ross, d. (2013) reliability of emg/iopi in opd/omd diagnosis

RELIABILITY OF EMG/IOPI IN OPD/OMD DIAGNOSIS 1

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Inter-rater Reliability of Clinical Measures of Oromyofunctional

Disorders and Oropharyngeal Dysphagia

by

Dave Ross

B.Sc., Boston University, 2004

M. Sc., University of Alaska, 2009

M.Sc., Idaho State University, 2013

A thesis

submitted in partial fulfillment

of the requirements for the degree of

Master of Science in Speech-Language Pathology

Idaho State University

May 2013


Acknowledgements

Dr. Seikel, Dr. Sorenson; Dr. Mercaldo; Teri Peterson - for being a supportive committee.

Ruth Reardon, Chad Seibold, Blake Tanner and Savannah Leckington – it‟s over!

Marc Maron; Maria Bamford; Andy Dick – for keeping me sane lo these long nights.

Jude Jones and Sarah Knudsen – for all your kind help these years.

Donna Plant – for the final look-throughs!

My mother and father who have supported me unconditionally through the years.


TABLE OF CONTENTS

List of Tables……………………………………………………………………………..ix

List of Figures…………………………………………………………………………......x

Abstract……………………………………………………………………………….......xi

Chapter 1: Introduction…………………………………………………………………....1

Chapter 2: Review of Literature…………………………………………………………..3

A:Reliability Studies of OPD/OMD………………………………………3

B:The Normal Swallow…………………………………………………...6

C:Etiologies and Pathologies of OPD……………………………………..7

D:Etiologies and Pathologies of OMD……………………………………8

E:Clinical Measures of OPD………………………………………………9

F:Clinical Measures of OMD…………………………………………….11

G: ICC versus Pearson r…………………………………………………11

Chapter 3: Methodology…………………………………………………………………13

A:Participants……………………………………………….………........13

B:Instrumentation………………………………………..………............14

C: Procedures…………………………………………………………….14

IOPI Measurements……………………………………………...15

EMG Measurements……………………………………………..16

Observational Measurements…………………………………….17

D:Variables………………………….…………………………...............18

E:Reliability………………………………………………………...........18

Chapter 4: Results and Discussion……………………………………….........................20

A:Data Analysis………………………………………….…………........20

B:Results and Discussion………………………………..…………….....21

Laryngeal Elevation……………………………………...22

IOPI………………………………………………………24

Masseter Baseline………………………………………..26

Masseter………………………………………………….27

Comparing ICC to Pearson r……………………………..29


C: Summary………………………………………………….…………..30

Limitations and Considerations………………………………….33

References………………………………………………………..………........................34

Appendix A: Graphs of ICC Values……………………………………………………..40

Appendix B: Human Subjects Consent Form…………………………………………....46

Appendix C: Demographic Survey…………………………………………………........49

Appendix D: ISU Tongue Thrust Protocol…………………………………………........58


List of Tables

Table 1.1 Problems of data collection inter-rater reliability may uncover……………….4

Table 1.2 Tongue thrust impact on swallowing…………………………………………...9

Table 2.1 Instrumental tasks recorded during the study……………………….………...14

Table 2.2 Three orders of protocols used for assessment during the study……………...15

Table 3.1 Coding procedures used during data analysis………………………………..22

Table 3.2 ICC Values for Judging Group 1 (Laryngeal elevation)……………………...23

Table 3.3 ICC Values for Judging Group 1 (IOPI)…………………………….………..25

Table 3.4 ICC Values for Judging Group 1 (Masseter baseline)……………………......26

Table 3.5 ICC Values for Judging Group 1 (Masseter)……………………………….....28


List of Figures

Figure 1 Coefficient Frequency for Judging Group 1 (Laryngeal elevation)……………24

Figure 2 Coefficient Frequency for Judging Group 1 (IOPI)……………………………26

Figure 3 Coefficient Frequency for Judging Group 1 (Masseter baseline)………….......27

Figure 4 Coefficient Frequency for Judging Group 1 (Masseter)……………………….29

Figure 5 Difference between ICC and Pearson r values for Masseter Baseline………...30

Figure 6 Coefficient Frequency for Judging Group 1 (Overall)…………………………31


ABSTRACT

Inter-rater reliability shows the degree of concordance among a group of raters observing

or performing the same action; a high level of inter-rater reliability indicates that any

results are not due to chance. In Speech-Language-Pathology, two instruments are used in

the diagnosis of oropharyngeal dysphagia and oromyofunctional disorders: The Iowa oral

performance instrument and Electromyography. This study examined the reliability of

these instruments as used in conjunction with the ISU Tongue Thrust Protocol. Two

judges examined inter-rater reliability by assessing a group of 24 healthy adults twice, on

two separate occasions, by two separate judges. The data were subjected to an intra-class

correlation. Data analysis revealed an overall moderate-almost perfect level of reliability

across all parameters analyzed; 60% of data points were strong-almost perfect

(ICC >0.700); no data point fell below 0.300. Overall data analysis supports the use of

IOPI and EMG in conjunction with the ISU Tongue Thrust Protocol.

.

Key Words: Inter-rater Reliability, Dysphagia, Oromyofunctional Disorders


Chapter 1 Introduction

Swallowing has been defined clinically as “the entire act of swallowing

(deglutition) from placement of food in the mouth through the oral, pharyngeal and

esophageal phases of the swallow until the prepared material (bolus) enters the stomach

through the gastro-esophageal junction” (Logemann 1998, p.4). Swallowing consists of

highly intricate movements that are coordinated by the cortical brain, brainstem reflexes

and the muscles and cartilages of the swallowing system. While swallowing is a

necessary daily function, many variables can impact its integrity; the impacts from these

variables all fall under the umbrella term swallowing disorders.

Broadly, swallowing disorders are defined as being either oropharyngeal or

oromyofunctional in nature, with oropharyngeal dysphagia (OPD) the most common. A

person with OPD may be at risk for penetration (food/liquid above the level of the vocal

folds) or aspiration (food/liquid below the level of the vocal folds), and in some cases,

complications from OPD can lead to death (Riquelme et al., 2008). Distinct from OPD is

the group of oromyofunctional disorders (OMD), which are disorders of the muscles

involving the face, mouth, lips, or jaw. Tongue thrust is the most well-known OMD, and

a large amount of research has been conducted on this disorder (Benkert, 1997;

Hemmings et al., 2000).Tongue thrust is thought of as the relic of an immature swallow

pattern, categorized by the tongue‟s far anterior rest or protrusion through the teeth

during speech, swallowing (Hanson & Mason, 2003).

Both OPD and OMD have some overlapping signs and symptoms, such as poor

lingual control and inadequate bolus retropulsion (Logemann, 1998; Hanson et al., 2003),

yet they are generally assessed and treated separately in the field. The Idaho State


University Tongue Thrust Protocol clinically assesses the presence of OMD and OPD in

a patient. During the clinical evaluation, both oral muscle contraction and oral

performance are gauged via electromyography (EMG) and the Iowa Oral Performance

Instrument (IOPI), respectively. The interpretation of the results of these instruments

depends on some subjective judgments, and the inter-rater reliability of these judgments

has been poorly researched. This study seeks to examine the inter-rater reliability of these

instruments combined with the protocol; this study is part of a larger study which seeks to

provide evidence of the relationship between diagnostic indicators of OMD and OPD

across the lifespan.

Inter-rater reliability is important as reliability speaks directly to the consistency

of the results collected during research. In order for research to be considered evidence-

based, the study should be able to produce similar results when repeated; a study is not

reliable if it cannot be reproduced with similar results. In the medical field, it is assumed

that different clinicians will be using a given protocol to assess either a new patient, or

the same patient (e.g., for therapy progress or baseline probing); this way, a degree of

concordance can be calculated between the different clinicians working with the patient.

In statistics, this is termed inter-rater reliability, and its calculation provides a researcher

with the degree of concordance among different observations taken at different times.

The following review of literature discusses the use of inter-rater reliability during

clinical evaluations of swallowing, the normal swallow, etiologies and pathologies of

OPD/OMD, and the methods of clinical assessments of OPD/OMD.


