing Lingual Endurance Training in people with Dysphagia, Oral Phase and Stroke, Ischemic, run by University of Cincinnati at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dysphagia, Oral Phase, Stroke, Ischemic
- What is being tested?
- Lingual Endurance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2022to 28 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Dysphagia, Oral Phase, Stroke, Ischemic
- Being tested
- Lingual Endurance Training
- Keywords
- swallowing, dysphagia, sub-acute stroke, tongue, exercise
- Medical subject headings
- Deglutition Disorders, Ischemic Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lingual Endurance TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Lingual Endurance Training | Experimental | 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. Receives: Other: Lingual Endurance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
% [(total number of days of attempted exercise/total number of days prescribed over 8 weeks of therapy)x100]
Measured: Assessed at 8 weeks (study completion)
Change From Baseline Modified Barium Swallowing Impairment Profile (MBSImP) Oral Total Score
Improvement on Oral Total (OT) score MBSImP; OT score minimum score (best) =0; OT maximum score (worst) = 22
Measured: Baseline and 8 Weeks
Secondary outcomes (8)
Participant Improving Worst Penetration Aspiration Scale (PAS) Score
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
Measured: Baseline and 8 Weeks
Change From Baseline in Post-swallow Residue (Solid)
Analysis of Swallowing Physiology, Kinematics, Events, Timing (ASPEKT): The ASPEKT method uses ImageJ pixel based measures of post-swallow residue (Total% of C2-C4)
Measured: Baseline and 8 Weeks
Change From Baseline in Post-swallow Residue (Puree)
Analysis of Swallowing Physiology, Kinematics, Events, Timing (ASPEKT): The ASPEKT method uses ImageJ pixel based measures of post-swallow residue (Total% of C2-C4)
Measured: Baseline and 8 Weeks
Change From Baseline in Post-swallow Residue (Thin Liquids)
Analysis of Swallowing Physiology, Kinematics, Events, Timing (ASPEKT): The ASPEKT method uses ImageJ pixel based measures of post-swallow residue (Total% of C2-C4)
Measured: Baseline and 8 Weeks
Change From Baseline in Post-swallow Residue (Mildly Thick Liquids)
Analysis of Swallowing Physiology, Kinematics, Events, Timing (ASPEKT): The ASPEKT method uses ImageJ pixel based measures of post-swallow residue (Total% of C2-C4)
Measured: Baseline and 8 Weeks
Change From Baseline in Post-swallow Residue (Moderately Thick Liquids)
Analysis of Swallowing Physiology, Kinematics, Events, Timing (ASPEKT): The ASPEKT method uses ImageJ pixel based measures of post-swallow residue (Total% of C2-C4)
Measured: Baseline and 8 Weeks
Change From Baseline in Swallowing Quality of Life Questionnaire (SWAL-QoL)
Patient reported outcome measure of swallowing quality of life, 0 = best score; 100 = worst score
Measured: Baseline and 8 Weeks
Change From Baseline Eating Assessment Tool (EAT-10) Score
patient reported outcome tool; 0 = best score, 50 = worst score
Measured: Baseline and 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start2 Aug 2022
- Primary completion28 Nov 2023
- Study completion28 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for Dysphagia, Oral PhaseStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Some participants will practice only lingual endurance exercise 3 times a day, others will have a effortful swallow exercise to practice in place of their third session.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Brittany Krekeler, University of Cincinnati
- Investigators
- Brittany Krekeler, PhD, Principal investigator, University of Cincinnati, Department of Otolaryngology-Head and Neck Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523973
- Sponsor's protocol ID
- 2022-0218
- Other IDs
- P2CHD101899
- Status last verified
- Apr 2025
- First submitted
- 25 Aug 2022
- Last updated
- 7 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martino R, Foley N, Bhogal S, Diamant N, Speechley M, Teasell R. Dysphagia after stroke: incidence, diagnosis, and pulmonary complications. Stroke. 2005 Dec;36(12):2756-63. doi: 10.1161/01.STR.0000190056.76543.eb. Epub 2005 Nov 3.
PubMed 16269630Ojo O, Brooke J. The Use of Enteral Nutrition in the Management of Stroke. Nutrients. 2016 Dec 20;8(12):827. doi: 10.3390/nu8120827.
PubMed 27999383Crary MA, Humphrey JL, Carnaby-Mann G, Sambandam R, Miller L, Silliman S. Dysphagia, nutrition, and hydration in ischemic stroke patients at admission and discharge from acute care. Dysphagia. 2013 Mar;28(1):69-76. doi: 10.1007/s00455-012-9414-0. Epub 2012 Jun 9.
PubMed 22684924Krekeler BN, Rowe LM, Connor NP. Dose in Exercise-Based Dysphagia Therapies: A Scoping Review. Dysphagia. 2021 Feb;36(1):1-32. doi: 10.1007/s00455-020-10104-3. Epub 2020 Mar 5.
