Physiological Flow of Liquids in Healthy Swallowing
Conditions: Deglutition, Healthy Swallowing, Aging
Sponsor: University Health Network, Toronto

 
Steele. Physiological Flow of Liquids in Healthy Swallowing.  
REB#: 15-9431-D    
Version date: August 1, 2018. 
 
CAPCR-ID: 15-9431 
 
 
 
STUDY PROTOCOL 
PHYSIOLOGICAL FLOW OF LIQUIDS IN HEALTHY SWALLOWING 
(Experiments 2 and 4 of  
Physiological Flow of Liquids Used in Dysphagia Management) 
NCT04114617 
 
PI: Catriona M. Steele, Ph.D. 
Swallowing Rehabilitation Research Laboratory 
Toronto Rehabilitation Institute – University Health Network 

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TABLE OF CONTENTS 
 
1. Introduction ................................................................................................................................ 4 
2. 
Steering Committee ................................................................................................................ 5 
3. 
Purpose and Specific Aims ...................................................................................................... 5 
4. 
Methods .................................................................................................................................. 7 
Participants: ................................................................................................................................ 7 
Exclusion Criteria: ....................................................................................................................... 7 
Recruitment: ............................................................................................................................... 8 
Stimuli: ........................................................................................................................................ 8 
Data to be collected from each participant: ............................................................................... 9 
Data Collection Procedures: ....................................................................................................... 9 
Data Processing: ........................................................................................................................ 10 
Data Analysis: ............................................................................................................................ 11 
5. 
Risks and Benefits ................................................................................................................. 12 
Risks .......................................................................................................................................... 12 
Benefits ..................................................................................................................................... 13 
6. 
Privacy and Confidentiality ................................................................................................... 13 
7. 
Compensation ....................................................................................................................... 13 
8. 
Conflicts of interest ............................................................................................................... 14 
9. 
Informed Consent Process .................................................................................................... 14 
10. 
Scholarly Review ................................................................................................................ 14 
11. 
Additional Ethics Reviews .................................................................................................. 14 
12. 
Contracts ............................................................................................................................ 15 
13. 
Clinical Trials ...................................................................................................................... 15 
14. 
Budget ................................................................................................................................ 15 
15. 
References ......................................................................................................................... 16 
16. 
Appendices ......................................................................................................................... 18 

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Appendix A.  IDDSI Gravity-Flow Testing Method ................................................................ 18 
Appendix B. Exclusion Criteria Questionnaire ...................................................................... 19 
Appendix C. Race and Ethnicity Form ................................................................................... 20 
Appendix D. Standard Operating Procedure for Mixing Barium Stimuli .............................. 21 
Appendix E. Standard Operating Procedures for Videofluoroscopy Rating ......................... 21 
Appendix F. Summary Statement from NIH Review ............................................................. 22 
Appendix G. Budget .............................................................................................................. 34 
Appendix H. Budget Justification .......................................................................................... 36 
Personnel: ................................................................................................................................. 36 
Equipment: ................................................................................................................................ 37 
Materials and Supplies: ............................................................................................................. 38 
 
 
 

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1. Introduction 
This protocol covers two experiments (experiments 2 and 4) that form part of a larger project 
entitled Physiological Flow of Liquids Used in Dysphagia Management. The project has been 
submitted to the National Institutes of Health for R01 funding, and has scored at the 9th %ile. 
Confirmation of funding is expected by October, 2015.   
The overall goal of the project is to collect measurements of liquid flow through the oropharynx 
(i.e., mouth and throat) during swallowing.  The factors that are expected to influence liquid 
flow include the liquid consistency (i.e., thin, slightly-thick, mildly-thick, moderately-thick, 
extremely thick) and the forces applied during swallowing (i.e., tongue pressures and 
swallowing muscle contraction).   The objective is to determine how these factors interact to 
influence the flow of a liquid through the oropharynx, both in healthy adults and in adults who 
have swallowing impairment.   
Experiments 1 and 3 of the project involve basic science bench experiments, in which we will 
develop and test the liquid stimuli for use in the subsequent human subject experiments. 
Experiments 1 and 3 involve collaboration with co-investigators Dr. Ben Hanson (University 
Colllege London) and Dr. Lisa Duizer (University of Guelph) and consultant Dr. David James 
(University of Toronto, Mechanical Engineering).   
Experiments 2 and 4 (which comprise the focus of this protocol) will use the liquids developed 
in experiments 1 and 3 and collect measures of liquid flow and swallowing behaviour in healthy 
adults, i.e., those with no known swallowing impairment.  Experiments 2 and 4 will take place at 
the Swallowing Rehabilitation Research Lab of the Toronto Rehabilitation Institute.  
Videofluoroscopy x-rays for Experiment 2 will be conducted on a purchased service basis in the 
diagnostic imaging department at the Toronto General Hospital. 
Experiment 5 (for which a separate protocol will be submitted at a later date) will collect the 
same measures of liquid flow and swallowing behaviour in adults with swallowing impairment 
due to 5 different etiologies, and will be a multi-site study involving co-investigators Dr. Mark 
Bayley (Toronto Rehabilitation Institute – Brain and Spinal Cord Program), Drs. Anthony Burns 
and Cathy Craven (Toronto Rehabilitation Institute – Lyndhurst Centre – Brain and Spinal Cord 
Program), Drs. Douglas Chepeha and Andrew Hope (Princess Margaret Hospital Head and Neck 
Cancer Centre) and Dr. Emily Plowman (University of Florida, Gainesville). 
 
 

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2. Steering Committee 
In addition to the PI, co-investigators and consultants named above, Dr. Julie Cichero and Mr. 
Peter Lam, who are co-chairs of the International Dysphagia Diet Standardisation Initiative 
(www.iddsi.org) will serve as consultants to the project. Together, this team of 12 key 
personnel will form the steering committee for the project.  An annual face to face meeting and 
quarterly teleconference calls are planned for study oversight and progress review. 
3. Purpose and Specific Aims 
Dysphagia (swallowing impairment) is a serious condition, involving two primary functional 
concerns[1]:  
1)  the ability to swallow safely, without material entering the airway (penetration-
aspiration);  
2)  the ability to swallow efficiently, without leaving residue behind in the pockets of the 
pharynx.  
Impaired swallowing safety is linked to pneumonia[2] while impaired efficiency contributes to 
risk of malnutrition[3-8]. Dysphagia is estimated to affect 6.7% of hospital admissions in the USA 
with an annual attributable cost of $547 million[9, 10]. Dysphagia is common in the elderly[5, 11] 
and in individuals with stroke[12], brain injury[13], head and neck cancer[14-16], cervical spine injury 
or surgery[17], and developmental or neurodegenerative conditions[18-20]. When an individual 
presents with dysphagia, the most common intervention is to alter the consistency of the foods 
and fluids they consume[21, 22]. Thicker liquids flow more slowly (making them easier to control 
and making penetration-aspiration less likely). Pureed/ minced/soft foods are thought to be 
easier to transport than unaltered solid foods. Despite the simplicity of these ideas, we lack 
evidence to guide the modification of food and liquid textures for clinical benefit.  
 
