The Effects of a Motor Imagery Exercise Program on Tongue Strength
Phase: NA
Conditions: Dysphagia
Sponsor: University of South Florida

 
 
 
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The effects of a motor imagery exercise program on tongue strength. 
PI: Sarah Hegyi, PhD, CCC-SLP  
Protocol#00033331  
Version #3; 09/04/2018 
 
1. Rationale for the study, area of current scientific concern and why the research is needed 
Although motor imagery (MI) has not yet been researched in the field of swallowing 
rehabilitation, the potential benefit is far reaching. Difficulty swallowing, or dysphagia, can 
occur in people who have a history of stroke, head injury, neurological disease (such as 
Parkinson’s disease, ALS, etc.), and head/neck cancer. A person with dysphagia may have 
difficulty eating everyday foods and may require an altered diet, such as tube feedings or pureed 
foods. Because of this, having dysphagia is often associated with increased feelings of isolation 
and depression. Speech-language pathologists work with people with dysphagia to rehabilitate 
their swallow, with the goal of reducing their risk of choking and improving their ability to eat 
normal foods.  The use of MI as a way to augment dysphagia rehabilitation has implications for 
patients who aren’t safe to have any food by mouth as well as those who fatigue easily.  
2. Background information, description of existing research and information that is 
already known 
 
 
Motor imagery (MI) is the mental rehearsal of physical movement without any body movement 
and can use various mental frameworks such as auditory, visual, tactile, gustatory, and 
kinesthetic imagery (Dickstein & Deutsch, 2007).  MI has been used in sports science to improve 
speed, performance accuracy, strength, and movement dynamics of athletes (Taktek, 2004). It 
has also been used in rehabilitative medicine, specifically physical and occupational therapies, to 
improve upper and lower extremity function (Peters & Page, 2015). Target patient populations 
for research have included stroke, spinal cord injury, Parkinson’s disease and other neurological 
disorders.  Commonly MI is combined with actual physical practice for optimal rehabilitation 
outcomes and there is evidence for neural reorganization with MI. MI requires minimal direct 
supervision, minimal expense and no specialized equipment. Additionally it has no known risk, 
which is important for patients with high levels of impairment and fatigue.  
3. The research questions, objectives and purpose 
This is a collaborative project between Dr. Sarah Hegyi at USF-Sarasota-Manatee, Dr. Erin 
Kamarunas at James Madison University (JMU), Dr. Christina Nobriga at Loma Linda 
University (LLU), and Dr. Teresa Drulia at Texas Christian University (TCU). Each study site 
will acquire IRB approval from each respective university IRB.  
This research study is a six-week treatment pilot study to determine the effect of motor imagery 
for tongue strengthening exercises on measures of tongue strength and swallowing pressure in 
typically aging older adults. Typically-aging older adults represent a group “at risk” for 
dysphagia secondary to sarcopenia of striated musculature important to swallowing.  Participants 

 
 
 
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at all study sites will be randomly selected into one of four groups: 1) placebo (active jaw open 
against resistance/close against resistance/lateralize/protrusion exercises with relaxation 
exercises), 2) active tongue exercises against resistance only, 3) active tongue exercises against 
resistance + motor imagery of tongue exercises against resistance, and 4) motor imagery of 
tongue exercises against resistance only. In some JMU participants we will also determine 
cortical activation patterns differences during motor execution and motor imagery of tongue 
exercises between the groups using near-infrared spectroscopy. The results of this study will 
inform refinement/further development of the mental practice protocol to use with patients with 
dysphagia in future studies.  
The research questions are as follows:  
1. Does a 6 week treatment of motor imagery tongue exercises with or without active 
tongue exercise improve tongue strength in healthy older adults compared to a 6 week 
treatment of placebo exercises and 6 week treatment of active tongue strengthening 
exercises?  
2. Does a 6 week treatment of motor imagery tongue exercises with or without active 
tongue exercise improve swallowing pressures in healthy older adults compared to a 6 
week treatment of placebo exercises and 6 week treatment of active tongue 
strengthening exercises?  
3. Does a 6 week treatment of motor imagery tongue exercises with or without active 
tongue exercise alter cortical hemodynamic response patterns in healthy older adults 
compared to a 6 week treatment of placebo exercises and 6 week treatment of active 
tongue strengthening exercises? (JMU participants only) 
 
