You are on page 1of 29

Module:

Research Methods

Title of summative assessment:

‘Can a protocol be devised to standardise field use of myoton technology


when assessing effects of contractile state in the quadriceps muscle of healthy
adults?’

Date of Submission:

18 March 2024

Student number:

Word count: 2885

Student no:
Page 1
Abstract

This cross sectional convenience study of 20 Southampton University members


will test a protocol for examining the effect of contractile state on myoton
parameters. The purpose of the study is to see if a protocol can be developed to
standardise the level of contraction in the quadriceps muscle without the use of
equipment to test muscle strength allowing for it to be utilised in a field setting. In
both relaxed sitting and a square sit position, mechanical properties of the rectus
femoris muscle will be recorded using the MyotonPro and recorded data will be
analysed. If square sitting is able to be standardised the protocol could be utilised
in various areas of physiotherapy practice including: rehabilitation, to verify the
functional state of muscles, to improve accuracy of diagnosis and to evaluate the
effectiveness of different treatments (Marusiak et al., 2012); sport and fitness, to
maximize workouts and avoid over training that results in possible muscle
damages (Croce and Miller, 2006); and also in pediatrics, to study the process of
muscle developing activity in children, monitoring immediately eventual muscle’s
trophy (Myoton AS, 2011). .

Student no:
Page 2
1. Introduction

The MyotonPro (Figure 1) is a relatively new piece of technology that can be used
to objectively measure skeletal muscles, ligaments and tendons by detecting
changes in the state and properties of tissues (Myoton AS, 2011). The device
records various muscular mechanical properties including: stiffness, tone and
elasticity. Assessment of these parameters has been shown to have beneficial
consequences in science, sport and medicine (Gavronski et al., 2007; Marusiak et
al., 2012; Bizzini and Mannion, 2003). However, a standardised protocol has not
yet been developed for assessment of contractile state and its effect on the
mechanical properties of muscle.

Figure 1: The MyotonPro (Myoton AS, 2011)

1.1 Muscle Physiology

Muscles are made of long fibres containing force producing units known as
sarcomeres. These sarcomeres produce force through interactions between the
actin and myosin proteins that form them. The human quadriceps muscle has over
40,000 sarcomeres (Meijer, Bosch, Bobbert, Soest & Huijing, 1998a). Even at rest,
when the sarcomeres are not contracting, a muscle is in a state of tension known
as muscle tone. This is due to a combination of neural and non-neural factors such
as reflex excitability, the viscoelastic properties of the musculotendinous unit, and
the intrinsic properties of the contractile elements (Dietz, Quintern, and Berger,
1981). Tone and other mechanical properties of muscles can be recorded either at
rest or during contraction using the MyotonPro.

The process of muscle contraction can be physiologically explained through the


sliding filament theory as seen in figure 2 (Hill, 1974).When a muscle contracts the

Student no:
Page 3
myosin and actin filaments from cross bridges between parallel fibres and
sarcomeres shorten. When a muscle position is fixed e.g. in the Quadriceps
muscle during a square sit, tension builds up in the muscle but the muscle length
remains the same (Aidley, 1998). This is known as an isometric contraction and
will be utilised to standardise muscle length and joint position in this study.

Figure 2: Diagram illustrating sliding filament theory (All About Sports Medicine, no
date)

1.2 Reliability

Various studies have been conducted into the reliability of the MyotonPro and its
earlier prototypes (Agyapong-Badu et al., 2013; Chuang, Wu, and Lin, 2012; Aird,
Samuel, and Stokes, 2012; Bizzini and Mannion, 2003; Pruyn, Watsford, and
Murphy, 2015; Mullix, Warner, and Stokes, 2012). These have shown that the
MyotonPro demonstrates excellent or very high within day and intra-rater reliability
and high or good interrater and between day reliability, particularly high in the
rectus femoris muscle of both older and younger males (Agyapong-Badu et al.,
2013). However, the aforementioned study by Agyapong-Badu et al. (2013) was
only tested on male volunteers who had been selected based on convenience.
This means that the results of the study may not be relevant to wider general
population demographics. Although the study does meet the recommended
Student no:
Page 4
sample size for reliability, larger and more representative studies are needed
before any definitive conclusions can be drawn (Atkinson and Nevill, 2001).

