The Effects of Kinesio Tape® on Arthrogenic Muscle Inhibition and Rate of Torque Development
Phase: NA
Conditions: Neural Inhibition, Injuries, Ankle
Sponsor: Oregon State University

Human Research Protection Program 
Institutional Review Board 
Office of Research Integrity 
B308 Kerr Administration Building, Corvallis, Oregon 97331-2140 
(541) 737-8008 
IRB@oregonstate.edu | http://research.oregonstate.edu/irb  
1 
HRPP Form | v. date May 2016 
 
RESEARCH PROTOCOL 
 
RESEARCH PROTOCOL 
July 13, 2017 
1. 
Protocol Title: The Effects of Kinesio Tape® on Arthrogenic Muscle Inhibition and 
Rate of Torque Development  
PERSONNEL 
2. 
Principal Investigator: Marc Norcross, PhD, ATC  
3. 
Student Researcher(s): Yu-Lun Huang, MS, ATC 
4. 
Co-investigator(s): Sam Johnson, PhD, ATC, CSCS; Cathleen Brown Crowell, 
PhD, ATC 
5. 
Study Staff: Whitley Nelson  
6. 
Investigator Qualifications 
The PI, Dr. Norcross, and Dr. Crowell both have a Ph.D. in Human Movement Science 
(Biomechanics) and extensive experience in neuromechanics research including 
research on lower extremity injury prevention. Dr. Johnson has a Ph.D. in Exercise 
Science and has previously conducted multiple research investigations using the 
methodology that will be employed in this investigation. 
7. 
Training and Oversight 
Yu-Lun Huang is a doctoral student in Kinesiology under the direction of Dr. Norcross. 
She is a certified athletic trainer, and has experience providing treatment and injury 
prevention protocols to athletes. Ms. Nelson has been/ will be trained by the PI, co-
Investigator, or Ms. Huang prior to performing any data collection, reduction, or 
analysis, and have completed the research ethics and compliance training.  Ms. Nelson 
will be under direct supervision by either the PI, a co-Investigator, or Ms. Huang during 
all testing sessions to oversee and direct their involvement in the project.   
If additional study staff is recruited to assist in this project throughout data collection, 
reduction, and analysis, the PI will ensure that: 
1) they complete ethics and compliance training 
2) they undergo rigorous training on the study procedures 
3) a project revision form is submitted and approved by the IRB before any contact 
with participants or participants’ data.  
8. 
Conflict of Interest 
There are no conflicts of interest to disclose. 
 
 
 
FUNDING 

 
Marc Norcross, PhD, ATC 
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July 13, 2017 
9. 
Sources of Support for this project (unfunded, pending, or awarded) 
 
This project is unfunded. 
 
DESCRIPTION OF RESEARCH 
10. Description of Research 
Decreased ability to voluntarily activate the entire motoneuron (MN) pool following joint 
injury is known as arthrogenic muscle inhibition (AMI), which is commonly quantified by 
measuring central activation ratio (CAR). AMI is not only observed immediately after 
joint injury, but has been shown to persist during and after rehabilitation. It is proposed 
that AMI, by negatively impacting neuromuscular factors such as muscle strength, 
muscle activation, and rate of torque development (RTD), contributes to a prolonged 
rehabilitation process and higher risk of re-injury. Unfortunately, AMI cannot be reduced 
by traditional rehabilitation interventions such as strength training alone. Therefore, it is 
necessary to identify an intervention that can effectively decrease AMI in order to 
facilitate improvements in muscle function in individuals with AMI.  
Kinesio Tape® is commonly used to facilitate muscle contraction in athletic populations. 
This elastic therapeutic tape is popular in the athletic setting because it can be applied 
and used continually during exercise and activities of daily living for up to 2-3 days 
without restricting movement. It has been suggested that Kinesio Tape® facilitates 
muscle contraction by inducing increased sensory input via skin stimulation. The tape 
activates cutaneous mechanoreceptors with the greater afferent  feedback thought to 
improve the efferent output from the central nervous system to the target muscles 
(Akbaş, Atay, & Yüksel, 2011; Yoshida & Kahanov, 2007). While this technique is widely 
used in the clinical setting to improve muscle function, the facilitative effect of Kinesio 
Tape® has not been demonstrated- perhaps due to three key limitations of previous 
investigations. First, previous studies have predominantly recruited healthy participants 
without muscle function deficits. Therefore, there could have been a ceiling effect 
whereby there was no observable effect of Kinesio Tape® due to a lack of muscle 
dysfunction in these healthy individuals. Second, most investigators have generally 
taken outcome measurements immediately before Kinesio Tape® application and less 
than 24 hours later. This is much shorter than the 2-3 days that Kinesio Tape® is used 
clinically and may not be long enough to induce an observable, facilitative effect.  Finally, 
the protocols utilized in previous investigations also failed to mimic clinical practice by 
not combining Kinesio Tape® application with a therapeutic exercise protocol targeting 
the inhibited muscle.  
 
Therefore, the purpose of this study is to investigate the effects of prolonged application 
(> 48hours) of Kinesio Tape® incorporated with a therapeutic exercise protocol on AMI 
and muscle function.  To do so, we will use the peroneus longus muscle in individuals 
with functional ankle instability (FAI) as a model, given that AMI has been shown to 
exist in this muscle in individuals with FAI (McVey, Palmieri, Docherty, Zinder, & 
Ingersoll, 2005).  
 
The following specific aims will be tested: 

 
Marc Norcross, PhD, ATC 
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July 13, 2017 
 
