Effects of Device-Facilitated Isometric Progressive Resistance Oropharyngeal (I-PRO) Therapy on Dysphagia Related Outcomes in Patients Post-stroke
Phase: NA
Conditions: Stroke
Sponsor: University of Wisconsin, Madison

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Scientific Protocol 
 
Title:  Effects of Device-Facilitated Isometric Progressive Resistance Oropharyngeal (I-PRO) 
Therapy on Dysphagia Related Outcomes in Patients Post-stroke 
 
Principal Investigator:  Nicole Pulia, PhD, CCC-SLP 
 
Institution:  University of Wisconsin-Madison 
 
Co-Investigators:  Justin Sattin, MD 
 
Protocol Version Date:  07-07-2015 
 
Funding Sponsor:  This study is funded by an American Speech-Language-Hearing Foundation 
(ASHFoundation) New Investigator grant. 
 
Project Summary:  The overall goal of this randomized controlled pilot study is to characterize 
effects of SwallowSTRONG® Device-Facilitated Isometric Progressive Resistance 
Oropharyngeal (DF I-PRO) therapy in a dose response framework on swallowing-related 
outcomes in a group of unilateral ischemic stroke patients.  These results will be used to 
determine adequate sample size in order to support a larger clinical trial focused on the efficacy 
of this therapy approach for improving swallowing safety.  The first aim is to determine 
differences in swallowing physiology and bolus flow measures a) between a group of unilateral 
ischemic stroke subjects undergoing SwallowSTRONG® DF I-PRO therapy and controls and b) 
between 8 and 12 weeks of treatment.   The second aim is to examine changes in level of oral 
intake and swallowing quality of life in post-stroke patients undergoing DF I-PRO therapy as 
compared to a control group and as they relate to treatment duration response at 8 weeks and 12 
weeks.  The third aim is to evaluate effects of DF I-PRO therapy on overall health status 
reflected by the number of pneumonia diagnoses and overall hospital readmission rates in post-
stroke subjects undergoing DF I-PRO therapy compared to controls. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Background and Significance 
   
Prevalence:  Every 40 seconds, on average, someone in the United States experiences a stroke.1 
Due to the advancing age of the US population, by 2030, an estimated four million additional 
people will have had a stroke, a 21.9% increase in prevalence from 2013.1  Dysphagia is 
estimated in up to 76% of acute stroke patients2,3 and is known to increase the risk for critical 
post-stroke health sequelae, including pneumonia, malnutrition, dehydration, and mortality.2,4–6   
Complications: Developing pneumonia post-stroke results in a significantly increased relative 
risk (2.99) of death within 30 days of hospital discharge.2  Those patients who experience 
aspiration are seven times more likely to develop pneumonia than those who do not aspirate.7  
Relatedly, patients with dysphagia following stroke experience significant decreases in quality of 
life, increased eating dependency, diminished rehabilitation potential, and longer hospital 
stays.2,8,9 
Swallowing physiology:  Videofluoroscopic findings in patients post-stroke include poor tongue 
control, increased bolus transit times, reduced  laryngeal closure duration, decreased and/or 
incomplete laryngeal elevation, and higher (worse) penetration-aspiration scale scores compared 
to controls.9,11 Sensory deficits also are common following stroke leading to silent aspiration. 
Oral sensory deficits also may occur making it difficult for a patient safely to control the bolus or 
to initiate a swallow.9  
Tongue strength:  Swallowing consists of a series of pressure changes that begin at the lips and 
the muscular tongue is a major propulsive force during the swallow.  Pressures produced when 
the tongue contacts the palate play a critical role moving the bolus through the oropharynx and 
into the esophagus.13  Patients with dysphagia post-stroke3 have lower average maximal 
isometric tongue pressures than those without dysphagia.  Tongue pressure production has been 
found to be closely related to post-stroke dysphagia.14   
Age effects: The vast majority of  all strokes occur in people over age 65.9  Healthy older adults 
swallow more slowly and generate lower maximum isometric lingual pressures than younger 
controls.13 These reductions in strength are likely due, at least in part, to the effects of 
sarcopenia, age-related skeletal muscle loss of the head and neck musculature.15  Swallowing 
pressure reserve, the difference between isometric (maximal) tongue pressures and tongue 
pressures during swallowing (submaximal), is reduced with age which places older adults at 
higher risk for dysphagia following additional insult, such as stroke.16  Kays et al17 studied the 
effects of consuming an entire meal on tongue endurance in healthy young and old adults and 
results indicate that both groups experience reduction in tongue strength and endurance post-
meal.17 Older adults perceived increased effort and fatigue upon completing a meal and coughing 
or throat clearing later in the meal, suggesting airway invasion. These results reflect that the act 
of dining decreases tongue strength and tongue endurance with potentially harmful effects 
(aspiration) in older healthy individuals. Such findings have great implications for dysphagic 
stroke patients who already demonstrate impairments in tongue strength. 
Swallowing Interventions in Patients Post-stroke:  Traditionally, interventions to improve 
swallowing in elderly patients are focused on energy conservation and are largely compensatory 
in nature minimizing the need for intense activity.  Postural adjustments, such as a chin tuck or 
head turn, are frequently recommended in order to modify bolus flow.  Diet modifications, such 
as withholding thin liquids or restricting liquid intake to thickened liquids, are commonly used in 
hospitals and long-term care facilities to minimize or eliminate thin liquid aspiration.  Evidence 
for these approaches is limited.18–20  In addition, these practices may negatively affect health 

