Tongue-strengthening Exercises in People With ALS.

Part of paid clinical trials in Davie, Florida.

Sponsor
Nova Southeastern University
Study ID
NCT07295990
Status
Recruiting
Apply to this trial

Conditions

  • ALS (Amyotrophic Lateral Sclerosis)
  • ALS - Amyotrophic Lateral Sclerosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Isometric Lingual Strength Exercises — PROCEDURE
    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 Details

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.

Key Dates

Start date
May 1, 2026
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nova Southeastern UniversityDavieFlorida33314
Raquel Garcia, SLP.D.
[email protected]
786-399-4053
Lauren Tabor Gray, Ph.D.
[email protected]
954-914-5447

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Nova Southeastern University· Davie, FL

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