PubMed 32140905McKenna VS, Zhang B, Haines MB, Kelchner LN. A Systematic Review of Isometric Lingual Strength-Training Programs in Adults With and Without Dysphagia. Am J Speech Lang Pathol. 2017 May 17;26(2):524-539. doi: 10.1044/2016_AJSLP-15-0051.
PubMed 28282484Smaoui S, Langridge A, Steele CM. The Effect of Lingual Resistance Training Interventions on Adult Swallow Function: A Systematic Review. Dysphagia. 2020 Oct;35(5):745-761. doi: 10.1007/s00455-019-10066-1. Epub 2019 Oct 14.
PubMed 31612288Moon JH, Hahm SC, Won YS, Cho HY. The effects of tongue pressure strength and accuracy training on tongue pressure strength, swallowing function, and quality of life in subacute stroke patients with dysphagia: a preliminary randomized clinical trial. Int J Rehabil Res. 2018 Sep;41(3):204-210. doi: 10.1097/MRR.0000000000000282.
PubMed 29621048Park JS, Kim HJ, Oh DH. Effect of tongue strength training using the Iowa Oral Performance Instrument in stroke patients with dysphagia. J Phys Ther Sci. 2015 Dec;27(12):3631-4. doi: 10.1589/jpts.27.3631. Epub 2015 Dec 28.
PubMed 26834320Steele CM, Bayley MT, Peladeau-Pigeon M, Nagy A, Namasivayam AM, Stokely SL, Wolkin T. A Randomized Trial Comparing Two Tongue-Pressure Resistance Training Protocols for Post-Stroke Dysphagia. Dysphagia. 2016 Jun;31(3):452-61. doi: 10.1007/s00455-016-9699-5. Epub 2016 Mar 2.
PubMed 26936446Steele CM, Cichero JA. Physiological factors related to aspiration risk: a systematic review. Dysphagia. 2014 Jun;29(3):295-304. doi: 10.1007/s00455-014-9516-y. Epub 2014 Feb 23.
PubMed 24562507McConnel FM. Analysis of pressure generation and bolus transit during pharyngeal swallowing. Laryngoscope. 1988 Jan;98(1):71-8. doi: 10.1288/00005537-198801000-00015.
PubMed 3336265Nicosia MA, Hind JA, Roecker EB, Carnes M, Doyle J, Dengel GA, Robbins J. Age effects on the temporal evolution of isometric and swallowing pressure. J Gerontol A Biol Sci Med Sci. 2000 Nov;55(11):M634-40. doi: 10.1093/gerona/55.11.m634.
PubMed 11078092Nicosia MA, Robbins JA. The fluid mechanics of bolus ejection from the oral cavity. J Biomech. 2001 Dec;34(12):1537-44. doi: 10.1016/s0021-9290(01)00147-6.
PubMed 11716855Clark HM. Neuromuscular treatments for speech and swallowing: a tutorial. Am J Speech Lang Pathol. 2003 Nov;12(4):400-15. doi: 10.1044/1058-0360(2003/086).
PubMed 14658992Todd JT, Lintzenich CR, Butler SG. Isometric and swallowing tongue strength in healthy adults. Laryngoscope. 2013 Oct;123(10):2469-73. doi: 10.1002/lary.23852. Epub 2013 Aug 5.
PubMed 23918664
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lingual Endurance Exercise on Rehabilitation of Swallowing Impairment After Ischemic Stroke
- ClinicalTrials.gov ID
- NCT05523973
- Acronym / sponsor ID
- 2022-0218
- Conditions
- Dysphagia, Oral Phase, Stroke, Ischemic
- Keywords
- swallowing, dysphagia, sub-acute stroke, tongue, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 1 Sep 2022 (actual)
- Results
- Posted 7 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Some participants will practice only lingual endurance exercise 3 times a day, others will have a effortful swallow exercise to practice in place of their third session.