Chapter 2 Review of Literature

A. Reliability studies in OPD/OMD

Inter-rater reliability is simply the degree of concordance among a group of raters

observing or performing the same action, and is quite useful in establishing whether a

certain tool is appropriate for measuring a certain variable (e.g., using a given instrument

to assess the severity of OPD in a patient); it also allows researchers to show the

consistency of how data were collected. With a high degree of inter-rater reliability, a

researcher is able to show a high level of confidence in both the way the data were

collected as well as feel confident that the same results may be obtained in the future

(Keyton et al., 2004).In an evidence-based paradigm (as is the case in the field of

medicine), reliability stands as a strong way of supporting hypotheses. High-quality

evidence can only come from statistically strong data, such as data that comes from inter-

rater reliability. Krippendorf (2004a) argued that the statistical tools used to measure

inter-rater reliability “provide a logistical proof that the answers collected are more than

simple chance” (p.2). Inter-rater reliability also exits to combat some experimenter bias.

While inter-rater reliability is important to show the amount of confidence and

agreement between raters, it can also help highlight some problems that may occur during

data collection. Neuendorf (2002) highlighted some of these problems in Table 1.1:

Table 1.1

Problems of data collection inter-rater reliability may uncover

1. Poorly executed coding procedures (in surveys/interviews)

2. Poor survey/interview administration

3. Poor research design


Computing inter-rater reliability is not difficult; programs exist both for free on

the internet, as well as for purchase (Keyton et al., 2004).Computing inter-rater reliability

is a fairly straightforward procedure and some of the main statistical tools used include

Cohen‟s kappa, the Intra-class correlation coefficient, and the Pearson Product Moment

Correlation.

The impedance of the EMG signal has been shown to be somewhat problematic

with EMG (Duff, Nolan, Rybansky & O‟Malley, 2002). EMG electrode placement for

the masseter trials was somewhat imprecise. This is because, no matter how perfect a

judge may follow procedure, when it comes to EMG placement on the face, there is no

accounting for impedance due to skin issues, hair, cuts/scars/bruises (scar tissue is more

fibrous than regular tissue), sweating and makeup. The true levels of impedance for each

material (e.g., cotton, blush, scar tissue) have not been calculated in relation to EMG (and

is beyond the scope of this project), but it is important to note that the variation in data

seen with the masseter trials during chewing and swallowing may be due to this fact.

While reliability studies have been conducted on various aspects of the non-

invasive instrumental assessment of swallowing disorders (Butler et al., 2009; Stierwalt

et al., 2009), very few studies have looked at the reliability of the invasive instrumental

assessment tools. Stoeckli, Huisman, Seifert and Martin–Harris (2003) examined the

inter-rater reliability for VFSS in relation to the timing of oral and pharyngeal phase, the

presence of penetration/aspiration (including amount of aspiration/penetration), and the

location of bolus residue. Stoeckli et al. found that only the aspiration presence was

evaluated with high reliability and all other parameters had poor inter-rater reliability. A

study done by Leslie, Drinnan, Finn, Ford and Wilson (2004) examined inter-rater


reliability in cervical auscultation (CA) and found that clinicians‟ rating of twenty audio

files of swallows (both normal and abnormal) was poor. Colodny (2002) looked at inter-

rater reliability in relation to aspiration and penetration seen during a FEES evaluation.

Colodny filmed seventy-nine swallows that four raters would judge the resultant levels of

aspiration and penetration; data analysis showed good inter-rater reliability for both

aspiration and penetration (inter-rater reliability of penetration was the highest).

As IOPI has been used recently as a part of many OMD and OPD assessments, a

fair amount of research has been done on the reliability of IOPI, however, most of these

studies have looked at the reliability of IOPI as it relates strictly to lingual strength and

endurance for a variety of speech and non-speech tasks (Robin, Goel, Somodi & Luschei,

1992; Youmans, Stierwalt, & Clark, 2002; Clark et al., 2003). EMG has recently become

popular to use in therapy, especially as a biofeedback device (Fritz, Chiu, Patterson and

Light, 2005), and some research has been done in the inter-rater reliability of EMG in

therapy. Vaiman, Eviatar and Segal (2004) were the first to look solely at the reliability

of EMG data as it relates to the oral preparatory and oral phase of the swallow. EMG

studies were performed on 440 normal adults in order to establish a normative database

for duration of oral muscle activity during swallowing (both solid and liquid boluses),

which is clinically useful for both SLPs and ENT outpatients. Vaiman and his colleagues

examined the timing of activity of the orbicularis oris, masseter, submental, and

infrahyoid muscle groups, and organized the data into discrete age groups for each

muscle. The normative data collected by this group allows future clinicians to compare

their patient‟s data with a peer group (similar to the scope of this study).While there have

been a fair number of studies conducted on the inter-rater reliability for some various


aspects of the instrumental assessment of swallowing as a whole, it should be noted that

very little research has focused on the inter-rater reliability of the instruments used during

a clinical evaluation of OMD and OPD, which is the focus of this study.

B. The Normal Swallow

The normal swallow consists of highly intricate muscle movements (with both

voluntary and reflexive components), as well as perceptual feedback from the muscles

and nerves that innervate the swallowing anatomy. The typical swallow has four phases,

each with their own anatomical and physiological function (Logemann, 1998). The four

phases are: (1) the oral preparatory phase, (2) the oral phase, (3) the pharyngeal phase,

and (4) the esophageal phase; each of the phases of the swallow requires coordinated

movements to achieve proper bolus preparation for transport to the next phase. This paper

will only cover the first three phases.

During the oral preparatory phase, food or liquid is introduced to the oral cavity,

and the lips form a seal so neither food nor liquid can escape. This labial seal is

important, as it allows for pressure to build up in the oral cavity which is integral in the

proper movement of the bolus throughout the entire swallow. The food or liquid is

prepared (masticated if food) and mixed with saliva to form a bolus. If the bolus is liquid,

mastication is not required though the liquid bolus will be held on the tongue until the

next phase of the swallow (the oral phase) is initiated (Logemann, 1998).

During the oral phase, the prepared bolus is transported to the posterior

tongue/fauces, in order to trigger the next phase (the pharyngeal phase). In this phase, the

tongue moves in a systematic way in order to propel the bolus posteriorly; when the

posterior tongue base hits the posterior pharyngeal wall, the next phase is triggered.


During the pharyngeal phase, a few major physiological events occur in a very

short amount of time. The first major event is the closing of the velopharyngeal port,

which helps prevent bolus material from leaking into the nasopharynx (nasal

regurgitation). The second major event is hyo-laryngeal excursion (the anterior and

superior movement of the hyoid and larynx), which aids in the opening of the upper

esophageal sphincter (UES). The third major event is the protection of our airway via

inversion of the epiglottis and adduction of the true and false vocal folds (to protect

against aspiration or penetration through the larynx). The fourth major event is the

opening of the UES, which the bolus passes through to the next phase.

C. Etiologies and Pathologies of OPD

The etiologies of OPD fall into three categories: structural, neurogenic, and

functional; OPD can occur as a result of any dysfunction to any structure in the oral or

pharyngeal region of the swallowing mechanism (Logemann, 1998). The structural

etiologies of OPD can all be attributed to something affecting the structure of the

swallowing anatomy either externally (tissue/muscle removed or added), or internally

(tissue/muscle altered so it does not move as easily). Patients who have had surgery for

pharyngeal or laryngeal cancer may have difficulty moving the bolus into the esophagus,

and may be at risk for aspiration or penetration (Riquelme et al., 2008). The neurogenic

etiologies are the largest group of etiologies of OPD; Domench (1999) and Terre-Boliart

(2004) have both proposed that the majority of people develop OPD due to a neurogenic

etiology. These etiologies cause a disruption in the neural-muscular signals from the

brain to the swallowing anatomy (ASHA, 2008). The functional etiologies of OPD are


the smallest category of etiologies. Functional OPD has been defined by Clause (2003) as

“OPD with no organic cause that can be identified.”

D. Etiologies and Pathologies of OMD

The etiologies of tongue thrust are widespread and varied; Hemmings et al. have

put forth a fairly substantial list of possible etiologies (p.15, 2000). Barrett and Hanson

argue that tongue thrust is a normal behavior in infants, and by about the age of five,

most children appear to be swallowing without the tongue thrust. Barrett and Hanson

further suggest that, “when tongue thrust occurs in children beyond the age of 7 years, it

represents either a fixation of, or a regression to, early childhood behavior” (p.130, 1998).

This preservation of childhood tongue thrust into the adult years can cause some

problems with both speech and swallowing. Both Barrett and Hanson (1988) and Benkert

(1997) provide a fairly extensive list of impacts on swallowing by tongue thrust, as seen

in Table 1.2. Many children with tongue thrust may present clinically with frontal or

lateral lisps, and may have difficulty producing the grammatical morphemes for plural

marking (/s/, /z/) and for the contractible copula (-„s as in „he‟s happy‟). Phonemes /t/,

/d/, /n/, and /l/ may also be at risk due to poor tongue tip muscles (ASHA, 2008).