Our hypothesis, based on previous research, is that the group receiving both active and MI 
treatment will make the most gains in all three measures, followed by the active only group, then 
the MI only group, then the placebo group (control).   
4. The study design including information that is needed to answer the research questions 
Subjects will be recruited by USFSM email blast, word of mouth, and community 
advertisements (local clubs, community centers, clinics, physician offices).  
Compensation Schedule  
• 
4 in-person visits for a total of $60 in Amazon gift cards should a participant complete 
the entire, 6-week research protocol. 
• 
Visit 1 (Recruitment Phase 2 & Baseline) - $20 Amazon gift card provided 
at end of visit. 
• 
Visit 2 (end of Week 2 of 6-week exercise program).  
• 
Visit 3 (end of Week 4 of 6-week exercise program). $20 Amazon gift 
card provided at end of visit. 
• 
Visit 4 (end of Week 6 of 6-week exercise program). $20 Amazon gift 
card provided at end of visit. 

 
 
 
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Recruitment (Phases 1 & 2)  
Phase 1 Recruitment (anticipated 20-25 minutes in length):  
 Telephone pre-screen for verbal consent and inclusion/eligibility telephone 
screening (includes EAT-10 screening tool) completed with persons responding to 
advertisement. 
o If preferred by potential subject, a hard copy of the screening forms will 
be mailed to address provided, including a pre-stamped/labeled return 
envelope. 
o If preferred by potential subject, an electronic copy of the screening forms 
will be e-mailed to e-mail address provided and scanned completed 
screening forms accepted in return. 
 Potential subjects meeting the screening forms criteria will be invited for Phase 2 
of recruitment + baseline (if eligible) in-person visit at USFSM, participant’s 
home, or private location at a community center (e.g., conference room at an 
independent living facility) if preferred 
 
Phase 2 Recruitment + Baseline (if eligible) (Visit #1) (Phase 2 Recruitment 
anticipated 30 minutes in length): 
 Each in-person visit will be conducted confidentially and privately at USFSM, a 
the participant’s home, or a private location at a community center. 
 Intraoral examination will be completed to confirm absence of tongue 
piercings/oral apparatus that may interfere with tongue exercises. 
 Investigator will administer the Kinesthetic and Visual Imagery Questionnaire 
(KVIQ-10) and Mini Mental State Examination (MMSE).  
 Both the KVIQ-10 and MMSE must be passed to continue.  
o If fails KVIQ-10 or MMSE, the individual will be notified that he/she 
does not qualify to participate in the study and thanked for taking the time 
to complete the recruitment activities. 
o If passes both KVIQ-10 and MMSE, detailed study information and 
informed consent form will be reviewed, with time provided for potential 
subject to ask questions. Should the potential subject decide to voluntarily 
participate in the study, informed consent form will be signed and the 
baseline experimental session will begin. 
 
The following equipment will be used to take measures at baseline and other follow up visits:  
1. Iowa Oral Performance Instrument (IOPI) - Uses an air filled bulb held in the mouth to 
measure oral pressures in kilopascals.  Maximal isotonic tongue pressures as well as 
pressures generated from normal swallows will be measured at baseline and three follow 
up visits (described below). This equipment is portable.  