1.3 Existing tests

The modified Ashworth scale is currently one of the most accepted clinical
measure of tone and involves subjective assessment of resistance to passive
stretch through a 6-point ordinal scale (Bohannon and Smith, 1987; Gregson et al.,
1999; Li, Wu, and Li, 2014). However, this assessment technique is subjective and
therefore makes it liable to bias introduced by the examiner as their own
experiences and opinions will serve to influence their judgements. This and other
factors have led to its reliability being questioned in the literature (Fleuren et al.,
2010). Various objective devices are available to test tone and the mechanical
properties of muscle (Gavronski et al., 2007; Tous-Fajardo et al., 2010; Gennisson
et al., 2005) but most are not clinically feasible. This highlights the need for
technology such as the MyotonPro.

A study published by Agyapong-Badu et al (2015) states how tools for assessing


muscle health are needed that are not influenced by pain or cognition so the older
generation can be assessed for musculoskeletal aging and frailty. The MyotonPro
is an objective means of assessing muscle health that meets this criteria. The
study had large sample size of 123 individuals, both male and female participants
and also a large age range therefore it can be considered as more reliable than
those similar that did not meet these criteria. These factors make it more
representative of the whole population, however, participants were gathered
through a convenience sample so the paper’s true applicability to the wider
population requires some further investigation.

1.4 Clinical significance

The MyotonPro boasts a non-invasive, cost-effective, in-vivo way to assess


mechanical properties of muscle (Gavronski et al., 2007). The hand held, easy to
use, portable nature of the device means there is potential for it to be used to aid
treatment in a field or clinical based setting. Unlike most of the existing tests the
Student no:
Page 5
device produces objective data so conclusions regarding muscle properties can be
gathered consistently. Studies have shown it could aid diagnosis and management
of Stroke (Chuang, Wu, and Lin, 2012), Parkinson’s disease (Marusiak et al.,
2012) and even be used as a screening tool to identify muscle imbalances or
potential injury risks in athletes (Mullix, Warner and Stokes, 2012). However, no
few standardised protocols for its use exist and currently its use is limited to
research.

1.5 Standardisation

Standardisation involves producing a set of guidelines for activities so they are


able to be repeated (Department for Business, Innovation & Skills, 2012). In
practice it reduces variation in the treatment of patients and improves the quality of
care (Balogun, 2008). Standardised tests that are both repeatable and reliable are
an important part of physiotherapy practice as they allow monitoring of treatment
effects meaning professionals are able to determine their effectiveness (Bellamy,
2011).

It is commonly known that joint angle and muscle length have an effect on the
mechanical properties of muscle, therefore, a standardised square sit position
ensures these factors are controlled. During the square sit an isometric contraction
occurs in the quadriceps muscle as the length of the muscle and the angle of the
knee joint at 90 degrees do not change. The position allows for repeatable
readings to be taken between individuals and between assessments allowing
progress between treatments or effects of medications to be monitored.

However, research regarding standardised protocols for the MyotonPro are


somewhat limited and there is slight discrepancy between studies as to how the
relaxed state of muscle should be measured. In Bizzini and Mannion’s study
(2003) the individual lay supine on a couch with the knee slightly flexed and
supported by a cushion. However, in more recent studies (Mullix, Warner, and
Stokes, 2012; Bailey et al., 2013) there is no mention of a supporting cushion
during Rectus Femoris measurements. Having the knee slightly flexed may not be
accurate technique as the exact joint position may not be obtained each time
impacting on between day and inter-rater reliability. Also the more recent studies
Student no:
Page 6
seem to be in agreement with each other that the hip should be in neutral and
knee extended (Aird, Samuel, and Stokes, 2012; Agyapong-Badu et al., 2013;
Agyapong-Badu et al., 2015) ). Therefore no cushion will be used in this study..

1.6 Study aims

This study aims to determine and test whether or not a protocol can be developed
to standardise the level of contraction in the quadriceps muscle without the use of
any strength testing equipment so that it can be utilised in a field setting..

Student no:
Page 7
2. Methodology

2.1 Research design

The study will be cross sectional and quantitative for the following reasons; to be
representative of the general population and accurately represent the objective
tools we are using.

2.2 Participants

A convenience sample number of 20 Southampton University students and staff,


male and female, aged 18 years and above will be recruited for this study through
social media advertising. A sample of 20 participants is recommended as the
minimum for reliability testing (Atkinson and Nevill 2001) and convenient for time
constraint. The exclusion criteria will include: a high BMI (>30) (Gapeyeva and
Vain 2008), neurological conditions, history of severe lower limb injury (Agyapong-
Badu et al 2015), arthritis, skin conditions, skeletal muscle relaxant use currently
or any medication that effects muscle tone or contractile ability and those unable
to understand study requirements (Folstein 1975). Ethical considerations were
contemplated and no risk was identified with myoton technology. All participation
will be voluntary and without influence or coercion.