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status, particularly the recommendation of honey-thickened liquids.19  They also affect quality of 
life and fail to capitalize on the neural basis of recovery post-stroke.  Finally, these techniques 
require use with each swallow which may be disruptive to the eating process and difficult to 
maintain. 
Resistance Training and Swallowing:  Past assumptions that the swallowing process is a function 
of the reflexive neural underpinnings and is not responsive to voluntary modification have been 
proven incorrect through studies reporting the occurrence of dysphagia following, not only 
brainstem stroke, but also bilateral and unilateral cortical stroke.9,21  Now considered a patterned 
sensorimotor process or response within a complex neural network involving both automatic and 
volitional systems that respond to sensory inputs, swallow function is amenable to restoration.3  
Intensive, repetitive strengthening that results in central neuroplastic modifications as well as 
peripheral increases in muscle mass and strength has been found to substantially improve 
swallow muscle physiology and functional outcomes related to swallow behavior.3 
Effects of sarcopenia that occur with aging in striated musculature have been shown to be 
largely reversible through studies of healthy older adults.22  Eight weeks of progressive 
resistance training by frail elders has been associated with increased gait speed, activity level, 
stair climbing and diminished risk for falls.22  In addition, stroke subjects who complete a 
strengthening regimen for the extremities have shown improvements in functional activities such 
as timed stair climbing, walking and chair rising.23,24  Progressive resistance strength training can 
be defined as progressive increases in resistance to a muscle or group of muscles as training 
results in greater ability to create and maintain forces.  
Just as participation in progressive resistance training can strengthen striated limb 
musculature  to improve mobility22, it also benefits bulbar-innervated striated muscles of the 
head and neck.  A recent study of community-dwelling individuals aged 70 years and older 
demonstrated positive correlations between isometric tongue pressure and grip strength and jump 
height.  These data support the effects of sarcopenia on the head and neck musculature and 
consideration of oropharyngeal functional decline as part of the sarcopenia syndrome.25  Results 
of a study by Robbins et al13 demonstrated positive changes in lingual isometric and swallowing 
strength of healthy adults over 70 years of age following progressive isometric resistance (high 
intensity, repetitive, non-specific) exercises for the tongue and related musculature using the 
Iowa Oral Performance Instrument (IOPI).  In 2007, Robbins et al3 used the same approach with 
ten patients post-stroke.  Subjects demonstrated statistically significant changes in isometric 
tongue strength as well as pressures generated by the tongue during swallowing, indicating 
carryover into functional activity. Aspiration and oropharyngeal residue were reduced with 
liquids in these stroke subjects; and a subset of subjects demonstrated an increase in tongue 
volume as measured by magnetic resonance imaging implying enhanced tongue muscle mass.3 
Device-facilitated I-PRO therapy:  Device-facilitated (DF) Isometric Progressive Resistance 
Oropharyngeal (I-PRO) therapy is an approach to oropharyngeal strengthening based on core 
principles of exercise physiology derived from the sports medicine literature.22  At the start of 
therapy, the patient’s one repetition maximum, or the maximum amount of pressure s/he can 
produce with the tongue against the palate, is calculated.  Then, the patient is instructed to press 
against a sensor located along the palate at 60 to 80% of that maximum.  Therapy involves 
pressing the tongue against each sensor ten times, three times per day, and three days per week 
for eight weeks.  Maximum pressures are re-determined every 2 weeks to progress therapy 
targets as patients become stronger.   

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Existing studies of DF I-PRO therapy showing improved swallow function have utilized 
the IOPI.3,13 which comprises a single air-filled plastic bulb attached to a hand-held pressure 
transducer.26  The smooth plastic bulb may slide in the oral cavity as patients apply pressure and 
may cause varying pressure readings due to inconsistent placement.26  In contrast, the Madison 
Oral Strengthening Therapeutic (MOST®) device 1.0 (Swallow Solutions LLC, Madison, WI, 
USA) has an intraoral mouthpiece that comprises 5 air-filled sensors that independently target 
the anterior, posterior, left, right, and middle tongue.26,27  This mouthpiece is custom-fit to the 
hard palate, registers to the anterior upper dentition or alveolar ridge, facilitating consistent 
placement over time.26  The MOST® device recently has undergone its second iteration which 
uses a touch screen tablet and is now referred to as the SwallowSTRONG® device.    
 
 A federally-funded Clinical Demonstration Program, the Swallow STRengthening 
OropharNGeal (Swallow STRONG) program, has shown positive results for a group of 40 
Veterans with oropharyngeal dysphagia resulting from a variety of medical etiologies including 
stroke.28  Veterans underwent 8 weeks of MOST® DF I-PRO therapy and were assessed at 
baseline prior to beginning the program as well as following completion.  Maximum isometric 
pressures were found to increase significantly at the front and back sensors (p<.001) selected for 
the regimen.  Decreases were observed in penetration-aspiration scale scores for 3ml and 5ml 
thin liquid boluses.  Scores on the eating desire, physical, fear, social, fatigue, and mental health 
subscales of the Swallowing Quality of Life (SWAL-QOL29) questionnaire improved (p<.03).  
Ratings of effort with swallowing decreased (p<.01) as did ratings for the statement “Food sticks 
in my mouth when eating” (p<.01).  Functional Oral Intake Scale30 (FOIS) scores improved 
significantly (p<.02), representing progression from feeding tube dependency to full oral intake.  
For patients who could be tracked 6 months or longer following enrollment, the number of 
pneumonia diagnoses decreased by 88% and hospital admissions decreased by 79%.28   
This initial work supports the potential of this therapy approach to affect health-related 
outcomes in addition to swallowing-specific outcomes in a variety of patient groups.  However, 
the efficacy of SwallowSTRONG® DF I-PRO therapy for treating dysphagia and overall health 
status in patients post-stroke has yet to be established in a larger, more homogeneous group of 
subjects and with comparison to a control group.   
 