 
 
 
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Baseline Visit #1 Protocol: (anticipated 30 minutes)    
1. Investigator completes basic education and training about how the IOPI is used/protocol for collecting IOPI 
measurements. 
2. Investigator will measure subject’s maximum/peak tongue pressure using IOPI device. 
o 
Six measurements will be taken, with 30-40 seconds between each.  
o 
Mean value will be used as the subject’s maximum tongue strength 
3. Investigator will measure subject’s regular swallowing pressures using the IOPI device. Swallows will be 
completed using the participant’s saliva (no water or other liquid given during measurement).  
o 
Six measurements will be taken, with 30-40 seconds between each.  
o 
Participants will be given 20-30 mL of water to swallow between each rep to help moisten the 
mouth.  
o 
Mean value will be used as the subject’s normal swallowing pressure  
4. Investigator will randomly assign subject to one of four study groups: 
(1) Placebo (control) exercise 
(2) Active 
tongue 
exercise 
(3) Active 
tongue 
exercise + 
Motor 
Imagery 
exercise 
(4) Motor 
Imagery 
exercise 
5. Investigator completes jaw 
exercise training with subject, 
including basic education about 
physical strengthening exercise. 
o 
Instructions will be rehearsed 
verbally and written 
instructions will be provided 
to each subject to use in home 
environment. 
o 
Limited practice opportunity 
provided to confirm subject’s 
5. Investigator 
completes active 
tongue exercise 
training with 
subject, including 
basic education 
about physical 
strengthening 
exercise. 
5. Investigator 
completes active 
tongue exercise 
training with 
subject, including 
basic education 
about physical 
strengthening 
exercise. 
5. Investigator 
completes mental 
practice exercise 
training with 
subject, including 
basic education 
about motor 
imagery and 
mental practice. 

 
 
 
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understanding of exercise 
instructions.  
o 
A lightweight, portable 
counter clicker will be 
provided to the subject to 
keep track of active exercise 
repetitions. 
 
AND 
 
Investigator completes 
visualization relaxation training 
with subject. 
o 
Instructions will be rehearsed 
verbally and written 
instructions will be provided 
to each subject to use in home 
environment.* 
 
 
 
o 
Instructions 
will be 
rehearsed 
verbally and 
written 
instructions 
will be 
provided to 
each subject 
to use in 
home 
environment. 
o 
Limited 
practice 
opportunity 
provided to 
confirm 
subject’s 
understandin
g of exercise 
instructions.  
o 
Tongue 
depressors 
will be 
provided to 
the subject 
to use for 
resistance 
during active 
exercises. 
o 
A 
lightweight, 
portable 
counter 
clicker will 
be provided 
to the 
subject to 
keep track of 
active 
exercise 
repetitions.  
o 
Instructions 
will be 
rehearsed 
verbally and 
written 
instructions 
will be 
provided to 
each subject 
to use in 
home 
environment.  
o 
Limited 
practice 
opportunity 
provided to 
confirm 
subject’s 
understandin
g of exercise 
instructions. 
o 
Tongue 
depressors 
will be 
provided to 
the subject 
to use for 
resistance 
during active 
exercises. 
o 
A 
lightweight, 
portable 
counter 
clicker will 
be provided 
to the 
subject to 
keep track of 
active 
exercise 
repetitions. 
 
AND 
Investigator 
completes mental 
practice exercise 
training with 
subject, including 
basic education 
o 
Instructions 
will be 
rehearsed 
verbally and 
written 
instructions 
will be 
provided to 
each subject 
to use in 
home 
environment. 
o 
A 
lightweight, 
portable 
counter 
clicker will 
be provided 
to the 
subject to 
keep track of 
mental 
practice 
repetitions 
(to reduced 
cognitive 
load of 
counting 
repetitions 
while 
completing 
mental 
practice). 
Mental 
practice 
instructions 
are outlined 
below.** 
o 
Limited 
practice 
opportunity 
provided to 
confirm 
subject’s 
understandin
g of exercise 
instructions. 
o 
Investigator 
observes to 
confirm no 
overt 
muscular 
activity in 

 
 