2.3 Pre-session checklist

Prior to commencement of data collection, participants will receive information


about the study (See appendix 1), input their details on a data capture form (See
appendix 2) and sign a written informed consent form (See appendix 3).
Participants will be asked to refrain from partaking in strenuous physical activity
within 24 hours of testing and will be invited ten minutes early to their allocated
appointment to allow relaxation before testing begins (Bailey et al 2013). Height
and mass will be recorded prior to the testing stages; height measured using a
tape measure against a wall and mass measured using Salter weighing scales.
These measurements will be used to calculate the individuals BMI. Finally, an ID
Student no:
Page 8
number will be allocated to each individual and a ball kick test will be performed to
determine leg dominance (Hoffman et al 1998, Kong et al 2010).

2.4 Testing equipment

The MyotonPro is a handheld device able to record data regarding mechanical


properties of muscles (tone, elasticity and stiffness). It is the latest piece of myoton
technology and has the highest average reliability ratings compared the earlier
prototypes (Agyapong-Badu et al., 2013; Bizzini and Mannion, 2003). The device is
capable of measuring tissue stiffness within a depth of 2 cm subcutaneous
(Andonian et al., 2015) making it suitable for analysis of mechanical properties in
the Rectus Femoris muscle in this study.

Other relevant equipment includes: a skin safe viscot pen for marking the test
point to ensure no harm or permanent damage is caused to the skin; a quadriceps
strength chair for measuring relaxed readings in a position similar to the wall sit
with hips and knees both at 90 degrees and providing support to the muscle during
testing; a football will be required for the ball kick test to ascertain leg dominance;
and as previously mentioned, salter weighing scales and a tape measure to allow
BMI to be calculated so entry criteria can be met. .

Student no:
Page 9
2.5 Preparation

Testing conditions will aim to be standardised to allow for reproducibility in a field-


based setting. Initially, participants will be positioned in supine with the knee
extended and the hip in neutral. Measurements will be taken at two thirds of the
distance between the anterior iliac spine and the superior pole of the patella on the
dominant leg, so a reproducible point on the muscle belly of Rectus Femoris may
be identified (Mullix, Warner and Stokes 2012 and Delaney et al, 2010). Once
located this point will be marked with a safe Viscot pen and named point 1 (See
Figure 3). Order of testing is detailed in Table 1 and includes some details
regarding the use of ultrasound imaging and the use of myoton on the
gastrocnemius muscle. These studies were being conducted simultaneously
during data collection and will have no further involvement in this study.

Figure 3: Testing points – point 1 only is relevant to this study

Student no:
Page 10
Table 1: Order of testing
Protocol Test Time in
order minutes
1 Completing forms and rest period 10

2 Participant measurements (height/weight) 5


Ball Kick test
Marking of sites on skin ready for testing

(Simultaneous study 1) Prone gastrocnemius relaxed


3 state- myoton readings 2
Left and right 2
Prone 90 degree passive stretch against the wall left 2
and right 2
prone gastrocnemius relaxed state Left and right
Prone 90 degree passive stretch against the wall left
and right

Dominant quadriceps muscle


4 Seated Relaxed 1
Square sit 2
rest 2
Seated Relaxed 1
Square sit 2

(Simultaneous study 2) Dominant quadriceps muscle


5 - Ultrasound imaging (USI) 8
Seated relaxed three points
(Simultaneous study 3) Dominant quadriceps muscle
6 - 2
USI 2
rest 2
Square sit
Total session length 45

Student no:
Page 11
2.6 Procedure

Participants will begin sat relaxed on a quad strength chair in a standardized


position (Hacker et al 2016) with hips and knees at 90 degrees flexion, arms
crossed against their chest and feet suspended from the floor. In this position 2
sets of 10 MyotonPro readings will be obtained using point 1. Following this
participants will be asked to take up an isometric wall squat position with hips and
knees at 90 degrees flexion, feet shoulder width part and facing forward and arms
crossed against their chest (See figure 4). In this contracted muscle state a further
2 sets of 10 readings will be obtained. Between the two sets participants will rest in
a seated position for 2 minutes (Pescatello et al, 2013). If unsuccessful after 30
seconds, a 2 minute rest will be utilised to prevent fatigue. All data will be
automatically saved on the MyotonPro device and later uploaded anonymously on
to a laptop where the results will be collected and data analysed.