Salivary Analyses:  A decrease in ratings of mouth dryness has also been observed in patients 
enrolled in the VA Clinical Demonstration Program previously referred to.  The reason for this 
decrease in mouth dryness in unclear.  Additionally, levels of substance P, a protein in saliva, 
have been shown to be related to the occurrence of silent aspiration in patients post-stroke.  
Some preliminary data have shown that intraoral stimulation may increase levels of substance P.  
Stimulation of the salivary glands provided by repeated lingual presses may have the same 
outcome.  Analyses of salivary flow rate as well as the quality of saliva will be important in more 
clearly understanding these observed changes in this group of patients post-stroke. 
 
 
Dose Response: In order to encourage optimal outcomes of SwallowSTRONG® DF I-PRO 
therapy, while simultaneously considering patient tolerance and compliance, knowledge of ideal 
treatment duration is critical.  In previous work, DF I-PRO therapy has been implemented as an 8 
week program; however, acute and chronic post-stroke patients have continued to demonstrate 
improvement at completion of the program.3  This suggests that a subset of patients may benefit 
from a longer protocol (dose).   

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Specific Aims  
 
This randomized controlled pilot study will characterize effects of SwallowSTRONG® Device-
Facilitated Isometric Progressive Resistance Oropharyngeal (DF I-PRO) therapy in a dose 
response framework on swallowing-related outcomes in a group of unilateral ischemic stroke 
patients.  These results will be used to determine adequate sample size in order to support a 
larger clinical trial focused on the efficacy of this therapy approach for improving swallowing 
safety.  This randomized study will expand upon previous work examining effects of this therapy 
approach on swallowing and health-related outcomes now limited to a heterogenous cohort of 
Veterans with dysphagia from a variety of etiologies.  It will focus specifically on patients post-
stroke who have been shown to experience improvements in swallow function following DF I-
PRO therapy.3   
Specific Aim 1: To determine differences in swallowing physiology and bolus flow measures a) 
between a group of unilateral ischemic stroke subjects undergoing SwallowSTRONG® DF I-
PRO therapy and controls and b) between 8 and 12 weeks of treatment.      
Hypothesis 1a:  Subjects treated with DF I-PRO therapy at both treatment duration points will 
demonstrate greater improvements in swallow physiology (isometric and swallowing pressures) 
as well as bolus flow measures (levels of airway invasion, post-swallow residue/stasis, oral 
transit times, and stage transition duration times) as compared to the control group. 
Hypothesis 1b:  Subjects treated with DF I-PRO therapy will experience improvements in 
swallow physiology and bolus flow measures at the 12 week duration compared to 8 weeks.   
Specific Aim 2:  To examine changes in level of oral intake and swallowing quality of life in 
post-stroke patients undergoing DF I-PRO therapy as compared to a control group and as they 
relate to treatment duration response at 8 weeks and 12 weeks 
Hypothesis 2a:  Patients undergoing DF I-PRO therapy will require less restrictive diets and will 
report improved swallowing-related quality of life compared to those in the control group at both 
treatment duration points. 
Hypothesis 2b:  Twelve weeks of DF I-PRO therapy will result in greater improvements (least 
restrictive diets and improved quality of life) compared to the 8 week duration.   
Specific Aim 3:  To evaluate effects of DF I-PRO therapy on overall health status reflected by the 
number of pneumonia diagnoses and overall hospital readmission rates in post-stroke subjects 
undergoing DF I-PRO therapy compared to controls. 
Hypothesis 3a:  There will be a greater decrease from pre- to post-enrollment in the number of 
pneumonia diagnoses and overall hospital readmissions for those subjects who complete 12 
weeks of DF I-PRO therapy compared to controls. 
 
Research Design and Methods: 
Subjects 
Forty medically stable unilateral ischemic stroke subjects with dysphagia will be consecutively 
accrued from the University of Wisconsin Hospital and Clinics (UWHC).   There is a counterpart 
application that is currently under review with the IRB for enrollment of Veterans into this study 
as well (IRB #2014-0939).  Therefore, the forty subjects will be the sum of those enrolled 
through this protocol as well as the VA protocol under review.   