Aim#1. To investigate the effect of prolonged application (> 48hours) of Kinesio 
Tape® incorporated with a therapeutic exercise protocol on AMI of the peroneus 
longus in individuals with FAI.  
Aim#2. To investigate the effect of prolonged application(> 48hours) of Kinesio 
Tape®  incorporated with a therapeutic exercise protocol on peroneus longus 
muscle function in individuals with FAI. 
Our central hypothesis is that prolonged application of Kinesio Tape® in combination 
with therapeutic exercise will diminish AMI and improve muscle function of the inhibited 
peroneus longus muscle.  
The results of this study will be submitted for publication to a clinical, peer-reviewed 
journal and/or presented at scientific meetings. In addition, the results of this study will 
guide clinicians who work with patients with joint injuries to have a better understanding 
of whether Kinesio Tape® is a beneficial intervention to reduce AMI, and whether any 
facilitative effect of the motor neuron pool results in greater muscle function. If Kinesio 
Tape® is shown to be an effective intervention for reducing AMI and increasing muscle 
function, this investigation would provide a much-needed evidence base regarding the 
clinical usefulness of Kinesio Tape® during rehabilitation for patients with AMI.  
11. Background Justification 
Muscle weakness and joint instability resulting from alteration of neuromuscular control 
have been reported following joint injury (Delahunt, 2007; McVey et al., 2005). This 
protective response adapted following injury is known as arthrogenic muscle inhibition 
(AMI) (Palmieri et al., 2005; Pietrosimone, Hertel, Ingersoll, Hart, & Saliba, 2011). 
Unfortunately, traditional rehabilitation and strength training are unable to reduce AMI 
(Palmieri-Smith, Hopkins, & Brown, 2009). As a result, AMI not only causes muscle 
strength deficits, prolongs the rehabilitation process, and delays time to return to play, 
but also may predispose patients to further injury (J T Hopkins & Ingersoll, 2000; Suter 
& Herzog, 2000). Therefore, effective interventions for reducing AMI should be identified.   
Kinesio Tape® is widely used to treat neuromuscular injuries in athletic populations. 
Kinesio Tape® is proposed to facilitate muscle activation by stimulating cutaneous 
mechanoreceptors, which may reduce AMI and further improve muscle contraction 
(Akbaş et al., 2011; Yoshida & Kahanov, 2007). However, the effect of Kinesio Tape® 
on reducing AMI has not been established in previous studies.  
Introduction and negative effects of AMI 
It has been suggested that following joint injury, swelling and damage to joint structures 
causes a continuing presynaptic inhibition of muscles, even though these muscles are 
not necessarily injured (J T Hopkins & Ingersoll, 2000). AMI compromises the ability to 
fully contract inhibited muscles voluntarily, and will lead to muscle weakness and 
strength deficits over time (Arnold, Linens, De La Motte, & Ross, 2009). Previous 
studies have shown that AMI has negative effects on muscle strength (Mizner, Stevens, 
& Snyder-Mackler, 2003) as well as RTD. Kline et al. reported that 6 months after 
anterior cruciate ligament reconstruction,  patients had lesser RTD of the quadriceps on 
their injured side compared to the uninjured side (Kline, Morgan, Johnson, Ireland, & 

 
Marc Norcross, PhD, ATC 
Page 4 of 25 
July 13, 2017 
Noehren, 2015). Residual symptoms and complaints following injury including pain, 
swelling, and joint instability may be highly related to AMI. Unfortunately, despite the 
completion of a rehabilitation program following joint injury, AMI is a significant barrier to 
restoring function and can lead to atrophy, poor muscle function, and a prolonged 
rehabilitation process because of not being able to fully contract the inhibited muscles 
during therapeutic exercise (J T Hopkins & Ingersoll, 2000). Without full recovery of 
muscle function, patients are more susceptible to recurrent injury (Fyfe, Opar, Williams, 
& Shield, 2013) and joint instability (Delahunt, 2007; Gutierrez, Kaminski, & Douex, 
2009). For instance, AMI has been found in the peroneal muscle group in individuals 
with functional ankle instability (FAI) (McVey et al., 2005). Following lateral ankle 
sprains, greater than 39% of patients have residual complaints such as instability, pain, 
or giving-way (Verhagen, De Keizer, & Van Dijk, 1995) that  may be related to  AMI of 
the peroneal muscle group. Hence, identifying interventions that can diminish AMI is 
important to improve the effectiveness of rehabilitation.  
Mechanism of AMI 
In order to develop interventions addressing AMI, it is important to understand the 
underlying mechanism. Supraspinal centers play a critical role in modulating signals 
from different sensory afferent receptors and controlling the motor response (D. A. Rice 
& McNair, 2010). Supraspinal centers receive information provided by local joint 
receptors regarding the environment- including joint position and movement-, 
summarize and process that information, and coordinate a proper motor response by 
sending an efferent output to muscles surrounding the joint. However, if the afferent 
input from local receptors is changed due to distension from swelling or damage to 
structures due to a current or previous joint injury (J T Hopkins & Ingersoll, 2000), the 
abnormal afferent stimuli will activate an inhibitory response and decrease the ability to 
voluntarily recruit the motoneuron (MN) pool of the muscles surrounding the joint. In 
consequence, lesser efferent output is delivered to muscles by the MN pool, which 
leads to weaker muscle contraction and impaired muscle function.   
Treatment of AMI 
Previous studies have shown that AMI cannot be overcome by traditional rehabilitation 
and strength training alone (Gutierrez et al., 2009; Palmieri-Smith et al., 2009). Recent 
years has seen increased attention being given to interventions for AMI because AMI 
plays such an important role in a patient’s recovery following joint injury with a wide 
range of interventions including cryotherapy, transcutaneous electrical nerve stimulation 
(TENs), and joint manipulation evaluated (Doeringer, Hoch, & Krause, 2010; Grindstaff 
et al., 2011; J Ty Hopkins & Stencil, 2002; Nishikawa & Grabiner, 1999; Pietrosimone, 
Hart, Saliba, Hertel, & Ingersoll, 2009). The basic concept of these interventions is to 
decrease presynaptic inhibition, and to increase efferent motor output by stimulating 
sensory receptors so that inhibitory interneurons are no longer activated (J T Hopkins & 
Ingersoll, 2000).  
There is conflicting evidence regarding the use of cryotherapy to reduce AMI. While 
cryotherapy effectively increased the motor excitability of inhibited muscle in effusion 
model studies by stimulating thermoreceptors around the joint (J. T. Hopkins, Ingersoll, 

