ALS (Amyotrophic Lateral Sclerosis)NCT07295990
Tongue-strengthening Exercises in People With ALS.
A study testing Isometric Lingual Strength Exercises in people with ALS (Amyotrophic Lateral Sclerosis) and ALS - Amyotrophic Lateral Sclerosis, run by Nova Southeastern University at 1 site in United States.
Trial summary
This study is testing a tongue exercise program for people living with ALS to see if it can help support speech and swallowing. All participants will receive the treatment, and researchers will measure changes over time by comparing each person's results to their own earlier results. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- ALS (Amyotrophic Lateral Sclerosis), ALS - Amyotrophic Lateral Sclerosis
- What is being tested?
- Isometric Lingual Strength Exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to Jan 2029
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of possible, probable, or definite ALS (El-Escorial Revisited)
- Lingual exercises naïve
- Impaired lingual strength generation compared to normative data
- EAT-10 score <3
Who cannot join
- Stroke
- Head injury
- Head and neck cancer
- Tracheostomy
- Other concomitant neurogenic disorder
- Recent oral surgery other than routine dental surgery
Show all 10Show fewer
- Unable to generate isometric lingual pressure on lingual manometer
- Participation in another clinical trial intervention that may confound results
- NPO (nothing by mouth)
- Anarthric
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
Nova Southeastern University
Davie, Florida, 33314
Raquel Garcia, SLP.D., 786-399-4053, rw602@nova.edu
Lauren Tabor Gray, Ph.D., 954-914-5447, Lauren.TaborGray@nova.edu
About this study
Official title: The Impact of Dysphagia Exercise on Oropharyngeal Swallowing Function in Patients With ALS
This study is testing a tongue exercise program for people living with ALS to see if it can help support speech and swallowing. All participants will receive the treatment, and researchers will measure changes over time by comparing each person's results to their own earlier results.
People who join the study will have two in-person visits and four weekly telehealth sessions with a speech-language pathologist. During these sessions, participants will practice tongue resistance exercises, complete speech and swallowing tasks, and answer surveys about their experience. They will also use a small device at home to measure tongue strength and swallowing.
The exercise program involves pressing the tongue against a device several times a day, five days per week, for five weeks. Researchers want to learn if this program is safe, practical, and helpful for people with ALS.
Read the detailed description
Study Timeline and Procedures In this within-subject repeated measures design, people with ALS (pALS) will serve as their own controls, enabling comparison of outcomes across multiple time points while accounting for interparticipant variability (i.e., disease heterogeneity). All participants will receive the intervention, and treatment-related changes will be evaluated relative to each individual's baseline performance.
Study participation will include two in-person evaluations (baseline and post-treatment), and five weekly telehealth therapy sessions. Outcome measures will be collected longitudinally to assess changes over time.
Each telehealth session will incorporate tongue isometric resistance training (maximum anterior tongue press) to ensure treatment fidelity. During these sessions, the following measures will be obtained: speaking rate using the Bamboo Passage (words per minute),the 3-ounce water swallow test to screen swallowing safety, and the Test of Masticating and Swallowing Solids (TOMASS) to assess swallowing efficiency. Patient-reported outcomes will include the Exercise Therapy Burden Questionnaire (ETBQ), EAT-10, and the ALS Functional Rating Scale (ALSFRS).
To facilitate home-based assessment of lingual strength and support exercise adherence, participants will be provided with a commercially available lingual manometer (Tongueometer), including protocols for maximum anterior tongue press and saliva swallow using lingual bulbs.
Screening/Baseline 1 (Week 0). Following consenting and screening procedures, study personnel will complete the initial baseline assessment procedures. Participants will complete the initial in-person baseline assessment in approximately 60-90 minutes.