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Recruitment Process:  Inpatients or Outpatients who meet the inclusion criteria related to their 
stroke diagnosis (unilateral or bilateral ischemic or hemorrhagic stroke within 6 months of 
diagnosis) with none of the exclusion criteria will be referred by Dr. Justin Sattin, a stroke 
neurologist and Medical Director of the UW Comprehensive Stroke Program or a member of his 
team, to participate in the study.  Patients also may be referred by the UW Voice and Swallowing 
Clinic clinicians involved in this study.  In order to have earlier identification of inpatients who 
are potential participants, Dr. Michael Pulia, an Emergency Department physician, will be 
screening the list of admitted emergency patients daily for those who meet study criteria based 
on stroke diagnosis.  He will then notify Dr. Nicole Pulia of these potential participants and she 
will confirm eligibility with Dr. Sattin, his team, or the ENT clinicians.  Once general eligibility 
for meeting inclusion criteria is confirmed via Dr. Sattin's review of the patient's medical record 
and it has been determined that the patient will require videofluoroscopic examination (VFSE) of 
his/her swallowing as part of routine clinical care, Dr. Justin Sattin, a member of his team, or a 
clinician from the UW Voice and Swallowing Clinic will ask the patient to fill out a permission-
to-contact form and subsequently will notify Dr. Nicole Pulia that this form has been signed so 
that she can follow-up with the patient.     
If an Outpatient, those who meet inclusion criteria and require a VFSE will be contacted by 
phone by Dr. Sattin or their SLP clinician to inquire regarding interest in the study.  If they 
indicate interest and verbally provide permission to be contacted, Dr. Nicole Pulia or Allison 
Limke would be notified and will follow-up with the patient.  The general purpose and the length 
of the study will be explained to potential participants either by phone (if outpatient) or in-person 
if an inpatient or at the hospital for outpatient visit.  Dr. Nicole Pulia will see inpatients in their 
hospital room to obtain informed consent prior to the VFSE.  For Outpatients, a 30 minute visit 
in the Voice and Swallowing Clinic or Speech, Swallowing, and Dining Enhancement (SWAL-
ADE) Program's laboratory immediately prior to their VFSE will be scheduled during which 
time more information about the study will be provided and informed consent will take place by 
Dr. Nicole Pulia.  Throughout the informed consent process, the potential participant will be 
provided with multiple opportunities to seek clarification of any information that is presented.  
Following review of the informed consent document, the potential participant will be asked to 
accept or decline further participation. Should s/he accept, the participant will indicate agreement 
with all study procedures by signing the informed consent form. The participant will be provided 
with a copy of the consent form, along with contact information for affiliated investigators.   
Following consent, the subject will undergo a videofluoroscopic examination of swallowing 
according to the protocol outlined below.  If the subject is does not meet diagnostic criteria for 
dysphagia on the videofluoroscopic swallowing exam (Penetration-Aspiration Scale score of 3 or 
higher and/or a score of 2 on the Residue scale at any location), s/he will not be randomized to a 
study group and will no longer continue participation in the study.   
For those patients who have already had a recent videofluoroscopic swallow study, the consent 
process will take place after completion of this swallow study.  Potential subjects must meet 
diagnostic criteria for dysphagia on their videofluoroscopic swallowing examination.  If during 
this exam the patient meets specified inclusion criteria, the UW ENT clinicians will subsequently 
approach the patient regarding participation.  If the patient is interested in participating, the study 
staff will be notified and will follow-up with the patient.  Once general eligibility for meeting 
inclusion criteria is confirmed by review of the patient’s medical record, the general purpose of 

7 
 
the study and the length of the study will be explained to potential participants either by phone 
(if outpatient) or in-person if an inpatient or at hospital for outpatient visit.  If the potential 
participant expresses interest, more details about the study will be provided, including a copy of 
the consent form.  Then, the same process for obtaining consent will be followed. 
Inclusion criteria: 1) clinical diagnosis of unilateral or bilateral ischemic or hemorrhagic strokes 
by attending physician (according to the National Institute of Health Stroke Scale31 (NIHSS)); 2) 
within 6 months of acute stroke diagnosis; 3)  referral for a videofluoroscopic swallowing study; 
4)  a score of 3 or higher on the Penetration-Aspiration scale32 OR a score of 2 on the Residue 
scale at any location (oral cavity, valleculae, or pharynx) that is instrumentally documented by a 
participating SLP during the standardized videofluoroscopic swallowing study; 4) between the 
ages of 21 and 95; 5) ability to perform the strengthening protocol independently or with the 
assistance of a caregiver; 6) physician approval of medical stability to participate and 7) 
decision-making capacity to provide informed consent (confirmed through discussion with the 
subject’s primary physician); 8) phone access; and 9) ability to return to the clinic for required 
follow-up appointments.  
Exclusion Criteria: 1) degenerative neuromuscular disease; 2) prior surgery to the head and neck 
region that would affect muscles involved in swallowing; 3) history of radiotherapy or 
chemotherapy to the head and neck; 4) patient unable to complete the exercise program; 5) 
taking medications that depress the central nervous system; 6) allergy to barium (used in 
videofluoroscopic swallowing assessment); 7) currently pregnant.   
Intervention 
 
Participants who meet criteria for dysphagia on the videofluoroscopic swallowing examination 
will be randomly assigned into one of two groups: 1) a control group that will be receiving 
compensatory treatments only or 2) 12-week DF I-PRO therapy plus compensatory treatments, 
such as thickened liquids and/or postural strategies during natural swallowing activities for 12 
weeks.  Patients will be enrolled and trained in DF I-PRO therapy by Dr. Pulia who regularly 
uses the SwallowSTRONG®-facilitated I-PRO therapy in clinical practice or a UW Voice and 
Swallowing clinician involved in this study who has been adequately trained in DF I-PRO 
therapy.  Regardless of the treatment group to which a subject is randomized, they will be 
evaluated in the hospital at baseline and 8-week time points.  If a patient in either group no 
longer meets criteria for dysphagia (Penetration-Aspiration Scale score of 3 or higher OR a 
rating of 2 on the Residue scale in any location) on the 8-week videofluoroscopic swallowing 
examination, s/he will no longer continue participation in the study.  If a patient in either group 
remains dysphagic at the 8-week visit, s/he will continue participation in the study through the 
12-week assessment point. Dr. Pulia or a UW Voice and Swallowing clinician will conduct the 8 
and 12 week assessments.   
 
