Physiological Flow of Liquids Used in Dysphagia Management (Neuro)

• ClinicalTrials.gov Identifier: NCT03192358
• Recruitment Status: Completed
• First Posted: June 20, 2017
• Results First Posted: July 14, 2022
• Last Update Posted: September 15, 2022
• Sponsor: University Health Network, Toronto
• Collaborators: University of Florida; National Institute on Deafness and Other Communication Disorders (NIDCD)
• Information provided by (Responsible Party): University Health Network, Toronto

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Cross-Sectional
• Conditions: Amyotrophic Lateral Sclerosis; Parkinson Disease; Dysphagia
• Interventions: Diagnostic Test: Videofluoroscopic Swallowing Examination; Other: Tongue Strength Measurement
• Enrollment: 40

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Amyotrophic Lateral Sclerosis (ALS)	Parkinson Disease
Arm/Group Description	Adults with a neurologist-confirmed diagnosis of ALS who completed a videofluoroscopy involving swallows of different liquid consistencies.	Adults with a neurologist-confirmed diagnosis of Parkinson Disease who completed a videofluoroscopy involving swallowing of different consistencies of liquid.
Period Title: Overall Study
Started	20	20
Completed	20	20
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Amyotrophic Lateral Sclerosis	Parkinson's Disease	Total
Arm/Group 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).	We will be recruiting individuals with a diagnosis of Parkinson's disease, 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).	Total of all reporting groups
Overall Number of Baseline Participants		20	20	40
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Median (Inter-Quartile Range); Unit of measure: Years
	Number Analyzed	20 participants	20 participants	40 participants
		65; (53 to 70)	70; (65 to 75)	67; (58 to 72)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	20 participants	20 participants	40 participants
	Female	10 50.0%	4 20.0%	14 35.0%
	Male	10 50.0%	16 80.0%	26 65.0%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	20 participants	20 participants	40 participants
	Hispanic or Latino	1 5.0%	1 5.0%	2 5.0%
	Not Hispanic or Latino	19 95.0%	19 95.0%	38 95.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	20 participants	20 participants	40 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	1 5.0%	0 0.0%	1 2.5%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	1 5.0%	1 5.0%	2 5.0%
	White	18 90.0%	19 95.0%	37 92.5%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	20 participants	20 participants	40 participants
		20	20	40

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Residue of Concern (Observational)
Description	Residue is material remaining behind in the pharynx after the swallow. We measured residue by tracing the area of barium visible on a lateral view x-ray (in pixels, using ImageJ software) and dividing that area by the squared length C2-C4 cervical spine. This cervical spine scalar provides a common anatomical reference that is a proxy for pharyngeal size, and enables the comparison of residue severity across different people with different neck length and pharynx size. Smaller values are considered better. The 75th percentile healthy reference values for this measure are 1.7% on thin liquids, 1.9% on slightly thick liquids, 2.2% on mildly thick liquids, 1.6% on moderately thick liquids and 1.5% on extremely thick liquids. Values above these thresholds are considered atypical and of clinical concern. We report the number of participants who display atypical total pharyngeal residue measures per consistency.
Time Frame	Single timeframe (baseline only)

Outcome Measure Data

Analysis Population Description

Two cohorts of participants were enrolled in this observational study: 1) A cohort of 20 adults with Amyotrophic Lateral Sclerosis (ALS); and 2) A cohort of 20 adults with Parkinson disease. Due to data quality issues, partial data were missing for some consistencies.

Arm/Group Title	Amyotrophic Lateral Sclerosis: Thin Liquids	Amyotrophic Lateral Sclerosis: Slightly Thick Liquids	Amyotrophic Lateral Sclerosis: Mildly Thick Liquids	Amyotrophic Lateral Sclerosis: Moderately Thick Liquids	Amyotrophic Lateral Sclerosis: Extremely Thick Liquids	Parkinson Disease: Thin Liquid	Parkinson Disease: Slightly Thick Liquids	Parkinson Disease: Mildly Thick Liquids	Parkinson Disease: Moderately Thick Liquids	Parkinson Disease: Extremely Thick Liquids
Arm/Group Description:	Participants were asked to swallow a series of 3 comfortably sized sips of thin liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of slightly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of mildly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of moderately thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of extremely thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of thin liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of slightly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of mildly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of moderately thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of extremely thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).
Overall Number of Participants Analyzed	20	19	18	17	17	17	17	17	17	17
Measure Type: Count of Participants; Unit of Measure: Participants
	6 30.0%	6 31.6%	3 16.7%	6 35.3%	4 23.5%	2 11.8%	3 17.6%	3 17.6%	1 5.9%	2 11.8%

