In vivo muscle
morphology
comparison between
walking with and
without ankle-foot
orthosis in healthy
adults.
MAIN FIELD: Prostethics and Orthotics AUTHORS: Vilma Thunberg & Anna Jansson SUPERVISOR: Christina Zong-Hao Ma JÖNKÖPING 2020 May
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Sammanfattning
En jämförelse i muskelmorfologi vid gående med och utan ankel-fot-ortos hos friska vuxna.
En förstudie med överkorsningsmetod.
Bakgrund: Personer som har genomgått en stroke lider ofta av diverse komplikationer. En vanlig komplikation är muskelsvaghet i den nedre extremiteten. Ett vanligt hjälpmedel för personer med dessa problem är en ankel-fot-ortos (AFO). Denna studies syfte var att undersöka muskelmorfologi (areaförändringar) i quadriceps muskeln när man går med en AFO jämfört med att gå utan.
Metod: Denna förstudie är en korsstudie som utfördes på 7 friska unga vuxna. Ett SMG-system användes på quadriceps för att mäta muskelarean. Enheten mätte muskelarea förändringar, EMG –och MMG aktivering, knävinkel samt plantara krafter. Statistiska analyser genomfördes på all insamlade data förutom knävinkeln.
Resultat: Arean för quadriceps var signifikant mindre när deltagarna gick med AFO i mid swing jämfört med utan (p=0,035). En signifikant skillnad visade sig i den plantara kraften under MTP1 (p=0,016) och under hälen (p=0,042) i toe off (60%). Resultatet visade inga signifikanta skillnader i initial contact (p=0,617), mid stance (p=0,287), toe off (p=0,527) eller i terminal swing (p=0,712) för quadriceps, eller plantara krafter på MTP5 under toe off (p=0,704).
Slutsats: Resultaten pekar på att deltagarna behöver använda sin quadriceps mer i mid swing när de går med en AFO. Fler studier på området behöver göras för att uppnå klinisk relevans.
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Summary
Background: People who have survived a stroke often have post-stroke complications. One common complication is muscle weakness in the lower extremities. To treat this, patients can use an ankle-foot orthosis (AFO). The purpose of this study was to investigate muscle morphology in the quadriceps when walking with an AFO.
Method: This feasibility cross over study was made on 7 healthy adults. To measure the morphology, an SMG device was used. The device measured muscle area change, EMG -and MMG activation, knee angle and plantar forces. Statistical analyzes was made for all measured data except knee angle. Result: The area of the quadriceps was significantly smaller when walking with the AFO in mid-swing phase than without (p=0,035). A significant reduction in force could also be found under the MTP1 (p=0,016) and under the calcaneus (p=0,042) in toe off (60%). The result did not show any significant differences in initial contact (p=0,617), mid stance (p=0,287), toe off (p=0,527) or terminal swing (p=0,712) for muscle area change of quadriceps, or plantar force at MTP5 in toe off (p=0,704).
Conclusion: The results suggest that the subjects needed to work more with the quadriceps muscles when walking with the AFO. More studies are needed to reach clinical relevance.