Table 1.2

Tongue Thrust Impact on Swallowing (adapted from Benkert, 1997)

1. Poor lingual control

2. Poor bolus control/propulsion

3. Poor labial seal

4. Poor lingual tone

5. Poor oral musculature tone


E. Clinical Measures of OPD

The clinical measures used in the assessment and diagnosing of OPD fall broadly

into two categories: instrumental and behavioral. Instrumental assessments of OPD tend

to focus on the anatomy and physiology of the patient‟s disordered swallow (e.g., amount

of residue left in the pyramidal sinus), while behavior assessments of OPD tend to focus

on the patient‟s presentation of signs/symptoms of the disordered swallow (e.g., vocal

quality post-swallow). While both types of assessment are used to create a full picture of

the patient‟s swallowing mechanism, an instrumental view provides a clinician with an

intimate first-hand look at the patient‟s unique swallowing structures, which may be used

to make a final diagnosis.

During an instrumental assessment of OPD, a clinician may use either a non-

invasive instrument or an invasive instrument. A non-invasive instrumental assessment

may include instruments like electromyography (EMG) and the Iowa Oral Performance

Instrument (IOPI), which are easily placed on the patient, and require very little training.

The information gained from this type of instrumental assessment can help a clinician

evaluate the levels of bolus timing, oral pressures, and muscular contractions during the

swallow (mainly in the oral preparatory and oral phase). However, this type of

instrumental assessment does not give very in-depth information relating to the

physiology of the patient‟s swallow. An invasive instrumental assessment may include

instruments like fluoroscopy (e.g., videofluoroscopic swallow study, VFSS), endoscopy

(e.g., flexible endoscopic swallow study, FEES), ultrasound, and manometry, which

evaluates pressure throughout the swallowing mechanism (ASHA, 2008).


Behavioral assessment of OPD does not require any additional instruments, with

the exception of possibly a stethoscope and/or a tongue depressor. Primarily, clinicians

are most interested in vocal quality, bolus texture/shape, eye/nose watering, and

coughing/choking (Logemann et al., 2002). Cervical auscultation (CA) is used to detect

presence of swallow and aspiration by listening to the sounds produced by the patient's

body before, during and after the swallow with a stethoscope (Zenner, Losinki& Mills,

1995, p.3). Zenner et al. (1995) examined the use of CA in the clinical dysphagia

examination in long-term care; their results support the use of cervical auscultation as a

"highly sensitive and specific method of dysphagia assessment" (Zenner et al., 1995, p.5).

Information gained from CA is behavioral-based, but can help provide the clinician with

further information on how the swallowing disorder is affecting the patient. As with

anyinstrumental assessment in the medical field, the reading of any findings found during

an OPD assessment relies heavily on the clinician‟s expertise and experience in the field.

F. Clinical Measures of OMD

While clinicians have a variety of instrumental and behavioral assessments to help

them diagnosis the presence (or absence) of OPD, very few assessments exist to help

diagnose OMD. A clinician diagnosing an OMD usually uses a behavioral assessment

(e.g., checklist of signs and symptoms). These types of assessments allow the clinician to

gauge the amount of support the patient may need during swallowing; in the case of

tongue thrust. When diagnosing OMD, it is important to note that there is not a large

amount of normative data on variables like tongue strength, or amount of deviation.

However, instruments like EMG and IOPI allow the clinician to objectively gauge (with

an allowable error of measurement) some variables, like swallow timing, as well as oral


musculature strength. Stierwalt and Youmans (2007) found a positive correlation

between reduced tongue strength and OPD. Further, Stierwalt, Youmans and Youmans

(2009) stated that “the addition of an objective, quantifiable method for evaluating tongue

strength that is reliable and valid, such as the IOPI, makes it possible to establish ranges

of normal tongue strength and tongue strength during swallowing” (p. 64).

G. ICC versus Pearson r

The intra-class correlation coefficient was chosen as a superior value to the

Pearson product moment correlation (Pearson r) as ICC values measure correlations in

conjunction with more than two observers, while a Pearson r measures a similar

correlation for two observers; with three total judges, the ICC is the standard and most

appropriate metric to analyze the data (Romberg, 2009). Used in this study, the ICC will

highlight how strong or weak participants in each judging group resemble each other.

Evans (2003) noted that the ICC can be used for a number of different reasons. He argued

that the ICC algorithm is the most appropriate when a group of more than two judges

wish to “analyze the homogeneity within groups relative to the homogeneity overall”

(Evans, 2003). Evans (2003) further noted that "the Pearson product-moment correlation

coefficient does not measure agreement, only trend"; as the purpose of this study is to

measure the agreement between two different observers and not the trends, the ICC was

ultimately chosen as the most appropriate for this study. Evans (2003) also noted that the

ICC is a more appropriate algorithm to use than a Cohen‟s kappa for measuring

agreement along an ordinal/interval scale. It is of prime importance to choose the most

appropriate statistical algorithm to analyze the data, as this study‟s results ultimately

speaks to the validity of the ISU Tongue Thrust Protocol.


The purpose of this research project was to determine the level of inter-rater

reliability of the instruments used during the clinical assessment of OPD and OMD (e.g.,

EMG and IOPI). This was determined by using the EMG and IOPI to measure intra-oral

pressure, lingual strength, masseter contraction and transit timing in a group of healthy

adults. Three raters assessed both OMD and OPD in this group of healthy adults using the

Logemann (1998) clinical evaluation for OPD, and using the ISU Tongue Thrust protocol

for OMD. The question posed by this study was “to what degree are measures of EMG

and IOPI stable when used to measure oral function by two different raters on the same

subject?” The three judges were split into three judging groups (with two judges per

group); this study tracked judging group one.


Chapter 3 Methodology

The purpose of this research project was to determine the level of inter-rater

reliability of the instruments used during the clinical assessment of OPD and OMD (e.g.,

EMG and IOPI). This was determined by using the EMG and IOPI to measure intra-oral


adults. Three raters assessed both OMD and OPD in this group of healthy adults using the

Logemann (1998) clinical evaluation as well as the ISU Tongue Thrust protocol. The

question posed by this study is “to what degree are measures of EMG and IOPI stable

when used to measure oral function by two different raters on the same subject?”

A. Participants

Participants chosen for this study were healthy adults (no diagnosis of OMD or

OPD) between 18 and 60 years of age (participants were split evenly between male and

female; 4 were between age 20-30, 3 were between 31-40; 1 was 41-60). Participants

were chosen from around the Pocatello area of southeastern Idaho. Participants were

selected after responding to an email (or other personal contact) generated from the

researchers, and a total of 24 participants were selected. A demographic survey was

conducted that questioned various aspects of their health histories, eating habits, age,

smoking habits, and other health- and diet-related questions (Appendix B). The

Logemann (1998) clinical evaluation served as the basis for OPD assessment, and the

ISU Tongue Thrust Protocol served as the tool for OMD assessment.

B. Instrumentation

This study utilized surface electromyography (EMG) as well as the Iowa Oral

Performance Instrument (IOPI) as the main tools of instrumental assessment. The IOPI


measured superior tongue tip, tongue dorsum, masseter and lip strength. The EMG (a 2-

channel Infiniti) measured masseter contraction and oral transit time. During the clinical

evaluation of OPD, a Hunt‟s Snack Pack Sugar Free chocolate pudding was used, as well

as water, and Triscuit brand crackers. A 10-cc syringe was used to measure pudding

amounts and water. Other materials used included gloves and tongue depressors.

C. Procedures

Both OMD and OPD were assessed both objectively (via instrumentation) and

subjectively (via clinician observation). Tasks for both assessments are seen in Table 2.1.

Table 2.1

Instrumental tasks recorded during the study

1. Tongue dorsum elevation (via IOPI)

2. Tongue tip strength (via IOPI)

3. Lip strength (via IOPI)

4. Masseter contraction (via EMG and IOPI)

5. Oral transit time (via EMG)

Three different protocols were utilized during assessment (seen in Table 2.2), and

the order of the tasks within each assessment was counter balanced in order to

compensate for any possible presentation effect. Participants were allowed a drink of

water after each trial was presented.

Table 2.2

Three orders of protocols used for assessment during the study

Group A:IOPI EMG Masseter EMG oropharyngeal transit time

Group B:EMG Masseter EMG oropharyngeal transit time IOPI

Group C: EMG oropharyngeal transit time IOPI EMG Masseter


Participants were assessed at the Idaho State University Speech-Language-

Hearing clinic. Participants were seated in an upright position, and both signed a consent

form as well as filled out the demographic survey. After the survey and consent form

were completed, the assessment began, and the stimuli were presented to the participants

(following the protocol found in Appendix D). The participants were informed about the

IOPI and EMG, including where the IOPI bulb is placed (and how it works), as well as

where the EMG electrodes are placed (and how it works). All participants were made

aware that they were able to end the procedure at any time during the study.