| Arm | Type | Receives |
|---|---|---|
| Lingual Endurance Training | Experimental | Other: Lingual Endurance TrainingParticipants 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Lingual Endurance TrainingParticipants 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. | Other | Lingual Endurance Training |
Primary outcome
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]
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
8 secondary outcomes
Participant Improving Worst Penetration Aspiration Scale (PAS) Score
Time frame: Baseline and 8 Weeks
Change From Baseline in Post-swallow Residue (Solid)
Time frame: Baseline and 8 Weeks
Change From Baseline in Post-swallow Residue (Puree)
Time frame: Baseline and 8 Weeks
Change From Baseline in Post-swallow Residue (Thin Liquids)
Time frame: Baseline and 8 Weeks
Change From Baseline in Post-swallow Residue (Mildly Thick Liquids)
Time frame: Baseline and 8 Weeks
Change From Baseline in Post-swallow Residue (Moderately Thick Liquids)
Time frame: Baseline and 8 Weeks
Change From Baseline in Swallowing Quality of Life Questionnaire (SWAL-QoL)
Time frame: Baseline and 8 Weeks
Change From Baseline Eating Assessment Tool (EAT-10) Score
Time frame: Baseline and 8 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16269630Martino R, Foley N, Bhogal S, Diamant N, Speechley M, Teasell R. Dysphagia after stroke: incidence, diagnosis, and pulmonary complications. Stroke. 2005 Dec;36(12):2756-63. doi: 10.1161/01.STR.0000190056.76543.eb. Epub 2005 Nov 3.
- Background: PubMed 27999383Ojo O, Brooke J. The Use of Enteral Nutrition in the Management of Stroke. Nutrients. 2016 Dec 20;8(12):827. doi: 10.3390/nu8120827.
- Background: PubMed 22684924Crary MA, Humphrey JL, Carnaby-Mann G, Sambandam R, Miller L, Silliman S. Dysphagia, nutrition, and hydration in ischemic stroke patients at admission and discharge from acute care. Dysphagia. 2013 Mar;28(1):69-76. doi: 10.1007/s00455-012-9414-0. Epub 2012 Jun 9.
- Background: PubMed 32140905Krekeler BN, Rowe LM, Connor NP. Dose in Exercise-Based Dysphagia Therapies: A Scoping Review. Dysphagia. 2021 Feb;36(1):1-32. doi: 10.1007/s00455-020-10104-3. Epub 2020 Mar 5.
- Background: PubMed 28282484McKenna VS, Zhang B, Haines MB, Kelchner LN. A Systematic Review of Isometric Lingual Strength-Training Programs in Adults With and Without Dysphagia. Am J Speech Lang Pathol. 2017 May 17;26(2):524-539. doi: 10.1044/2016_AJSLP-15-0051.
- Background: PubMed 31612288Smaoui S, Langridge A, Steele CM. The Effect of Lingual Resistance Training Interventions on Adult Swallow Function: A Systematic Review. Dysphagia. 2020 Oct;35(5):745-761. doi: 10.1007/s00455-019-10066-1. Epub 2019 Oct 14.
- Background: PubMed 29621048Moon JH, Hahm SC, Won YS, Cho HY. The effects of tongue pressure strength and accuracy training on tongue pressure strength, swallowing function, and quality of life in subacute stroke patients with dysphagia: a preliminary randomized clinical trial. Int J Rehabil Res. 2018 Sep;41(3):204-210. doi: 10.1097/MRR.0000000000000282.
- Background: PubMed 26834320Park JS, Kim HJ, Oh DH. Effect of tongue strength training using the Iowa Oral Performance Instrument in stroke patients with dysphagia. J Phys Ther Sci. 2015 Dec;27(12):3631-4. doi: 10.1589/jpts.27.3631. Epub 2015 Dec 28.
- Background: PubMed 26936446Steele CM, Bayley MT, Peladeau-Pigeon M, Nagy A, Namasivayam AM, Stokely SL, Wolkin T. A Randomized Trial Comparing Two Tongue-Pressure Resistance Training Protocols for Post-Stroke Dysphagia. Dysphagia. 2016 Jun;31(3):452-61. doi: 10.1007/s00455-016-9699-5. Epub 2016 Mar 2.
- Background: PubMed 24562507Steele CM, Cichero JA. Physiological factors related to aspiration risk: a systematic review. Dysphagia. 2014 Jun;29(3):295-304. doi: 10.1007/s00455-014-9516-y. Epub 2014 Feb 23.
- Background: PubMed 3336265McConnel FM. Analysis of pressure generation and bolus transit during pharyngeal swallowing. Laryngoscope. 1988 Jan;98(1):71-8. doi: 10.1288/00005537-198801000-00015.
- Background: PubMed 11078092Nicosia MA, Hind JA, Roecker EB, Carnes M, Doyle J, Dengel GA, Robbins J. Age effects on the temporal evolution of isometric and swallowing pressure. J Gerontol A Biol Sci Med Sci. 2000 Nov;55(11):M634-40. doi: 10.1093/gerona/55.11.m634.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Brittany Krekeler, PhD principal investigator
University of Cincinnati, Department of Otolaryngology-Head and Neck Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lingual Endurance Training in people with Dysphagia, Oral Phase and Stroke, Ischemic, 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 4 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: finished, as of the sponsor's last update on 7 May 2025. 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. 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?
Yes. Results are posted in the registry (first posted 7 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: Assessed at 8 weeks (study completion)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05523973, which also lists 48 linked publications.
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 7 May 2025.