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Table of contents
SAMMANFATTNING ... 2 SUMMARY ... 3 TABLE OF CONTENTS... 4 INTRODUCTION ... 5 PROBLEM STATEMENT ... 5 AIM ... 5 RESEARCH APPROACH ... 5 BACKGROUND ... 6 GAIT ...6 ANKLE-FOOT ORTHOSES ... 8TOOLS FOR GAIT ANALYSIS ...9
AIM ... 11
MATERIAL AND METHOD ... 11
SUBJECTS ... 11 ETHICAL ASPECTS ... 11 MATERIAL ... 11 DATA COLLECTION ... 12 DATA ANALYSIS ... 14 MATLAB ... 14 ULTRASOUND ... 15 SPSS ... 16 RESULTS... 17 SUBJECTS ... 17 EFFECT ... 17 PLANTAR FORCE... 18 GAIT SPEED... 19 EMG AND MMG ... 20 DISCUSSION ... 22
MUSCLE AREA CHANGES ... 22
PLANTAR FORCES ... 22
EMG ACTIVITY ... 22
METHODS ...23
SUBJECTS ...23
CLINICAL RELEVANCE ... 24
LIMITATIONS /SOURCES OF ERROR ... 24
CONCLUSION... 24
ACKNOWLEDGEMENTS ... 24
REFERENCES ... 25
APPENDIX ... 29
APPENDIX 1. INFORMATION SHEET AND CONSENT FORM. PART 1. ... 29
APPENDIX 1. INFORMATION SHEET AND CONSENT FORM. PART 2. ... 30
APPENDIX 1. INFORMATION SHEET AND CONSENT FORM. PART 3. ... 31
APPENDIX 2. CONSENT FORM PHOTOGRAPHY MANAGEMENT. ...32
APPENDIX 3. MEAN AREA, P-VALUE AND PERCENTAGE DIFFERENCE. ...33
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Introduction
Problem statement
To be able to perform an effective and normal gait pattern, the involvement from the two muscles triceps surae and tibialis anterior is important (Fujisawa et al, 2015). Lacking the ability to contract one of these muscles will affect the gait cycle. Since several diseases can lead to weakness in these muscles, hemiplegia for example, problems with this is rather common.
In 2018, 25 500 people in Sweden got a stroke (Socialstyrelsen, 2020). Post stroke, different gait dysfunctions are usual. Generally, it is varying a lot amongst patients how these dysfunctions turn out but commonly is often slow and asymmetrical walking (Tyson et al, 2013). Hemiplegia resulting in weakness of distal muscles making it hard to dorsiflex in the ankle, creating a so-called drop foot is common post stroke (Kluding et al, 2013).
An ankle-foot orthosis (AFO) is a frequently described walking aid for people with hemiplegia. Wearing an AFO stabilizes the ankle joint (Daryabor et al, 2018) and help support the foot from dropping in the swing phase (Daryabor et al, 2018) (Daan et al, 2010).
However, being paralyzed in a muscle or immobilized in a joint, as by an AFO, often leads to compensatory movements and/or forces from other joints and muscles (Costa et al, 2010) (Park et al, 2019) (Yamamoto et al, 2018).
Compensatory movements could lead to overloaded joints resulting in injuries (Yamamoto et al, 2018). Therefore, the knowledge of muscle behavior is crucial for understanding effects of treatments. The Quadriceps is one muscle group that have been reported to act compromising due to AFOs (Costa et al, 2010). Earlier studies have been made on the quadriceps investigating compensatory kinematics and EMG activity changes using AFOs (Costa et al, 2010). In this study it was suggested that the quadriceps muscle activity was higher when wearing an AFO but that the difference was not significant and therefore did not affect the gait pattern (Costa et al, 2010).
Muscle area have also been studied before on the quadriceps (Akazawa et al, 2018) where they found that muscle thickness was positively correlated to muscle strength. Though, since earlier ultrasound systems has not been mobile, they have only been made with the muscle in static positions. No known study has yet measured the quadriceps muscle’s area changes while walking.
With a newly developed wearable sonomyograph-system (SMG-system) it is now possible to measure muscle area changes through ultrasound while walking (Ma et al, 2019).
Aim
The aim of this study was to provide a greater knowledge on morphology muscle area changes of the quadriceps muscle during a gait cycle and how the muscle form gets affected while walking with an ankle-foot orthosis.
Research approach
To answer the research question, a mobile SMG device was fixed to the thigh to measure muscle morphology differences in the quadriceps between walking with and walking without an AFO.
Healthy young adults with no issues walking were chosen for this feasibility study to avoid other factors than the AFO affecting their gait pattern. Younger adults tend to have a more stable and consequent walking pattern than elderly (Almarwani et al, 2015). Young, healthy people would therefore probably give more valid and reliable results for this kind of study.
