Tongue-strengthening Exercises in People With ALS.
Purpose
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.
Conditions
- ALS (Amyotrophic Lateral Sclerosis)
- ALS - Amyotrophic Lateral Sclerosis
Eligibility
- Eligible Ages
- Between 18 Years and 99 Years
- Eligible Sex
- All
- Accepts 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Within subject repeat measures design
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Davie, Florida 33314
More Details
- Status
- Recruiting
- Sponsor
- Nova Southeastern University
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.