The following baseline measures will be completed:
- Maximum isometric lingual pressures captured via lingual manometry (Tongueometer) 3. Speech Rate: Bamboo Passage 5. Swallowing Safety: 3-ounce water test 6. Oral Efficiency: TOMASS 7. Swallowing Safety and Efficiency: Videofluoroscopic Swallow Study (VFSS) 8. Patient Reported Outcome Measures: Eat-10, ALSFRS scale, ETBQ
Telehealth Appointments (Active Training Weeks 1-5) Weekly telehealth therapy appointments will be conducted during the active training period using the Zoom platform (Zoom Video Communications, Inc). During these sessions, the research clinician will lead a lingual resistance training session with the participant, complete Bamboo passage, complete 3-ounce water test, and administered surveys including the ALS Functional Rating Scale- Revised, Exercise Therapy Burden Questionnaire (ETBQ), and the EAT-10. Surveys will be screen shared with the participants and data will be recorded on the source documents by the research clinician. Each telehealth appointment will take 30-60 minutes.
Active Exercise Training Regimen Frequency 5 exercise sessions per week Duration 5 weeks Intensity Exercise training at 60% of each participants maximum isometric anterior lingual pressure generation (MAIP) Volume 6 sets of 5 repetitions per day 30 repetitions per day 150 repetitions per week Contraction Each isometric tongue press to be held for approximately 2 seconds Progression Training thresholds will be modified during telehealth each week to maintain training at 60% of the MIAP
Final Evaluation (Week 6) The Final Evaluation appointment will consist of the identical assessment procedures conducted in the same order as Baseline 1 with inclusion of VFSS, and Exercise Therapy Burden Questionnaire (ETBQ). This evaluation will be in-person.
Follow-up Period (6-months). The participant's isometric lingual strength will be assessed during their next scheduled routine multidisciplinary ALS Clinic appointment.
- Being tested
- Isometric Lingual Strength Exercises
- Keywords
- ALS, Amyotrophic Lateral Sclerosis, Dysphagia, Dysarthria
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Deglutition Disorders, Dysarthria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric Lingual Strength ExercisesProcedure or surgery
Direct intervention will consist of an isometric lingual exercise program designed specifically for patients with ALS. Participants will complete five exercise sessions per week for a total of five weeks, with each session including six sets of five repetitions (30 repetitions daily, 150 repetitions weekly). Exercises will be performed at 60% of each participant's maximum isometric anterior lingual pressure (MAIP), with each tongue press held for approximately two seconds. Training thresholds will be adjusted weekly via telehealth to ensure the program remains at the prescribed 60% intensity, supporting both safety and consistency in progression. This structured protocol is intended to maximize lingual strength, swallow function, and overall adherence to the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Dysphagia Exercise Intervention | Experimental | This study arm will test a proactive dysphagia exercise program using lingual manometry and isometric lingual strength training in people with ALS (pALS). The intervention is designed to maximize lingual strength, improve speech intelligibility, enhance swallow safety and efficiency, and support patient-reported swallowing and quality-of-life outcomes in individuals with minimal decline in tongue function. Receives: Procedure: Isometric Lingual Strength Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Anterior Isometric Lingual Pressure Measured Using the TongueMeter Device
Measurement Tool:
Lingual pressure is measured using the TongueMeter, a handheld, pressure-sensing device designed to quantify tongue strength during isometric tasks. A calibrated intraoral pressure sensor is positioned against the hard palate. Participants are instructed to press the tongue upward with maximal effort for a standardized duration, and the device records the resulting pressure output.
Unit of Measure:
Lingual strength is quantified as peak pressure, reported in kilopascals (kPa).
Outcome Variable:
The primary outcome is the maximum peak lingual pressure (kPa) achieved across trials, with higher values indicating greater lingual strength
Measured: Participant will start using the tongue meter from day of enrollment. Baseline 1 : MAIP collected , Baseline 2: 5 weeks after baseline , then MAIP calculated at home , intensity of exercise set at 60% MAIP, 5 weeks of exercise at 60% MAIP
Videofluoroscopic Swallow Study
This measure assesses swallowing safety and efficiency in participants using standardized VFSS trials. Safety is quantified using the Penetration-Aspiration Scale (PAS) to capture airway compromise, while swallowing efficiency is measured with the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST), which integrates residue severity and functional impact.