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Background
Gait
A gait cycle is counted from when a heel first strikes the ground until the same heel strikes the ground again. The gait cycle can be divided into two phases, the stance phase and the swing phase. These two phases can as well be divided into different stages to be able to describe the gait cycle in detail (figure 1). The stance phase makes up 60% of the gait cycle and consists of four parts. First is Loading response then Mid stance, Terminal stance and Pre swing. The swing phase makes up 40% and is divided into three parts which are Initial swing (which starts with toe off), Mid swing and Terminal swing.
Figure 1. Shows one full gait cycle with names of every phase in the gait and where the stance and swing phase begins. It also places important happenings, such as the heel strike, toe off and opposite toe off with more (Levine et al, 2012).
A common term mentioned when talking about gait is the ground reaction force (GRF). GRF is the force reacting to the body when stepping on the ground (figure 2). This is a good indicator of how a patient put his/her load while walking.
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Figure 2. The arrow shows the Ground reaction force from loading response (Levine et al, 2012).
For a fully functional individual, the quadriceps muscle should be active at two times during a full gait cycle (figure 3). One time should be during Pre-swing when the hip joint is flexing. The second time should be when the terminal swing starts, extending the knee joint, until the middle of Mid stance where the knee starts flexing again to allow a heel rise. In the swing phase, the quadriceps muscle works isometric while keeping the hip flexed.
8 Figure 3. Showing all the muscles participating in the gait and when they are active. The quadriceps muscle is active from the terminal swing to midstance and in the pre swing (toe off) (Levine et al, 2012).
Lacking strength in the quadriceps can cause an anterior trunk bending (figure 4). Anterior trunk bending means that the subject walking, is bending the upper part of the body forward which also makes the trunk bend. The bending makes the line of the ground reaction force pass in front of the knee instead of behind the knee, creating a safe/locked extension in the stance phase (Whittle et al, 2012).
Figure 4. Anterior trunk bending. Making the line of the ground reaction force pass in front of the knee, creating a safe extension (Levine et al, 2012).
Quadriceps weakness can also lead to excessive knee extension. Again, this is a way of making the ground reaction force end up in front of the knee which creates a safe extension (Whittle et al, 2012). Locking the knee in hyperextension is of great value to patients experiencing weakness in the quadriceps muscles but doing this frequently stretches the muscles around the joint making the hyperextension bigger and might after some time develop osteoarthritis in the knee joint (Yamamoto et al, 2018) (Whittle et al, 2012). Quadricep weakness is exhibited in some post-stroke patients (Silvia-Couto et al, 2014).
For people who have suffered from stroke it is common to suffer from different gait deviations. Because of this, post stroke patients often have a larger energy expenditure when walking than able bodied people have (Kramer et al, 2016) (Platts et al, 2006). Usually they walk more asymmetric and slower than before. Its common that the affected side have a longer swing phase and a shorter stance phase. There can also be upper limbs and trunk affected which might also result in asymmetric gait (Li, Francisco & Zhou, 2018).
One gait abnormality that often occurs is a drop foot. A drop foot makes it problematic to walk with a free swing and may lead to gait deviations such as excessive knee flexion, circumduction and hip hiking to create a free swing (Neckel et al, 2008). In the stance phase, some common problems can be knee hyperextension and forward progression during midstance and/or excessive knee flexion in early and/or late stance phase (Baker et al, 2012).
Ankle-foot orthoses
Toe off AFOs is frequently described for stroke patients with hemiplegia.
A toe off AFO is an orthosis provided to hinder the foot from dropping, allowing a free swing in the gait. The toe off orthosis is today one commonAFO prescribed. It was developed to help the foot pre-position just before initial contact and during loading response (Lusardi, 2013). In stance phase the toe off orthosis helps with medial-lateral stability. In the late stand phase, the AFO lets tibia come forward and collect energy for the push off (Lusardi, 2013).
9 Walking speed often increases for post stroke patients when using a toe off AFO (Keiskburun et al, 2017) (Kluding et al, 2013) (Everaert et al, 2013). Since the AFO hinders the foot from dropping and allowing a free swing phase, there should be no need for hip hiking, circumduction or excessive knee flexion. Toe off AFOs have also showed positive effects for balance and stability, for post stroke patients (Keiskburun et al, 2017). When walking with AFO, cadence and single support duration has showed to increase while stride duration decreases (Nikamp et al, 2017).