Figure 4: Square sit

Student no:
Page 12
2.7 MyotonPro

To obtain readings the MyotonPro is held perpendicular to the muscle of interest


and a probe applies a constant preload (0.18N) compressing subcutaneous
tissues, independent of the investigator. It is recommended that the device is held
between 0 and 90 degrees so the muscle being tested is not left without bone
beneath it and oscillations can be produced effectively (Aird, Samuel, and Stokes,
2012).10 brief (15ms), low force (0.4N) mechanical impulses will be delivered by
the device, 1 second apart, inducing damped natural oscillations of underlying
tissues. These oscillations are identified by an acceleration sensor and data
surrounding the muscles properties is recorded. The investigator, who is trained in
myoton technology, will be the same individual for all readings.

2.8 Statistical analysis

The myoton readings will be labelled according to assigned participant numbers


and transferred to a storage device for later measurement and analysis. A
computer programme dedicated to the device will be used to upload the data. Data
will be transcribed and analysed using SPSS (IBM SPSS Statistics, version 23).
Paired T tests will be undertaken to analyse data as they allow the two contractile
states of muscle to be compared in this study (Whittaker et al, 2007). .

3. Potential difficulties
 Participants might feel pressured into joining the study – The studies will be
advertised publically to university students through social media to avoid
this.
 Standardizing joint angle – A 90 degree angle at the knee and hip joints is
required, using a goniometer would ensure this.
 Getting all measurements done before muscle fatigue- Rest periods have
been factored in to attempt to combat this.

Student no:
Page 13
4. Assumptions
 Participants will fully relax whilst seated on the quad strength chair.
 The short rest period will be long enough for the muscle to recover between
readings during square sitting so the results will not be effected by muscle
fatigue.
 Participants will be able to reach and maintain the 90 degree wall sit for
long enough for readings to be taken.

5. Implications of the study

If the data for this study provides significant results for testing the biomechanical
properties of the muscles in different states, there is potential for the technique to
be utilised in various field settings such as in clinic and sport. Research already
shows the MyotonPro device to be reliable, objective and non-invasive (Agyapong-
Badu et al., 2013; Chuang, Wu, and Lin, 2012; Aird, Samuel, and Stokes, 2012;
Bizzini and Mannion, 2003; Pruyn, Watsford, and Murphy, 2015; Mullix, Warner,
and Stokes, 2012) and these factors alongside its low cost, portability and
relatively easy to use nature mean that it has huge potential for use in clinical and
sport settings. If a standardised protocol for its use can be developed the device
could have the following uses:

 Monitoring the changes caused by muscle disorders,


 Gathering more information when diagnosing muscle diseases,
 Monitoring effects of interventions and treatments,
 Observing of the effects of training on muscles,
 Identifying causes of muscle overtraining,
 Determining optimal physical training load for muscles,
 Preventing muscle and tendon injuries

(Myoton AS, 2011)

Ultimately there is a lot of potential for the device out in the field once standardised
protocols have been established.

Student no:
Page 14
References

Agyapong-Badu, S., Aird, L., Mooney, K., Mullix, J., Warner, M., Samuel, D.,
Stokes, M. and Bailey, L. (2013) ‘Interrater reliability of muscle tone, stiffness and
elasticity measurements of rectus femoris and bi- ceps brachii in healthy young
and older males’, .
Agyapong-Badu, S., Warner, M., Samuel, D. and Stokes, M. (2015) ‘Measurement
of ageing effects on muscle tone and mechanical properties of rectus femoris and
biceps brachii in healthy males and females using a novel hand-held myometric
device’, Archives of gerontology and geriatrics., 62, pp. 59–67.
Aidley, D.J. (1998) ‘Mechanics and energetics of muscular contraction’, in The
physiology of excitable cells. New York, NY, USA: Cambridge University Press,
pp. 323–335.
Aird, L., Samuel, D. and Stokes, M. (2012) ‘Quadriceps muscle tone, elasticity and
stiffness in older males: Reliability and symmetry using the MyotonPRO’, Archives
of gerontology and geriatrics., 55(2).
All About Sports Medicine (no date) Sliding filament theory. Available at:
http://allaboutsportsmed.weebly.com/sliding-filament-theory.html (Accessed: 9
June 2016).
Andonian, B., Masi, A., Aldag, J., Barry, A., Coates, B., Emrich, K., Henderson, J.,
Kelly, J. and Nair, K. (2015) ‘Greater resting lumbar extensor myofasical stiffness
in younger ankylosing spondylitis patients than age-comparable healthy volunteers
quantified by myotonometry’, Archives of Physical Medicine and Rehabilitation,
96(11), pp. 2041–2047.
Atkinson, G. and Nevill, A. (2001) ‘Selected issues in the design and analysis of
sport performance research’, Journal of Sports Sciences, 19(10), pp. 811–827.
doi: 10.1080/026404101317015447.
Bailey, L., Samuel, D., Warner, M.B. and Stokes, M. (2013) ‘Parameters
representing muscle tone, elasticity and stiffness of biceps brachii in healthy older
males: Symmetry and within-session reliability using the MyotonPRO’, Journal of
Neurological Disorders, 1(1), pp. 1–7.
Balogun, A. (2008) Protocol based care. Available at:
http://www.institute.nhs.uk/quality_and_service_improvement_tools/