Unit of Measure:
PAS score for each swallow (ordinal 1-8)
DIGEST grade for overall swallowing function (ordinal 0-4)
Outcome Variable:
The primary outcome is the frequency and severity of airway compromise (PAS) and overall dysphagia severity (DIGEST) during VFSS. Higher PAS and DIGEST scores indicate worse swallowing safety and efficiency.
Measured: Baseline, Visit 1 (week 1), and Final Visit (week 10)swallowing safety/efficiency via DIGEST and PAS scores
Secondary outcomes (4)
EAT-10
The Eating Assessment Tool-10 (EAT-10) is a self-administered questionnaire used to screen for swallowing difficulties (dysphagia). It consists of 10 items that ask patients to rate symptoms such as effort during swallowing, coughing, and the impact of swallowing problems on quality of life. Each item is scored from 0 (no problem) to 4 (severe problem), with a total score of 3 or higher indicating possible dysphagia. It is quick, reliable, and widely used in both clinical and research settings.
Measured: From enrollment to the end of treatment at 10 weeks.
Test of Mastication and Swallowing Solids
The Test of Masticating and Swallowing Solids (TOMASS) is a clinical assessment tool used to evaluate solid food swallowing efficiency. During the test, a patient is asked to eat a standardized cracker as quickly and safely as possible while the clinician records the number of bites, chews, swallows, and the total time taken. These measures provide insight into the efficiency and safety of oral intake. TOMASS is simple, non-invasive, and useful for identifying swallowing difficulties in both clinical practice and research.
Measured: From enrollment to the end of treatment at 10 weeks.
ALS Functional Rating Scale
The ALS Functional Rating Scale (ALSFRS) is a standardized tool used to measure the functional status of individuals with amyotrophic lateral sclerosis (ALS). It assesses daily activities across key domains such as speech, swallowing, mobility, and respiratory function. Each item is scored from 0 (unable) to 4 (normal ability), with higher total scores indicating better functional status. The ALSFRS is widely used in both clinical care and research to track disease progression and treatment outcomes.
Measured: From enrollment to the end of treatment at 10 weeks.
The Eating Tool Burden Questionnaire
The Eating Tool Burden Questionnaire (ETBQ) is a patient-reported outcome measure designed to evaluate the burden of eating and swallowing difficulties. It captures the physical, emotional, and social challenges patients experience during mealtimes. Responses are scored to reflect the severity of perceived burden, with higher scores indicating greater impact on daily life. The ETBQ is useful for understanding patient perspectives, guiding clinical care, and measuring changes over time in both practice and research.
Measured: To be given during at week 5 (baseline 2) and week 10 (final)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start1 May 2026
- Primary completionDec 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALS (Amyotrophic Lateral Sclerosis)Studies 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
- Within subject repeat measures design
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauren Tabor Gray, Ph.D., Principal investigator, Neuroscience Institute, Cathy J. Husman ALS Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295990
- Sponsor's protocol ID
- Dysphagia Exercise ALS
- Status last verified
- Aug 2026
- First submitted
- 3 Dec 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be disseminated in open access publication.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Dysphagia Exercise on Oropharyngeal Swallowing Function in Patients With ALS
- ClinicalTrials.gov ID
- NCT07295990
- Acronym / sponsor ID
- Dysphagia Exercise ALS
- Keywords
- ALS, Amyotrophic Lateral Sclerosis, Dysphagia, Dysarthria
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 22 Dec 2025 (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.
This study is testing a tongue exercise program for people living with ALS to see if it can help support speech and swallowing. All participants will receive the treatment, and researchers will measure changes over time by comparing each person's results to their own earlier results.
People who join the study will have two in-person visits and four weekly telehealth sessions with a speech-language pathologist. During these sessions, participants will practice tongue resistance exercises, complete speech and swallowing tasks, and answer surveys about their experience. They will also use a small device at home to measure tongue strength and swallowing.