For healthy people with no gait deviations, AFOs have shown to negatively affect cadence, step time, step length and walking velocity (Romkes et Schweizer, 2015).
The AFO makes the ankle stiff which can lead to a poor push off (Daryabor et al, 2018). Lacking the ability to push off often leads to a short step length since it makes it hard to do the heel rise which forces the patients to lift the foot vertical and therefore also sooner in the gait cycle. However, many of the patients in need of AFOs are not able to perform a push off on their own either due to weak gastrocnemius muscles.
There are many orthotic suppliers who claims that their AFOs have push off assistance since the stiffness in the material is reproducing energy in the push off moment and therefore would help. It has been shown that ankle power depends a lot on the stiffness of the AFO where a too stiff AFO results in less power (Waterval et al, 2019). There has also been suggested that the timing of the push off might be affected by the stiffness where a too stiff AFO creates a push off too early in the step and a too flexible AFO makes the push off happen to late (Bregman et al, 2011). A common thought is that there is no golden standard for stiffness and that the ultimate AFO stiffness should be evaluated for each patient for the most energy efficient push off and gait pattern (Bregman et al, 2011) (Waterval et al, 2019)
Singer et al (2014) have suggested that some AFOs put added stress on the knee extensor muscles. This because increased dorsiflexion made by the AFO forces a greater flexion on the knee which the user then tries to counteract with the knee extensors. This might result in fatigue for the extensor muscles.
Tools for gait analysis
Force plates are a tool that are used to screen gait in ground reaction force (GRF). The information provided from this tool can show us how the patient puts his/her pressure against the floor in different parts of the gait cycle (Bracht-Schweizer et al, 2017). This method is though limited to only measure forces from the feet. Force plates are also hard to use in other places than a lab since it often needs to be mounted into the floor.
In shoe devices is also a system to measure pressure from the feet but unlike the force plates, the in-shoe devices are mobile. This mobile tool can be a big advantage, it makes it possible to used it everywhere. In shoe devices has showed to have a strong agreement with force plates making them just as safe to use for measuring plantar forces (Jönsson et al 2019).
To measure full body kinematics, camera-based systems can be used. The camera systems can look differently from place to place. It can be one or several cameras and force plates are sometime used as supplement for the camera system. A single-camera system can be used to evaluate gait in two dimensions. Multiple camera systems measure more accurate kinematic movements. This gives a 3D measurement of the human's movement (Whittle et al, 2012). There is different type of systems, but they work similar. The cameras are taking up information from “markers” that are made by reflecting material and are placed on the persons limbs. The cameras take up the reflectors through infrared or visible light (Whittle et al, 2012). The data system is then taking up information how the markers move and can from that information describe gait deviations and kinematics more precisely than the human eye (Whittle et al, 2012). A lack of this system is that it only gives information on visual kinematics and movements of the bones in the gait. It has no deeper information about the muscles impact.
To measure effects on compensatory movements or muscle activities, EMG measuring is common. Since EMG gives information about muscle activity in the response to the nerves impact, it is possible to determine muscle deviations (Whittle et al, 2012).EMG can measure the muscle activity live while walking which makes it possible to compare two different walks, such as with or without an AFO.
10 Mechanomyogram (MMG) is an alternative way to measure muscle activity, MMG is measuring the low frequency in the muscle contraction.
Differences in muscle activity in the quadriceps has been showed while walking with an AFO when measuring with EMG. When walking with the AFO both vastus femoris and rectus femoris had an increased muscle activity (Costa et al, 2010).
The problem with EMG and MMG is that it mostly shows the timing of the muscle contraction but has limited information about the actual muscle strength (Whittle et al, 2012) which can make it hard to draw conclusions about how big of an effect the measured activity from the muscle have on the body. Muscle strength have showed to have a strong impact on balance, gait and risk of falling (Spinoso et al, 2018) (Kasser et al, 2011).