IOPI Measurements

The IOPI measurements measured lip strength, tongue dorsum/tongue tip strength

and masseter strength. The IOPI bulb was placed on the tongue tip, and the participants

were told to bite down with their teeth and lips in order to compress the IOPI bulb against

the alveolar ridge. Participants were instructed to hold this positioning for about 2

seconds. Next, the IOPI bulb was placed on the tongue dorsum, just beneath where the

hard and soft palates meet. Participants were told to bite down with their teeth and lips

while pushing the bulb against the hard palate as hard as they can; participants were

instructed to hold this positioning for about 2 seconds over the course of three trials.

Next, the IOPI bulb was placed between the lips of the participants, who were told to

press their lips together as hard as they can (without biting down with their teeth);

participants were instructed to hold this positioning for about 2 seconds. Finally, the IOPI

bulb was placed between the participants‟ back right molars (both parallel and

perpendicular to the dental arch), who were instructed to bite down on their back molars


as hard as possible; participants were instructed to hold this positioning for about 2

seconds. This was repeated for the participants‟ back left molars.

EMG Measurement (Masseter Baseline and Masseter)

The EMG electrodes were placed on the masseter muscle (e.g., the lateral surface

of the face, medial to the ears). The EMG records the amount of muscular activity the

masseter produced. Electrodes were placed first in order to obtain a baseline

measurement for the given participant. Participants were instructed to clench their back

molars while the researcher palpated the belly of the masseter muscle. The electrodes

were placed bilaterally on the belly of the masseter (channel A of the EMG was assigned

to the right master, and channel B was assigned to the left masseter). The ground

electrode was placed on the participants‟ clavicle bone and the electrode cables were

attached to the participant‟s shirt. After the baseline was established, participants were

presented with 4 bolus trials: ½ teaspoon of pudding, 1½ teaspoons of pudding, 10cc of

water, and a Triscuit cracker. The participants were instructed to hold the bolus in their

mouth until instructed to swallow. The researcher palpated the laryngeal region using the

four-finger method of Logemann (1998), while concurrently depressing the spacebar of

the computer at initiation of the swallow (which placed a marker on the EMG recording).

During each swallow, the researcher marked the absence or presence of masseter

contraction on the EMG printout.

EMG Measurement (Laryngeal Elevation)

Oral transit timing was measured both instrumentally and behaviorally; this

helped to identify both the initiation and termination of the participant‟s swallow.

Initiation of swallowing was defined as movement of the tongue posteriorly (towards the


posterior pharyngeal wall) and was instrumentally measured by utilizing EMG electrodes

placed on the sub-mental region of the face (e.g., between the chin and the thyroid notch).

Termination of the swallow was defined as the depression of the larynx following the

participant‟s swallow. The termination of the swallow cannot be similarly gauged by

EMG, as the depression of the larynx is a passive movement (e.g., it produces no

myogenic response). This was thus measured behaviorally by using the four-finger

method of palpation by Logemann (1998), as well as by depressing the spacebar on the

computer at the initiation of the swallow and the depression of the larynx.

Observational Measurements

During separate trials utilizing a Triscuit cracker, bolus cohesion and amount of

oral residue was examined. Subjects were instructed to masticate the cracker until they

were ready to swallow, and then opened their mouths so the researcher could examine the

bolus cohesion. The participants were then instructed to swallow, and to then open their

mouths.

D. Variables

Independent variables included age, gender, and bolus characteristic, as well as

open mouth rest posture, tongue protrusion, bolus cohesion and amount of oral residue,

post-swallow. IOPI measurements included tongue tip, dorsum, and lip strength. EMG

measurements included masseter contraction during swallow as well as total

oropharyngeal transit time. Oropharyngeal transit time was marked behaviorally by

depressing the spacebar of the computer through which the EMG was recorded at onset

and offset of swallow. In addition to these measures, researchers examined the oral space


for post-swallow residue, as well as bolus quality. Tongue protrusion during swallow was

tested by pulling down on the lower lip during the swallow.

E. Reliability

A total of three raters were a part of this study; each of the 24 participants were

assessed on two different occasions (no more than one month apart) by two different

raters. In order to examine the relationship between two individual raters completing the

same protocol on the same participants, the participants were recorded by the first judge,

and then re-recorded by the second judge within a maximal month interval between

measurement sessions. Each judge measured his or her own data set, and the sets of

measures were subjected to an intra-class correlation to determine degree of agreement

between sessions; the inter-rater reliability was calculated as an intra-class correlation

(ICC) coefficient across the different parameters.

Though it will not be reported in this study, two additional raters were utilized as

well: a fourth judge examined the intra-judge reliability by assessing 16 separate

participants at two different times (maximal month interval between assessment sessions)

using the same protocol and by examining the set of procedures followed by each of the

raters during assessment; this helped to shed light on any variations seen during a given

judge‟s assessment, as well as making sure all raters followed the same procedures during

data collection. Data analysis includes correlational examination of relationships of

timing, force, and EMG/IOPI data, between examiners (inter-rater) and between

examinations of the same participants (intra-judge). This component of the study will

shed light on the reliability of clinical evaluations for both OPD and OMD.


Chapter 4 Results and Discussion

A. Data Analysis

This study sought to examine the level of inter-rater reliability of the instruments

used in the ISU Tongue Thrust Protocol (e.g., IOPI and EMG). To this end, the level of

inter-rater agreement of each trial (at each level) was measured by calculating the intra-

class correlation coefficient (ICC) via the SPSS Statistics software package (IBM;

Armonk, N.Y). Calculating the ICC involves choosing a type of model; a variety of

models are available (the most common are one-way random, two-way mixed, and two-

way random). These models simply describe how the judges and participants were

chosen as well as whether variances were considered important or not (differing studies

may interpret variances in the different as important or not important). Romberg (2009)

provides the following: Choosing a model should first entail choosing either a one-way or

two-way model; these terms are simply used to define what groups are being discussed

(one-way refers to the participants and two-way refers to both the participants and the

judges). The terms random and mixed refer to how the groups were chosen (mixed refers

to the group not being chosen from a larger pool, and random means the group was

chosen from a larger pool). As this study seeks to examine a random set of participants

by a random set of judges, a two-way random model was chosen.

After choosing the ICC model, the agreement type is chosen. There are two types

of agreements: consistency or absolute. These terms refer to whether variances in the data

are important or not; if the variances are important, or if a study is looking for an absolute

value, an absolute type is chosen. If the variances in the data are not important, or if a

study is looking to examine the consistency of values across judges, a consistency model


is chosen. As this study sought to examine the consistency of observations among the

three judges, a consistency model was ultimately chosen.

The ICC value may be understood as a measure of consistency of computable

measurements made by different judges of the same quantity; this speaks directly to the

validity of the quantity being observed (in this case, an assessment tool for speech-

language pathologists). Inter-rater agreement for each level of food/liquid presentation

was obtained; confidence intervals across all levels and trials were 95%.

B. Results and Discussion

Each judge made a total of 2,048 ratings (16 participants x 128 items). In order to

examine the relationship between two individual raters completing the same protocol on

the same participants, data were subjected to an Intra-class Correlation Coefficient

analysis (ICC value) using the IBM SPSS Statistics Software Package1. For each food or

liquid presentation, each judge ran three trials to compensate for any random variances in

data collection, and these values were aggregated during data analysis. Interpretation of

the ICC values is as follows (adapted from Salkind, 2010): 0.0-0.2 indicates weak

agreement, 0.2-0.4 indicates fair agreement, 0.4-0.6 indicates moderate agreement, 0.6-

0.8 indicates strong agreement, and >0.8 indicates almost perfect agreement.

Three judges were utilized to examine this question, and these judges were

separated into three groups: judging group 1 (judge 1 compared to judge 2), judging

group 2 (judge 1 compared to judge 3) and judging group 3 (judging 2 compared to judge

3). This study will be tracking judging group 1, and the results are found below in section

B; two other studies (Reardon, 2013; Seibold 2013) report the other two judging groups.

There will be a total of four tables presented: laryngeal elevation, IOPI, masseter

1 Version 21.0.0


baseline, and masseter; discussions will follow each table presented. Post-hoc analyses

included examining trends in the data (across trials), as well as analysis of the judge‟s

journal that was kept, detailing any issues/extraneous concerns or questions the judge

noted during that particular participant‟s study. Graphs for each of the Tables will be

found in Appendix A. For the following tables, data were coded as in Table 3.1.

