An interventional study of Isometric Lingual Strength Exercises in ALS (Amyotrophic Lateral Sclerosis) and ALS - Amyotrophic Lateral Sclerosis, sponsored by Nova Southeastern University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Nova Southeastern University · Not applicable, Interventional, and Treatment
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.
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:
1. 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.
978 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 277 are open to participants now.
This study's planned enrollment of 20 is below the median of 38 across 662 interventional studies indexed under Amyotrophic Lateral Sclerosis.
Browse Amyotrophic Lateral Sclerosis studies →Nova Southeastern University is the lead sponsor of 80 studies on the registry; 18 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Exclusion Criteria:
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.
Procedure: Isometric Lingual Strength Exercises
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.
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
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
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.
Time frame: Baseline, Visit 1 (week 1), and Final Visit (week 10)swallowing safety/efficiency via DIGEST and PAS scores
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: To be given during at week 5 (baseline 2) and week 10 (final)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Data will be disseminated in open access publication.
Supporting information: Study protocol
Time frame: Data will be disseminated in open access publication.
Access criteria: Data will be disseminated in open access publication.
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