Group 1:  Compensatory treatments only:  This group will receive standard swallowing 
intervention, which is identified by the SLP as appropriate to treat the patient’s dysphagia and is 
common clinical practice. This group is not receiving experimental therapy. Their therapy may 
include: 1) modifying the foods the subject eats or the fluids s/he drinks; 2) changing his/her 
posture when eating or drinking (for example, by a simple chin tuck) or using a swallowing 
maneuver while eating or drinking; 3) having him/her eat more slowly or in a quiet environment 
to make swallowing easier and safer; or 4) performing range  of motion or vocal exercisesfor 

8 
 
Figure 1 
swallowing or speech.  Any progressive strengthening regimens or any type of lingual 
strengthening protocols specifically will be delayed until subjects have completed participation 
in this study in order to eliminate confounding influences on outcomes. No subjects will be at 
risk due to this delay as compensatory approaches mentioned above will be used and other 
strengthening regimens do not have enough evidence to support their inclusion in standard of 
care. Weekly check-in phone calls will be scheduled throughout the subjects’ participation in the 
study.  
 
Group 2:  SwallowSTRONG® device-facilitated I-PRO therapy plus compensatory treatments: 
Isometric tongue strengthening will be completed 
using the SwallowSTRONG® device (see Figure 1). 
This device hand-held instrument provides numeric 
readout of pressure (hPa) and digital feedback of 
performance. It consists of a short cord (approx. 10 
inches), which is attached to a small digital touch 
screen display. The 4-sensor array is custom-molded 
to the hard palate to ensure consistent placement. 
Tongue press exercises consist of pressing the tongue 
against the sensors. Isometric exercises will focus on 
the anterior and posterior sensor.  Subjects will be 
given a target pressure value for both the anterior and 
posterior sensor locations for which to aim during 
strengthening. Visual feedback on the display will 
signal the subject that they have attained their target 
pressure goal.  
 
Prior to initiation of the strengthening regimen, 
baseline one repetition maximum (1RM) lingual 
pressures will be obtained at the anterior and posterior sensors independently by gathering 3 
tongue press trials at each site that differ by less than 5% to adjust for variability in these 
measures.  Subjects will take the SwallowStrong® device home with them and will complete 20 
repetitions of the exercise (10 repetitions at the front sensor; 10 repetitions at the back sensor), 
three times per day on three days per week for twelve weeks.  It will take approximately 10 
minutes to complete 20 repetitions of the exercise resulting in about 30 minutes total for each 
home exercise session.  During week one of the regimen, the target value of each repetition will 
be 60% of the 1RM. For the remaining eleven weeks of the program, the target value will be 
increased to 80% of the 1RM. These values of 60% and 80% were chosen based on previous 
work that employed progressive resistance training for the limbs and lingual musculature with 
healthy elders and patients post-stroke.13,22,33  At weeks three, five, seven, nine, and eleven, the 
baseline will be re-measured by phone and the 80% target value re-calculated.  In addition, 
check-in phone calls also will be scheduled the other weeks of the study period. 
 
Visits 
 
Baseline visit only:   
Mouthpiece 
Digital touch screen  
Mouthpiece  

9 
 
After the informed consent process has been completed but prior to videofluoroscopic 
examination of swallowing, each participant will complete a medical history questionnaire to 
ensure they meet inclusion/exclusion criteria. This questionnaire will include items related to 
current medical status, medical history, and medication usage.  UW medical records also will be 
referenced to ensure the subject’s eligibility for participation.  As part of this screening, patients 
will undergo a urine pregnancy test to ensure they are not pregnant prior to participation.  The 
Mini-Mental Status Examination (MMSE) will be administered only at baseline as a common 
examination of cognitive functioning. In addition, the Barthel index will be administered to 
assess severity of impairments in activities of daily living.  For each patient, a form with 
demographics as well as a medication list will be filled out.  These questionnaires and tests will 
take approximately 45 minutes to complete.  For those subjects randomly assigned to Group 2, 
during this baseline visit, it also will take approximately 30 minutes to train the participant on 
how to do and record the exercises properly.  In addition to the consent process and these 
procedures that will occur only at the baseline visit, the procedures described below will also be 
completed at this visit.  The entire baseline visit will last about 2.5 hours.  For the baseline visit 
and 8 week visit, videofluoroscopic examination of swallowing will need to be completed before 
the other procedures outline below as the outcome of that examination will determine the 
patient’s continued participation in the study.  If s/he does not meet criteria for dysphagia on the 
videofluoroscopic swallowing exam, s/he will either not be randomized to a study group (at 
baseline visit) or will not continue participation past the 8 week point (if dysphagia has 
resolved). 
Measures at each assessment point (baseline, 8 weeks, and 12 weeks):  The 8 week and 12 week 
visits will last about 90 minutes per session. The study includes up to 3 sessions which will 
require up to 7 hours in total. In addition if in Group 2, participation in the home exercises will 
last about 10 minutes per session, 9 sessions per week for up to 12 weeks, which will require up 
to 18 hours total. 
Quality of Life Questionnaire:  Each subject will complete the Swal-QOL29, a validated 
questionnaire focused on swallowing-related quality of life. It comprises 10 multi-item scales, 2 
general scales, and a 14-item symptom battery. Care will be taken so that patients will not 
receive the tool from their treatment clinician, thereby avoiding potential bias in their responses.  
This questionnaire will take 10-15 minutes to complete. 
Dietary Questionnaire: Each subject will complete a questionnaire detailing his/her quantity and 
variety of nutritional intake.  From these responses, a Functional Oral Intake Scale30 (FOIS) 
score will be derived.  The FOIS is a validated scale that represents level of oral intake from no 
oral intake (enteral feeding) to total oral intake with no restrictions. This questionnaire will take 
10-15 minutes to complete. 
Isometric tongue pressure measurement:  One repetition maximum (1RM) isometric lingual 
pressures will be measured at the front and back sensors of the device. Subjects will be instructed 
to press with their tongue as hard as possible against the front and back sensors positioned on the 
palate.  Three 1RM values will be collected for both front and back sensors, with a 20-second 
rest between each measurement. 
Saliva collection and analyses:  Saliva samples will be collected from patients at each study 
visit.  We will attempt to schedule study visits between the hours of 12pm and 2pm when saliva 