Muscle area has showed to be correlated to muscle strength (Palakshappa et al, 2018) and to measure muscle area, ultrasound is a good choice. Ultrasound investigates how the muscle is working through images, showing form and area. It is a noninvasive way to look at the skeletal muscles.
Earlier versions of ultrasound systems have been limited since they are only able to measure the muscles while in a static position. This have made it impossible to compare different walking conditions such as the direct effects of AFOs on the gait.
Using a mobile ultrasound device, such as the new SMG-system, makes it possible not only to measure the form of the muscle but to measure the changes of the form live during the gait cycle.
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Aim
The aim of this study is to provide a greater knowledge on morphology, muscle area changes of the quadriceps muscle during a gait cycle and how the muscle area gets affected while walking with an ankle-foot orthosis.
The hypothesis of this study is that there will be a difference in the quadriceps muscle area when walking with the AFO (two-tailed).
Material and method
Subjects
For this clinical experiment healthy young adults were recruited. The subjects had to be above 18 years old and able to walk without any issues. Subjects were excluded if they had any pain or difficulty walking. They would also be excluded if they had any significant walking dysfunction.
Healthy subjects with no gait deviations was chosen to eliminate other factors than the AFO affecting the gait pattern.
To ensure the subjects had no gait deviations, a clinical examination was conducted. Possible leg length differences were measured but were only noted if it differed more than one centimeter since it should not affect the gait below that difference if the subject does not feel it (Gurney, R 2002). Range of motion in the ankle was checked. The subjects were asked to do toe-walking, heel-walking and then to jump on one leg. The subjects then got to start walking on the treadmill as warm-up and while walking, one last observation of the gait was made checking for possible deviations. If they were able to perform all the tasks and had no history of injuries that could affect the gait, they were considered healthy walkers.
Ethical aspects
Ultrasound systems are safe to use on all kinds of patients since it does not affect the body like an X-ray or a magnetic resonance imaging (MRI) (Blankstein, 2011).
An ethical self-assessment was handed in before the recruitment of subjects started.
The subjects were given both verbal and written information about the study and was asked to sign a written consent (appendix 1) before any trial was conducted. To avoid any identity disclosure, every subject was assigned a code in the place for their name when working with personal data.
The subject whom pictures were taken off got information about the purpose of the pictures and had to sign a consent (appendix 2).
Material
AFOs from Camp Scandinavia AB was borrowed and used for all subjects. The model used was the “Toe Off Flow 2½” (figure 5). The model is, amongst other diagnoses, aimed for active drop foot patients and is a relatively flexible orthosis which allows a greater range of motion compared to other AFOs from Camp (Camp Scandinavia, 2020).
The AFO is made of carbon fiber and during the trials it had a padding on the front cover where the AFO put pressure on the skin of the subjects to make it more comfortable.
The same person conducted all the fittings of the AFO to make sure it was conducted the same way every trial. The three most common sizes were used (Small, Medium, Large) which all have a heel height of 7mm. The stiffness of the AFO varies from sizes where larger sizes have a higher stiffness (Camp Scandinavia, 2020). Sizes for the subjects were chosen by the size of the shoes they brought. In the fitting, focus was put on not creating a hyperextending moment in the knee. If the AFO did not have the same heel height as the shoes of the subject, extra material was put under the AFO in the heel to create the same height and a less loose fit. This was made because it has been showed that AFOs which create hyper extension moments in the knee joint also put a lot of added stress on the knee extensor muscles (Singer et al, 2014) which might would have affected the results of this study.
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Figure 5. Toe Off Flow 2½ from Camp Scandinavia AB (Camp Scandinavia, 2020).
The SMG-system that was used, consists of several parts. It has the mobile ultrasound, mechanomyogram (MMG) and electromyogram (EMG) electrodes, force sensors and a goniometer (two axis). The device is driven by batteries and are connecting through Wi-Fi (Ma et al, 2019). Just as the fitting of the AFO, the placing of the SMG-device was also done by only one person.