The exercise program involves pressing the tongue against a device several times a day, five days per week, for five weeks. Researchers want to learn if this program is safe, practical, and helpful for people with ALS.
Detailed description
Study Timeline and Procedures In this within-subject repeated measures design, people with ALS (pALS) will serve as their own controls, enabling comparison of outcomes across multiple time points while accounting for interparticipant variability (i.e., disease heterogeneity). All participants will receive the intervention, and treatment-related changes will be evaluated relative to each individual's baseline performance.
Study participation will include two in-person evaluations (baseline and post-treatment), and five weekly telehealth therapy sessions. Outcome measures will be collected longitudinally to assess changes over time.
Each telehealth session will incorporate tongue isometric resistance training (maximum anterior tongue press) to ensure treatment fidelity. During these sessions, the following measures will be obtained: speaking rate using the Bamboo Passage (words per minute),the 3-ounce water swallow test to screen swallowing safety, and the Test of Masticating and Swallowing Solids (TOMASS) to assess swallowing efficiency. Patient-reported outcomes will include the Exercise Therapy Burden Questionnaire (ETBQ), EAT-10, and the ALS Functional Rating Scale (ALSFRS).
To facilitate home-based assessment of lingual strength and support exercise adherence, participants will be provided with a commercially available lingual manometer (Tongueometer), including protocols for maximum anterior tongue press and saliva swallow using lingual bulbs.
Screening/Baseline 1 (Week 0). Following consenting and screening procedures, study personnel will complete the initial baseline assessment procedures. Participants will complete the initial in-person baseline assessment in approximately 60-90 minutes.
The following baseline measures will be completed:
- Maximum isometric lingual pressures captured via lingual manometry (Tongueometer) 3. Speech Rate: Bamboo Passage 5. Swallowing Safety: 3-ounce water test 6. Oral Efficiency: TOMASS 7. Swallowing Safety and Efficiency: Videofluoroscopic Swallow Study (VFSS) 8. Patient Reported Outcome Measures: Eat-10, ALSFRS scale, ETBQ
Telehealth Appointments (Active Training Weeks 1-5) Weekly telehealth therapy appointments will be conducted during the active training period using the Zoom platform (Zoom Video Communications, Inc). During these sessions, the research clinician will lead a lingual resistance training session with the participant, complete Bamboo passage, complete 3-ounce water test, and administered surveys including the ALS Functional Rating Scale- Revised, Exercise Therapy Burden Questionnaire (ETBQ), and the EAT-10. Surveys will be screen shared with the participants and data will be recorded on the source documents by the research clinician. Each telehealth appointment will take 30-60 minutes.
Active Exercise Training Regimen Frequency 5 exercise sessions per week Duration 5 weeks Intensity Exercise training at 60% of each participants maximum isometric anterior lingual pressure generation (MAIP) Volume 6 sets of 5 repetitions per day 30 repetitions per day 150 repetitions per week Contraction Each isometric tongue press to be held for approximately 2 seconds Progression Training thresholds will be modified during telehealth each week to maintain training at 60% of the MIAP
Final Evaluation (Week 6) The Final Evaluation appointment will consist of the identical assessment procedures conducted in the same order as Baseline 1 with inclusion of VFSS, and Exercise Therapy Burden Questionnaire (ETBQ). This evaluation will be in-person.
