The Impact of Dysphagia Exercise on Oropharyngeal Swallowing Function in Patients With ALS
Nova Southeastern University
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.
Description
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 long…
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
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
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.
Location
- Nova Southeastern UniversityDavie, Florida