The National Dysphagia Diet(6), a guideline that is currently in use in the USA, describes four 
levels of liquid consistency: thin, nectar-, honey- and spoon-thick liquids. Although viscosity 
ranges are proposed for these categories, these lack empirical evidence. Viscosity 
measurement is complex and not practical for caregivers, clinicians or institutional kitchens to 
perform. A recent systematic review published by the International Dysphagia Diet 
Standardisation Initiative (IDDSI) concluded, “there is a need to classify food and fluid behavior 
in the context of the physiological processes involved in oral transport and flow initiation”[23]. 
We propose to take up this challenge with a pivotal and comprehensive study to determine 
physiological-rheological correlates (i.e. bolus flow and swallowing kinematics) across a 
continuum of liquid consistency in healthy and disordered swallowing. To do this, we will 
prepare starch- and gum-thickened liquids in 5 consistencies (Level 0 - thin, Level 1 - slightly-
thick, Level 2 - mildly-thick, Level 3 - moderately-thick and Level 5 - extremely-thick) according to 
the IDDSI framework. Operational definitions for these consistencies have been developed by 

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IDDSI based on gravity-flow tests (i.e. practical tests that can be used to verify consistency at 
the time of preparation). The IDDSI gravity-flow testing method is illustrated in Appendix A. 
Experiments 1 and 3 will be basic science experiments to confirm the flow properties of these 
liquids and to identify barium and non-barium liquids with matching flow properties. In 
experiments 2, 4 and 5 we will use these liquids and collect time-linked videofluoroscopic 
measures of bolus flow and physiological measures of swallowing behavior (i.e. tongue 
pressures and submental muscle contraction patterns) to determine the dose-response 
pattern of progressive increments of liquid thickening in adults with and without dysphagia.  
 
We have three specific aims, the first two of which will be addressed in this protocol:  
 
Aim 1:  To determine the relationship between bolus flow and healthy swallowing 
physiology. In Experiment 2, we will collect concurrent videofluoroscopic and physiological 
measures of swallowing (tongue pressure, electromyography [sEMG], nasal airflow) in healthy 
adults using barium stimuli across the continuum of liquid consistency. Significance: This will 
show the impact of consistency on bolus flow through the oropharynx, controlling for the 
forces used to initiate flow and propel the bolus. 
 
Aim 2: To compare healthy swallowing physiology for barium versus non-barium stimuli. In 
Experiment 4, we will collect physiological measures of swallowing using barium and non-
barium stimuli matched for consistency. Significance: This will determine how swallowing 
behaviors (tongue pressures, sEMG, nasal airflow, tracheal sounds and accelerometry, where 
captured) differ between barium and non-barium stimuli with matched consistency, enabling us 
to develop models of flow accounting for these differences. 
 
Aim 3: To explore the relationship between bolus flow and swallowing physiology in 
dysphagia. In a future planned experiment (Experiment 5), we will collect concurrent 
videofluoroscopy and physiological measures of swallowing in adults with dysphagia using 
barium stimuli across the continuum of liquid consistency. We will study 5 groups in whom 
dysphagia is common: stroke; acquired brain injury; oropharyngeal cancer; cervical spine 
surgery/injury; and neuro-degenerative disease. Significance: This will enable us to identify the 
boundaries of ideal thickening (i.e., not too thin and not too thick), based on swallowing 
pathophysiology (altered pressure and force generation capacity). 
 
 

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4. Methods 
Participants: 
Experiments 2 and 4 will involve the participation of a single sample of participants in the 
following sub‐groups: 
i) 40 healthy adults, aged under 60 years old, recruited from the Toronto population at large; 
ii) 40 healthy adults, aged over 60 years old, recruited from the Toronto population at large; 
Participants will be asked to complete both experiments. Recruitment for Experiment 4 was 
terminated on July 24 2018 due to technical issues encountered with the equipment that could 
not be repaired by the manufacturer.   The target age ranges for the age sub‐groups in 
Experiments 2 and 4 have been selected based on our previous research, which suggests that 
significant age‐related differences in tongue pressures in swallowing are detectable over the 
age of 60[24-27]. We will recruit an equal number of male and female participants within each 
age-group. Participants of all ethnic and racial groups will be accepted, however adequate 
comprehension of the English language consent documents will be required.  
Exclusion Criteria:  
 The healthy adult participants for Experiments 2 and 4 will be accepted into the study, 
provided that they have no prior history of swallowing, motor speech, gastro‐
esophageal or neurological difficulties, chronic sinusitis or taste disturbance.  
 Individuals with a history of surgery to the speech or swallowing apparatus (other than 
routine tonsillectomy or adenoidectomy) will be excluded.  
 Similarly, due to the requirement to swallow stimuli containing starch based thickeners, 
which carry a significant carbohydrate load, individuals with Type 1 Diabetes will be 
excluded. 
 Due to the fact that neurological impairments comprise an exclusion criterion, 
individuals with cognitive communication difficulties that may hinder comprehension of 
the study documents will be excluded from this study.  
 Individuals with known allergies to latex or medical adhesive will be excluded, due to 
the probability that these items will come into contact with the oral mucosa, neck, and 
chin areas during data collection.  
 As a further precaution due to the use of radiation in experiment 2, we will exclude 
women who report current pregnancy and individuals who report that they have had an 
x-ray to the neck in the past 6 months.   
 Finally, individuals who report that they are occupationally exposed to radiation will be 
advised that they should not participate if they believe their occupational radiation 
exposure may exceed half the allowed Ontario annual limit of 20 mSv. 
 These exclusion criteria will be confirmed using a self‐report questionnaire form at the 
time of intake into the study (see Appendix B). Any questions will be clarified through 