 
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about motor 
imagery and 
mental practice. 
o 
Instructions 
will be 
rehearsed 
verbally and 
written 
instructions 
will be 
provided to 
each subject 
to use in 
home 
environment. 
o 
A 
lightweight, 
portable 
counter 
clicker will 
be provided 
to the 
subject to 
keep track of 
mental 
practice 
repetitions 
(to reduced 
cognitive 
load of 
counting 
repetitions 
while 
completing 
mental 
practice). 
Mental 
practice 
instructions 
are outlined 
below.** 
o 
Limited 
practice 
opportunity 
provided to 
confirm 
subject’s 
understandin
g of exercise 
instructions. 
o 
Investigator 
observes to 
head/neck 
area during 
motor 
imagery 
tasks. 

 
 
 
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confirm no 
overt 
muscular 
activity in 
head/neck 
area during 
motor 
imagery 
tasks. 
6. Investigator instructs subject to 
complete 1 set (10 repetitions in 
each direction – 
open/close/lateralization/protrusio
n) of placebo exercise, 3x day, 3 
days/week for two weeks.  
 
AND 
 
Following completion of all reps 
of the active exercises in a given 
set (10 reps per direction for 40 
reps total), subject will find quiet 
spot (without distraction) to 
complete relaxation exercises*. 
This will be repeated 3x/day, 3 
days a week for 2 weeks.  
6. Investigator 
instructs subject 
to complete 1 set 
(10 repetitions) 
in each direction 
(protrusion, 
elevation, left, 
right), 3x day, 3 
days/week for 
two weeks. 
6. Investigator 
instructs subject to 
complete 1 set of 
active tongue exercise 
(10 repetitions) in 
each direction 
(protrusion, elevation, 
left, right). 3x day, 3 
days/week for two 
weeks. 
 
AND 
 
Following completion 
of all reps of the 
active exercises in a 
given set (10 reps per 
direction for 40 reps 
total), subject will 
find quiet spot 
(without distraction) 
to complete mental 
practice exercises, 
including 10 
repetitions per 
direction (40 reps) of 
mental practice 
tongue exercises. This 
will be repeated 
3x/day, 3 days a week 
for 2 weeks.   
6. Investigator 
instructs subject 
to complete 1 set 
of mental 
practice exercise 
(10 repetitions) 
in each direction 
(protrusion, 
elevation, left, 
right), 3x day, 3 
days/week for 
two weeks. 
7. A record form will be reviewed and provided to subject, with instructions to document each exercise set 
complete each week (date and time) and to note any applicable personal comments as warranted (e.g., 
fatigue, pain, technical difficulty, interruptions during a set). Only the subject’s participant number will be 
recorded on the form. 
8. An appointment will be scheduled for Visit #2 around two weeks following Visit #1. Attempt to schedule 
subsequent visits at a consistent time of day, so that max measurements are taken around the same time of 

 
 
 
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day each visit, preferably at the time of day the subject feels strongest. 
9. Investigator will process subject’s first $20 participation incentive. 
 
*Visualization Relaxation Exercise Instructions: 
1. Find and comfortable and quiet spot where you will not be distracted. 
2. Set a timer for three to five minutes. 
3. Choose a place or situation that you find peaceful and calming (e.g., the beach or favorite 
vacation spot). 
4. When ready, start the timer and close your eyes. 
5. Imagine yourself in your peaceful and calm place or situation. 
6. Try to imagine the smells, sights, sounds, and touch when you are there (e.g., the smell of 
sunscreen, the sound of water, the sight of children building sand castles, and the feel of 
the sand between your toes at the beach). 
7. Focus on positive thoughts associated with your peaceful and calming place or situation. 
8. When your timer rings, open your eyes and count out-loud to 5 to bring yourself back to 
the present. 
 