 
Marc Norcross, PhD, ATC 
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Edwards, & Klootwyk, 2002; D. Rice, McNair, & Dalbeth, 2009), it did  not improve 
motoneuron excitability in individuals with functional ankle instability (Doeringer et al., 
2010). Further, Doeringer et al. reported that cyrotherapy had a negative effect on 
muscle strength evidenced by reduced eversion torque after icing. Thus, the effect of 
cryotherapy on reducing AMI is still not clear.  
Instead of stimulating thermorecepteors, the following interventions target other sensory 
receptors. TENs has been shown to increase quadriceps activity in patients with knee 
osteoarthritis by inducing afferent stimuli (Pietrosimone et al., 2009). Similarly, the effect 
of joint manipulation on reducing AMI has also been reported (Grindstaff et al., 2011). 
By stimulating sensory receptors, distal tibiofibular joint manipulation increased 
motoneuron excitability in the soleus, but not the peroneus longus muscle (Grindstaff et 
al., 2011). However, there is a drawback of joint manipulation and TENs treatments with 
respect to the length of time over which these interventions can provide sensory 
stimulation. There is evidence to support that the effects of joint manipulation last 30 
minutes after treatment, but whether the effects last more than 30 minutes is unknown 
(Grindstaff et al., 2011). Further, the residual  effects of a TENs treatment on AMI  have 
not been reported. Therefore, having an intervention, such as Kinesio Tape®, that can 
provide uninterrupted sensory stimulation for a longer period of time while also allowing 
for rehabilitative exercise to be performed concurrently may be highly effective for  
reducing AMI.    
Introduction of Kinesio Tape® 
Kinesio Tape® is commonly used to decrease pain (Aytar et al., 2011; Campolo, Babu, 
Dmochowska, Scariah, & Varuhese, 2013; Kuru, Yaliman, & Dereli, 2012; Parreira, 
Costa, Hespanhol, Lopes, & Costa, 2014), swelling, and facilitate muscle contraction in 
the athletic population (Kamper & Henschke, 2013). This elastic therapeutic tape is 
popular in the athletic field because it can be applied before and during exercise (up to 
2-3 days) without restricting movement. In theory, Kinesio Tape® is believed to increase 
muscle excitability because it induces sensory input via skin stimulations. The stimuli 
activate cutaneous mechanoreceptors to provide afferent input. As a result, this 
feedback is thought to improve efferent output from the central nervous system to the 
targeted muscles (Akbaş et al., 2011; Yoshida & Kahanov, 2007). Thus, due to the 
increased sensory feedback provided by Kinesio Tape®, this intervention may increase 
muscle activation, and improve muscle function and performance (Kase K, Wallis J, 
2003). While the facilitative effects of Kinesio Tape® have not been demonstrated in 
previous investigations, one study investigating the effect of an ankle brace on muscle 
excitation  found that stimulation of cutaneous mechanorecepters around the ankle joint 
increased H-reflex amplitude in the peroneal muscle group (Nishikawa & Grabiner, 
1999). Though it is still unknown if Kinesio Tape® can increase muscle excitability, it is 
possible that Kinesio Tape® might provide the same positive effect by stimulating 
sensory receptors in a similar manner as an ankle brace.  
A number of studies have investigated the effects of Kinesio Tape® on muscle strength 
and functional performance. However, the results are inconsistent. Some studies 
showed that Kinesio Tape® has positive effects on muscle function, including an 

 
Marc Norcross, PhD, ATC 
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July 13, 2017 
increase in hop distance and knee extension peak torque (Aktas & Baltaci, 2011), 
quadriceps eccentric muscle strength (Vithoulka et al., 2010), and explosive power of 
the gluteus maximus (Mostert-Wentzel et al., 2012). In contrast, the results from other 
studies indicate that Kinesio Tape® does not increase knee extension torque (Serra et 
al., 2015) and muscle strength (Fu et al., 2008; Gómez-Soriano et al., 2014). Recently, 
one meta-analysis summarized the effect of Kinesio Tape® on muscle function. It 
reported that Kinesio Tape® had some positive effects on muscle strength, but that the 
changes were negligible (Williams, Whatman, Hume, & Sheerin, 2012). In addition, this 
meta-analysis indicated that the long-term effects of Kinesio Tape® on muscle strength 
and the underlying mechanism of potential facilitative effects are still unclear. The 
authors concluded that small effects might result from insufficient application duration, 
which is less than 24 hours in most previous studies (Aktas & Baltaci, 2011; Fu et al., 
2008; Serra et al., 2015). Thus, the researchers recommended future studies to 
investigate the long-term effects of Kinesio Tape® application on muscle function 
(Williams et al., 2012). The authors also identified a common weakness in previous 
studies was the inclusion of healthy subjects instead of subjects with AMI (Williams et 
al., 2012). In the clinical setting, it is recommended to apply Kinesio Tape® for up to 2-3 
days, and Kinesio Tape® is usually coupled with therapeutic exercises and active 
movements to increase the effect of skin stimulation. As a result, it is critical that future 
studies recruit individuals exhibiting AMI to determine whether Kinesio Tape® has a 
facilitative effect that can reverse muscle inhibition. 
Gap in Knowledge 
The effectiveness of Kinesio Tape® to reduce AMI and improve muscle function is 
unknown. According to previous studies, the treatment approach that has been used to 
reduce AMI is to increase sensory input to eliminate the inhibitory response that occurs 
following joint injury. Given this rationale and the fact that Kinesio Tape® can stimulate 
cutaneous mechanoreceptors, this intervention may be effective for increasing efferent 
output and muscle performance. It is also apparent that it is critical to recruit individuals 
exhibiting AMI and replicate clinical practice by coupling Kinesio Tape® with therapeutic 
exercise when determining the facilitative effects of Kinesio Tape®. Individuals with 
functional ankle instability are known to exhibit AMI of their peroneal muscles. Therefore, 
by using this injured population as a model, we can investigate the effects of a 
combination of prolonged Kinesio Tape® application (>48 hours) and therapeutic 
exercise on AMI and muscle function.   
12. Subject Population 
The total enrollment number will be up to 70 participants with unilateral functional ankle 
instability (FAI). Age of the participants will be between 18 and 35 years-old. A minimum 
age of 18 has been selected to minimize the potential confounder of physical 
maturation. Participation in this study is restricted to individuals with FAI because 
previous research has demonstrated that AMI is present in the peroneal muscles of this 
specific population. FAI is common in both males and females (Gribble et al., 2014). 
Individuals will be eligible to participate in this study if they meet the following inclusion 
criteria which are endorsed by the International Ankle Consortium (Gribble et al., 2014): 

 
Marc Norcross, PhD, ATC 
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July 13, 2017 
1. 
A history of at least one significant ankle sprain on the involved (injured) limb 
i. 
The initial sprain must have occurred at least 12 months prior to the 
study enrollment   
ii. 
Was associated with inflammatory symptoms (pain, swelling, etc.)  
iii. 
Created at least one interrupted day of desired physical activity. 
2. 
The most recent injury on the involved (injured) ankle must have occurred more 
than 3 months prior to the study enrollment.   
3. 
 A history of the involved (injured) ankle joint ‘giving way’, and/or recurrent sprain 
and/or ‘feelings of instability’ on the involved (injured) limb  
Participants should report at least 2 episodes of ‘giving way’ in the 6 months prior 
to the study enrolment.  
4. 
Be 18-35 years of age 
5. 
Have not had a past allergic reaction to Kinesio Tape® 
The definition of an ankle sprain as “An acute traumatic injury to the lateral ligament 
complex of the ankle joint as a result of excessive inversion of the rear foot or a 
combined plantar flexion and adduction of the foot. This usually results in some initial 
deficits of function and disability” (Delahunt et al., 2010). The definition of ‘giving way’ is 
“The regular occurrence of uncontrolled and unpredictable episodes of excessive 
inversion of the rear foot (usually experienced during initial contact during walking or 
running), which do not result in an acute lateral ankle sprain” (Delahunt et al., 2010). 
The definition of ‘recurrent sprain’ as “Two or more sprains to the same ankle”.  The 
definition of feeling of ankle joint instability is “The situation whereby during activities of 
daily living (ADL) and sporting activities the subject feels that the ankle joint is unstable 
and is usually associated with the fear of sustaining an acute ligament sprain” (Delahunt 
et al., 2010).  
Individuals will be ineligible to participate if they: 
1. 
Have a history of previous surgeries to the musculoskeletal structures (i.e., 
bones, joint structures, nerves, etc.) in either lower extremity.  
2. 
Have a history of a fracture in either lower extremity requiring realignment.  
3. 
Had acute injury to the musculoskeletal structures of other joints of either lower 
extremity in the previous 3 months which impacted joint integrity and function 
(i.e., sprains, fractures, etc.) and resulted in at least 1 interrupted day of 
desired physical activity.  
4. 
Are not able to be matched according to our group allocation procedure 
5. 
Have had a past allergic reaction to Kinesio Tape® 
6. 
Currently display symptoms of an acute sprain including swelling, heat, 
redness, pain, discoloration, and/or loss of range of motion or function 