10 
 
production is at its peak for the day.  Before collection, patients will be asked to rinse their 
mouth thoroughly with distilled water to remove any food debris.  Saliva will be collected under 
an unstimulated condition (expectorating into a tube for 5 minutes without swallowing or 
moving the tongue or jaw) as well as a stimulated condition (expectorating into a tube for 5 
minutes while moving the jaw in a chewing motion to the rhythm of 70 beats per minute set with 
a metronome).  The order of conditions will be randomized for each patient.  A rest period of 10 
minutes will be provided between collection conditions.  Salivary flow rate will be determined 
by recording the volume of saliva produced in 5 minutes under each condition.  Samples will be 
aliquoted into two separate tubes (per collection condition) and placed immediately on ice.  One 
aliquot per condition will be transported to the laboratory of Rich Hartel, PhD in the Department 
to Food Science.  In Dr. Hartel’s laboratory, rheological and tribological analyses of the samples 
will be completed to characterize the fluid flow properties of saliva as well as its lubrication 
qualities.  The protocol for collection, transport, and discarding of saliva samples has been 
approved by the Office of Biological Safety (#B00000105).  Procedures outlined in that 
approved protocol will be followed to ensure proper handling of samples. Another aliquot per 
condition will be stored in the freezer within the laboratory of Dawn Davis, MD, PhD in the 
Department of Medicine for later completion of enzyme-linked immunosorbent assay to quantify 
levels of Substance P in the samples.  Dr. Davis’ lab is approved for analyses and storage of 
human samples (biohazardous materials).  
 
Videofluoroscopic (VFS) assessment:  The KayPENTAX® Digital Swallowing Workstation 
(DSW) will be used to capture full resolution fluoroscopic images in real time (30 frames per 
second). Each subject will be seated and viewed in the lateral plane. The image intensifier will be 
focused on the lips anteriorly, posterior pharyngeal wall posteriorly, hard palate superiorly, and 
just below the upper esophageal sphincter (UES) inferiorly. The oral cavity and pharynx will 
remain in view after the swallow for 2 seconds to assess oropharyngeal residue.  Subjects will 
swallow each of the following boluses twice: 3mL thin liquid, 10mL thin liquid, sips of thin 
liquid from a cup (approximately 10-15mL each sip), 3mL semi-solid boluses, and barium-
infused cookie boluses.  Subjects will also swallow one barium pill taken either with thin liquid 
barium from a cup or in approximately 3mL of semi-solid barium depending on how the patient 
normally takes pills.  Finally, subjects will swallow two 3mL semi-solid boluses in the anterior-
posterior view to allow for assessment of symmetry of the swallow.  This will result in a total of 
13 swallows.  Based on the barium given during these 13 swallows, a total of 56 ml of liquid 
barium sulfate solution (Varibar Thin, Bracco), up to 12ml of pudding barium sulfate solution 
(Varibar pudding, Bracco), two barium sulfate infused cookies (Wanda's Barium Cookies, 1.5" 
in diameter); and a barium pill will be ingested.  These boluses will be clinician-administered via 
teaspoon (3-ml) or self-administered via cup (10-ml, natural sips), or self-determined (portion of 
or whole cookie).  If aspiration occurs, that bolus condition will be terminated once the cause of 
the aspiration is determined to provide clinical remediation.  This VFS protocol is consistent 
with standard practice at the UW facilities. This assessment will take about 35 minutes. 
 
Swallowing Pressures: Swallowing pressures will be measured using three small air-filled 
bulbs (Kay Pentax, Lincoln Park NJ) mounted on a silica strip attached longitudinally with 
adhesive anteriorly to posteriorly at the midline of the hard palate. The Kay system allows time-
linking of swallowing pressure data with videofluoroscopic images.  
Outcomes 

11 
 
The primary outcome measure will be changes in the one repetition maximum (1RM) isometric 
lingual pressures measured at the front and back sensors of the device.  Secondary outcomes 
include bolus flow durational measurements taken from videofluoroscopic recordings, 
swallowing pressures, SWAL-QOL scores, and FOIS scores.  In addition, we will compare the 
number of pneumonia diagnoses for community, hospital-acquired, and aspiration pneumonia for 
the same period of time prior to enrollment and following completion of the study (up to nine 
months).  We also will track the number of hospital re-admissions for the same period of time 
prior to enrollment and following completion (up to 9 months).  Treatment compliance also will 
be tracked within the SwallowStrong® device and will serve as a covariate in statistical analyses. 
 