Adapted from: Mayo Foundation for Medical Education and Research. (2017). Stress 
management: Types of relaxation techniques. Retrieved from 
https://www.mayoclinic.org/healthy-lifestyle/stress-management/in-depth/relaxation-
technique/art-20045368?pg=2 
 
**Mental Practice Exercise Instructions: 
1. Set the counter clicker to zero. 
2. Assume a comfortable sitting position: seated upright (90°), both feet on the floor, arms 
resting comfortably in lap, and holding the counter clicker in one hand. 
3. Imagine the tongue exercise movements (protrusion, left, right, elevation): use the first-
person perspective, as if you were actually executing the exercise.  
4. Avoid actually moving or contracting muscles from your tongue, face, head, or neck. 
Keep a relaxed position. 
5. Remember to imagine seeing and feeling the movements from within – imagining 
completing each repetition as if you are pushing against a tongue depressor. 
6. When ready, imagine performing one tongue exercise at a time, using the counter clicker 
to keep track of each mental exercise repetition completed. Keep breathing normally. 
7. If you lose your concentration during a set (10 repetitions in each of the four directions), 
relax for a few moments and then start the exercise set again, re-setting the counter 
clicker to zero. 
8. Try to make as few errors as possible with each imagined tongue exercise movement. 
 

 
 
 
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Visit #2 (end of Week 2) (anticipated 30 minutes in length): 
1. Investigator will measure subject’s maximum/peak tongue pressure using IOPI device. 
o 
Six measurements will be taken, with 30-40 seconds between each.  
o 
Mean value will be used as the subject’s maximum tongue strength 
2. Investigator will measure subject’s regular swallowing pressures using the IOPI device. Swallows will be 
completed using the participant’s saliva (no water or other liquid given during measurement).  
o 
Six measurements will be taken, with 30-40 seconds between each.  
o 
Participants will be given 20-30 mL of water to swallow between each rep to help moisten the 
mouth.  
o 
Mean value will be used as the subject’s normal swallowing pressure  
3.  Subject’s exercise protocol instructions (as indicated) will briefly be reviewed to confirm subject’s 
understanding/correct completion of assigned exercise protocol. 
(1) No exercise 
(2) Active 
tongue 
exercise 
(3) Active 
tongue 
exercise + 
Mental 
practice 
exercise 
(4) Mental 
practice 
exercise 
4. Investigator instructs subject to 
complete 1 set (10 repetitions in 
each direction – 
open/close/lateralization/protrusion) 
of placebo exercise, 3x day, 3 
days/week for two weeks. 
 
4. Investigator 
instructs subject 
to complete 1 set 
(10 repetitions) 
in each direction 
(protrusion, 
elevation, left, 
right), 3x day, 3 
days/week for 
two weeks. 
o 
Additional 
tongue 
depressors 
will be 
provided to 
subject as 
needed. 
4. Investigator 
instructs subject to 
complete 1 set of 
active tongue exercise 
(10 repetitions) in 
each direction 
(protrusion, elevation, 
left, right), 3x day, 3 
days/week for two 
weeks. 
o 
Additional 
tongue 
depressors 
will be 
provided to 
subject as 
needed. 
AND 
 
Following completion 
of all reps of the 
active exercises in a 
given set (10 reps per 
direction for 40 reps 
total), subject will 
find quiet spot 
(without distraction) 
4. Investigator 
instructs subject 
to complete 1 
set of mental 
practice 
exercise (10 
repetitions) in 
each direction 
(protrusion, 
elevation, left, 
right), 3x day, 3 
days/week for 
two weeks. 
 

 
 
 
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to complete mental 
practice exercises, 
including 10 
repetitions per 
direction (40 reps) of 
mental practice 
tongue exercises. This 
will be repeated 
3x/day, 3 days a week 
for 2 weeks.  
5. Investigator reminds subject to continue to complete the record form each week. 
6. An appointment will be scheduled for Visit #3 around two weeks following Visit #2. Attempt to schedule 
subsequent visits at a consistent time of day, so that max measurements are taken around the same time of 
day each visit, preferably at the time of day the subject feels strongest. 
 