The ultrasound and EMG devices had to be placed on a part of the skin without hair and subjects with hair on their thighs were therefore shaved on the parts where it was needed. The ultrasound device was placed on the rectus femoris muscle for measuring, the depth chosen differed between subjects to get a clear picture of the muscles. The subjects were asked to contract their quadriceps, the probe was then placed where the rectus femoris looked to be (if it was hard to locate, the probe was put on the middle of the thigh). The probe was then moved around to find the edges of rectus femoris muscle. The edges of vastus medialis and lateralis was also located on both sides to make sure it was the rectus femoris in the middle that had been found. One set of EMG electrodes was put on the quadriceps, hamstring and patella. The EMG on the quadriceps were closely to the ultrasound to measure the signals from the quadriceps muscles.
The MMG were placed in between the two EMGs (figure 8). The second set of EMG was put on the hamstrings, the EMG was also placed as a reference point on the patella. To measure the angle of the knee the goniometer was placed here. The force sensors were put on the plantar side of the foot on the first and fifth metatarsal phalange (MTP1 and MTP 5) and under the center of calcaneus. The force sensors were placed between two flat insoles that were made for each patient to fit in their shoes. insoles were made for both shoes to avoid height difference.
A regular treadmill was used for the gait analysis (model Cybex 530T Pro+, from Cybex Medway, Massachusetts, USA, serial number A06–15530T9537NN02). The treadmill was chosen because it makes it easy to find a good self-selected speed since it is not limited by the length of the room, allowing the subject to take as big/small steps as wanted and not having to turn or stop. Finding a comfortable speed can take some steps (Plotnik et al, 2015) which makes it important to not be interrupted, by a wall for example. Using a treadmill also secures that the subjects are walking at the same speed throughout the whole trial since you change the speed via buttons.
Data collection
13 After the SMG-system (and the AFO for those who started with it) was put on the subject (figure 6, 7 and 8), they had a 5minute walk on the treadmill to get used to the device and to find a comfortable walking speed before the trial started. When the subjects started the second trail, they had another 5minute warm up to get used to the new condition in the same speed as the first trial, before the next trial started.
The subjects conducted one trial with the AFO and one without. In each trial, at least three valid gait cycles had to be recorded by the SMG-device to be considered approved. This was to get a reliable result. The same walking speed was used in both trials to minimize potential sources of error.
A randomized order decided if the first subject was supposed to start with an AFO or not. After that, every second subject started with the AFO and every other subject started without it. Half the group of subjects got measured on the right leg and the other half on the left leg. This was to make the collected data as randomized as possible.
Figure 6. is showing the device put on a subject in frontal plane. The ultrasound is put on the middle of the thigh behind the tape. Close to the ultrasound, the first two electrodes for EMG is put to measure the same muscle and in between the electrodes the MMG is placed. There are two EMG electrodes on the patella working as reference for both the EMG on the quadriceps and the EMG put on the hamstring muscles.
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Figure 7. is showing the device put on a subject in sagittal plane. The goniometer is put along knee joint.
Figure 8. Illustration on how the ultrasound probe and MMG -and EMG electrodes were placed beneath the tape (right leg). On the left leg it was placed the same way but mirrored.
Data analysis
Matlab
The SMG device collected data from the EMG, the force sensors, the goniometer and the ultrasound, saving it in a pre-coded program in Matlab (Ma et al, 2019) (figure 9). To extract a gait cycle, the force sensor beneath the calcaneus was used. One gait cycle was counted from one heel strike until right before the next one.
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Figure 9. Shows a gait cycle from one subject. The first line is the MMG signal. The second and third are values from the goniometer, the first one is showing valgus/varus in the knee and the next one shows the flexion. The fourth and fifth are EMG measurements where the first line is the EMG signals from the hamstrings and the second one is the signal from the quadriceps. The last three rows show the plantar force. The first of them is the MTP1, the second is the MTP5 and the last row shows the force beneath calcaneus. The force from under calcaneus was the one used to decide where the step started and where it should end (right before the next heel strike).