2. Primary Outcome

Title	Maximum Anterior Isometric Tongue Pressure
Description	Tongue strength was measured using a tongue pressure measurement system called the Iowa Oral Performance Instrument (IOPI). A small disposable bulb filled with air was placed in the mouth, just behind the front teeth. Participants were asked to press the front of their tongue upwards against the bulb as hard as possible. This task was repeated 3 times. The maximum value obtained across 3 repetitions was recorded as "maximum anterior isometric pressure". Higher values represent greater tongue strength. We report group mean values and standard deviations for this measure.
Time Frame	Single timeframe (baseline only)

Outcome Measure Data

Analysis Population Description

Two cohorts of participants were enrolled: 1) A cohort of 20 adults with Amyotrophic Lateral Sclerosis (ALS); and 2) A cohort of 20 adults with Parkinson disease. Due to data quality issues, anterior isometric pressure data were missing for 3 of the participants with ALS.

Arm/Group Title	Amyotrophic Lateral Sclerosis	Parkinson Disease
Arm/Group Description:	Individuals with a neurologist-confirmed diagnosis of ALS.	Individuals with a neurologist-confirmed diagnosis of Parkinson Disease.
Overall Number of Participants Analyzed	17	20
Mean (Standard Deviation); Unit of Measure: kilopascals
	34 (19)	55 (17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Amyotrophic Lateral Sclerosis, Parkinson Disease
	Comments	This was an observational study. The statistical test explores whether there were significant differences in tongue pressure between the two cohorts. The hypothesis was that individuals with ALS would display significantly lower maximum anterior isometric tongue pressures compared to the people with PD.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.001
	Comments	A priori threshold for statistical significance was p < 0.05.
	Method	ANOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Cohen's d
	Estimated Value	1.18
	Estimation Comments	Cohen's d values > 0.8 are considered large

3. Primary Outcome

Title	Regular Effort Saliva Swallow Tongue Pressure
Description	Tongue strength was measured using a tongue pressure measurement system called the Iowa Oral Performance Instrument (IOPI). A small disposable bulb filled with air was placed in the mouth, just behind the front teeth. Participants were asked to swallow their saliva with the bulb in this position. This task was repeated 3 times. The mean value obtained across 3 repetitions was recorded as "regular effort saliva swallow tongue pressure". Higher values represent greater tongue strength. We report group mean values and standard deviations for this measure.
Time Frame	Single timeframe (baseline only)

Outcome Measure Data

Analysis Population Description

Two cohorts of participants were enrolled: 1) A cohort of 20 adults with Amyotrophic Lateral Sclerosis (ALS); and 2) A cohort of 20 adults with Parkinson disease. Due to data quality issues, saliva swallow tongue pressure data were missing for 3 of the participants with ALS.

Arm/Group Title	Amyotrophic Lateral Sclerosis	Parkinson's Disease
Arm/Group Description:	We will be recruiting individuals with confirmed or probably ALS, who experience speech or swallowing problems, to attend one data collection session. 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.	We will be recruiting individuals with a diagnosis of Parkinson's disease, who experience speech or swallowing problems, to attend one data collection session. 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.
Overall Number of Participants Analyzed	17	20
Mean (Standard Deviation); Unit of Measure: kilopascals
	19 (12)	17 (8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Amyotrophic Lateral Sclerosis, Parkinson's Disease
	Comments	This was an observational study rather than a trial. The hypothesis was that individuals with ALS would display significantly lower regular effort saliva swallow pressures than the individuals with PD.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.001
	Comments	[Not Specified]
	Method	ANOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Cohen's d
	Estimated Value	1.75
	Estimation Comments	Cohen's d values > 0.8 are considered large

4. Primary Outcome

Title	Number of Participants With Unsafe Swallows (Observational)
Description	Swallowing safety was measured using the 8-point Penetration-Aspiration Scale, an 8-point categorical scale which captures the depth to which any material enters the airway and whether or not the material is ejected. Levels 1 and 2 on the scale are considered safe, while levels > 2 are considered unsafe. Actual scale scores (1-8) were recorded and then converted to binary categorical scores (< 3 vs >/= 3). We report the frequency (count) of participants showing scores > 2 by bolus consistency.
Time Frame	Baseline (Single timepoint only)

Outcome Measure Data

Analysis Population Description

Two cohorts of participants were enrolled in this observational study: 1) A cohort of 20 adults with Amyotrophic Lateral Sclerosis (ALS); and 2) A cohort of 20 adults with Parkinson disease. Due to data quality issues, partial data were missing for some consistencies.

