At a glance
ClinicalIndex Comparison Record- ✓Adults age 18 or older
- ✓Confirmed diagnosis of Amyotrophic Lateral Sclerosis (ALS)
- ✓Confirmed diagnosis of Parkinson's disease (PD)
- ✕Prior history of stroke
- ✕Prior acquired brain injury
- ✕Prior spinal or spinal cord injury
- ✕Prior cancer or surgery in head and neck region
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Physiological Flow of Liquids Used in Dysphagia Management
In Brief
An observational study evaluating Videofluoroscopic Swallowing Examination and Tongue Strength Measurement for Amyotrophic Lateral Sclerosis and 2 related conditions. Completed, enrolled 40 participants across 1 site.
Detailed Summary
For individuals with neurodegenerative conditions, such as Amyotrophic Lateral Sclerosis and Parkinson disease, swallowing impairment (i.e., dysphagia) is a common and serious symptom. Dysphagia places the affected individual at risk for secondary health consequences, including malnutrition and aspiration pneumonia, and negatively affects quality of life. Thickened liquids are commonly recommended for individuals with dysphagia, as they flow more slowly and reduce the risk of entry into the airway. However, there is limited understanding about how changes in liquid thickness modulate swallowing physiology in individuals with neurodegenerative conditions, and previous reports have shown that increased liquid thickness may contribute to the accumulation of residue in the throat. The purpose of this study is to explore swallowing physiology and function in individuals with neurodegenerative conditions, across five levels of liquid thickness (thin, slightly-thick, mildly-thick, moderately-thick, and extremely-thick), and to identify boundaries of "optimal liquid thickness", which maintain airway safety, without contributing to the accumulation of significant residue. Results from this study will help guide the clinical recommendations for thickened liquids in dysphagia management.
Study Details
Timeline
Interventions
During the videofluoroscopy, subjects will take up to 21 sips of liquid, ranging in thickness from thin (like water), to extremely-thick (like pudding or custard). The liquids will be mixed with E-Z-Paque barium sulfate, to allow it to be visible on the x-ray.
We will measure tongue strength using a tongue pressure measurement system called the Iowa Oral Performance Instrument (IOPI). A small disposable bulb filled with air will be placed in the mouth, just behind the front teeth. Participants will be asked to press their tongue upwards against the bulb as hard as they can, three (3) times at the front of the tongue and three (3) times at the back of the tongue (i.e., total of six (6) maximum isometric tongue presses). Participants will also be asked to swallow their saliva with the bulb placed in their mouth, three (3) times. Tongue pressure measurement will be completed twice in the data collection session - once at the beginning, and once at the end (following the videofluoroscopy).