RecruitingNot ApplicableNCT07295990

Tongue-strengthening Exercises in People With ALS.

The Impact of Dysphagia Exercise on Oropharyngeal Swallowing Function in Patients With ALS


Sponsor

Nova Southeastern University

Enrollment

20 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria4

  • 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 Criteria10

  • 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

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Interventions

PROCEDUREIsometric 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.


Locations(1)

Nova Southeastern University

Davie, Florida, United States

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NCT07295990


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