Student no:
Page 15
quality_and_service_improvement_tools/protocol_based_care.html (Accessed: 7
June 2016).
Bellamy, J. (2011) Outcome measures in patient care. Available at:
http://www.apta.org/OutcomeMeasures/ (Accessed: 7 June 2016).
Bizzini, M. and Mannion, A. (2003) ‘Reliability of a new, hand-held device for
assessing skeletal muscle stiffness’, Clinical biomechanics (Bristol, Avon)., 18(5),
pp. 459–61.
Bohannon, R.W. and Smith, M.B. (1987) ‘Interrater reliability of a modified
Ashworth scale of muscle Spasticity’, Research, 67(2), pp. 206–207.
Chuang, L., Wu, C. and Lin, K. (2012) ‘Reliability, validity, and responsiveness of
myotonometric measurement of muscle tone, elasticity, and stiffness in patients
with stroke’, Archives of physical medicine and rehabilitation., 93(3), pp. 532–40.
Croce, R. and Miller, J. (2006) ‘Angle- and velocity-specific alterations in torque
and semg activity of the quadriceps and hamstrings during isokinetic extension-
flexion movements’, Electromyography and clinical neurophysiology., 46(2), pp.
83–100.
Department for Business, Innovation & Skills (2012) Standardisation. Available at:
https://www.gov.uk/government/publications/standardisation/standardisation
(Accessed: 7 June 2016).
Dietz, V., Quintern, J. and Berger, W. (1981) ‘Electrophysiological studies of gait in
spasticity and rigidity. Evidence that altered mechanical properties of muscle
contribute to hypertonia’, Brain : a journal of neurology., 104(3), pp. 431–49.
Folstein M, Folstein S, McHugh P (1975) “Mini-mental state”. A practical method
for grading cognitive state of patients for the clinician. 12:189-98
Gapeyeva H, Vain A (2008) Principles of applying myoton in physical medicine
and rehabilitation. Tartu, Estonia: Muomeetria Ltd
Gavronski, G., Veraksits, A., Vasar, E. and Maaroos, J. (2007) ‘Evaluation of
viscoelastic parameters of the skeletal muscles in junior triathletes’, Physiological
measurement., 28(6), pp. 625–37.
Gennisson, J.L., Cornu, C., Catheline, S., Fink, M. and Portero, P. (2005) ‘Human
muscle hardness assessment during incremental isometric contraction using
transient elastography’, Journal of Biomechanics, 38(7), pp. 1543–1550. doi:
10.1016/j.jbiomech.2004.07.013.

