Recruiting

Tongue Exercise Program

Sponsor:

Nova Southeastern University

Code:

NCT07295990

Conditions

ALS (Amyotrophic Lateral Sclerosis)

ALS - Amyotrophic Lateral Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Isometric Lingual Strength Exercises

Study Details

Brief 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.

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.

Conditions

ALS (Amyotrophic Lateral Sclerosis)

ALS - Amyotrophic Lateral Sclerosis

Study ID

NCT07295990

Start date

May 1, 2026

Status verified date

Aug, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Stroke
  • Head injury
  • Head and neck cancer
  • Tracheostomy
  • Other concomitant neurogenic disorder
  • Recent oral surgery other than routine dental surgery
  • Unable to generate isometric lingual pressure on lingual manometer
  • Participation in another clinical trial intervention that may confound results
  • NPO (nothing by mouth)
  • Anarthric

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dysphagia Exercise Intervention

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.

Interventions

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.

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 ]
  • Videofluoroscopic Swallow Study [ Time Frame: Baseline, Visit 1 (week 1), and Final Visit (week 10)swallowing safety/efficiency via DIGEST and PAS scores ]

Central Contacts and Locations

Central contacts

Raquel Garcia, SLP.D.

17863994053rw602@nova.edu

Lauren Tabor Gray, Ph.D.

9549145447lauren.taborgray@nova.edu

Locations

Nova Southeastern University

Recruiting

Davie, Florida, United States, 33314

Contacts

Raquel Garcia, SLP.D.

786-399-4053rw602@nova.edu

Lauren Tabor Gray, Ph.D.

954-914-5447Lauren.TaborGray@nova.edu

More Information

Sponsor

Nova Southeastern University

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • ALS
  • Amyotrophic Lateral Sclerosis
  • Dysphagia
  • Dysarthria

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nova Southeastern University on 2026-08-12.