20 Participants NeededMy employer runs this trial

Tongue-strengthening Exercises for ALS

RG
LT
RG
Overseen ByRaquel Garcia, SLP.D
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Nova Southeastern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a tongue exercise program for people with ALS, a condition affecting nerve cells in the brain and spinal cord, leading to muscle weakness. The goal is to determine if isometric lingual strength exercises can improve speech and swallowing by strengthening the tongue. Participants will attend sessions with a speech-language pathologist and use a device at home to track progress. This trial may suit those diagnosed with ALS who haven't tried similar tongue exercises and have issues with tongue strength. As an unphased trial, it offers an opportunity to contribute to innovative research that could enhance the quality of life for ALS patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this tongue exercise program is safe for people with ALS?

Research has shown that tongue-strengthening exercises are generally safe for people with ALS, a disease that weakens muscles. Studies have found that these exercises can increase tongue strength without causing harm. Healthy adults and some individuals with swallowing problems have reported improvements in tongue strength after performing these exercises.

One study found that participants maintained their tongue strength even after stopping the exercises for four weeks, suggesting lasting benefits. Another review found no major harmful effects from these exercises. However, while these exercises appear safe, their impact on swallowing safety and efficiency has been mixed in some reports.

Overall, the exercises are well-tolerated, but participants should always follow healthcare professionals' advice during the trial.12345

Why are researchers excited about this trial?

Most treatments for ALS focus on managing symptoms with medications like riluzole and edaravone, which aim to slow disease progression. However, the tongue-strengthening exercises being tested are unique because they directly target the muscles involved in swallowing and speaking. Researchers are excited about these exercises because they use isometric lingual strength training, which may improve speech intelligibility and swallowing safety, potentially enhancing the quality of life for patients with minimal tongue function decline. This proactive approach could offer a new way to support patients' abilities to communicate and eat safely, addressing aspects of ALS that current drug treatments don't specifically target.

What evidence suggests that these tongue-strengthening exercises are effective for ALS?

Research has shown that exercises to strengthen the tongue can enhance the muscles in the mouth and throat, aiding in talking and swallowing. Studies have found that these exercises significantly boost tongue strength in both healthy individuals and those with certain conditions. In one study, participants increased their tongue strength by 13% after performing these exercises. This trial will test a proactive dysphagia exercise program using isometric lingual strength training in people with ALS. Although the effects on ALS are still under investigation, these exercises have shown promise in similar situations by potentially clarifying speech and making swallowing safer.12367

Who Is on the Research Team?

LT

Lauren Tabor Gray, Ph.D.

Principal Investigator

Neuroscience Institute, Cathy J. Husman ALS Center

Are You a Good Fit for This Trial?

This trial is for people diagnosed with ALS (Lou Gehrig's Disease) who have weaker tongue strength than normal and haven't done tongue exercises before. Participants should also have mild or no swallowing problems.

Inclusion Criteria

I have been diagnosed with ALS.
I have never done tongue exercises.
My tongue strength is weaker than normal.
See 1 more

Timeline for a Trial Participant

Screening/Baseline

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Active Training

Participants engage in tongue resistance exercises and complete speech and swallowing tasks

5 weeks
5 visits (virtual)

Final Evaluation

Participants undergo final assessments identical to baseline procedures

1 week
1 visit (in-person)

Follow-up

Participants' isometric lingual strength is assessed during their next scheduled routine multidisciplinary ALS Clinic appointment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Isometric Lingual Strength Exercises

Trial Overview

The study tests a daily tongue-strengthening exercise program over five weeks to see if it helps speech and swallowing in people with ALS. All participants do the exercises, both at home and during telehealth sessions, while their progress is tracked.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Dysphagia Exercise InterventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nova Southeastern University

Lead Sponsor

Trials
103
Recruited
12,000+

Citations

Tongue-strengthening Exercises in People With ALS.

This study is testing a tongue exercise program for people living with ALS to see if it can help support speech and swallowing.

A Systematic Review of Isometric Lingual Strength-Training ...

Studies reported gains in maximum peak lingual pressures following isometric lingual strength training for both healthy adults and select groups of individuals ...

3.

iopimedical.com

iopimedical.com/studies/

Studies

The investigators concluded that tongue strength exercise is effective in increasing the strength and thickness of the oropharyngeal muscles of older adults.

Flexibility for Intensity Dosing in Lingual Resistance ...

The objective of this study was to determine the effect of intensity dosing during tongue exercise on tongue pressure generation, adherence, and perceived ...

Tongue-Strengthening Exercises in Healthy Older Adults

No significant detraining effects were found after 4 or 8 weeks in any treatment arm either for MIPs or for effortful swallow pressures.

Device-Assisted Therapy for Lingual Function Rehabilitation

(2020) found mixed results related to effects of lingual strengthening exercise on swallow safety, efficiency, and timing. One study showed improvements in ...

Tongue-strengthening Exercises in People With ALS.

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 ...