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discussion with the research assistant responsible for participant intake, and, where 
necessary with the principal investigator. 
Children will not be involved in this protocol due to the use of radiation.  Although the research 
questions are of interest for all ages, including children, we feel that it is most appropriate to 
answer the current research questions in adults before considering whether similar studies 
should be repeated in children.  In particular, the variety of physiological variation we detect in 
both healthy adults and those with dysphagia will help to determine whether a future study 
involving healthy children requires videofluoroscopy to establish a healthy reference 
perspective.  
Recruitment: 
Recruitment of participants for Experiments 2 and 4 will be conducted in two ways: 
1) We will request permission to contact individuals who have registered with the Toronto 
Rehabilitation Institute research volunteer database, who have agreed to be contacted 
for future studies and who meet the broad inclusion criteria of the study.  
2) We will conduct a broad public advertising campaign through local newspapers, 
magazines, a web‐site, mailings and posters at community centres, seniors’ residences, 
places of worship, and around the University of Toronto and the Toronto Rehabilitation 
Institute. In particular, we anticipate advertising in a seniors’ magazine (50Plus) and its 
associated website, which has been useful in previous studies. Participants will be 
required to attend a 1‐hour intake appointment to confirm their eligibility to participate, 
introduce them to the research protocol, complete the intake questionnaire, and obtain 
informed consent (see attached consent documents in Appendices C and D).  
Stimuli:  
Prior to launching Experiments 2 and 4, we will develop an array of barium (Experiment 1) and 
non-barium (Experiment 3) stimuli in thin, slightly-thick, mildly-thick, moderately-thick and 
extremely-thick consistencies, defined using the International Dysphagia Diet Standardisation 
Initiative (IDDSI) gravity-flow measures. The barium stimuli will be prepared using E-Z-Paque® 
barium in 20% w/v barium concentration(84) with starch and gum-based thickening agents 
(Nestlé Resource® ThickenUp® and ThickenUp Clear®). The non-barium stimuli will be prepared 
using Nestlé® Pure Life® Splash, a mildly lemon-flavored water (87-89). Starch and gum-based 
thickening agents will be added to match the flow characteristics of the barium stimuli 
developed in Experiment 1. Experiments 1 and 3 will produce two arrays (barium; non-barium) 
of starch- and gum-thickened liquids representative of each IDDSI flow level, for a total array of 
1 thin and 8 thickened stimuli (4 gum; 4 starch). 
 
All stimuli will be prepared in the Swallowing Rehabilitation Research Laboratory not longer 
than 6 hours prior to scheduled use, according to a strict standard operating procedure (see 

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Appendix D). Barium stimuli will be transported to the radiology suite at Toronto General 
Hospital in a cooler, as per routine clinical procedures. 
Data to be collected from each participant: 
The following types of data will be collected from participants in Experiments 2, and 4: 
a) An intake questionnaire noting age, sex, ethnicity and race data and confirming eligibility 
based on the absence of reported exclusion criteria. 
b) During the intake process, we will ask to review a list of conditions that could alter the results 
of the research study and identify whether any of these conditions apply. This disclosing the use 
of any medications that they are currently taking, in order to allow us to control for the possible 
influence of medication on oral sensory and motor function.  Medications do not qualify as the 
basis for exclusion.  However, it is important for us to collect information regarding the use of 
benzodiazepines and neuroleptic medications that are known to have possible effects on 
swallowing, particularly with respect to causing xerostomia (dry mouth).   
 
Signals to be collected from each participant: 
c) Tongue‐pressure waveform data, using the hand-held Iowa Oral Performance Instrument 
(IOPI) will be collected at the anterior position during 3 anterior maximum presses and 3 saliva 
swallows.  
d) Nasal airflow collected using nasal cannula and registered on the KayPENTAX Swallowing 
Signals Lab during swallows.  
e) A videofluoroscopy recording of swallowing involving a pulse rate of 30 pulses per second 
and video capture at 30 frames per second. 
Data Collection Procedures: 
Experiment 2: Prior to data collection, a nasal cannula will be placed around the participant’s 
head with flexible prongs resting in their nostrils to measure airflow.  
A single use disposable tongue bulb for the 
hand-held Iowa Oral Performance Instrument 
(IOPI) will be placed inside the participant’s 
mouth. Tongue pressure signal will be 
collected at the anterior position during 3 
anterior maximum presses and 3 saliva 
swallows. 
 
Following sensor attachment, the participants will be seated on a chair inside the fluoroscopy 
unit.   The video output line from the fluoroscopy unit and the nasal cannula will then be 
connected to the KayPENTAX Digital Swallow Workstation Swallowing Signals Lab equipment, 
Image 1.  Tongue pressure sensors. 

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which is located on a properly insulated cart with an uninterrupted power supply and isolation 
transformer. 
 
Participants will be asked to swallow the barium stimuli developed in Experiment 1 (9 in total) 
in videofluoroscopy, with concurrent measurement of nasal airflow. Videofluoroscopy will be 
performed at maximum temporal resolution (30 pulses/second) and captured at 30 
frames/second. Each stimulus will be presented twice, in a randomized block design. 
Participants will be allowed to take natural sized sips of each stimulus from cups containing 40 
ml. Cup weights before and after each sip will be taken on a digital balance so that sip volume 
and mass can be calculated. 
 
Experiment 4: Experiment 4 was terminated on July 24 2018 due to technical issues 
encountered with the equipment that could not be repaired by the manufacturer. 
Data Processing: 
Signals collected from the participants (which may include tongue-pressure, sEMG, nasal 
airflow, tracheal sounds and accelerometry waveform data) will be segmented using an 
automatic segmentation algorithm developed previously in the PI’s lab.  Similarly, the 
videofluoroscopy recordings will be spliced into single bolus clips and the audio channel will be 
muted to remove cues that might bias rating. Blinded videofluoroscopy rating will then be 
performed in duplicate by trained raters in the Steele Lab following established procedures(85) 
(see Appendix E). Discrepancies between raters will be flagged and resolved at consensus 
meetings, as required.  These procedures will yield a large number of parameters for each 
swallow, as listed below: 
a) Peak tongue-pressure amplitude (in mm Hg); 
b) Rise-time to peak tongue-pressure (in ms); 
c) Decay-time for tongue-pressure (in ms); 
d) Tongue-pressure area-under-the-curve; 
e) Peak sEMG amplitude (in μV); 
f) Rise-time to peak sEMG amplitude (in ms); 
g) Decay-time for sEMG (in ms); 
h) sEMG area-under-the-curve; 
i) Duration of apnea (ms); 
j) Breathing pattern pre- and post- swallow; 
k) Bolus transit time from ramus of mandible to vallecular pit (in ms); 
l) Bolus dwell time in pharynx from ramus of mandible to laryngeal vestibule closure 
(in ms); 

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m) Pharyngeal bolus transit time from ramus of mandible to upper esophageal 
sphincter opening (in ms); 
n) Bolus transit time from ramus of mandible to tail exiting the upper esophageal 
sphincter (in ms); 
o) Amount of residual left behind in the valleculae and pyriform sinuses after the 
initial swallow (measured using the Normalized Residue Ratio Scale[28]; 
p) Number of swallows for the bolus. 
Data Analysis: 
We will model the impact of bolus consistency on videofluoroscopic measures of pharyngeal 
bolus flow (i.e., the interval from the bolus passing the mandibular ramus until laryngeal 
vestibule closure; pharyngeal transit time) and post-swallow residue (Normalized Residue Ratio 
Scale(45)). The analyses for Experiments 2 and 4 will involve linear mixed model ANOVAs with 
repeated measures. A path analysis approach(86) will be used to first identify differences in 
tongue-pressure and submental sEMG measures (amplitude, rise time, decay time) across 
stimuli.  The influence of variations in bolus volume will also be explored using univariate tests, 
and, if confirmed to be significant, will be used as a covariate in the subsequent statistical 
models. Similarly, differences in the dependent variables as a function of sex or age (continuous 
or divided into groups) will be explored first in a univariate fashion, and, if significant, these 
between-participant factors will be included in the model.  
 