Follow-up Period (6-months). The participant's isometric lingual strength will be assessed during their next scheduled routine multidisciplinary ALS Clinic appointment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Within subject repeat measures design
| Arm | Type | Receives |
|---|---|---|
| Dysphagia Exercise Intervention | Experimental | Procedure: Isometric Lingual Strength ExercisesThis study arm will test a proactive dysphagia exercise program using lingual manometry and isometric lingual strength training in people with ALS (pALS). The intervention is designed to maximize lingual strength, improve speech intelligibility, enhance swallow safety and efficiency, and support patient-reported swallowing and quality-of-life outcomes in individuals with minimal decline in tongue function. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of possible, probable, or definite ALS (El-Escorial Revisited)
- Lingual exercises naïve
- Impaired lingual strength generation compared to normative data
- EAT-10 score <3
Key exclusion criteria (10 listed)
- Stroke
- Head injury
- Head and neck cancer
- Tracheostomy
- Other concomitant neurogenic disorder
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 |
|---|---|---|
| Isometric Lingual Strength ExercisesDirect intervention will consist of an isometric lingual exercise program designed specifically for patients with ALS. Participants will complete five exercise sessions per week for a total of five weeks, with each session including six sets of five repetitions (30 repetitions daily, 150 repetitions weekly). Exercises will be performed at 60% of each participant's maximum isometric anterior lingual pressure (MAIP), with each tongue press held for approximately two seconds. Training thresholds will be adjusted weekly via telehealth to ensure the program remains at the prescribed 60% intensity, supporting both safety and consistency in progression. This structured protocol is intended to maximize lingual strength, swallow function, and overall adherence to the intervention. | Procedure or surgery | Dysphagia Exercise Intervention |
Primary outcome
Maximum Anterior Isometric Lingual Pressure Measured Using the TongueMeter Device
Time frame: Participant will start using the tongue meter from day of enrollment. Baseline 1 : MAIP collected , Baseline 2: 5 weeks after baseline , then MAIP calculated at home , intensity of exercise set at 60% MAIP, 5 weeks of exercise at 60% MAIP
Measurement Tool: Lingual pressure is measured using the TongueMeter, a handheld, pressure-sensing device designed to quantify tongue strength during isometric tasks. A calibrated intraoral pressure sensor is positioned against the hard palate. Participants are instructed to press the tongue upward with maximal effort for a standardized duration, and the device records the resulting pressure output. Unit of Measure: Lingual strength is quantified as peak pressure, reported in kilopascals (kPa). Outcome Variable: The primary outcome is the maximum peak lingual pressure (kPa) achieved across trials, with higher values indicating greater lingual strength
Videofluoroscopic Swallow Study
Time frame: Baseline, Visit 1 (week 1), and Final Visit (week 10)swallowing safety/efficiency via DIGEST and PAS scores
This measure assesses swallowing safety and efficiency in participants using standardized VFSS trials. Safety is quantified using the Penetration-Aspiration Scale (PAS) to capture airway compromise, while swallowing efficiency is measured with the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST), which integrates residue severity and functional impact. Unit of Measure: PAS score for each swallow (ordinal 1-8) DIGEST grade for overall swallowing function (ordinal 0-4) Outcome Variable: The primary outcome is the frequency and severity of airway compromise (PAS) and overall dysphagia severity (DIGEST) during VFSS. Higher PAS and DIGEST scores indicate worse swallowing safety and efficiency.
4 secondary outcomes
EAT-10
Time frame: From enrollment to the end of treatment at 10 weeks.
Test of Mastication and Swallowing Solids
Time frame: From enrollment to the end of treatment at 10 weeks.
ALS Functional Rating Scale
Time frame: From enrollment to the end of treatment at 10 weeks.
The Eating Tool Burden Questionnaire
Time frame: To be given during at week 5 (baseline 2) and week 10 (final)
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 12 Aug 2026.
- Individual participant dataSharing planned: Yes. Data will be disseminated in open access publication.
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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.
Lauren Tabor Gray, Ph.D. principal investigator
Neuroscience Institute, Cathy J. Husman ALS Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric Lingual Strength Exercises in people with ALS (Amyotrophic Lateral Sclerosis) and ALS - Amyotrophic Lateral Sclerosis, run by Nova Southeastern University 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 10 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 12 Aug 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. 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 Raquel Garcia, SLP.D. (17863994053, rw602@nova.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Anterior Isometric Lingual Pressure Measured Using the TongueMeter Device (time frame: Participant will start using the tongue meter from day of enrollment. Baseline 1 : MAIP collected , Baseline 2: 5 weeks after baseline , then MAIP calculated at home , intensity of exercise set at 60% MAIP, 5 weeks of exercise at 60% MAIP). 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?
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 12 Aug 2026.