Arm/Group Title	Amyotrophic Lateral Sclerosis: Thin Liquids	Amyotrophic Lateral Sclerosis: Slightly Thick Liquids	Amyotrophic Lateral Sclerosis: Mildly Thick Liquids	Amyotrophic Lateral Sclerosis: Moderately Thick Liquids	Amyotrophic Lateral Sclerosis: Extremely Thick Liquids	Parkinson Disease: Thin Liquid	Parkinson Disease: Slightly Thick Liquids	Parkinson Disease: Mildly Thick Liquids	Parkinson Disease: Moderately Thick Liquids	Parkinson Disease: Extremely Thick Liquids
Arm/Group Description:	Participants were asked to swallow a series of 3 comfortably sized sips of thin liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of slightly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of mildly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of moderately thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of extremely thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of thin liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of slightly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of mildly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of moderately thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of extremely thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).
Overall Number of Participants Analyzed	20	19	18	17	17	17	17	17	17	17
Measure Type: Count of Participants; Unit of Measure: Participants
	10 50.0%	9 47.4%	7 38.9%	6 35.3%	3 17.6%	2 11.8%	1 5.9%	1 5.9%	0 0.0%	1 5.9%

5. Secondary Outcome

Title	Maximum Posterior Isometric Tongue Pressure (Observational).
Description	Tongue strength was measured using a tongue pressure measurement system called the Iowa Oral Performance Instrument (IOPI). A small disposable bulb filled with air was placed in the mouth, with the front margin of the sensor aligned with the first molar tooth. Participants were asked to press the back of their tongue upwards against the bulb as hard as possible. This task was repeated 3 times. The maximum value obtained across 3 repetitions was recorded as "maximum posterior isometric pressure". Higher values represent greater tongue strength. We report group mean values and standard deviations for this measure. There was no statistical analysis comparing group values for this parameter.
Time Frame	Single timeframe (baseline only)

Outcome Measure Data

Analysis Population Description

Two cohorts of participants were enrolled: 1) A cohort of 20 adults with Amyotrophic Lateral Sclerosis (ALS); and 2) A cohort of 20 adults with Parkinson disease. Due to data quality issues, posterior isometric pressure data were missing for 3 of the participants with ALS.

Arm/Group Title	Amyotrophic Lateral Sclerosis	Parkinson Disease
Arm/Group Description:	Individuals with a neurologist-confirmed diagnosis of ALS.	Individuals with a neurologist-confirmed diagnosis of Parkinson Disease.
Overall Number of Participants Analyzed	17	20
Mean (Standard Deviation); Unit of Measure: kilopascals
	29 (20)	51 (19)

6. Secondary Outcome

Title	Number of Participants With Multiple Swallows Per Bolus (Observational)
Description	The number of swallows needed to clear a single bolus will be counted. A single swallow is considered efficient, while 2+ swallows for one bolus is considered atypical. We will report the number of participants with > 1 swallow per bolus.
Time Frame	Single timeframe (baseline only)

Outcome Measure Data

Analysis Population Description

Two cohorts of participants were enrolled in this observational study: 1) A cohort of 20 adults with Amyotrophic Lateral Sclerosis (ALS); and 2) A cohort of 20 adults with Parkinson disease. Due to data quality issues, partial data were missing for some consistencies.

Arm/Group Title	Amyotrophic Lateral Sclerosis: Thin Liquids	Amyotrophic Lateral Sclerosis: Slightly Thick Liquids	Amyotrophic Lateral Sclerosis: Mildly Thick Liquids	Amyotrophic Lateral Sclerosis: Moderately Thick Liquids	Amyotrophic Lateral Sclerosis: Extremely Thick Liquids	Parkinson Disease: Thin Liquid	Parkinson Disease: Slightly Thick Liquids	Parkinson Disease: Mildly Thick Liquids	Parkinson Disease: Moderately Thick Liquids	Parkinson Disease: Extremely Thick Liquids
Arm/Group Description:	Participants were asked to swallow a series of 3 comfortably sized sips of thin liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of slightly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of mildly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of moderately thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of extremely thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of thin liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of slightly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of mildly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of moderately thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of extremely thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).
Overall Number of Participants Analyzed	20	19	18	17	17	17	17	17	17	17
Measure Type: Count of Participants; Unit of Measure: Participants
	6 30.0%	8 42.1%	9 50.0%	5 29.4%	8 47.1%	6 35.3%	3 17.6%	2 11.8%	2 11.8%	2 11.8%