Student no:
Page 16
Gregson, J.M., Leathley, M., Moore, P.A., Sharma, A.K., Smith, T.L. and Watkins,
C.L. (1999) ‘Reliability of the tone assessment scale and the modified ashworth
scale as clinical tools for assessing poststroke spasticity ☆ ☆☆’, Archives of
Physical Medicine and Rehabilitation, 80(9), pp. 1013–1016. doi: 10.1016/S0003-
9993(99)90053-9.
Hill, T.L. (1974) ‘Theoretical formalism for the sliding filament model of contraction
of striated muscle part I’, Progress in Biophysics and Molecular Biology, 28, pp.
267–340. doi: 10.1016/0079-6107(74)90020-0.
Iridiastadi, H, & Nussbaum, M 2006, 'Muscular Fatigue and Endurance During
Intermittent Static Efforts: Effects of Contraction Level, Duty Cycle, and Cycle
Time', Human Factors, 48, 4, pp. 710-720, Computers & Applied Sciences
Complete, EBSCOhost, viewed 15 May 2016.
Li, F., Wu, Y. and Li, X. (2014) ‘Test-retest reliability and inter-rater reliability of the
modified Tardieu scale and the modified Ashworth scale in hemiplegic patients
with stroke’, European Journal of Physical and Rehabilitation Medicine, 50(1), pp.
15–9.
Marusiak, J., Jaskólska, A., Koszewicz, M., Budrewicz, S. and Jaskólski, A. (2012)
‘Myometry revealed medication-induced decrease in resting skeletal muscle
stiffness in Parkinson’s disease patients’, Clinical Biomechanics, 27(6), pp. 632–
635. doi: 10.1016/j.clinbiomech.2012.02.001.
Mullix, J., Warner, M. and Stokes, M. (2012) Testing muscle tone and mechanical
properties of rectus femoris and biceps femoris using a novel hand held
MyotonPRO device: Relative ratios and reliability. Available at:
http://eprints.soton.ac.uk/345538/ (Accessed: 7 June 2016).
Myoton AS (2011) Technology. Available at:
http://www.myoton.com/en/Technology (Accessed: 7 June 2016).
Pescatello, L, Arena, R, Riebe, D, & Thompson, P 2013, 'Preview of ACSM's
Guidelines for Exercise Testing and Prescription, Ninth Editon', ACSM's Health &
Fitness Journal, 17, 2, pp. 16-20, SPORTDiscus, EBSCOhost, viewed 14 May
2016.
Pruyn, E.C., Watsford, M.L. and Murphy, A.J. (2015) ‘Validity and reliability of
three methods of stiffness assessment’, Journal of Sport and Health Science, . doi:
10.1016/j.jshs.2015.12.001.

Student no:
Page 17
Rankin, G. and Stokes, M., 1998. Reliability of assessment tools in rehabilitation:
an illustration of appropriate statistical analyses. Clinical rehabilitation, 12(3),
pp.187-199.
Tous-Fajardo, J., Moras, G., Rodríguez-Jiménez, S., Usach, R., Doutres, D. and
Maffiuletti, N. (2010) ‘Inter-rater reliability of muscle contractile property
measurements using non-invasive tensiomyography’, Journal of electromyography
and kinesiology : official journal of the International Society of Electrophysiological
Kinesiology., 20(4), pp. 761–6.
Willan PLT, Ransome JA and Mahon M (2002) Variability in Human Quadriceps
Muscles: Quantitative Study and Review of Clinical Literature Clinical Anatomy
15:116–128 .

Student no:
Page 18
Appendix 1 – Participant Information Sheet
Study Title: Ultrasound imaging measurements and mechanical properties of
muscles for assessment of muscle health

Researchers:

Ethics number: ?

You are invited to take part in a research study. Please read this information
carefully before deciding to take part. Please ask questions if anything is
unclear or if you would like further information. Take your time to decide
whether or not you wish to take part. If you are happy to participate you will
be asked to sign a consent form.

What is the research about?

We are undertaking a Physiotherapy (pre-registration) BSc research project. For


our BSc this project we will be taking a range of measurements of muscles and
soft tissue in the lower limb using ultrasound and myoton technology. We will be
comparing results when the muscle is resting at rest and when the muscle is
contracted. We are interested to see if altering the scan site using ultrasound,
whilst measuring the thigh, changes thickness measurements. We want to know if
portable ultrasound is accurate and reliable at measuring muscle thickness in
various states. We also aim to determine whether a protocol can be devised to
standardise the use of myoton technology and ultrasound imaging in a field
setting.

This study will be carried out in the Faculty of Health Sciences, University of
Southampton.

Why have I been chosen?

You have been recruited as you responded to an email expressing interest in the
study. You are a student at the University of Southampton and have been chosen
to represent a healthy young adult.

What will happen to me if I take part?

You will be asked to complete a screening questionnaire to make sure that this
study will be safe for you. We need to ask you questions regarding your level of
physical activity to confirm that you are eligible for this study. There will also be
questions about medical conditions, medication use and any injuries you have had
in the past.

The study involves one visit to a research laboratory in Building 45 of the Faculty
of Health Sciences, University of Southampton. The data collection should take
approximately 45 minutes. You will be asked to complete a consent form to ensure
that you are happy to take part in the study. Additionally, you will be asked to wear
comfortable clothing and appropriate footwear to carry out physical testing. Your
Student no:
Page 19
height and weight will be measured. Several sites will be marked on your lower
limb where the measurements will be taken from. You will then take part in three
stages of testing.