 
Marc Norcross, PhD, ATC 
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July 13, 2017 
7. 
Any diagnosed vestibular disorder, Charcot-Marie-Tooth disorder, Ehlers-
Danlos, or other hereditary nerve, balance or connective tissue disorder 
8. 
Report a possibility that they may be pregnant as hormonal changes may 
affect ligamentous laxity 
9. 
Have suffered more than one ankle sprain on the uninvolved limb 
10. Have had an ankle sprain on the uninvolved limb within the past 12 months 
11. Have episodes of giving way of the ankle on the uninvolved limb besides the 
single time when they may have sprained this ankle. 
 
Participants in this investigation will be matched by gender and whether the limb with 
FAI is the dominant or non-dominant leg. Limb dominance will be identified by asking 
which leg will be used to kick a soccer ball for distance during the initial screening via 
phone, and will be confirmed during the in-depth screening and familiarization session. 
Twenty individuals will be allocated to the control and Kinesio Tape® intervention 
groups, respectively. Given our inclusion criteria, there are four possible sub-
classifications of participants: 1) female with FAI of the dominant limb, 2) female with 
FAI of the non-dominant limb, 3) male with FAI of the  dominant limb, and 4) male with 
FAI of the non-dominant limb. To ensure balanced and matched control and intervention 
groups, we will only schedule for an in-depth eligibility screening (please see Section 14) 
participants who: 1) can be matched on gender and limb dominance to a participant 
who has already been enrolled in the study, or 2) can be matched by a future participant 
of the same sub-classification without exceeding our target sample size of 20 per group. 
During the in-depth screening and familiarization session, three FAI self-report 
questionnaires (see Attachment A: Screening Questionnaires) and two clinical tests of 
the ankle (please see Section 14) will be implemented to determine if participants have 
unilateral FAI and a clearly uninvolved, uninjured “control” limb. If participants do not 
meet the criteria of the three FAI self-report questionnaires and two ankle tests, the 
participant will be excluded from further participation in the study.  
 
We aim to enroll 40 subjects (20 individuals per group) that will successfully complete 
all study procedures. This sample size is based upon an a priori power analysis that 
indicated that 20 participants per group is necessary to detect a medium size interaction 
effect (f = .23) with a power of 0.80 and an alpha level of 0.05 (G*Power 3.1.9.2). 
However, our total enrollment will be to up to 70 participants to account for participant 
drop-out and withdrawals due to failed eligibility screening or an inability to match 
participants using the process described above.  
Recruitment: 
Participants will be recruited through the posting of fliers in on-campus buildings (see 
Attachment B: Recruitment Flier); through brief presentations made to Oregon State 
University classes that are not taught by any of the research team after obtaining the 
instructor’s permission (see Attachment C: Recruitment In-Class Guide); and by word of 
mouth. Additionally, we will post fliers (see Attachment B: Recruitment Flier) in local 
physical  therapy clinics, medical offices, and fitness clubs, after obtaining appropriate 

 
Marc Norcross, PhD, ATC 
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July 13, 2017 
approval from these entities, in order to increase the potential participant pool to include 
active individuals in the community who may not be reached via on-campus recruitment 
methods.  Interested individuals will be instructed to contact the research staff either by 
telephone or e-mail. We will not perform any direct recruitment of employees, students, 
or community members except for the in-class method previously described.      
 
13. Consent Process 
Individuals that respond to recruitment will go through an oral consent process via 
phone followed by a short screening process. These procedures will be used to 
eliminate the burden of time and expense associated with coming to the Women’s 
Building on the OSU campus for individuals who are either ineligible to participate in the 
study or who will not be able to be matched to enrolled study participants according to 
our group allocation procedures.   
Potential participants responding to recruitment via phone will complete the oral consent 
and initial screening process either immediately or at a time that is scheduled with the 
research staff during the initial call. Potential participants that respond to recruitment via 
email will receive an email response (see Attachment D: Email Response to 
Recruitment) requesting to schedule a phone conversation. During the oral consent 
process, a researcher will explain the study, the criteria for eligibility, and the rights of 
participants to the interested individual (see Attachment E: Oral Consent Guidelines and 
Screening).  If the potential participant is still interested in participating, he/she will 
provide oral consent and then be screened for eligibility. Participants will be asked 
questions to determine if they meet the initial screening criteria and are able to be 
matched based upon the group allocation plan. Participants meeting these criteria will 
then be scheduled for a 60 minute in-depth eligibility screening and familiarization 
session (please see Section 14) and will be sent an email to confirm their appointment  
(see Attachment F: Confirmation of  In-depth Eligibility and Familiarization Session). If a 
participant is unable to schedule the in-depth screening and familiarization session 
immediately following the initial phone screening, he/she will be asked to email available 
dates and times to the research staff. If additional communication with participants is 
needed, we will only contact them via phone or by email using the contact information 
that they have provided.    
Written consent will be obtained from participants at the start of their in-depth eligibility 
screening and familiarization session in the Women’s Building on the OSU campus. In 
order to obtain written consent from participants, the following steps will be taken: 
• 
Step 1: They will read the informed consent document by themselves (Attachment 
G: Written Consent Form).  
• 
Step 2: The participant will be asked to verbally summarize the contents of the 
consent document to make sure the participant fully understands the procedures.  
• 
Step 3: The researcher will clarify if any misunderstanding of the concepts or 
questions exist, and will ask the participant if he or she has any questions and 
answer those questions until the participant fully understands the study procedures.  
• 
Step 4: The participant will be informed that their participation is voluntary and they 

 
Marc Norcross, PhD, ATC 
Page 10 of 25 
July 13, 2017 
have the right to withdrawal from this study without any consequence.  
• 
Step 5: Subject signatures indicate that the study has been explained to them, all of 
their questions have been answered, and they agree to be in the study. Researcher 
signatures indicate that the study was explained to the subject, comprehension was 
assessed and found to be sufficient, and the subject provided consent to participate 
in the study. If they do not consent to being in the study, no other information will be 
collected.  
Over the course of the study, testing will be stopped immeditaely if the participant is not 
willing to continue.   
 