Data Reduction and Analysis 
 
Videofluoroscopic Analysis: The videofluoroscopic images will be coded and sent to the Speech 
Swallowing And Dining Enhancement (SSwal-ADE) Program.  Clinicians blinded to subject 
information will obtain measures of bolus flow kinematics-direction (Penetration/Aspiration 
Scale32 scores), duration, and completeness (Residue Scale34 scores) from fluoroscopic 
recordings for each subject using Adobe Premier Pro software. Visual perceptual review will be 
performed by judges viewing each swallow at normal, slowed, and frame-by-frame speeds as 
often as needed for confident judgments. Twenty percent of the swallows will be chosen 
randomly and re-measured by the same judge and a different judge (one of the experienced UW 
SLPs) to assess inter and intra-judge reliability for all variables. Bolus flow durational 
measurements35 (oral transit time, stage transit duration, pharyngeal transit time, total swallow 
duration) will quantify timing of structural movement and bolus flow. Computational analysis of 
swallowing mechanism (CASM) will be performed in order to track anatomical coordinates 
during the swallow. This will allow us to quantity displacement of various swallowing related 
structures. 
Pressure Analysis:  Maximum isometric and swallowing pressures and their temporal 
characteristics (i.e., rise rate) will be quantified using the SwallowSTRONG® device and the 
DSW. Swallowing pressures will be quantified relative to the videofluoroscopic images to ensure 
that the pressure being measured is relevant to bolus flow and not bolus manipulation prior to the 
swallow. Twenty percent of the pressure wave forms will be chosen randomly and re-measured 
by the same judge and a different judge to assess inter- and intra-judge reliability. 
Swal-QOL: Responses will be extracted and scored for subsequent statistical analysis using a 
database scoring program. All of the Swal-QOL scales will be scored by using Likert’s methods 
of summated ratings. 
Saliva Analyses:  Each measure of viscoelasticity and lubrication properties will be recorded 
three times per sample.  Apparent viscosity will be determined using a TA Discovery, HR-2 
rheometer (TA Instruments, New Castle, DE, USA) equipped with a Peltier plate temperature 
control unit (233212.902).  All measurements will be carried out with a flat plate geometry with 
a diameter of 20 mm and an operating gap of 200 μm.  Each sample will first be allowed to 
equilibrate for 30 seconds at 37°C on the rheometer stage.  Viscosity will then be measured at 
37°C at shear rates ranging from 0.1 to 100 1/s.  In Dr. Davis’ laboratory, samples will be frozen 
until all have been collected.  Then, an enzyme-linked immunosorbent assay (ELISA) will be 
completed in order to quantify levels of the protein Substance P within the samples. 

12 
 
Hospital Readmissions and Pneumonia Diagnoses:  The number of pneumonia diagnoses and 
overall hospital readmissions will be compared for the same period of time prior to enrollment 
and following completion of the study (up to 9 months) for each subject.  Discharge reports will 
be used to tally the number of readmissions and clinic notes will be reviewed to determine 
number of pneumonia diagnoses (community, hospital-acquired, and aspiration pneumonia) for 
each subject.   
Study Timeline 
We estimate achieving our target enrollment in 9 months and completion of the project within 
the specified 12-month period as outlined below in Table 1.  Patients will be referred from the 
UWHC Neurology Department where approximately 500 ischemic stroke patients are seen 
yearly.  This large volume of patients ensures that 40 subjects will be easily accessible for 
recruitment into the proposed study.  
Table 1: Study Timeline 
 Tasks 
1/1/2015-12/31/2015 
Q1 
Q2 
Q3 
Q4 
Database build & training of study staff 
→ 
 
 
 
Subject enrollment  
→ 
→ 
→ 
 
Study close out, data analysis 
 
 
 
→ 
 
Data Safety and Monitoring 
During visits for study participation, subjects will be accompanied by study personnel at all 
times. Subjects will be contacted by study staff weekly to assess for unanticipated problems or 
complications. If an unanticipated problem takes place, study personnel will be immediately 
aware and will take action (i.e., request medical support). As this is a low risk study, adverse 
events are expected to be very rare. Any unanticipated problems will be reported to the IRB 
according to posted guidance.  Subjects will also have a study contact number and be encouraged 
to contact study staff with their questions or concerns.  Throughout the study, we will notify 
participants of new information that may become available and might affect their decision to 
remain in the study. 
There are no known social, legal, psychological, or financial risks associated with participation.   
Confidentiality:  Breach of confidentiality is possible, but not likely because of safeguards in 
place.  The procedures for protecting the participants' confidentiality are in place. All participants 
will sign the informed consent document prior to participating in the study. All paper documents 
will be locked in a filing cabinet in a secure room within the University of Wisconsin-Madison's 
Department of Medicine UW Speech, Swallowing, and Dining Enhancement (SSWAL-ADE) 
laboratory and only study staff will have access to that cabinet.  All electronic files related to 
data will be password protected and stored on a password- protected hospital network. Once 
enrolled, each subject will be assigned a code number crossing over to the private health 
information (PHI) gathered from his/her medical record, and all data gathered under the research 