For Experiment 2, our main hypothesis is that liquids with similar gravity-flow properties will 
show similar pharyngeal bolus flow. Our goal will be to detect differences in bolus flow 
measures ≥200 ms as a function of consistency, with a medium effect size (Cohen’s d ≥ 0.5)(96). 
We hypothesize that the healthy participants in these experiments will use higher amplitudes of 
tongue pressure and/or submental muscle contraction (sEMG) during oral propulsion of starch-
thickened stimuli, thereby achieving a similar outcome for both starch- and gum-thickened 
liquids in terms of pharyngeal bolus flow. Model fit for different covariance structures will be 
explored using restricted log likelihood estimation. Age-group (< vs. > 60 years) will be used as a 
between-groups factor while bolus consistency will be used as the within-participants factor. 
Sample size calculations have been performed using the data from the PI’s previous grant, in 
which ultrasound measures of the duration of hyoid movement differed by 200-400 ms 
between age-groups and tongue-pressure amplitudes varied by 10-35 mm Hg depending on the 
liquid studied. A power calculation shows that 36 participants per group will be needed to 
detect this difference with 80% power (α=0.05). Allowing a margin for attrition, we have 
therefore planned to enroll n=40 per participant group: total N=80 for Experiments 2 and 4. 
This sample size will also be adequately powered for Experiment 4 to detect differences ≥10 
mm Hg in tongue-pressure amplitudes.  
 

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For Experiment 4, our main hypothesis is that liquids with similar flow properties based on 
the IDDSI gravity-flow tests will elicit different tongue pressure and sEMG measures based on 
their actual viscosities. This hypothesis is predicated on the idea that healthy adults modulate 
oral phase propulsive forces used for boluses of differing consistency with the goal of 
establishing uniform pharyngeal flow (as hypothesized for Experiment 2). Significant contrasts 
are expected between the two extremes of the liquid continuum: [thin and slightly-thick] vs. 
[moderately- and extremely-thick]. We expect that measures for the mildly-thick liquids will fall 
in between, but that differences may not be large enough to achieve statistical significance 
versus the extremes in pairwise comparisons. We predict that barium stimuli will elicit higher 
amplitudes of tongue-pressure than non-barium stimuli based on their increased density.  
5. Risks and Benefits 
Risks 
The following risks will be disclosed to all participants in Experiments 2 and 4 prior to obtaining 
their consent to participate: 
a) It is possible that participants may dislike the taste or texture of some of the thickened liquid 
stimuli in the study. Participants will be reminded that they are free to discontinue participation 
at any time. 
b) It is possible that participants may experience some fatigue during the data collection 
sessions. Participants will be reminded that they should disclose any fatigue or discomfort to 
the research team, and that they are free to discontinue any particular session or to withdraw 
from the study at any time. 
c) Participants will receive exposure to radiation during the videofluoroscopy.  Based on a 
previous videofluoroscopic study that we have conducted in healthy adults, Experiment 2 is 
expected to involve 118+/-18 seconds of radiation exposure[29], with an associated dose 
estimate of <0.35 milliSieverts. Moro and Cazzani[30] showed that this dose (0.35mSv) 
corresponds to a risk of 1 in 39,000 of developing a radiation-induced stochastic effect from a 
videofluoroscopy. We will use a 3-minute warning bell to alert the data collection team to 
exposure time, and will terminate the protocol at the first opportunity following the bell. 
d) Aspiration (entry of material into the airway) is a possible risk during the videofluoroscopic 
swallowing study that will be performed. This risk is always present for videofluorscopic 
swallowing studies, which are intended to document the presence and severity of swallowing 
abnormalities, including (but not limited to aspiration). When aspiration is observed, standard 
procedures will be followed to encourage coughing and throat clearing to expel the aspirated 
material.  The protocol will be terminated immediately. Any participant who experiences 
aspiration will be counseled regarding aspiration prevention strategies and aspiration‐risk 
following the videofluoroscopy. 

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e) Choking is an extremely unlikely event.  However, in the event of choking, routine emergency 
procedures will be followed.  All study personnel carry current CPR certification.   
f) In the unlikely event that an incidental finding is noted on the videofluoroscopy (such as a 
diverticulum or a mass) the attending SRRL licensed speech-language pathologist will consult 
the on-call radiologist and generate a clinical report documenting the observation. These 
findings will be communicated with the participant as per usual clinical practice. 
Benefits 
There are no benefits anticipated for participants in this study. 
6. Privacy and Confidentiality 
Routine practices for ensuring the confidentiality and privacy of all participants will be followed 
in this study. All research personnel at the Toronto Rehabilitation Institute are required to sign 
a confidentiality agreement at the time of hire. Participants will be assigned a non‐identifying 
alphanumeric study code, and the master key for this code will be retained separately by the 
Principal Investigator in a password‐protected file on a secure, password‐protected, encrypted 
research server. Daily back‐up of this research server is performed centrally at the Toronto 
Rehabilitation Institute to protect against data loss. Hard copies of the participant consent 
forms will be maintained in a binder, kept in a locked filing cabinet in the Swallowing 
Rehabilitation Research Lab.   
All waveform and videofluoroscopic data will be stored electronically on the secure, password 
protected, encrypted research server. Any hard copy data will be transcribed into an electronic 
file (stored on the server), and the hard copy records will be stored in a locked filing cabinet in 
the Swallowing Rehabilitation Research Lab. Only the participant’s alphanumeric study code 
number will appear on the data collection sheets and in the data collection files. 
Access to participant information and experimental raw data will be restricted to the study 
personnel named in this application. All records will be destroyed after 10 years under the 
supervision of Dr. Steele. 
7. Compensation 
Data collection for each participant will involve 2 separate appointments: a) intake; b) 
Experiment 2 (ivideofluoroscopy). Each appointment is expected to last 1 hour. An honorarium 
of $50 will be provided per participant to cover expenses associated with participation in the 
study.  This will be paid at the end of your final study visit. 