14. Eligibility Screening 
 
All study participants will complete an in-depth eligibility screening in the Women’s 
Building on the Oregon State University campus.  
To be eligible to continue participating in the study, the individual must meet the specific 
criteria for FAI and be deemed to not have mechanical ankle instability on the involved 
(injured) limb. In addition, the individual must meet the specific criteria for lack of FAI on 
the uninvolved (control) limb.  First, the individual will complete the general checklist 
(see Attachment H: General checklist) and Tegner Activity Scale (see Attachment I: 
Tegner Activity Scale) by themselves to confirm if he/she meet the general inclusion 
criteria. He/she will also complete the Functional Ankle Instability Questionnaire (FAIQ), 
Ankle Instability Instrument (AII) and the Cumberland Ankle Instability Tool (CAIT) (see 
Attachment A: Screening Questionnaires). Lastly, the talar tilt test and anterior drawer 
test will be performed by student researcher, Yu-Lun Huang, who is a certified athletic 
trainer and qualified to perform these tests.  
The talar tilt and anterior drawer are two commonly-used clinical special tests that have 
previously been used to identify mechanical ankle instability (Palmieri-Smith et al., 
2009). We will use the talar tilt test to check the integrity of the calcaneofibular ligament, 
and the anterior drawer test to check the integrity of the anterior talofibular ligament. 
The procedures for conducting these special tests are fully described in section 15.  
Specific criteria  for determining FAI on the involved (injured) limb: 
o 
Functional Ankle Instability Questionnaire (Hubbard & Kaminski, 2002): 
i. 
”Yes” for questions 3, 5, 6, 7, and 9  
ii. 
“No” for questions 4, 8, and 10  
iii. 
No clinical signs of mechanical instability can be present (see below).  
o 
Ankle Instability Instrument  (Gribble et al., 2014): 
i. 
“Yes” for question 1 
ii. 
“Yes” for  at least 4 other questions. 

 
Marc Norcross, PhD, ATC 
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July 13, 2017 
o 
Cumberland Ankle Instability Tool (CAIT)  (Gribble et al., 2014): 
i. 
Total score < 24 
 
Specific criteria for determining lack of FAI on the uninvolved (control) limb: 
o 
Functional Ankle Instability Questionnaire (Hubbard & Kaminski, 2002): 
i. 
”Yes” to question 1 
ii. 
“No” to question 4 
iii. 
No clinical signs of mechanical instability can be present (see below).  
o 
Ankle Instability Instrument  (Gribble et al., 2014): 
ii. 
“No” to all questions 
o 
Cumberland Ankle Instability Tool (CAIT)  (Gribble et al., 2014): 
i. 
Total score ≥ 28  
 
Specific procedure for ruling out mechanical ankle instability 
i. 
Talar tilt test and anterior drawer test will be performed as described in 
Section 15 to detect and rule out individuals with mechanical ankle 
instability  
ii. 
If both or one of these tests is positive, the participant will be excluded 
Potential participants that are determined to be ineligible by the screening will be 
thanked for their participation and withdrawn from the study. They will be asked not to 
provide any further information, and will not be scheduled for future testing sessions. 
The researcher will retain the individual’s name, contact information, and reason for 
ineligibility in a secure document that will be retained along with the documentation of 
consent that was provided. 
Participants that are determined to be eligible by the in-depth screening will immediately 
complete a familiarization session as described in Section 15 below and be scheduled 
for two additional testing sessions.  
 
15. Methods and Procedures 
Study Overview:  
Participants will complete an initial phone screening and report to the Women’s 
Building at Oregon State University for three different study sessions: 
ii. 
Session 1: Written consent, in-depth eligibility screening, and 
familiarization session 
iii. 
Session 2: Testing session A 
iv. 
Session 3: Testing session B 

 
Marc Norcross, PhD, ATC 
Page 12 of 25 
July 13, 2017 
 
Protocol  
Session 1:  
o 
Participants will complete the written consent  
o 
Eligibility screening  
i. 
Complete the general checklist (see Attachment H: General Checklist) and 
the Tegner Activity Scale (see Attachment I: Tegner Activity Scale) 
o 
Complete the Functional Ankle Instability Questionnaire, the Ankle Instability 
Instrument and the Cumberland Ankle Instability Tool (see Attachment A: 
Screening Questionnaires). These are patient-reported outcome measures 
from self-report questionnaires that indicate the perceived level of function, 
pain, etc. These are not medical records from a physician or other provider. 
o 
Talar tilt test and anterior drawer test will be performed on both ankles. The 
testing procedures and the signs of positive test are described below (Starkey 
et all., 2015) : 
Talar tilt test:  
o 
Participant position: sitting with legs over the edge of a table 
o 
Procedure: the examiner will first use one hand to stabilize the leg, and use 
the other hand to grasp the calcaneus and talus and provide an inversion 
stress by rolling the calcaneus medially to evaluate the integrity of the 
calcaneofibular ligament. 
During the testing, the ankle 
will be maintained in 
approximately 10 degrees of 
dorsiflexion (Figure 1).  
o 
Positive test: if the talus tilts 
excessively compared with 
the uninvolved ankle or 
lacking of end feel, the result 
will be determined as 
positive.  
 
 
 
 
 
 
 
Figure 1: the left picture is the starting position 
and the right picture is the end position  

 
Marc Norcross, PhD, ATC 
Page 13 of 25 
July 13, 2017 
 
       Anterior drawer test 
o 
Participants position: sitting over the edge of the table with the knee flexed  
o 
Procedure: the examiner will first use one hand to stabilize the leg, and use 
the other hand to cup the calcaneus while the forearm supports the foot in a 
position of slight plantarflexion. The examiner will then draw the calcaneus 
and talus forward while 
stabilizing the distal leg to 
evaluate the integrity of 
the talofibular ligament. 
(Figure 2).  
o 
Positive test: if the talus 
slides anteriorly from 
under the ankle mortise 
compared with the 
uninjured side, the talus 
subluxates and relocates, 
or there is a lack of a firm 
end feel, the result will be 
determined as positive. 
   Familiarization session: 
The following steps will be taken: 
A. Position the participant on the Biodex dynamometer (Figure 3) 
Participants will be asked to sit on the chair of the dynamometer (Biodex) 
with the hip angle set at 70 to 80 
degrees flexion, and straps placed 
over the chest, waist, and tested leg 
to prevent extra movement during 
testing. The knee will be extended, 
and the participant’s foot strapped 
to the footplate with a Velco strap in 
≈10 degrees of plantar flexion 
(Willems, Witvrouw, Verstuyft, Vaes, 
& De Clercq, 2002) and ≈7 degrees 
of inversion (Aydoǧ, Aydoǧ, Çakci, 
& Doral, 2004). The thigh will be 
supported by a supportive bar. The 
contralateral limb will not be 
restricted.  
 