Table 3.1

Coding procedures used during data analysis

Pud1 = Food trial of .5 tsp of pudding,

Pud2 = Food trial of 1.5 tsp of pudding

Water = Liquid trial of 10ccs of water

Triscuit = Food trial of Triscuit cracker

Lips = IOPI bulb between lips

TT = IOPI bulb at tongue tip

TD = IOPI bulb at tongue dorsum

RMAS PAR= IOPI bulb for right masseter contraction parallel to dental arch

RMAS PAR = IOPI bulb for right masseter contraction perpendicular to dental arch

LMAS PAR= IOPI bulb for left masseter contraction parallel to dental arch

LMAS PAR = IOPI bulb for left masseter contraction perpendicular to dental arch

A AVG = Average reading for EMG electrode A

B AVG = Average reading for EMG electrode B

A MAX = Maximum reading for EMG electrode A

B MAX = Maximum reading for EMG electrode B

1. Laryngeal Elevation

In these trials, the timing of the laryngeal mechanism was examined. Timing was

judged by measuring the difference in time between the initiation of the swallow and the

ending of the swallow. These times were judged both instrumentally (via EMG) as well

as behaviorally (via researcher pressing the spacebar on the computer).


Table 3.2

ICC Values for judging group 1 (laryngeal elevation measures via EMG)

Trial ICC Value Interpretation of ICC values

Pud1 T1 .326 Fair

Pud1 T2 .651 Strong

Pud1 T3 .429 Moderate

Pud2 T1 .443 Moderate

Pud2 T2 .923 Almost Perfect

Pud2 T3 .680 Strong

Water T1 .636 Strong

Water T2 .843 Almost Perfect

Water T3 .709 Strong

Triscuit T1 .441 Moderate

Triscuit T2 .521 Moderate

Triscuit T3 .708 Strong

In Table 3.2, the laryngeal elevation data are presented, with ICC values ranging

from .326 to .923. In these data, most notably, the Pud1 trials showed the lowest

correlations. One reason for this may be that these levels provide the smallest amount of

material to the participant; because of this, it can be somewhat difficult to form a

traditional bolus with a small amount of material. As such, there tends to be a large

variety in bolus formation produced by participants at these levels (some choosing to just

abandon bolus formation for a quick swallow versus those who continue to try to form a

tradition bolus before initiating the swallow). Having more material with which to create

a bolus is preferred, and there is less variety in bolus formation and cohesion with larger

amounts of material (Logemann, 1988). This may potentially be seen in the higher

correlations found in the levels that provide more material (e.g., Pud2, Triscuit).The

variability relative to bolus size only serves to increase the inherently unstable nature of

EMG amplitude measurement (as compared to the timing measurements to be discussed).


The reduced cohesion of these data most likely reflects the sum of experimenter learning,

participant variability and instrumental instability.

While 92% of the data points were considered to have a moderate level of

agreement (or above), 8% fell below this level; post-hoc analysis revealed one participant

with major dental work which may be partly at fault for some variance (see Figure 1).

Figure 1 Coefficient Frequency for Judging Group 1 for Laryngeal Elevation (n=12)

2. IOPI

In these trials, the IOPI machine was used to gauge the force of the oral

articulators (e.g., lips, tongue and masseter). Participants enacted force on the IOPI bulb

(e.g., pushing, biting or compressing the bulb with the articulators).

0

1

1

2

2

3

3

4

0.3 0.4 0.5 0.6 0.7 0.8 0.9

Fre

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Range of ICC Values of Laryngeal Elevation


Table 3.3

ICC Values for judging group 1 (for measurements using IOPI)

Trial ICC Value Interpretation of ICC value

LIPS T1 .334 Fair

LIPS T2 .467 Moderate

LIPS T3 .580 Moderate

TT T1 .875 Almost Perfect

TT T2 .911 Almost Perfect

TT T3 .746 Strong

TD T1 .716 Strong

TD T2 .544 Moderate

TD T3 .685 Strong

RMAS PAR T1 .884 Almost Perfect



RMAS PERP T1 .721 Strong

RMAS PERP T2 .662 Moderate

RMAS PERP T3 .567 Moderate

LMAS PAR T1 .561 Moderate



LMAS PERP T1 .561 Moderate

LMAS PERP T2 .792 Strong

LMAS PERP T3 .409 Moderate

In Table 3.3, the IOPI data are presented, with ICC values ranging from .334

to .911.For this judging group, IOPI was largely correlative. However, the lips trials

showed the lowest agreement. Post-hoc analysis revealed that some participants

compensated for lip closure by using their mandible, which was error on the part of the

researcher; this likely caused some larger readings found in this group. The other low

agreement value was with the LMAS PERP (which had the IOPI bulb placed on the

participant‟s left side with the bulb perpendicular to their dental arch).

About 96% of the data points were considered to have a moderate-almost perfect

level agreement, while about 4% fell below this level; post-hoc analysis revealed one

participant with major dental work on their left side, which most likely influenced the


moderate agreement seen throughout all the trials on that side of the mouth (see Figure

2). Overall, these higher results were likely due to the IOPI bulbs being largely easier to

place than the EMG electrodes.

Figure 2 Coefficient Frequency for Judging Group 1 of IOPI (n=21)

3. Masseter Baseline (EMG)

In these trials, the EMG was utilized to record baseline data for each participant‟s

masseter muscle. Electrodes were placed on both of the participant‟s masseter muscles

and participants were told to clench their back teeth in order to gauge their baseline data.

Table 3.4

ICC Values for judging group 1 (masseter baseline measures via EMG)


A AVG T1 .696 Strong

B AVG T1 .845 Almost Perfect

A AVG T2 .716 Strong

B AVG T2 .642 Strong

A AVG T3 .903 Almost Perfect

B AVG T3 .736 Strong

In Table 3.4, the masseter baseline data are presented, with ICC values ranging

from .642 to .903. The average of the masseter contraction was used for calculations of

0

1

2

3

4

5

6

7

0.3 0.4 0.5 0.6 0.7 0.8 0.9

Fre

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Range of ICC Values of IOPI


ICC as opposed to the peak measure since it is more stable. As can be seen, the general

trend was towards strong-almost perfect. In these trials, 100% of data points were

considered to have a strong-almost perfect level of agreement; as such, no post-hoc

analysis was conducted for these trials (see Figure 3).

Figure 3 Coefficient Frequency for Judging Group 1 of Masseter Baseline (n=6)

4. Masseter (EMG)

In these trials, the same configuration was kept from the masseter baseline trials;

however, in these trials, participants were instructed to masticate and swallow food and

liquid presentations. Masseter values were taken as a maximum recording of the masseter

contraction.

0

1

1

2

2

3

0.6 0.7 0.8 0.9

Fre

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Range of ICC Values of Masseter Baseline


Table 3.5

ICC Values for judging group 1 (masseter measures via EMG)


PUD1 AMAX T1 .955 Almost Perfect

PUD1 BMAX T1 .813 Almost Perfect

PUD1 AMAX T2 .437 Moderate

PUD1 BMAX T2 .698 Strong

PUD1 AMAX T3 .513 Moderate

PUD1 BMAX T3 .474 Moderate

PUD2 AMAX T1 .622 Strong

PUD2 BMAX T1 .624 Strong


PUD2 BMAX T2 .459 Moderate


PUD2 BMAX T3 .316 Fair

WAT AMAX T1 .557 Moderate

WAT BMAX T1 .698 Strong


WAT BMAX T2 .694 Strong


WAT BMAX T3 .307 Fair

CRAC AMAX T1 .352 Fair

CRAC BMAX T1 .907 Almost Perfect

CRAC AMAX T2 .552 Moderate


CRAC AMAX T3 .346 Fair


In Table 3.5, the masseter data are presented, with ICC values ranging from .307

to .955. These data represent a generally moderate level of agreement and reflect the

lowest level of agreement in this judging group. However, even as the lowest level of

agreement, relationships remain at the fair or better level of agreement. In this study, 84%

of data points were considered to have a moderate level of agreement (or above), while

16% of data points fell below; post-hoc analysis revealed some issues related to skin

impedance (e.g., electrodes not sticking well on three participants, and skin scarring

noted on one participant). While these issues were most likely the cause of the variances


seen in these data, the inherent learning curve may also have affected these data (see

Figure 4).