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8. Conflicts of interest 
Dr. Steele, the principal investigator, holds current and prior research contracts with Bracco 
Canada and Nestle Health Science, who are manufacturers of the barium products and 
thickening agents that will be used in this study.  She has also served in an advisory capacity on 
expert panels for Nestle Health Science. These relationships will be disclosed to participants in 
the study information sheet. All products for use in the study will be purchased.  Neither Bracco 
Canada nor Nestle Health Science will have any role as sponsors of this study.  Dr. Steele will 
not receive any financial payment, either personally or to the lab, related to the use of Nestle or 
Bracco products in this study. 
9. Informed Consent Process 
All participants who show an interest in participating will be provided with detailed information 
about this study via the Participant Information Sheet and Consent Form . Only after confirming 
they have understood all the information that is provided and after verifying they have no more 
questions, can they sign the consent form. A copy of the consent form will be provided to them.  
The consent form includes a specific section requesting consent to use of study-related images 
for future educational and teaching purposes. 
10. 
 Scholarly Review 
This study has undergone scientific review by the MFSR Study Section of the National Institutes 
of Health (USA).  Reviewer comments are attached in Appendix F. 
11. 
 Additional Ethics Reviews 
There are no additional ethics reviews planned for Experiments 2 and 4, as covered by this 
protocol. Additional ethics submissions are planned for other experiments in the overall project 
as follows: 
 Experiment 3c involves a sensory experiment, in which a panel of trained raters will be 
asked to describe the taste, texture and mouthfeel of the stimuli developed for the 
study.  This experiment will be run independently by Dr. Lisa Duizer at the University of 
Guelph.   A separate ethics application will be submitted at the University of Guelph 
regarding this experiment. 
 Experiment 5 is a future planned experiment to measure bolus flow in individuals with 
swallowing impairment due to different etiologies.  The experiment will involve multiple 
sites and co-investigators. A separate ethics protocol will be submitted for that 
experiment at a future date.  

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12. 
 Contracts 
There are no contracts required for experiments 2 and 4, which will be conducted exclusively at 
the Toronto Rehabilitation Institute.  Subgrants have been requested, and contracts will be set 
up separately for the collaborations required for Experiments 1, 3 and 5 of the overall project.  
13. 
 Clinical Trials 
Not applicable. 
14. 
 Budget 
All costs for this study will be covered pending funding confirmation from the National 
Institutes of Health.  The budget and budget justification for Experiments 2 and 4 are included 
in Appendices H and I. 
 
 

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15. 
References 
1. 
Rofes, L., V. Arreola, and P. Clave, The volume-viscosity swallow test for clinical 
screening of dysphagia and aspiration. Nestle Nutrition Institute Workshop Series, 2012. 
72: p. 33-42. 
2. 
Pikus, L., et al., Videofluoroscopic studies of swallowing dysfunction and the relative risk 
of pneumonia. AJR Am J Roentgenol 2003. 180(6): p. 1613-6. 
3. 
Carrion, S., et al., Nutritional measurements and body composition among patients with 
oropharyngeal dysphagia. Dysphagia, 2011. 26 (4): p. 486-487. 
4. 
Carrion, S., et al., Malnutrition as a complication of oropharyngeal dysphagia in specific 
clinical situations. Dysphagia, 2013. 28 (2): p. 294. 
5. 
Rofes, L., et al., Diagnosis and Management of Oropharyngeal Dysphagia and Its 
Nutritional and Respiratory Complications in the Elderly. Gastroenterol Res Pract, 2011. 
2011. 
6. 
Carrion, S., et al., Association between oropharyngeal dysphagia and malnutrition in 
elderly patients with acute diseases admitted to a general hospital. Clinical Nutrition, 
Supplement, 2012. 7 (1): p. 8. 
7. 
Carrion, S., et al., Prevalence and association between oropharyngeal dysphagia and 
malnutrition in patients hospitalized in an acute geriatric unit (AGU). Dysphagia, 2011. 
26 (4): p. 479. 
8. 
Carrion, S., et al., Oropharyngeal dysphagia is a prevalent risk factor for malnutrition in a 
cohort of older patients admitted with an acute disease to a general hospital. Clin Nutr, 
2014. 
9. 
Altman, K.W., Dysphagia Evaluation and Care in the Hospital Setting: The Need for 
Protocolization. Otolaryngol Head Neck Surg, 2011. 
10. 
Altman, K.W., G.P. Yu, and S.D. Schaefer, Consequence of dysphagia in the hospitalized 
patient: impact on prognosis and hospital resources. Arch Otolaryngol Head Neck Surg, 
2010. 136(8): p. 784-9. 
11. 
Clave, P., et al., Pathophysiology, relevance and natural history of oropharyngeal 
dysphagia among older people. Nestle Nutr Inst Workshop Ser, 2012. 72: p. 57-66. 
12. 
Martino, R., et al., Dysphagia after stroke: incidence, diagnosis, and pulmonary 
complications. Stroke, 2005. 36(12): p. 2756-63. 
13. 
Halper, A.S., et al., Dysphagia after head trauma: the effect of cognitive-communicative 
impairments on functional outcomes. J Head Trauma Rehabil, 1999. 14(5): p. 486-96. 
14. 
Eisbruch, A., Dysphagia and aspiration following chemo-irradiation of head and neck 
cancer: Major obstacles to intensification of therapy. Annals of Oncology, 2004. 15(3): p. 
363-364. 
15. 
Eisbruch, A., et al., Objective assessment of swallowing dysfunction and aspiration after 
radiation concurrent with chemotherapy for head-and-neck cancer. Int J Radiat Oncol 
Biol Phys, 2002. 53(1): p. 23-8. 
16. 
Rosenthal, D.I., J.S. Lewin, and A. Eisbruch, Prevention and treatment of dysphagia and 
aspiration after chemoradiation for head and neck cancer. Journal of clinical oncology : 
official journal of the American Society of Clinical Oncology, 2006. 24(17): p. 2636-2643. 