 
 
Figure 2: the left picture is the starting position and 
the right picture is the end position 
Figure 3. Testing position on the Biodex 
dynamometer 

 
Marc Norcross, PhD, ATC 
Page 14 of 25 
July 13, 2017 
 
B. RTD familiarization  
Participants will be asked to have their arms crossed over their chest to 
perform isometric eversion against the footplate of the dynamometer.  
i. 
They will be instructed to push against the footplate by everting the ankle 
as hard and fast as possible, and maintain the maximum isometric 
contraction for 3 seconds. Sixty second rest intervals will be given 
between each trial to minimize the potential for muscle fatigue (Aydoǧ et 
al., 2004).  
ii. 
The participant will be instructed to only contract their peroneal muscles to 
evert the foot without compensating by using other body parts. The 
research staff will monitor for compensatory movements during the task 
and if any compensation is observed, we will instruct the participant in how 
to eliminate the compensation. 
iii. 
Approximately three to six practice RTD trials will be performed and torque 
data recorded using the Biopac software. Extra practice may be performed  
if necessary until the participant can perform the motion correctly.  
C. Maximal Voluntary Isometric Contraction (MVIC) familiarization 
MVICs will be performed with the participant postioned on the Biodex as 
described above (Figure 3). Participants will be asked to have their arms 
crossed over their chest during these contractions.  
i. 
Participant will be asked to push against the footplate of the Biodex 
dynamometer by contracting his/her foot evertor gradually until reaching 
their maximal effort and to maintain their maximal effort for at least 3 
seconds.  
ii. 
The participant will be instructed to only contract their peroneal muscles to 
evert the foot without compensating by using other body parts. The 
research staff will monitor for compensatory movements during the task 
and if any compensation is observed, we will instruct the participant in how 
to eliminate the compensation. 
iii. 
Approximately three to six practice MVIC trials will be performed and 
torque data recorded using the Biopac software. Extra practice may be 
performed  if necessary until the participant can perform the motion 
correctly.  
D. Repeat RTD familiarization and MVIC familiarization on the other leg. 
E. Ankle exercise protocol familiarization   
Participants will be shown a video to assist in teaching them how to correctly 
perform the below ankle exercises that will be completed during Session 2 of 
the protocol.  Approximately three to six practice reptitions will be performed 
for each exercise. Extra practice may be performed if necessary until the 
participant can perform the exercises correctly.  

 
Marc Norcross, PhD, ATC 
Page 15 of 25 
July 13, 2017 
The descriptions of the ankle exercises are listed below: 
1. 
The participant will be instructed to stretch his/her gastrocnemius muscle on 
the FAI limb by keeping a straight knee in a lunge position and to stretch the 
soleus by bending the knee slightly in the same postion (Figures 4 and 5).  
 
 
 
 
 
 
 
 
 
 
 
2. 
The participant will be 
instructed to perform a single-
limb calf raise on the FAI limb 
with the knee straight using 
only body weight for 
resistance (Figure 6).   
       
 
 
 
 
3. 
The participant will be instructed to 
perform anke dosiflexion exercises on 
the FAI limb with theraband (Figure 7). 
Participants will select the theraband 
color that provides the participant a 
moderate resistance while still being 
able to maintain good quality muscle 
contraction throughout the whole 
range of motion.  
 
 
Figure 4: gastrocnemius muscle 
stretching 
Figure 5: soleus muscle 
stretching 
Figure 6: the left picture is the starting position 
and the right picture is the end position 
Figure 7: ankle dosiflexion exercises 

 
Marc Norcross, PhD, ATC 
Page 16 of 25 
July 13, 2017 
 
4. 
 The participant will be instructed to perform anke inversion and eversion 
exercises on the injured 
limb with self-selection 
theraband (Figures 8 
and 9). To select a 
proper resistance of 
theraband, the particiant 
should feel moderate 
resistance while still be 
able to maintain good 
quality muscle 
contraction throughout 
whole range of motion.  
 
5. 
The participant will be instructed to stand on 
his/her FAI limb while barefoot and eyes closed, 
put the hands on the iliac crests, and maintain 
his/her balance for 30 seconds (Figure 10).  
 
   
 
 
 
6. 
The participant will be instructed to stand on his/her FAI limb while barefoot. 
The research staff will toss a ball to the participant in random directions to 
create an external perturbation, and 
the participant will toss the ball back 
immediately after they catch it (Figure 
11). The number of toss in low-left, 
low-right, high-left, hight-right and 
short toss will be evenly distributed. 
He/she will be instructed to attempt to 
maintain balance throughout. If the 
participant’s foot touches the ground, 
the trial will not be counted as a 
successful trial. The participant will 
practice ten successful catch-toss 
trials or up to 15 catch-toss trails total.  
 
Total time Session 1 = ~60 minutes 
Figure 10: closed eyes 
single-limb stance with 
barefoot 
Figure 11: single-limb stance ball 
toss with barefoot 
Figure 8: inversion 
Figure 9: eversion 

 
Marc Norcross, PhD, ATC 
Page 17 of 25 
July 13, 2017 
 
Session 2.  
o 
Height and weight without shoes will be measured (~ 5 minutes) 
Participants will remove their shoes. A wall mounted stadiometer will be 
used to measure height, while weight will be measured using a standard 
scale.  
o 
Range of motion of both ankles will be measured (~ 5 minutes) 
A goniometer will be used to measure inversion, eversion, dorsiflexion and 
plantarflexion angles of both ankles. 
o 
Position the participant on the Biodex dynamometer (~ 5 minutes) 
The participant will be postioned the same as they were during the 
familiarization session (Figure 3).  
o 
Electrode placement (~ 5 minutes) 
i. 
Prior to application of the following 
electrodes, participant’s skin will be 
cleaned with alcohol and excess hair 
shaved.  One stimulating electrode 
will be placed behind the head of the 
fibula over the location of the 
common peroneal nerve to deliver a 
small shock. One dispersive 
electrode will be placed over the 
posterolateral surface of the lower leg 
(Figure 12).  
 
