Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
NCT ID:
NCT03192358
Group ID:
EG000
Title:
Amyotrophic Lateral Sclerosis
Description:
We will be recruiting individuals with confirmed or probably ALS, who experience speech or swallowing problems, to attend one data collection session. All participants will undergo the same protocol, including a Videofluoroscopic Swallowing Examination, and Tongue Strength Measurement.
Videofluoroscopic Swallowing Examination: 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.
Tongue Strength Measurement: 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).
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
20
Other Number Affected:
0
Other Number At Risk:
20
Study:
NCT03192358
Results Section:
NCT03192358
Adverse Events Module:
NCT03192358