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17. 
Martin, R.E., M.A. Neary, and N.E. Diamant, Dysphagia following anterior cervical spine 
surgery. Dysphagia 1997. 12(1): p. 2-8. 
18. 
Leonard, R.J., et al., Swallowing in myotonic muscular dystrophy: a videofluoroscopic 
study. Arch Phys Med Rehabil, 2001. 82(7): p. 979-85. 
19. 
Troche, M.S., et al., Respiratory-swallowing coordination and swallowing safety in 
patients with Parkinson's disease. Dysphagia, 2011. 26(3): p. 218-24. 
20. 
Palmer, P.M., et al., Swallow characteristics in patients with oculopharyngeal muscular 
dystrophy. J Speech Lang Hear Res, 2010. 53(6): p. 1567-78. 
21. 
Garcia, J.M., E.t. Chambers, and M. Molander, Thickened liquids: practice patterns of 
speech-language pathologists. Am J Speech Lang Pathol 2005. 14(1): p. 4-13. 
22. 
Robbins, J., et al., Defining physical properties of fluids for dysphagia evaluation and 
treatment., in Perspectives on Swallowing and Swallowing Disorders (Dysphagia). 
American Speech-Language Hearing Association Special Interest Division 13 Newsletter 
2002. p. 16-19. 
23. 
Steele, C.M., et al., The Influence of Food Texture and Liquid Consistency Modification 
on Swallowing Physiology and Function: A Systematic Review. Dysphagia, 2014. 
24. 
Steele, C.M., et al., Variations in Tongue-Palate Swallowing Pressures When Swallowing 
Xanthan Gum-Thickened Liquids. Dysphagia, 2014. 
25. 
Steele, C.M., et al., Age and strength influences on lingual tactile acuity. Journal of 
Texture Studies, 2014. 45(317-323). 
26. 
Steele, C.M., A comparison of approaches for measuring functional tongue-pressure 
reserve. , in 2nd Annual Congress of the European Society for Swallowing Disorders. 
2012: Barcelona. 
27. 
Fei, T., et al., Age-related Differences in Tongue-Palate Pressures for Strength and 
Swallowing Tasks. Dysphagia, 2013. 
28. 
Pearson, W.G., Jr., et al., Image-based Measurement of Post-Swallow Residue: The 
Normalized Residue Ratio Scale. Dysphagia, 2012. 
29. 
Molfenter, S.M. and C.M. Steele, Variation in temporal measures of swallowing: sex and 
volume effects. Dysphagia, 2013. 28(2): p. 226-33. 
30. 
Moro, L. and C. Cazzani, Dynamic swallowing study and radiation dose to patients. 
Radiol Med, 2006. 111(1): p. 123-9. 
 
 

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16. 
Appendices 
Appendix A.  IDDSI Gravity-Flow Testing Method 
 
 

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Appendix B. Exclusion Criteria Questionnaire 
This is a list of conditions that could alter the results of this research study, or impact your 
eligibility to participate.   
Please read the list and let us know if any of these apply to you, so that we can be certain that 
you meet the requirements to participate in the study.   
a) Medical or Occupational Conditions: 
• People with a prior medical history of stroke 
• People with a prior medical history of acquired brain injury 
• People with a diagnosis of Parkinson’s Disease 
• People with a diagnosis of Multiple Sclerosis (MS) 
• People with a diagnosis of Amyotrophic Lateral Sclerosis (ALS) 
• People with a diagnosis of Huntingdon’s Disease 
• People who have slurred speech or facial muscle problems 
• People who have a swallowing disorder 
• People who have Type I (insulin-dependent) Diabetes 
• People who have had surgery in the head and neck area (other than tonsillectomy or 
adenoidectomy) 
• People who have had radiation to the head and neck for cancer 
• People who experience extreme mouth sensitivity (for example, when you go to the dentist) 
• People who wear a full upper-plate denture, which covers the roof of the mouth 
• Women who are pregnant 
• People who have allergies to barium, potato starch, corn starch, xanthan gum, milk products, 
latex or adhesives 
• People who have had an x-ray of their neck in the past 6 months 
• People who work in a setting where they are exposed to radiation 
 
b) Medication, Drug and Alcohol Use 
• People who are taking sleeping pills or medication that makes them drowsy 
• People who are taking “anti-Parkinson’s” medications like Levodopa 
• People who are experiencing dry mouth as a side effect of medication 
• People who use drugs (Cocaine, Methamphetamine, Heroin, Ecstacy, etc.)  
• People who are taking medicine that affects their sense of taste or smell 
 
 
 
 

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Appendix C. Race and Ethnicity Form 
This study is funded by the National Institutes of Health in the United States. 
As a condition of that funding, we are required to track the cultural heritage of participants in 
our study, to ensure representation of minority groups. 
 
If you are willing, please tell us which of the following racial groups you would identify yourself 
with most closely: 
 
 Asian 
 Black or African-American 
 Hawaiian/Pacific Islander 
 Native American Indian 
 White 
 Other: _______________________________________ 
 I prefer not to disclose my racial heritage 
 
In addition, please tell us whether Spanish or Portuguese is your mother tongue: 
 
 Yes 
 No 
 

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Appendix D. Standard Operating Procedure for Mixing Barium Stimuli 
(Attached as a separate document) 
 
Appendix E. Standard Operating Procedures for Videofluoroscopy Rating 
(Attached as a separate document) 
 
 
 
 
 

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Appendix F. Summary Statement from NIH Review 
 
 
 

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Appendix G. Budget 
The amounts below cover direct costs for Dr. Steele and her lab associated with the first two 
years of the overall project.  Additional money is budgeted for the other experiments involving 
subgrants and collaborations. 
YEAR 1 (2016) 
  
  
  
  
  
  
  
  
  
Salary Costs 
  
  
  
  
Person 
Project 
Role 
Requested 
Salary 
Benefits 
Funds 
Requested 
Professor Catriona Steele 
PI 
$41,100.00 
$10,275.00 
$51,375.00 
Melanie Peladeau-Pigeon 
Clinical 
Research 
Coordinator 
$25,874.00 
$6,468.00 
$32,342.00 
Melanie Tapson 
Clinical 
Research 
Coordinator 
$19,405.00 
$4,851.00 
$24,256.00 
Talia Wolkin 
Clinical 
Research 
Coordinator 
$12,937.00 
$3,234.00 
$16,171.00 
Carly Barbon 
Research 
Associate 
$13,650.00 
$3,413.00 
$17,063.00 
Ashley Waito 
Graduate 
Student 
$17,062.50 
$4,265.50 
$21,328.00 
Teresa Valenzano 
Graduate 
Student 
$17,062.50 
$4,265.50 
$21,328.00 
  
  
  
  
  
Equipment Costs 
  
  
  
  
New KayPENTAX Digital Swallow Workstation 
$114,393.00 
  
  
  
  
  
Other Direct Costs 
  
  
  
  
Materials and Supplies 
$7,000.00 
Consultant Services 
$6,000.00 
Computer Services 
$4,200.00 
Videofluoroscopies and Participant Honoraria 
$17,000.00 
Statistical Support 
$4,050.00 
  
  
  
  
  
  
  
  
TOTAL YEAR 1 
BUDGET: $336,506.00 
 
 

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YEAR 2 (2017) 
  
  
  
  
  
  
  
  
  
Salary Costs 
  
  
  
  
Person 
Project 
Role 
Requested 
Salary 
Benefits 
Funds 
Requested 
Professor Catriona Steele 
PI 
$42,333.00 
$10,583.00 
$52,916.00 
Melanie Peladeau-Pigeon 
Clinical 
Research 
Coordinator 
$26,650.00 
$6,662.00 
$33,312.00 
Melanie Tapson 
Clinical 
Research 
Coordinator 
$39,975.00 
$9,994.00 
$49,969.00 
Talia Wolkin 
Clinical 
Research 
Coordinator 
$26,650.00 
$6,662.00 
$33,312.00 
Carly Barbon 
Research 
Associate 
$14,060.00 
$3,515.00 
$17,575.00 
Ashley Waito 
Graduate 
Student 
$17,074.50 
$3,690.50 
$20,765.00 
Teresa Valenzano 
Graduate 
Student 
$17,074.50 
$3,690.50 
$20,765.00 
  
  
  
  
  
Other Direct Costs 
  
  
  
  
Materials and Supplies 
$6,500.00 
Consultant Services 
$6,000.00 
Computer Services 
$0.00 
Videofluoroscopies and Participant Honoraria 
$24,433.00 
Statistical Support 
$4,050.00 
  
  
  
  
  
  
  
  
TOTAL YEAR 2 
BUDGET: $269,597.00 
 
 
 
 

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Appendix H. Budget Justification 
Personnel:  
All salary and fringe benefits costs for study personnel assume a 3% annual inflation rate. 
 