ii. 
We will identify the precise location for the stimulating electrode by 
delivering stimuli to the participant as the electrode is moved slighlty over 
the area behind the head of the fibula (i.e., the location of the common 
peroneal nerve). During each stimulus, the participant will feel a shock 
behind the head of the fibula and a muscle contraction of the peroneal 
muscles, and we will record the torque produced by this contraction.  
Between each shock there will be at least 10 seconds of rest. We will 
identify andmark with a permanent marker the location of the stimulating 
electrode that induced the largest eversion torque and use this location of 
the stimulating electrode for both testing sessions. In total, participant will 
receive ≈ 5–10 shocks to locate the optimal stimulating electrode location. 
iii. 
The stimulating and dispersive electrodes will be secured with tape to 
minimize the movement of the electrodes during testing.   
o 
Measurement of RTD  (~10 min) 
The participant will perform 2-3 practice trials, if necessary, and 3 testing 
Figure 12 Electrode placement 
 

 
Marc Norcross, PhD, ATC 
Page 18 of 25 
July 13, 2017 
trials using the methods described previously and practiced during the 
familiarization session.   
o 
Measurement of MVIC (~ 10 minutes) 
Testing of MVIC will be done with the participant postioned on the Biodex as 
described previously. Participants will be asked to have their arms crossed 
over their chest during the measurement.  
iv. 
The participant will perform 2-3 MVIC practice trials, if necessary, and 3 
testing trials using the methods described previously and practiced during 
the familiarization session. A total of 3 successful trials will be measured 
to obtain the MVIC.  
o 
Measurement of superimposed burst (SIB) (~ 10 minutes) 
The average peak torque recorded during the 3 MIVC trials will be used as 
the threshold for triggering an exogneous electircal stimulus delivered 
through the stimulating electorde during SIB trials. The participant will be 
asked to perform 3 more MVICs as they had done previously.  However, 
during these trials, an exogenous stimulus will be delivered by the data 
collection system when the participant reaches the defined threshold torque. 
This stimulus is intended to fully activate the enitre motor unit pool and the  
torque produced during this supramaximal voluntary contraction will be 
recorded. This procedure will be performed three times with 60 seconds rest 
between each trial. 
Measurements during session 2 will be taken on both limbs in a counterbalanced order 
so that we may compare AMI and muscle function between the FAI and uninvolved 
sides.  
o 
Repeat participant positioning on the Biodex dynamometer (~ 5 minutes) and 
electrode placement (~ 5 minutes) on the other leg. Measure RTD (~ 10 
minutes), MVIC (~ 10 minutes), and SIB (~ 10 minutes) on the other leg.  
 
Following completion of the above testing, participants will be assigned to either the 
Kinesio Tape® intervention group or the control group using randomization without 
group replacement. As noted previously, sub-groups for the purpose of randomization 
and insuring equal intervention and control group sizes will be based on gender and 
whether FAI is on the dominant or non-dominant leg.  
o 
Apply Kinesio Tape® on FAI  limb (treatment group) or sit quietly (control group) 
(~10 minutes) 
The application of Kinesio Tape® is according to the guidelines provided by 
the Kinesio Taping Association (Kase, K. 2016). For preparing for placement 
of the Kinesio Tape®, each participant will be shaved (if necessary), and 
cleaned with alcohol pre pads over the peroneus longus from the origin to 
the insertion. Participants will be positioned in ankle inversion to place the 
peroneus longus on stretch. A 5 cm width strip of Kinesio Tape® (Kinesio 
TEX Products, NKT-050, Japan) will be applied from origin (the head of the 

 
Marc Norcross, PhD, ATC 
Page 19 of 25 
July 13, 2017 
fibula) to insertion (the medial cuneiform and first metatarsal) of the 
peroneus longus in a longitudinal direction (Figure 13). The proximal 
anchors will be applied without tension, and the Kinesio Tape® placed on 
approximately 50% stretch before being applied over the peroneus longus 
and the distal anchor point. 
  
 
 
 
 
o 
Exercise protocol (~20 minutes) 
Following 10 minutes of stationary bicycle (Monark Bicycle Ergometer) riding at a 
self-selected resistance, all participants will perform a standardized set of 
therapeutic exercises that are commonly implemented in ankle rehabilitation 
programs. The ankle exercises have been fully described previously in Section 
15. Table 1 lists the specific number of sets and repetitions for each exercise. 
Table 1. Standard Ankle Exercise Protocol 
Tasks 
Sets/Repetitions 
Limb 
Warm-up: 
• 
Stationary bicycle ride at a standard light resistant 
(Monark Bicycle Ergometer) 
10 minutes  
N/A 
Stretch 
• 
Gastrocnemius (stretch with straight knee)  
• 
Soleus (stretch with knee slightly bent) 
3 sets x 20 seconds 
each 
FAI  
limb only 
Strengthening exercise: 
• 
Single-limb calf raise with bodyweight 
• 
Ankle dorsiflexion with self-selection theraband 
• 
Ankle inversion with self-selection theraband 
• 
Ankle eversion with self-selection theraband 
3 sets x 15 reps each 
FAI  
limb only 
Neuromuscular control: 
• 
Closed eyes single-limb stance with barefoot    
• 
Single-limb stance ball toss with barefoot  
2 sets x 30 seconds, 
2 sets x 10 reps 
FAl  
limb only 
 
 
Figure 13: Kinesio tape application  

 
Marc Norcross, PhD, ATC 
Page 20 of 25 
July 13, 2017 
 
Participants in the Kinesio Tape® group will be instructed to keep the tape in place until 
they have completed session 3. All participants will be asked to maintain their normal 
activity and to report back to the laboratory two days later for their final scheduled 
testing session.  
 
Total time Session 2 = ~120 minutes 
Session 3.  
All testing will be completed in the Women’s Building using previously described 
methods. However, during session 3, measurements will only be taken on the limb with 
FAI and the Kinesio Tape® will be left in place during testing. 
o 
Position the participant on the Biodex dynamometer (~ 5 minutes) 
o 
Electrode placement (~ 5 minutes) 
o 
Measurement of RTD  (~10 min) 
o 
Measurement of MVIC (~ 10 minutes) 
o 
Measurement of SIB (~ 10 minutes) 
Total time Session 3 = ~40 minutes 
16. Compensation 
Participants will not be compensated for their participation in this investigation.  
 
17. Costs 
The participants will be responsible for their own transportation to and from the testing 
site and any fees associated with parking. There will be no other costs borne by 
participants for participating in this study except for their time.  
 