Visit #3 (end of Week 4) (anticipated 30 minutes in length): 
1. Investigator will measure subject’s maximum/peak tongue pressure using IOPI device. 
o 
Six measurements will be taken, with 30-40 seconds between each.  
o 
Mean value will be used as the subject’s maximum tongue strength 
2. Investigator will measure subject’s regular swallowing pressures using the IOPI device. Swallows will be 
completed using the participant’s saliva (no water or other liquid given during measurement).  
o 
Six measurements will be taken, with 30-40 seconds between each.  
o 
Participants will be given 20-30 mL of water to swallow between each rep to help moisten the 
mouth.  
o 
Mean value will be used as the subject’s normal swallowing pressure  
(1) No exercise 
(2) Active 
tongue 
exercise 
(3) Active 
tongue 
exercise + 
Mental 
practice 
exercise 
(4) Mental 
practice 
exercise 
3. Investigator instructs subject to 
complete 1 set (10 repetitions in 
each direction – 
open/close/lateralization/protrusion) 
of placebo exercise, 3x day, 3 
days/week for two weeks. 
3. Investigator 
instructs subject 
to complete 1 set 
(10 repetitions) 
in each direction 
(protrusion, 
elevation, left, 
right), 3x day, 3 
days/week for 
two weeks. 
o 
Additional 
tongue 
depressors 
3. Investigator 
instructs subject to 
complete 1 set of 
active tongue exercise 
(10 repetitions) in 
each direction 
(protrusion, elevation, 
left, right), 3x day, 3 
days/week for two 
weeks. 
o 
Additional 
tongue 
depressors 
will be 
3. Investigator 
instructs subject 
to complete 1 
set of mental 
practice 
exercise (10 
repetitions) in 
each direction 
(protrusion, 
elevation, left, 
right), 3x day, 3 
days/week for 
two weeks. 

 
 
 
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will be 
provided to 
subject as 
needed. 
provided to 
subject as 
needed. 
AND 
 
Following completion 
of all reps of the 
active exercises in a 
given set (10 reps per 
direction for 40 reps 
total), subject will 
find quiet spot 
(without distraction) 
to complete mental 
practice exercises, 
including 10 
repetitions per 
direction (40 reps) of 
mental practice 
tongue exercises. This 
will be repeated 
3x/day, 3 days a week 
for 2 weeks.  
 
4. Investigator reminds subject to continue to complete the record form each week and to bring completed 
record form to next, final visit (#4). 
5. An appointment will be scheduled for Visit #4 around two weeks following Visit #3. Attempt to schedule 
subsequent visits at a consistent time of day, so that max measurements are taken around the same time of 
day each visit, preferably at the time of day the subject feels strongest. 
6. Investigator will process subject’s second $20 participation incentive. 
 
Visit #4 (end of Week 6/Final session) (anticipated 30-45 minutes in length): 
 
     1. Investigator will measure subject’s maximum/peak tongue pressure using IOPI device. 
o 
Six measurements will be taken, with 30-40 seconds between each.  
o 
Mean value will be used as the subject’s maximum tongue strength 
2. Investigator will measure subject’s regular swallowing pressures using the IOPI device. Swallows will be 
completed using the participant’s saliva (no water or other liquid given during measurement).  
o 
Six measurements will be taken, with 30-40 seconds between each.  
o 
Participants will be given 20-30 mL of water to swallow between each rep to help moisten the 
mouth.  
o 
Mean value will be used as the subject’s normal swallowing pressure  
3. Investigator will collect subject’s completed record form for review and storage. 
4. Investigator will process subject’s third (final) $20 participation incentive. 

 
 
 
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4. Thank you letter/email will be sent to subject. 
 