Principal Investigator: Dr. Catriona M. Steele, Ph.D., CCC-SLP, BCS-S, ASHA Fellow will serve as 
Principal Investigator on this project. Dr. Steele is a Senior Scientist and Director of the 
Swallowing Rehabilitation Research Laboratory at the Toronto Rehabilitation Institute – 
University Health Network, as well as status-only Professor in the Department of Speech-
Language Pathology at the University of Toronto. She has over 10 years of clinical research 
experience focusing on the measurement and rehabilitation of swallowing function. Dr. Steele’s 
effort will be at 4.0 calendar months throughout the year. Her role will be to supervise key 
personnel, all data collection, and all data analyses. She will lead data interpretation and 
manuscript preparation. Salary support and fringe benefits are requested. 
 
Research Engineer and Lab Manager: Ms. Melanie Peladeau-Pigeon, M.H.Sc., is a Clinical 
Engineer currently employed as Research Coordinator in Dr. Steele’s laboratory. In this 
capacity, she oversees daily lab operations, including ordering supplies, managing institutional 
protocols and compliance with regulations and overseeing data entry, quality and retention. In 
addition to this, Melanie has particular expertise in signal processing as applied to the analysis 
of physiological swallowing signals (tongue pressure waveforms, submental EMG).  She will 
oversee the development and use of automated signal processing methods to extract key 
parameters regarding tongue pressure and electromyography in Experiments 2, 4 and 5a-e.  
Melanie will contribute 4.0 calendar months to the project across the duration of the grant. 
Salary plus fringe benefits are requested. 
 
Clinical Research Coordinator: Ms. Melanie Tapson, M.H.Sc., is currently Clinical Research 
Coordinator and Speech-Language Pathologist in Dr. Steele’s laboratory. In this capacity, she 
will oversee the recruitment of participants (both healthy and patient participants) and all 
clinical aspects of data collection including videofluoroscopy. She will also train and supervise 
graduate research assistants in data collection.  Melanie will contribute 3.0 calendar months to 
the project in year 1, 6.0 calendar months in years 2-4 and 3.0 calendar months in year 5 of the 
grant. Salary plus fringe benefits are requested. 
 
Research Associate: Talia Wolkin (Goldhar), M. H.Sc.,  is currently a Research Associate and 
Speech-Language Pathologist in Dr. Steele’s laboratory.  In this capacity, she will oversee the 
blinded rating of all videofluoroscopies for the grant, including extraction of kinematic 
measures.  She will also train and supervise graduate research assistants in videofluoroscopy 
rating. Talia will contribute 2.0 calendar months to the project in year 1 and 4.0 calendar 
months annually across the remainder of the grant. Salary plus fringe benefits are requested. 
 
 
 
 

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Graduate Research Assistants: To be named 
 Two Graduate Research Assistants will be recruited at 50% effort beginning in year 1 of 
the project. These individuals will have a B.S. or M.S. in communication sciences and 
disorders, psychology, neuroscience, or a related field. These individuals will be 
responsible for assisting Dr. Steele with data collection for Experiments 2 and 4. These 
trainees will also receive training in videofluoroscopy rating and swallowing signal 
analysis, and will assist Dr. Steele with data analysis and manuscript preparation. 
 
Consultants: 
 Dr. David James is Professor of Mechanical Engineering, University of Toronto. Dr. James 
will serve as a consultant on this project. His contribution to the project will be to make 
facilities and equipment for rheological testing available in Toronto and to advise 
regarding rheological testing methods. An annual consulting fee of $2000 is requested, 
which will cover Dr. James’ time advising regarding rheological testing as well as enable 
Dr. James’ participation in annual project meetings. 
 Dr. Julie Cichero, Ph.D. is a Speech-Language Pathologist and Honorary Senior Fellow in 
the School of Pharmacy, Faculty of Health and Behavioural Sciences at the University of 
Queensland, Australia.  Together with Mr. Peter Lam (below), Dr. Cichero serves as Co-
Chair of the International Dysphagia Diet Standardisation Initiative (www.iddsi.org).  Dr. 
Cichero will serve as a consultant on this project.  Her contribution will be to advise 
regarding the terminology, definitions and practical measurement of fluid consistency 
developed by IDDSI and the roll-out of IDDSI’s recommendations to clinical audiences.  
An annual consulting fee of $2000 is requested, which enable Dr. Cichero’s participation 
in annual project meetings. 
 Mr. Peter Lam, R.D. is a Dietitian and Food Service Executive who serves as Co-Chair of 
the International Dysphagia Diet Standardisation Initiative (www.iddsi.org).  Together 
with Dr. Cichero, Mr. Lam will serve as a consultant on this project.  His contribution will 
be to advise regarding the terminology, definitions and practical measurement of fluid 
consistency developed by IDDSI and the roll-out of IDDSI’s recommendations to clinical 
audiences.  An annual consulting fee of $2000 is requested, which enable Mr. Lam’s 
participation in annual project meetings. 
Equipment:  
 Funds are requested to purchase a new KayPENTAX Digital Swallow Workstation (DSW) 
with Swallowing Signals Lab (SSL) for Dr. Steele’s laboratory.  This equipment will 
supplement and eventually replace Dr. Steele’s previous system, which is currently10 
years old and beginning to show some wear and tear due to the need to move it 
repeatedly between Dr. Steele’s laboratory and the videofluoroscopy suite at the 
Toronto General Hospital – University Health Network (a 20-minute journey in each 
direction through a connecting tunnel system and involving entry and exit through 3 
elevators, which can cause jolts to the equipment cart).  The DSW and SSL are required 
for registering all physiological signals during experiments 2 and 4 as well as for 
capturing concurrent videofluoroscopy in experiment 2. By purchasing a new system for 

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this project, we will be able to house one system in the videofluoroscopy suite and (for 
the remainder of its usable life), keep the original system in Dr. Steele’s laboratory.   
 Funds are requested for a one-time initial purchase of 300 tongue pressure sensors for 
the KayPENTAX Swallowing Signals Lab.  This supply will be sufficient to cover the need 
for these sensors across the entire duration of the project. 
 A 25% allowance for brokerage and customs fees is included for year 1 equipment costs. 
 