18. Medical Devices 
• Indication if data related to the safety or efficacy of the device will be collected: 
This investigation will evaluate the effectiveness of the combination of a 
prolonged Kinesio Tape® application (>48 hours) and therapeutic exercise for 
reducing AMI and improving muscle function. 
• Rationale for choosing the device to be used: As described in Section 11, Kinesio 
tape is popular in the athletic field because it can be applied before and during 
exercise (up to 2-3 days) without restricting movement. In theory, Kinesio Tape® 
is believed to increase muscle excitability because it induces sensory input via 
skin stimulations. The stimuli activate cutaneous mechanoreceptors to provide 
afferent input. As a result, this feedback is thought to improve efferent output 
from the central nervous system to the targeted muscles (Akbaş et al., 2011; 

 
Marc Norcross, PhD, ATC 
Page 21 of 25 
July 13, 2017 
Yoshida & Kahanov, 2007). Thus, due to the increased sensory feedback 
provided by Kinesio Tape®, this intervention may increase muscle activation, and 
improve muscle function and performance (Kase K, Wallis J, 2003). 
• Device description:  
 
Kinesio Tape, as shown above and in Figure 13, is classified as a “Tape and Bandage, 
Adhesive” medical device by the Food and Drug Administration.  It is manufactured by 
the Kinesio Holding Corporation, which is registered with the FDA> 
 
 
 
 
 
 
 
 
 

 
Marc Norcross, PhD, ATC 
Page 22 of 25 
July 13, 2017 
 
 
 
A description of how the device will be used is provided in Section 15 and based upon 
the instructions set forth in Illustrated Kinesio Taping 4th ed. Written by the developer fo 
the technique, Kenzo Kase, D.C. 
 
• Proposed Intended Use/Indications for Use:   
• As described in the methods and procedures, we propose to apply this 
device to the lateral aspect of the lower leg in individuals with FAI for 
approximately 48 hours.  Participants will complete a standard ankle 
exercise program immediately after tape application and indicators of 
muscle inhibition and performance at 48 hours post-treatment will be 
compared to participants with FAI that only completed the exercise 
protocol. A copy of the product labeling is provided below.  
 

 
Marc Norcross, PhD, ATC 
Page 23 of 25 
July 13, 2017 
 
 
• We have no intent to commercialize or patent the device.  
19. Though the medical device that we propose to use in this study is not exempt from 
the specified requirements described in 21 CFR 812, we believe that this 
investigation qualifies as a Nonsignificant Risk device study because the device is: 
not implanted; not used to support or sustain human life; nor does it present a 
potential for serious risks to the health, safety, or welfare of participants.Anonymity 
or Confidentiality 
An electronic spreadsheet, known as the “Master List” will contain the name and contact 
information of each individual who responds to recruitment. To protect the confidentiality 
of the participants, their data will be identified by an assigned code. The code will be 
linked to their data. The Master List will document the identification code, whether the 
individual met the eligibility criteria, the scheduled test date and time, and the reason for 
ineligibility, if applicable.  
With the exception of the Master List, all other forms, files, and recordings will be coded 
using the assigned identification code without names or contact information. 
All study related materials will be stored in a secure manner, either on a computer 
belonging to the researchers that is password protected or on a computer or locked file 
cabinet that is in the researchers’ laboratory or office for a minimum of three years post 
study termination.  Data from individuals who are found to be ineligible for participation 
during the screening process will also be stored with an identification code assigned 
following the oral consent process. All computers on which data will be stored that are 
connected to a network have fully patched operating systems and applications, and 
current antivirus software with current virus definitions. No information will be stored in 
cloud-based servers. Any document that includes the participants’ name will be stored 
separately from any coded information.  
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law. This Web site will not include information that can identify 
individual participants and at most, the Web site will include a summary of the results.  

 
Marc Norcross, PhD, ATC 
Page 24 of 25 
July 13, 2017 
Results in the form of research manuscripts will be submitted to OSU scholars’ archives 
and for peer-reviewed publication. Results will also be presented at scientific meetings.  
In all cases, a participant’s identity will not be disclosed.  Results will be reported in a 
summarized manner such that participants cannot be identified.   
20. Risks 
No more than minimal risk is expected. The possible risks and/or discomforts include: 
As with any physical activity, participation in this study carries a risk of bodily injury such 
as muscle strain, ligament sprain, or (in rare instances) a potentially disabling injury.  
The motions that participants will be asked to perform are ones that repeatedly occur 
during physical activity and performance testing.  Following testing and exercises, 
participants may experience muscle soreness and/or fatigue.  To minimize these risks, 
they will be instructed to warm up with practice trials to prepare for testing and will be 
provided with 60 seconds of rest between trials. 
The electrical stimulation may cause some discomfort. In rare situations, the electrical 
stimulation could cause a participant to feel dizziness, nausea, and/ or faint.  The 
researchers will closely monitor the participants throughout the testing to ask how they 
are feeling. The participants will be able to tell the researcher if they are not willing to 
continue the testing session. The following study personnel (Dr. Norcross, Dr. Johnson, 
Dr. Brown Crowell and Ms. Huang) are certified athletic trainers trained in emergency 
response. At least one of them will be present at all testing sessions, and in the event of 
an injury, will evaluate the situation and either activate the emergency medical system 
(EMS) or assist the participant in seeking medical assistance for non-life threatening 
injuries. All adverse events will be reported immediately to the appropriate IRB official. 
Although Kinesio Tape® is latex-free and rarely irritates the skin, some individuals may 
have an allergy to Kinesio Tape®. To minimize this risk, we will exclude participants that 
report having an allergic reaction to Kinesio Tape® and we will instruct participants to 
remove the tape and immediately seek medical attention if they suspect that they are 
having an allergic reaction. Every participant has the right to stop participation anytime 
with no negative consequences. In the chance that a participant experiences discomfort 
or allergic reaction, the event will be documented and reported to the OSU IRB.  
21. Benefits 
It is unlikely that the participants will experience any noticeable benefits from their 
participation in this study.  However, it is possible that the Kinesio Tape®  intervention 
may facilitate muscle activation and reduce AMI in the peroneal muscles of participants 
who receive this intervention. 
Society will benefit from this study because the results of this study may provide 
clinicians and patients with evidence supporting a therapeutic treatment option to 
reverse AMI and facilitate muscle function.  
 
22. Assessment of the risks and benefits  
Although some risks and/or potential discomforts are associated with this study, they 
are minimal due to the protective measures taken against them.  It is expected that the 

 
Marc Norcross, PhD, ATC 
Page 25 of 25 
July 13, 2017 
knowledge to be gained from the completion of this investigation with respect to whether 
Kinesio Tape® is a useful intervention to reduce AMI following joint injuries or surgeries 
is a benefit to society that outweighs the risks.   
 
23. Attachments: 
• 
Attachment A: Screening Questionnaires  
• 
Attachment B: Recruitment Flier 
• 
Attachment C: Recruitment In-Class Guide 
• 
Attachment D: Email Response to Recruitment  
• 
Attachment E: Oral Consent Guidelines and Screening 
• 
Attachment F: Confirmation of  In-depth Eligibility and Familiarization Session 
• 
Attachment G: Written Consent Form  
• 
Attachment H: General Checklist 
• 
Attachment I: Tanger Activity Scale