13 
 
protocols will be recorded only by this code number. The link connecting the subject and code 
number will be password-protected stored separately in electronic format on the password-
protected hospital network and only the PI (Nicole Pulia) will have access.  Only the approved 
project research staff (Allison Limke, Justin Sattin) will have access to the coded study data. All 
information about the subject will be treated confidentially and will not be revealed unless 
required by law.  All HIPAA regulations pertaining to protection of participants and eliminating 
identification will be followed.  Data will be de-identified at the close of the study.  Any breach 
of confidentiality will immediately be reported to the IRB.  Individual medical records will be 
accessed twice during the one year duration of this study:  once by Dr. Sattin initially to confirm 
the subjects' eligibility for the study and then again at the end of the study (one year point) to 
determine number of pneumonia diagnoses and hospital readmissions for the same number of 
months pre- and post-enrollment.  Results of study-related procedures performed solely for 
research purposes (not standard of care) will not be placed in the subjects’ medical record. 
Videofluoroscopic Swallowing Assessment:  Subjects are at risk for aspirating during the VFS 
assessment. If aspiration occurs during the VFS assessment, the particular bolus condition will 
be terminated once the cause of the aspiration is determined. Following completion of the study 
protocol, compensatory approaches to treatment (e.g., postures, diet modification) may be 
attempted in order to determine which strategies are most effective in reducing or eliminating the 
occurrence of airway penetration and/or aspiration, thereby ensuring safety with swallowing for 
patients in both treatment groups.   
Subjects will be exposed to radiation exposure equivalent to one to two years of background 
radiation (less than 2.5 minutes) during the videofluoroscopic swallowing study. The risks of that 
amount are considered to be very small, and there is no indication of harmful effects to an 
individual. Subjects will not be included if they are pregnant. Radiation exposure during the VFS 
assessment will be limited as much as possible through attention to time restraints and adherence 
to ASHA’s Guidelines for Speech-Language Pathologists Performing Videofluoroscopic Studies.  
Protective apparel with lead-shielding (lead apron, thyroid shield) will be worn at all times.   
Muscle Soreness:  Subjects who report muscle soreness during the treatment protocol will be 
offered breaks throughout treatment sessions if needed.   
Abstaining from strengthening approaches to dysphagia treatment in the acute post-stroke phase 
of recovery:  There may be unknown risks for subjects randomized to Group 1 who will be 
abstaining from strengthening approaches for the treatment of dysphagia that might be included 
as part of standard care.  As there is not a clear standard regarding strengthening approaches for 
dysphagia rehabilitation post-stroke, it is unclear if omission of these approaches will result in 
adverse effects.   
Statistical Analyses 
 
Prior to data analyses, the data collected under this study will be combined with data from its VA 
counterpart (IRB #2014-0939).  Statistical analyses will be performed using this combined data 
set. 
Aim 1: A repeated measures analysis model will be used to model changes in tongue strength in 
treatment and control groups, adjusted for age, gender, and baseline tongue strength.  Each 
subject will have three observations: change between baseline and 8 weeks, baseline and 12 

14 
 
weeks, and 8 weeks and 12 weeks.  This model will allow for comparison of differences between 
a) treatment durations (dose response) and b) between control and treatment groups. 
Aim 2: Changes in oral intake and swallowing quality of life between baseline and 8 weeks, 
baseline and 12 weeks, and 8 weeks and 12 weeks will be modelled in a repeated measures 
analysis on treatment, adjusting for age, gender, and baseline outcome. 
Aim 3:  Change in number of new pneumonia diagnoses and number of hospital readmissions 
over a 1 year period, pre and post-study, will be modelled in linear regression models on 
treatment, adjusting for age, gender, and pre-study outcome. 
All analyses will be performed on a randomized, or intention to treat basis, regardless of the 
actual treatment received. Study dropout by the subject will result in inclusion of incomplete data 
for that patient. 
 
 Sample size calculation:   
 
Due to funding restrictions, we propose a sample size for this pilot study of 15 subjects per 
group.  We plan to enroll 40 subjects to account for dropout of patients who do not meet the 
radiographic criteria for dysphagia on their initial videofluoroscopic swallowing examination.  
Previous data have been collected on the 
proposed treatment and measurement device 
through our Swallow STRONG clinic 
(N=40).  These data have shown changes in 
maximum isometric lingual pressures at the 
front and back sensors of the MOST® device 
over 8 weeks of DF I-PRO therapy.  The 
mean difference in pressure between baseline and 8 weeks was 103 hectopascals (hPa) (SD=100 
hPa) at the front sensor, and the mean difference in pressure at the back sensor was 90 
hectopascals (SD=94 hPa).  If we assume an SD=100 hPa for treatment and control groups, with 
a sample size of 15 per group, the power to detect a difference, based on a 2-sample t-test, is 
shown in Table 2.  For the treatment group we can expect an improvement of 100 hPa on 
average.  For a control group with no strength training, we might expect an improvement of 20 
hPa.  This would give us approximately 56% power to detect a difference, which is adequate for 
a pilot study.  All analyses will be conducted in SAS (SAS Institute, Cary NC).  
 
Data and Record Keeping 
 
Dr. Nicole Pulia and Allison Limke will manage the study data.  All paper documents will be 
locked in a filing cabinet in a secure room within the University of Wisconsin-Madison's 
Department of Medicine UW Speech, Swallowing, and Dining Enhancement (SSWAL-ADE) 
laboratory and only study staff will have access to that cabinet.  All electronic files related to 
data will be password protected and stored on a password- protected hospital network. Once 
enrolled, each subject will be assigned a code number crossing over to the private health 
information (PHI) gathered from his/her medical record, and all data gathered under the research 
protocols will be recorded only by this code number. The link connecting the subject and code 
number will be password-protected stored separately in electronic format on the password-
protected hospital network and only the PI (Nicole Pulia) will have access.  Only the approved 
project research staff (Allison Limke, Justin Sattin) will have access to the coded study data. All 
Table 2: Power to detect a difference between  
treatment/control groups, SD = 100, alpha=0.05 
Difference between case/control mean change 
Power 
100 hPa 
75% 
80 hPa 
56% 
60 hPa 
35% 
40 hPa 
18% 

15 
 
information about the subject will be treated confidentially and will not be revealed unless 
required by law.  All HIPAA regulations pertaining to protection of participants and eliminating 
identification will be followed.  A clinical report following the videofluoroscopic swallow 
evaluations will be entered into Healthlink for each subject and the actual videofluoroscopic 
swallow images will be loaded into the Patient Archiving and Communication System (PACS).   
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