Figure 4 Coefficient Frequency for Judging Group 1 of Masseter (n=24)

Comparing ICC values to Pearson r

Though this study used an ICC to calculate the level of inter-rater reliability, and

it has been argued that the ICC is the most appropriate statistical algorithm to use for

calculating inter-rater reliability in a research paradigm such as this project, Figure 5

highlights a sample data analysis of the Masseter Baseline data, calculated both as an ICC

as well as a Pearson r. This is simply to capture the differences between the two different

algorithms as well as to highlight the more robust and reliable coefficients that were

analyzed via ICC.

0

1

2

3

4

5

6

7

8

0.3 0.4 0.5 0.6 0.7 0.8 0.9

Fre

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Range of ICC Values of Masseter


Figure 5 Difference between ICC and possible Pearson r for Masseter Baseline

As seen in Figure 5, this sample set of data was run both through the ICC

algorithm (the results of which were reported on page 25), as well as through the Pearson

r algorithm. Correlation values for ICC ranged from .642 to .903, while correlation

values for Pearson r ranged from .486 to .741. Across all parameters, the Pearson r values

were below the ICC values. Both Evans (2003) and Romberg (2009) argue that this is one

of the main reasons why, in a research paradigm such as this study, an ICC provides a

more reliable and robust analysis of the data.

C. Summary

This research project examined the level of inter-rater reliability of the

instruments used during the clinical assessment of OPD and OMD (EMG and IOPI) in

conjunction with the ISU Tongue Thrust Protocol. This was determined by using the

EMG and IOPI (as well as a through some behavioral methods) to measure intra-oral


0.000

0.100

0.200

0.300

0.400

0.500

0.600

0.700

0.800

0.900

1.000

MB A AVGT1

MB B AVGT1

MB A AVGT2

MB B AVGT2

MB A AVGT3

MB B AVGT3

Co

rre

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Masseter Baseline Trials

ICC

Pearson r


adults. The question posed by this study is “to what degree are measures of EMG and

IOPI stable when used to measure oral function by two different raters on the same

subject?” Three judges were utilized to examine this question, and intra-rater reliability

was calculated as an intra-class correlation coefficient. The three judges were separated

into three groups: judging group 1 (judge 1/judge 2), judging group 2 (judge 1/judge 3),

and judging group 3 (judge 2/judge 3); this study tracked judging group 1. Figure 5 below

presents the total ICC value frequency across judging group 1.

Figure 6 Coefficient Frequency for Judging Group 1 (n=63)

Figure 6 highlights the overall ranges of coefficients (ICC values) found for

judging group one (across all participants and trials). Following Salkind‟s (2010) ICC

interpretation table, reliability for this judging group generally tended towards a

moderate-strong correlation (>.4). 90% of all the data points fell in this range (57 out of

63 total data points) with 60% of the data in the strong- almost perfect range (37 out of 63

total data points), and in this judging group, no data points fell below .34 (no data points

in the poor/no agreement range); in total, only 10% of all data points were considered to

have a fair level of agreement or less (6 out of 63 total data points).

0

2

4

6

8

10

12

14

16

0.3 0.4 0.5 0.6 0.7 0.8 0.9

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Range of ICC Values of Total


The present study showed lower overall agreement than the other two groups

(Reardon, 2013; Seibold, 2013), which is in part due to an amount of learning bias on

behalf of the judges (this group was the first group to run participants). However, the

overall reliability of this group showed strong reliability, and it is also worth noting that

the Leckington (2013) post-hoc analysis of all three judges revealed a similar overall

upward trend in reliability as time progressed. That is to say the more each researcher ran

subjects, the more reliable their results were. As this judging group was the first to run

participants, it is theorized that the majority of the variance seen in this group is due to

the novelty of the task. Notably, the masseter baseline values were steady due to the fact

that participants only had to clench their masseter muscle versus performing swallows

with food or liquid. IOPI values were steady as the IOPI does not have the same

impedance issues noted with the EMG, and is largely easier to place than EMG.

Masseter values showed the most variance, though by and large this is due to the

facial placement of electrodes for these trials, which are more susceptible to

movement/electrode displacement issues. Because the electrodes for these trials are

placed on the face (directly over the masseter), movements during feeding, chewing,

swallowing, drinking and talking affect the data that is collected. It is impossible to

recreate every movement of the participants for both times they were observed.

Limitations and Considerations

The issues noted with EMG electrode placement on certain parts of the body (e.g.,

the face) should not be overlooked when using the EMG in these types of studies. EMG

data largely showed moderate-strong-almost perfect agreement, but there were some

large variances in the data perhaps attributable to the impedance issues noted by Duff


(2002) Future studies should examine the somewhat large skin impedance issues noted

with EMG, or if possible, have researchers spend time becoming familiar with the ISU

Tongue Thrust Protocol and the IOPI and EMG instruments (e.g., practicing on real

people); it was noted in a comparison study (Leckington, 2013) that the more the

researchers ran participants and became more familiar with the instruments and protocol,

the overall reliability increased. It is worth noting that, though EMG is inherently

variable due to issues of placement, impedance and performance, it does allow for a high

level of agreement, as seen in the majority of the data, thus the imprecision of the EMG

measure itself may be partly at fault for causing some of this variance. Ultimately, the

results of the data analysis support both IOPI and EMG as instruments in the assessment

of oropharyngeal dysphagia and oromyofunctional disorders, as used in conjunction with

the ISU Tongue Thrust Protocol.


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Seikel, J.A., King, D. W., & Drumright, D. G. (2010).Anatomy and physiology for

speech,language, and hearing (4th

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Learning.

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Dysphagia, 24, 57–65.

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Appendix A: Graphs of ICC Values

1. Laryngeal Elevation

0.000

0.200

0.400

0.600

0.800

pud1 T1 pud1 T2 pud1 T3

Series1

0.000

0.200

0.400

0.600

0.800

1.000

pud2 T1 pud2 T2 pud2 T3

Series1

0.000

0.200

0.400

0.600

0.800

1.000

wat T1 wat T2 wat T3

Series1

0.000

0.200

0.400

0.600

0.800

crac T1 crac T2 crac T3

Series1


2. IOPI

0.000

0.200

0.400

0.600

0.800

LIPS T1 LIPS T2 LIPS T3

Series1

0.000

0.200

0.400

0.600

0.800

1.000

TT T1 TT T2 TT T3

Series1

0.000

0.200

0.400

0.600

0.800

TD T1 TD T2 TD T3

Series1

0.750

0.800

0.850

0.900

RMASPAR T1

RMASPAR T2

RMASPAR T3

Series1

0.000

0.200

0.400

0.600

0.800

RMASPERP T1

RMASPERP T2

RMASPERP T3

Series1


3. Masseter Baseline

0.000

0.200

0.400

0.600

0.800

LMAS PART1

LMAS PART2

LMAS PART3

Series1

0.000

0.200

0.400

0.600

0.800

1.000

LMASPERP T1

LMASPERP T2

LMASPERP T3

Series1

0.000

0.200

0.400

0.600

0.800

1.000

MB A AVG T1 MB B AVG T1

Series1

0.600

0.650

0.700

0.750


Series1


4. Masseter

0.000

0.200

0.400

0.600

0.800

1.000


Series1

0.700

0.750

0.800

0.850

0.900

0.950

1.000

pud1 A MAX T1 pud1 B MAX T1

Series1

0.000

0.200

0.400

0.600

0.800


Series1

0.440

0.460

0.480

0.500

0.520


Series1


0.621

0.622

0.623

0.624

0.625


Series1

0.000

0.200

0.400

0.600

0.800


Series1

0.000

0.100

0.200

0.300

0.400

0.500

0.600

0.700

0.800


Series1

0.000

0.200

0.400

0.600

0.800

wat A MAX T1 wat B MAX T1

Series1


0.000

0.200

0.400

0.600

0.800


Series1

0.000

0.100

0.200

0.300

0.400

0.500

0.600


Series1

0.000

0.200

0.400

0.600

0.800

1.000

crac A MAX T1 crac B MAX T1

Series1

0.000

0.200

0.400

0.600

0.800

1.000


Series1

0.000

0.200

0.400

0.600

0.800

1.000


Series1


Appendix B: Human Subjects Consent Form

Idaho State University

Human Subjects Committee

Informed Consent Form for Non-Medical Research

CONSENT TO PARTICIPATE IN RESEARCH

RELIABILITY OF CLINICAL MEASURES OF

OROMYOFUNCTIONAL DISORDERS AND OROPHARYNGEAL

DYSPHAGIA

You are asked to participate in a research study conducted by Tony Seikel, Ph.D., of

Communication Sciences & Disorders, and Education of the Deaf, Idaho State University

(208.282.3992). The co-investigator for this study is Dave Ross, Idaho State University

Graduate Student (907.347.7860). Data from this study will be reported in this student‟s

Master‟s thesis. You have been asked to participate in this research because you have not

been identified as being a healthy adult between the ages of 18 and 60 years. This study is

part of a larger study, and for this study a total of 24 subjects will be used (with a total of

444 subjects for the larger study). Your participation in this research project is voluntary.

