Tongue-strengthening Exercises in People With ALS.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorNova Southeastern University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Stroke

Head injury

Head and neck cancer

Tracheostomy

Trial design

Design model

Single group

Treatments tested in this trial

  • Isometric Lingual Strength Exercises

    Procedure/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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Dysphagia Exercise InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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.
2

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.
3

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.
4

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)

Other outcomes

Sponsors and contacts

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