Firstly, you will be asked to lie on your front facedown on a plinth, a small device
called the MyotonPRO will be used to test how toned your calf muscles are. A
blunt probe will gently tap your muscles, causing the muscle to vibrate, although
this will be so gentle you will not be able to see the movement. The vibration of the
muscle will be detected and measured by the device to give recordings of muscle
tone and stiffness. Then another set of readings will be taken whilst your foot is
relaxed against a wall to allow for a passive stretch. Next, you will move from the
plinth to a chair where another two sets of readings will be taken using the myoton
device this time on your thigh muscle.

Following this, whilst still seated six ultrasound images will be taken at 3 points on
the thigh. Ultrasound is a procedure that uses high frequency sound waves to
create an image of part of the inside of the body. During the procedure some gel
will be placed on your skin and a probe will then be moved over your skin to take
the scan. The process is harmless and will not be painful but the gel may feel a
little cold. The ultrasound scans will be measured at a later date to examine how
thick your muscles are, as well as surrounding fat.

Next, you will be asked to perform a bodyweight squat against a wall with your
hips and knees and ankles at 90’ so that your thighs are parallel to the floor. From
here another two sets of 10 readings will be taken using the Myoton device with a
2 minute rest in between.
Following this you will be asked to resume the same position for two further holds
(2 minute break in between) where two ultrasound images will be captured whilst
performing the holds.

In total, data collection will take approximately 45 minutes. You will not be required
for anything else; there will be no additional testing days or follow ups.

What do we ask of you?

If you agree to participate in this study, we ask that you:


 Refrain from drinking alcohol for 24 hours before your visit and from taking
part in strenuous physical activity for 48 hours before each visit.
 Contact the researcher to reschedule if you are no longer able to make an
appointment. The researcher will try to arrange a more convenient time.

Are there any benefits in my taking part?

It is anticipated that this study will provide a better insight into the use and
application of Ultrasound and myoton technology. There are no direct benefits for
you however there are a number of benefits for the healthcare profession and the
wider population.

Student no:
Page 20
Are there any risks involved?

There are no known risks involved with either the ultrasound imaging or the
MyotonPro. Your leg muscles may feel sore after the wall sit Ultrasound scan and
this may last for up to 3 days however this is unlikely.

Will my participation be confidential?

Yes. The study will comply with the Data Protection Act (1998) and the University
of Southampton policy to ensure that all personal information is kept confidential.
You will be provided with an ID number which will be used throughout the project.
The data will therefore remain anonymous and you name will not be disclosed,
thus your identity will be unknown. Personal information will be kept on a
password protected computer to which only the researchers have access. Any
written information will be stored in a locked filing cabinet. Data will be stored for a
maximum of 10 years and destroyed in accordance with the University of
Southampton regulations. You will not be personally identifiable in any written
work that is submitted for publication. We will ask for your permission to contact
your GP should any information come to light during the study which we feel
needs to be shared with them.

What happens if I change my mind?

Participation in the study is voluntary and you have the right to withdraw at any
point during the study without your legal rights being affected. You do not have to
provide a reason for withdrawal. If you have any queries or concerns during the
study you are encouraged to speak to the researcher or another member of the
research team and you will be provided with any necessary information. If you
wish to withdraw from the study you can let the researcher know either in person
or by using the contact details provided.

What happens if something goes wrong?

In the unlikely event that you wish to make a complaint, or express any concerns,
you should contact: Diana Galpin (Head of Intellectual Property, Contracts and
Policy) Address: Building 37, University of Southampton, University Road,
Southampton, SO17 1BJ. Email: d.galpin@soton.ac.uk Telephone: 023 8059
8673

What happens after the study is complete?

The study will be written up and submitted for assessment. We also intend to
publish the findings in a research journal. All data will be managed, stored and
then destroyed in accordance with current University of Southampton policy.

How can I contact you for more information?


If you would like to volunteer or you have any questions about the study, you can
contact the researchers:

Student no:
Page 21
You may also contact the project supervisor:
Professor Maria Stokes
Faculty of Health Sciences, Building 45
University of Southampton, Highfield Campus
Southampton, SO17 1BJ
Tel: 02380 596868 Email: M.Stokes@soton.ac.uk

Thank you for considering participating and for taking time to read this
sheet.