You should read the information below, and ask questions about anything you do not

understand, before deciding whether or not to participate.

1. PURPOSE OF THE STUDY

This study is designed to examine several aspects of how a person swallows, including

muscle strength, timing of swallowing, and swallow pattern.

2. PROCEDURES

If you volunteer to participate in this study, I would ask you to do the following things:

a. You will be asked to fill out a questionnaire concerning eating and health habits. The

form will only have a number on it (not your name) so that your responses won‟t be

identified with your name.

b. I will apply electrodes to the side of your face to measure muscle contraction, and then

I will ask you to bite down while I make recordings. I will then ask you to chew and

swallow pudding and a cracker, as well as to take drinks of water while I make these

same recordings. I will hold your lips open at one point so I can observe what your

tongue is doing during the swallow process. I will also ask to look inside your mouth.

c. I will then apply electrodes under your chin and to the area of your larynx (voice-box)

and ask you to chew and swallow liquid, crackers, and pudding.

d. There are no specific subgroups in this study, besides male versus female.

e. The total time should be approximately 40-50 minutes for your participation.

f. The study will be performed at the ISU Speech and Hearing Center in Pocatello, or in

your home if you wish.


3. POTENTIAL RISKS AND DISCOMFORTS

The procedures are standard procedures used to examine a person‟s swallow function.

Preparation of your skin will involve cleaning an area using an electrode preparation gel,

much like that used in EMG recordings. This may make your skin temporarily red, but

that effect will not last long after the period of the study. If you are diabetic we will

provide foods with artificial sweetener. If you are allergic to the foods being presented

we ask that you not participate in the study. You might feel embarrassment by the

attention to your eating habits. You could take food or liquid into your lungs (aspiration),

which would be a sign of significant swallowing problems. In that case we would end

the study and refer you to a Speech-Language-Pathologist for attention to this problem.

The research procedures may involve risks that are currently unforeseeable.

4. ANTICIPATED BENEFITS TO SUBJECTS

This study may identify either an oromyofacial or a swallowing problem that you may so

that you could receive treatment to alleviate the problem.

5. ANTICIPATED BENEFITS TO SOCIETY

This study will examine the reliability of measures used to assess both swallowing

disorders and oromyofunctional disorders, which will assist during assessment and

diagnosis.

6. ALTERNATIVES TO PARTICIPATION

Participation is voluntary, and you may end participation at any time. There are no other

alternatives to participation.

7. PAYMENT FOR PARTICIPATION

There is no payment offered or available for participation.

8. FINANCIAL OBLIGATIONS

You will not be asked to pay for any of these procedures.

9. PRIVACY AND CONFIDENTIALITY

The only people who will know that you are a research subject are members of the

research team. No information about you, or provided by you during the research, will be

disclosed to others without your written permission, except (a) if necessary to protect our

rights or welfare (for example, if you are injured), or (b) if required by law.

When the results of the research are published or discussed in conferences, no

information will be included that would reveal your identity. If photographs, videos, or

audiotape recordings of you will be used for educational purposes, your identity will be

protected or disguised. If a video of your participation were to be used you would be

informed and have the right to decline its use. Data will be stored in a file cabinet in a

locked office, and will be separated from your name so that no one could identify your

data individually. Contact data will be destroyed seven years after publication of the

research findings.


10. PARTICIPATION AND WITHDRAWAL

Your participation in this research is VOLUNTARY. If you choose not to participate,

that will not affect your relationship with Idaho State University, or your right to receive

services at Idaho State University to which you are otherwise entitled. If you decide to

participate, you are free to withdraw your consent and discontinue participation at any

time without prejudice to your future at Idaho State University.

11. WITHDRAWAL OF PARTICIPATION BY THE INVESTIGATOR

The investigator may withdraw you from participating in the research if circumstances

arise which warrant doing so. If you experience any of the following (coughing or hoarse

voice after swallowing) you may have to drop out of the research, even if you would like

to continue. The principal researcher will make the decision and let you know if it is not

possible for you to continue. The decision may be made either to protect your health and

welfare, or because it is part of the research plan that people who develop certain

conditions may not continue to participate.

12. IDENTIFICATION OF INVESTIGATORS

In the event of a research related injury or if you experience an adverse reaction, please

immediately contact one of the investigators listed above. If you have any questions

about the research, please feel free to contact Tony Seikel at 208.282.3992 or

[email protected], or Dave Ross at 907.347.7860 or [email protected] any time.

13. RIGHTS OF RESEARCH SUBJECTS

You may withdraw your consent at any time and discontinue participation without

penalty. You are not waiving any legal claims, rights or remedies because of your

participation in this research study. If you have any questions regarding your rights as a

research subject, you may contact the Human Subjects Committee office at 282-2179 or

by writing to the Human Subjects Committee at Idaho State University, Mail Stop 8130,

Pocatello, ID83209.

Appendix C: Demographic Survey

Subject ID#________________

Demographic Survey

mailto:[email protected]


1. Birth Date: _________________________

2. Circle One: MALE FEMALE

3. Ethnicity (check one):

□ (1) European American (not Hispanic)

□ (2) White Hispanic

□ (3) Latino

□ (4) Asian

□ (5) African American

□ (6) Native American

□ (7) Other / Multi-racial

Health Status

4. Do you have or have you experienced any of the following? (check yes or no)

Heart & Blood

a. Heart & Blood Problems (including chest pain due to heart problems, irregular

heartbeat, high blood pressure, blood clots, anemia, hypertension, blood

transfusion, high cholesterol, heart failure, or heart bypass surgery)

□ Yes □ No

b. COPD (Chronic Obstructive Pulmonary Disorder)

□ Yes □ No

c. Bleeding GI (stomach, throat, intestines)

□ Yes □ No

Psychiatric

d. Psychiatric Treatment for depression or anxiety


□ Yes □ No

Illness

e. Cancer (what kind _________________________?)

□ Yes □ No

f. Rheumatologic Disease (Sjogren‟s, Lupus, Arthritis)

□ Yes □ No

Neuromedical Risks/Condition

g. Head injury (describe and include point of impact)

__________________________________________________________________

_____________________________________________________________________

□ Yes □ No

h. Loss of consciousness (how long?) _________________________________

□ Yes □ No

i. Seizures

□Yes □ No

j. Stroke/TIA

□Yes □ No

k. Sleep Apnea

□Yes □ No

l. Toxin/Chemical Exposure (what kind?)

_______________________________________

□Yes □ No


m. Parkinson‟s Disease (when

diagnosed?)________________________________________

□ Yes □ No

n. Huntington‟s Disease (when diagnosed?)

______________________________________

□ Yes □ No

o. Brain Masses (location)

____________________________________________________

□ Yes □ No

p. Multiple Sclerosis (when diagnosed?)

_________________________________________

□ Yes □ No

q. Cerebral Palsy

□ Yes □ No

r. Dementia/Alzheimer's (when diagnosed?)

_____________________________________

□ Yes □ No

s. Oral Apraxia (when diagnosed?)

_____________________________________________

□ Yes □ No

t. Spinal Injury (describe)

____________________________________________________

□ Yes □ No


u. Brain Surgery (describe)

___________________________________________________

□ Yes □ No

v. Poliomyelitis (when diagnosed?)

_____________________________________________

□ Yes □ No

w. Guillain-Barre (when diagnosed?)

____________________________________________

□ Yes □ No

aa. Riley-Day Syndrome or Dysautonomia (when diagnosed?)

________________________

□ Yes □ No

bb. ALS (when diagnosed?)

____________________________________________________

□ Yes □ No

cc. Werdig- Hoffmann Disease (when diagnosed?)

_________________________________

□ Yes □ No

dd. Myasthenia Gravis (when diagnosed?)

________________________________________

□ Yes □ No


ee. Muscular Dystrophy (when diagnosed?)

_______________________________________

□ Yes □ No

ff. Dystonia (when diagnosed?)

