Tongue-strengthening Exercises in People With ALS.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Isometric Lingual Strength Exercises.
- Who it may be relevant to
- Registry conditions: ALS (Amyotrophic Lateral Sclerosis), ALS - Amyotrophic Lateral Sclerosis. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Impact of Dysphagia Exercise on Oropharyngeal Swallowing Function in Patients With ALS
Overview
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.
Detailed 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 longitudinally to assess changes over time.
Each telehealth session will incorporate tongue isometric resistance training (maximum anterior tongue press) to ensure treatment fidelity. During these sessions, the following measures will be obtained: speaking rate using the Bamboo Passage (words per minute),the 3-ounce water swallow test to screen swallowing safety, and the Test of Masticating and Swallowing Solids (TOMASS) to assess swallowing efficiency. Patient-reported outcomes will include the Exercise Therapy Burden Questionnaire (ETBQ), EAT-10, and the ALS Functional Rating Scale (ALSFRS).
To facilitate home-based assessment of lingual strength and support exercise adherence, participants will be provided with a commercially available lingual manometer (Tongueometer), including protocols for maximum anterior tongue press and saliva swallow using lingual bulbs.
Screening/Baseline 1 (Week 0). Following consenting and screening procedures, study personnel will complete the initial baseline assessment procedures. Participants will complete the initial in-person baseline assessment in approximately 60-90 minutes.
The following baseline measures will be completed:
1\. Maximum isometric lingual pressures captured via lingual manometry (Tongueometer) 3. Speech Rate: Bamboo Passage 5. Swallowing Safety: 3-ounce water test 6. Oral Efficiency: TOMASS 7. Swallowing Safety and Efficiency: Videofluoroscopic Swallow Study (VFSS) 8. Patient Reported Outcome Measures: Eat-10, ALSFRS scale, ETBQ
Telehealth Appointments (Active Training Weeks 1-5) Weekly telehealth therapy appointments will be conducted during the active training period using the Zoom platform (Zoom Video Communications, Inc). During these sessions, the research clinician will lead a lingual resistance training session with the participant, complete Bamboo passage, complete 3-ounce water test, and administered surveys including the ALS Functional Rating Scale- Revised, Exercise Therapy Burden Questionnaire (ETBQ), and the EAT-10. Surveys will be screen shared with the participants and data will be recorded on the source documents by the research clinician. Each telehealth appointment will take 30-60 minutes.
Active Exercise Training Regimen Frequency 5 exercise sessions per week Duration 5 weeks Intensity Exercise training at 60% of each participants maximum isometric anterior lingual pressure generation (MAIP) Volume 6 sets of 5 repetitions per day 30 repetitions per day 150 repetitions per week Contraction Each isometric tongue press to be held for approximately 2 seconds Progression Training thresholds will be modified during telehealth each week to maintain training at 60% of the MIAP
Final Evaluation (Week 6) The Final Evaluation appointment will consist of the identical assessment procedures conducted in the same order as Baseline 1 with inclusion of VFSS, and Exercise Therapy Burden Questionnaire (ETBQ). This evaluation will be in-person.
Follow-up Period (6-months). The participant's isometric lingual strength will be assessed during their next scheduled routine multidisciplinary ALS Clinic appointment.
Interventions
- Procedure 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 wi
Primary outcome measures
- 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]
Secondary outcome measures (4)
- EAT-10 [Time frame: From enrollment to the end of treatment at 10 weeks.]
- Test of Mastication and Swallowing Solids [Time frame: From enrollment to the end of treatment at 10 weeks.]
- ALS Functional Rating Scale [Time frame: From enrollment to the end of treatment at 10 weeks.]
- The Eating Tool Burden Questionnaire [Time frame: To be given during at week 5 (baseline 2) and week 10 (final)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Nova Southeastern University — Davie
Identifiers
NCT: NCT07295990 · Dysphagia Exercise ALS