Appendix 2 - Data Collection Form


Student no:
Page 22
Participant ID: Age (19-35?): Gender (Circle): M F

Consent form completed?(Circle): Yes No Researcher initial:

Height (m): Mass (Kg): BMI:

Dominant Leg (To be tested)(Researcher to circle): L R

MyotonPro: Data sets collected & Notes:

Dominant gastrocnemius medialis (centre of Relaxed: (Nikki) Stretched: (Nikki)


muscle belly by palpation)
1- 1-

2- 2-

Relaxed: (Nikki) Stretched: (Nikki)


Non-dominant gastrocnemius medialis (centre
1- 1-
of muscle belly by palpation)
2- 2-

Dominant Quad (2/3 from ASIS to superior Relaxed: (Abi) Contracted: (Abi)
patella) (Point X)
1- 1-
Length= cm ( x 2/3) = cm
2- 2-

Ultrasound Data collected


Images:

(Point X) 1: (Ian and 2: (Ian and Notes:


Tom) Tom)
Dominant
Quad:
(relaxed
sitting)
(2/3)

Dominant 1: (Tom) 2: (Tom) Notes:


Quad:
position 2cm
lateral from
(X)

Student no:
Page 23
Dominant 1: (Tom) 2: (Tom) Notes:
Quad:
position 2cm
medial from
(X)

Dominant 1: (Ian) 2: (Ian) Notes:


quad: at (X):
contracted

Appendix 3 – Consent Form (Version 1)

Student no:
Page 24
Study title: Ultrasound imaging measurements and mechanical properties of
muscles for assessment of muscle health

Researchers names:
Study reference: ?
Ethics reference: ?

Please initial the box(es) if you agree with the statement(s):

I have read and understood the information sheet (insert date /version
no. of participant information sheet) and have had the opportunity to
ask questions about the study.
I agree to take part in this research project and agree for my data to be
used for the purpose of this study

I understand my participation is voluntary and I may withdraw at any


time without my legal rights being affected

I am happy to be contacted regarding other unspecified research


projects. I therefore consent to the University retaining my personal
details on a database, kept separately from the research data detailed
above. The ‘validity’ of my consent is conditional upon the University
complying with the Data Protection Act and I understand that I can

Data Protection
I understand that information collected about me during my participation in this
study will be stored on a password protected computer and that this information
will only be used for the purpose of this study. All files containing any personal
data will be made anonymous.

Name of participant (print name)……………………………………………………

Signature of participant……………………………………………………………..

Date…………………………………………………………………………………

Appendix 4 – Gantt charts


Research Proposal Activity Log
Student no:
Page 25
Title Session Content
Team
Introduction to Whole Focus of Q3: Prepare for research
Q3 class assessment: proposal (abstract, critical review,
proposal)

Research Met with Determined research questions


question and supervisor Began lit review search process
Lit Review and
search research
group and
self-
directed
study
Lit review Met with Discussed research question with supervisor
research and Simon to Continued reading/ analysing papers for lit
method run review
considerations through Wrote inclusion/ exclusion criteria
practical Wrote my section of the method
use of the Started thinking about aims/ objectives
equipment
and self-
directed
study
Began writing Working Aims and objectives for group study, began
protocol with putting the group methods together
including research
participants, group
Inc/Exc,
methods/
order of
testing
Ethics work with Data collection/analysis – peer assessed
documents supervisor Self-directed study: Protocol writing
s in
research
group
Research work with Submitted to supervisor for review and
Design, supervisor feedback
Sampling, s in
Data analysis research
group
Revised work with Protocol submission – to supervisor for review
protocol research and feedback
developed and group
edited

Writing up the Self- Formatting all documents into one including:-


Student no:
Page 26
literature directed Abstract, Critical Review, Protocol, Gannt,
review, aims study Search Strategy, Ethics Documents
and
objectives,
abstract,
gannt and
search
strategy

Final Proposal submission for marking


submission

Research project complete timescale


Protocol Apply Participant Data Data Assignment
Writing - for UoS Recruitme Collectio Analysi submission
Peer Ethics nt n s and
Review Write-
Submissi up
on

Student no:
Page 27
Appendix 5 – Search strategy

Search areas used Key words


PubMed Normal
Eprints Clinical
Delphis Muscle
Cinahl Assessment*
Google scholar Properties
Google browser Mechanical
Citations from existing papers Rectus Femoris
Prevention
Injury
Musculosketal
Treatment
Effectiveness
Standardise*
Muscle state*
Contractile state*
Skeletal muscle*
Quadricep*
Myoton
Technology
Test*
Reliability
Change*
Rehabilitation
Application*
Isometric

Student no:
Page 28
..

Student no:
Page 29

You might also like