________________________________________________

□ Yes □ No

Oromyofunctional Risks/Conditions

gg. Recurrent Pneumonia

□ Yes □ No

hh. Frequent Temperature Spikes

□ Yes □ No

ii. History of Artificial Airway

□ Yes □ No

jj. Mouth Breather

□ Yes □ No

kk. History of Finger Sucking

□ Yes □ No

ll. History of Cheek Biting

□ Yes □ No

mm. Deviated Septum

□ Yes □ No

nn. Enlarged Tonsils/Adenoids

□ Yes □ No


oo. Tonsils/Adenoids Removed

□ Yes □ No

pp. Open Spaced During Mixed Dentition

□ Yes □ No

qq. Current Open Spaces in Dentition

□ Yes □ No

rr. Allergies (explain)

_______________________________________________________

□ Yes □ No

ss. TMJ Syndrome

□ Yes □ No

tt. Eating Disorders

□ Yes □ No

uu. Oral Surgery (explain)

_____________________________________________________

□ Yes □ No

vv. Neck Surgery (explain)

____________________________________________________

□ Yes □ No

ww. Oral Sores

□ Yes □ No

Other


xx. Other Surgery (explain)

____________________________________________________

□ Yes □ No

5. List and describe any serious accidents that required hospitalization.

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________

Medications

6. Have you taken any medication today? □ Yes □ No

If yes, list medication, dose, time taken, and reason for taking it. (Use back of

page for more room)

Name of medication Time Taken Dose Reason for Taking

________________ _________ ______mg _______________

________________ _________ ______mg _______________

________________ _________ ______mg _______________

________________ _________ ______mg _______________

________________ _________ ______mg _______________

________________ _________ ______mg _______________

________________ _________ ______mg _______________

________________ _________ ______mg _______________

________________ _________ ______mg _______________

________________ _________ ______mg _______________


Alcohol and Tobacco

7. Do you consume alcohol? □ Yes □ No

8. If you answered yes to question 7, how much alcohol do you typically consume in 1

month?

_______ glasses/month

9. Do you chew tobacco? □ Yes □ No

10. If you answered yes to question 9, how much do typically use in a month?

________

cans/month

11. Do you smoke? □ Yes □ No

12. If you answered yet to question 11, how much do you smoke in a month?

________

packs/month

Food Information

13. What are your three favorite foods?

_____________________________________________

14. What are your three least favorite foods?

_________________________________________

15. Are there any foods that you avoid?

________________________________________________________________________

16. How often do you chew gum?

_________________________________________________

17. Have you ever participated in tongue thrust therapy? □ Yes □ No


Appendix D: Idaho State University Tongue Thrust Protocol

ISU Tongue Thrust Protocol

Note: To derive a total score for prediction purposes circle numbers in “score” box for

items representing problems.

Name:_____________________________ Examiner:_________________________

Date:______________________________


DOB:_____________________________

Case History Information

Characteristic Presence/

absence

Score Notation

Feeding History

Nursed or bottle fed

Age for solid food (4-6 for

cereal)

Age hard food (carrot,

celery)

Food preferences (hard,

soft)

History swallow problem

(choke, gag)

History regurgitation

Tx regurgitation

Persistent

regurgitation

Food allergy

Family Issues (genetics)

Fam. Hx. Tongue thrust

Fam. Hx feeding problems

Famhx low tone

Famhx allergy

Fam. Hx upper respiratory

FamHxMacroglossia

FamHx Small nares

FamHx Deviated septum

FamHx Dental problems

(small mouth requiring

extractions)

FamHx Mouth breathing or

nasal

Habits

Digit sucking (lips, tongue,

finger, thumb, hand)

Late bottle use

Late pacifier use

Mouth breathing

Cheek biting

Medical/Anatomical


history

Open spaces during mixed

dentition

Diastema?

Micrognathia?

Missing dentition?

Hypertrophied

adenoids/tonsils

Allergies

New?

Old?

When develop?

Treated?

Hypertrophied turbinates?

Cleft palate?

Tonsillitis

ENT visits for tx?

Removed?

When

Neurophysiological issues

Low sensory awareness

/sensation seeking

Drooling, saliva pooling

Oral discrimination ability


Tongue Thrust Assessment Protocol

Characteristic Action Score Notation

1. Observation Observe client at

rest

2. Facial tone

Observe client at

rest

3. Facial symmetry

Observe client at

rest

4. Mouth or nose

breathing

Observe client at

rest

5. When mouth

open, how much of

upper dentition is

covered by lip?

Criterion: Upper

lip covers ½ of

upper teeth

Less=1

6. Rest posture of

tongue

observe: contact

upper dental arch

at rest

If not=1

7. Lip movement

during dry swallow

Observe for open

or clamped

(watch for

wrinkle of chin as

sign of clamping)

Present=

1

8. Tongue out,

mouth open

Perception of

macroglossia?

1

Oral Examination:

1. Dentition

Bite down on

molars;

Tongue depressor

in buccal cavity;

Ask to spread lips

Class I

malocclusion

Mandibular 1st

molar ½ tooth

ahead of

maxillary 1st

molar; anterior

teeth maligned

1

Class II Retracted

mandible

1

Class III Prognathic

mandible

1

Open bite Front teeth don‟t 1


occlude

Closed bite

Back teeth don‟t

occlude

Teeth meet at

rest

Observe rest

posture re:

muscles of

mastication

1

2. Nares:

Deviated

septum

Ask in Hx;

observe

Apparent

blockage

Ask in Hx;

observe breathing

3. Lips

Contact

Criterion: Rest

along entire

length without

effort

If not=1

Chapping?

Chapping

indicates mouth

breathing, tongue

thrust

“fat” lower

lip: low

tone?

Indicates low tone

Overjet:

If excessive

dental overjet,

crease in lower

lip where teeth

rest

1

4. Hard palate

High Vault

View with open

mouth, flashlight

1

5. Soft palate

Elevates with

/a/?

Transilluminate

Watch in /a/

Observe and

palpate

Length

adequate?

Transilluminate

Watch in /a/

Observe and

palpate

Blue

coloration?

(submucous)

Transilluminate

Watch in /a/

Observe and

palpate


6. Tongue

microglossia

Observe, mouth

open

Lingual

frenulum

Protrude tongue;

heart shape

anterior?

1

Macroglossia Observe, mouth

open

1

resting

posture?

Ask; criterion =

contact upper

dentition at rest

1

7. Respiration

mouth versus

nose

breathing

Observe

Sustain vowel

Manometer use

Listen

adequate

support?

Manometer;

count to 30 at 1

word per second

(number of

words/breath)

easily

fatigues?

Observe, ask

Respiratory

noise

(adenoids?)

Observe

Water Swallow

1. Water retention Water on tongue,

open mouth,

retains water?

2. Water swallow x3

lips closed

Masseter

contract?

Swallow water:

Palpate

Fail=1

Symmetrical

contract?

Swallow water:

Palpate

Thyroid

elevate?

Swallow water:

Palpate

Fail=1

3. Water swallow,

lips open x 3

lip tension?

Swallow water:

Lips open, pull

lips open

Observe for

protrusion,

interdental

Tense=1

Water loss?

Swallow water:

Lips open, pull

Loss=1


lips open;

Observe

protrusion;

interdental; water

loss

Tongue

thrust?

Swallow water:

Lips open; pull

lips open;

Observe

protrusion;

interdental

1

Food mastication

1. Cracker/cookie

mastication x 3

bolus:

scatter, tube,

ball?

Observe before

swallow, after

swallow

Scatter=

1

Saliva:

mixed?

Observe Dry=1

too large

bite?

Observe

Too small

bite?

Observe

Lips open

when chew?

Observe 1

2. Cracker/cookie

swallow X 3

number of

swallows?

Observe >2

swallow

=1

Cleaned

using

tongue?

Observe

Followed

with water?

Observe 1

Lips clamp in

swallow?

Observe; watch

for wrinkling of

mentalis

Clamp

or

wrinkle

=1

Masseter

contract?

palpate no

contracti

on = 2

Food remains

in sulcus

after swallow

Observe after

swallow using

tongue depressor

1

Excessive Look for position 1


food on

tongue after

swallow

of tongue and lips

on glass

Tongue

protrudes in

swallow

Pull down lower

lip

1

Hold water

on tongue

Can client cup

tongue and hold

water?

3. Type of tongue

thrust

Unilateral

Left

Unilateral

right

Spread

Bilateral

Upper thrust

Lower thrust

Pull lip down

Resting posture

Swallowing

movement

Look at dentition

4. severity

0=normal

1= dental

contact, but

not pass

through teeth

or over teeth

2.=dental

contact, and

between

teeth, onto

occlusal

surface, or

contact lips

Observation: be

specific!

Total Score (add

circled numbers)

ross, d. (2013) reliability of emg/iopi in opd/omd diagnosis

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