Statistical Analysis 
Tongue strength means (max and during swallowing) will be analyzed using SPSS in a three way 
mixed ANOVA. 
5. Sample size 
It is anticipated that around 20-30 subjects will be recruited to participate in this study at 
USFSM. 
6. Study Population or inclusion and exclusion criteria 
Participants will be healthy older adults without a history of swallowing problems or 
neurological disorders. Inclusion/exclusion criteria are stated below.  
Inclusion criteria include: 
• 
Adults aged 60-89 
• 
< 3 on EAT-10 (part of health questionnaire) 
• 
Mean of ≥2.5 on the KVIQ-10 questions (Kinesthetic and Visual Imagery Questionnaire, 
short version), a screening questionnaire that assesses a person’s motor imagery abilities 
• 
> 24 on MMSE (Mini Mental State Examination), a screening questionnaire that assesses 
cognitive abilities. 
• 
Availability to complete a consecutive 6-week exercise regimen 
• 
There are certain conditions that are common to the aging study population we are 
recruiting which will be acceptable: controlled hypertension and controlled diabetes 
mellitus 
 
Exclusion criteria include: 
• 
History of diagnosed dysphagia (swallowing disorder) 
• 
History of a seizure(s) 
• 
Current or past problem with pain disorders involving the jaw muscles or joint of the 
mandible (e.g., TMJ disorder or myofacial pain disorder) – these are contraindicated for 
tongue strengthening exercises 
• 
Presence of oral piercings/oral apparatus that may interfere with tongue exercises 
• 
Medical conditions that would affect oral motor performance (e.g., history of acute or 
degenerative neurological condition, head/neck cancer), as determined by investigator 
• 
History of a diagnosed dementia or other cognitive impairment 
• 
Uncontrolled high blood pressure 
• 
Visual impairment that would prevent the subject from independently viewing written 
mental exercise instructions and visual images, corrected contacts or lenses are 
acceptable  

 
 
 
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• 
Hearing impairment that would prevent the subject from receiving verbal instruction 
from investigators 
• 
Motor impairment or injury that would interfere with subject’s ability to independently 
manipulate a lightweight, portable counter clicker tool or perform jaw exercises. 
• 
English is not the person’s primary language 
 
 
No potential subject will be disqualified based on information regarding ethnicity, race, gender, 
sex, or socioeconomic status information.  
 
7. The expected results of the research, such as reports, papers, and contributions to theory 
It is anticipated that the results of the proposed research study will significantly contribute to 
the field of speech-language pathology, both in its pioneered innovation as an approach not 
yet explored for muscles important to swallowing and as a potential therapeutic intervention 
technique that may advance patient care. Further, the results of the study may also inform 
preventative wellness and care in speech-language pathology, as the normal aging process 
can include lingual weakening and dysphagia in the typical aging population, in those 
without a contributing disease process. Data may be presented at national/international 
conferences. Data may be published in peer-reviewed journals. Data may be used as pilot 
data for grant applications. The audience interested in our reported work will include speech-
language pathologists, rehabilitation specialists, neuropsychologists, and neurologists. 
8. Name of the Principal Investigator and Faculty Advisor if applicable 
The Principal Investigator is Dr. Sarah Hegyi, an Assistant Professor of Communication 
Sciences & Disorders at University of South Florida Sarasota-Manatee and a licensed/certified 
Speech-Language Pathologist.  
9. Any potential risks to the subjects 
There is no known risk for motor imagery exercises. There are no known risks for oral motor 
exercises (tongue strengthening exercises).  
10. Any experimental procedures or interventions that will be implemented 
Study groups will include: 1) placebo (jaw exercises with relaxation exercises), 2) active tongue 
exercises only, 3) active tongue exercise + motor imagery of tongue exercises, and 4) motor 
imagery of tongue exercises only. Experimental interventions include groups 3 and 4. 
11. Any potential benefits to subjects 
Depending on group assignment, participants will be participating in a tongue strengthening 
protocol, which may have specific swallowing related benefits; however, this will not be directly 
measured and there is no guarantee of any swallow related benefit.  
12. Human subjects considerations including ∙ description of the informed consent process; 
∙ discussion of how the privacy and confidentiality of the subjects will be maintained.  