Materials and Supplies: 
Lab Supplies:  
Funds are requested for general lab supplies including slip tip syringes, gloves, weigh boats, 
pipettes, thickening agents, barium, digital balances, cleaning supplies and EMG sensors.  
 
Software Licenses:  
The materials and supplies budget includes funds for additional software licenses (SPSS; 
MATLAB) for Dr. Steele’s group and annual software maintenance fees (SPSS; MATLAB) across 
the duration of the project. 
 
Computer Services: 
A 4TB expansion unit for the dedicated server space used by Dr. Steele’s lab is requested (at a 
cost of $4200) to enable secure storage of the videofluoroscopy recordings collected during the 
project.  
 
Statistical Support: 
Biostatistician Karen Grace Martin of The Analysis Factor (www.AnalysisFactor.com) will serve 
as the statistical advisor for the project with a budget of 30 hours each year (@ $135/hr).  
 
Videofluoroscopy:  
Funds are requested for radiographic imaging studies (videofluoroscopic swallow studies) to be 
conducted in a radiology suite for Experiment 2. For the Toronto based participants 
(Experiment 2), we will require a 15-minute booking in the Diagnostic Imaging department at 
the Toronto General Hospital – University Health Network, at a standard cost of $325 per 
procedure including radiologist and radiation technologist support.  
 
Participant Honoraria:  
Funds are requested to provide participants in Experiments 2 and 4 with an honorarium of $50 
in recognition of their contribution and time. 
 
 
 
 

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1. 
Rofes, L., V. Arreola, and P. Clave, The volume-viscosity swallow test for clinical screening 
of dysphagia and aspiration. Nestle Nutrition Institute Workshop Series, 2012. 72: p. 33-
42. 
2. 
Pikus, L., et al., Videofluoroscopic studies of swallowing dysfunction and the relative risk 
of pneumonia. AJR Am J Roentgenol 2003. 180(6): p. 1613-6. 
3. 
Carrion, S., et al., Nutritional measurements and body composition among patients with 
oropharyngeal dysphagia. Dysphagia, 2011. 26 (4): p. 486-487. 
4. 
Carrion, S., et al., Malnutrition as a complication of oropharyngeal dysphagia in specific 
clinical situations. Dysphagia, 2013. 28 (2): p. 294. 
5. 
Rofes, L., et al., Diagnosis and Management of Oropharyngeal Dysphagia and Its 
Nutritional and Respiratory Complications in the Elderly. Gastroenterol Res Pract, 2011. 
2011. 
6. 
Carrion, S., et al., Association between oropharyngeal dysphagia and malnutrition in 
elderly patients with acute diseases admitted to a general hospital. Clinical Nutrition, 
Supplement, 2012. 7 (1): p. 8. 
7. 
Carrion, S., et al., Prevalence and association between oropharyngeal dysphagia and 
malnutrition in patients hospitalized in an acute geriatric unit (AGU). Dysphagia, 2011. 
26 (4): p. 479. 
8. 
Carrion, S., et al., Oropharyngeal dysphagia is a prevalent risk factor for malnutrition in a 
cohort of older patients admitted with an acute disease to a general hospital. Clin Nutr, 
2014. 
9. 
Altman, K.W., Dysphagia Evaluation and Care in the Hospital Setting: The Need for 
Protocolization. Otolaryngol Head Neck Surg, 2011. 
10. 
Altman, K.W., G.P. Yu, and S.D. Schaefer, Consequence of dysphagia in the hospitalized 
patient: impact on prognosis and hospital resources. Arch Otolaryngol Head Neck Surg, 
2010. 136(8): p. 784-9. 
11. 
Clave, P., et al., Pathophysiology, relevance and natural history of oropharyngeal 
dysphagia among older people. Nestle Nutr Inst Workshop Ser, 2012. 72: p. 57-66. 
12. 
Martino, R., et al., Dysphagia after stroke: incidence, diagnosis, and pulmonary 
complications. Stroke, 2005. 36(12): p. 2756-63. 
13. 
Halper, A.S., et al., Dysphagia after head trauma: the effect of cognitive-communicative 
impairments on functional outcomes. J Head Trauma Rehabil, 1999. 14(5): p. 486-96. 
14. 
Eisbruch, A., Dysphagia and aspiration following chemo-irradiation of head and neck 
cancer: Major obstacles to intensification of therapy. Annals of Oncology, 2004. 15(3): p. 
363-364. 
15. 
Eisbruch, A., et al., Objective assessment of swallowing dysfunction and aspiration after 
radiation concurrent with chemotherapy for head-and-neck cancer. Int J Radiat Oncol 
Biol Phys, 2002. 53(1): p. 23-8. 
16. 
Rosenthal, D.I., J.S. Lewin, and A. Eisbruch, Prevention and treatment of dysphagia and 
aspiration after chemoradiation for head and neck cancer. Journal of clinical oncology : 
official journal of the American Society of Clinical Oncology, 2006. 24(17): p. 2636-2643. 

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17. 
Martin, R.E., M.A. Neary, and N.E. Diamant, Dysphagia following anterior cervical spine 
surgery. Dysphagia 1997. 12(1): p. 2-8. 
18. 
Leonard, R.J., et al., Swallowing in myotonic muscular dystrophy: a videofluoroscopic 
study. Arch Phys Med Rehabil, 2001. 82(7): p. 979-85. 
19. 
Troche, M.S., et al., Respiratory-swallowing coordination and swallowing safety in 
patients with Parkinson's disease. Dysphagia, 2011. 26(3): p. 218-24. 
20. 
Palmer, P.M., et al., Swallow characteristics in patients with oculopharyngeal muscular 
dystrophy. J Speech Lang Hear Res, 2010. 53(6): p. 1567-78. 
21. 
Garcia, J.M., E.t. Chambers, and M. Molander, Thickened liquids: practice patterns of 
speech-language pathologists. Am J Speech Lang Pathol 2005. 14(1): p. 4-13. 
22. 
Robbins, J., et al., Defining physical properties of fluids for dysphagia evaluation and 
treatment., in Perspectives on Swallowing and Swallowing Disorders (Dysphagia). 
American Speech-Language Hearing Association Special Interest Division 13 Newsletter 
2002. p. 16-19. 
23. 
Steele, C.M., et al., The Influence of Food Texture and Liquid Consistency Modification on 
Swallowing Physiology and Function: A Systematic Review. Dysphagia, 2014. 
24. 
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