7. Secondary Outcome

Title	Number of Participants Displaying Prolonged Pharyngeal Bolus Transit (Observational)
Description	The time interval from the first frame showing the bolus entering the pharynx (passing the shadow of the ramus of the mandible) until the first frame showing the bolus entering the upper esophageal sphincter was calculated (in milliseconds) for each bolus. The 75th percentile healthy reference values for this measure are 533 ms on thin liquids, 567 ms on slightly thick liquids, 701 ms on mildly thick liquids, 867 ms on moderately thick liquids and 1001 ms on extremely thick liquids. Pharyngeal transit durations above these values are considered prolonged and atypical. We will report the number of participants who present with atypical pharyngeal transit duration above these 75th percentile reference value thresholds per consistency.
Time Frame	Single timeframe (baseline only)

Outcome Measure Data

Analysis Population Description

Two cohorts of participants were enrolled in this observational study: 1) A cohort of 20 adults with Amyotrophic Lateral Sclerosis (ALS); and 2) A cohort of 20 adults with Parkinson disease. Due to data quality issues, partial data were missing for some consistencies.

Arm/Group Title	Amyotrophic Lateral Sclerosis: Thin Liquids	Amyotrophic Lateral Sclerosis: Slightly Thick Liquids	Amyotrophic Lateral Sclerosis: Mildly Thick Liquids	Amyotrophic Lateral Sclerosis: Moderately Thick Liquids	Amyotrophic Lateral Sclerosis: Extremely Thick Liquids	Parkinson Disease: Thin Liquid	Parkinson Disease: Slightly Thick Liquids	Parkinson Disease: Mildly Thick Liquids	Parkinson Disease: Moderately Thick Liquids	Parkinson Disease: Extremely Thick Liquids
Arm/Group Description:	Participants were asked to swallow a series of 3 comfortably sized sips of thin liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of slightly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of mildly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of moderately thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of extremely thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of thin liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of slightly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of mildly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of moderately thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Participants were asked to swallow a series of 3 comfortably sized sips of extremely thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).
Overall Number of Participants Analyzed	18	19	17	15	17	17	17	17	17	17
Measure Type: Count of Participants; Unit of Measure: Participants
	5 27.8%	10 52.6%	7 41.2%	7 46.7%	8 47.1%	5 29.4%	4 23.5%	5 29.4%	5 29.4%	6 35.3%

Adverse Events

Time Frame	1 week following the single appointment data collection session
Adverse Event Reporting Description	Standard definitions were used
Arm/Group Title	Amyotrophic Lateral Sclerosis	Parkinson's Disease
Arm/Group 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).	We will be recruiting individuals with a diagnosis of Parkinson's disease, 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).
All-Cause Mortality
	Amyotrophic Lateral Sclerosis	Parkinson's Disease
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/20 (0.00%)	0/20 (0.00%)
Serious Adverse Events
	Amyotrophic Lateral Sclerosis	Parkinson's Disease
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/20 (0.00%)	0/20 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Amyotrophic Lateral Sclerosis	Parkinson's Disease
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/20 (0.00%)	0/20 (0.00%)

Limitations and Caveats

This was an observational study. For the majority of measures, we report count data for each cohort but do not compare frequencies across cohorts or across conditions (i.e. bolus consistencies) within cohort.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Director, Swallowing Rehabilitation Research Laboratory
• Organization: University Health Network
• Phone: 416 597 3422 ext 7802
• EMail: tri-swallowinglab@uhn.ca

Publications:

Pearson WG Jr, Molfenter SM, Smith ZM, Steele CM. Image-based measurement of post-swallow residue: the normalized residue ratio scale. Dysphagia. 2013 Jun;28(2):167-77. doi: 10.1007/s00455-012-9426-9. Epub 2012 Oct 23.

Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. doi: 10.1007/BF00417897.

• Responsible Party: University Health Network, Toronto
• ClinicalTrials.gov Identifier: NCT03192358
• Other Study ID Numbers: 17-5421; 5R01DC011020-05 ( U.S. NIH Grant/Contract ); CAPCR 17-5421 (NIH_Neuro) ( Other Identifier: University Health Network Research Ethics Board ); IRB201701608 ( Other Identifier: University of Florida Institutional Review Board )
• First Submitted: June 12, 2017
• First Posted: June 20, 2017
• Results First Submitted: June 20, 2022
• Results First Posted: July 14, 2022
• Last Update Posted: September 15, 2022