 
 
 
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Participation will be entirely voluntary and an extensive inclusion/eligibility screening process 
will be completed prior to the informed consent process. Consent will be obtained prior to the 
screening process (both over the phone and/or via email/mail prior to obtaining the Screening 
Inclusion-Eligibility and EAT-10 screening forms completion and prior to beginning the in-
person screening session). Should a participant qualify for the study, the informed consent form 
will be reviewed with the subject, providing ample time as needed to answer subject questions 
prior to voluntary signature. The privacy and confidentiality of the participants will be 
maintained. Telephone screenings and in-person visits will be completed in private and 
confidential locations. All data will be stored on Dr. Hegyi’s password-protected USFSM laptop. 
Study files on this laptop will also be password-protected. The data on the laptop will be 
encrypted for protection, in case the laptop is lost or stolen. Each subject’s identity will be 
disassociated from the subject’s personal data - a subject number will be assigned to each subject 
upon signing of the informed consent. Physical data (e.g., subject record forms) will be identified 
according to subject number as much as possible. All physical data will be stored in a locked 
desk cabinet in the secure and locked office of the investigator. Only Dr. Hegyi will have access 
to the desk cabinet key.  
Tongue strength measures from each of the four sessions will be recorded on paper forms for 
convenience and transferred to a digital spreadsheet after each session. Participant record forms 
for weeks of practice will be in paper format. All paper forms will be identified only by 
participant ID. Tongue strength measures (kPa) will be transferred to a digital spreadsheet (de-
identified). Participant record forms (de-identified) will be scanned into digital format. De-
identified paper forms will be stored in a locked file cabinet in Dr. Hegyi’s office, which requires 
lock/key access. Spreadsheets of tongue strength measures will be stored on Dr. Hegyi’s USFSM 
laptop, which is password protected and requires permission by Dr. Hegyi to access. Non-
USFSM researchers at JMU and LLU will have access to de-identified digital data in spreadsheet 
format. De-identified data will be shared between universities using a password protected 
Dropbox account. The only identifiable information that will be shared between study sites will 
include participants’ first/last names and email addresses so that the USFSM study site can 
process participant incentives in the form of Amazon gift cards. The JMU, LLU, and TCU study 
site principal investigators will send Dr. Hegyi individual participant names and emails included 
in an encrypted Word document, which will be used to generate an Amazon gift card as payment 
for the completed session, according to the compensation schedule above. As participants get 
paid in three installments, this will be done three times for each participant. Dr. Hegyi will delete 
the encrypted file as soon as the gift card is sent by email. All other study data will remain shared 
in de-identifiable form only. 
Only de-identified data will be kept after the project ends. Consent forms will be destroyed five 
years after publication.  

 
 
 
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13. If the study is greater than minimal risk, describe the data and safety monitoring plan, 
whether or not there is a data and safety monitoring board, how often data will be 
reviewed for safety, early stopping criteria, etc.  
We do not anticipate the study involving greater than minimal risk. Participation will be entirely 
voluntary and subjects will be allowed to opt-out of the study at any time. 
14. Research references 
 
Dickstein, R., & Deutsch, J. E. (2007). Motor imagery in physical therapist practice. Physical 
Therapy, 87(7), 942-953.  
Peters, H. T., & Page, S. J. (2015). Integrating mental practice with task-specific training and 
behavioral supports in poststroke rehabilitation: Evidence, components, and augmentative 
opportunities.  Phys Med Rehabil Clin N Am., 26(4), 715-727.  
Taktek, K. (2004). The effects of mental imagery on the acquisition of motor skills and 
performance: A literature review with theoretical implications. Journal of Mental Imagery, 
29, 79-114.