Ultrasound
To measure the muscle area change, the SMG-system was used. The ultrasound probe collected images of the muscle through the gait cycle. To measure the area, the edges of the muscles was marked manually (figure 10). The Matlab program could then count the area (mm²) of the marked muscle. This was done in every 0,1 seconds of every gait cycle collected. For example, a gait cycle on 1,3 seconds therefore left 13 muscle area values.
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Figure 10. shows how the muscle area was measured. Lines were manually put on the outer white lines which are the edges of the muscle. This was done through every phase of the gait on every subject.
The muscle area values were put in an Excel file and for every subject, a mean from the three gait cycles with the AFO and a mean from the three gait cycles without AFO was calculated. After this the gait cycle was divided in five stages. Initial contact (IC, 0%), Midstance (MS, 30%), Toe off (TO, 60%), Mid swing (MSw, 80%), and Terminal swing (TS, 100%). These five phases were then used to compare the quadriceps muscle area for walking with the AFO versus walking without it.
SPSS
The collected data was put in SPSS for analyzing. At first, a test of normality was conducted and since the data was normally distributed, the Paired T-test was then used for analyzing. The level of significance was put on 95%. Data from the ultrasound, EMG -and MMG probes and the force sensors was analyzed statistically in five different phases of the gait cycle (10%, 30%, 60%, 80% and 100%).
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Results
Subjects
Nine people participated in the study. Two of the subject’s data could not be used due to measuring issues. No subject chose to leave/terminate the study. The subjects whose data could be collected from, consisted of three male and four female subjects. The average age was. 23,3 years (21-29). Average speed was 3,9 km/h (2,0-4,6). All the subjects passed the requirements, they all walked unobstructed and passed the clinical tests. One subject experienced pain while walking with the AFO due to the shoes used, which were too small to fit the AFO and therefore caused the pain. The subject did not express any need to stop the experiment but was asked to loosen the shoelaces which seemed to help. The trial then continued.
Effect
All the data was normally distributed and therefore, the paired t-test was used to analyze the data. Mid swing was the only phase in the gait cycle that showed a significant difference between walking with an AFO and without (p=0,023) (figure 11, table 1). The quadriceps muscle area was significantly smaller with the AFO during mid swing (677mm² without versus 626mm² with the AFO, see appendix 3). There is a 51mm² difference between the mean values in mid swing and the muscle area reduction had a mean at 7,5%.
For initial contact, no significant difference could be spotted (p=0,858) (table 1). Neither could it be seen in mid stance (p=0,838), toe off (p=0,428) or terminal swing (p=0,554).
Figure 11. Shows the quadriceps area mean of all the subjects during the gait cycle. The blue line shows muscle area for walking without the AFO and the red line shows the muscle area for walking with the AFO.
At initial contact, the mean quadriceps muscle area was 1,6% bigger with the AFO than without it (mean 518mm² without AFO and 527mm² with the AFO) (appendix 3). The differences between the means were 9mm². The differences were not big enough to be considered significant.
18 In midstance the mean muscle area was 0,3% smaller when wearing the AFO. Toe off had a 1,4% smaller area and terminal swing had a 1,1% smaller area with the AFO (appendix 3).
The results varied from the subjects and no pattern could be seen. The mean value in Mid stance was higher without AFO than with (682mm² and 679mm²). Toe off showed a higher mean without the AFO (726mm² without and 717mm² with AFO) and terminal stance showed higher mean without AFO (529mm² without AFO and 524mm² with AFO).
Table 1. Shows the results of the paired T-test in every measured part of the gait cycle. Comparing the AFO gait with the not assisted gait. A significant result can be found in the line of mid swing (p=0,023).
Plantar force
The values collected from the force sensors showed that there was a significant difference in load in the push off (60%) under the MTP1 (p=0,016) and under calcaneus (p=0,042), where the load was smaller when wearing the AFO (table 2). For MTP5, no significant different was found (p=0,704). The mean force for MTP1 was 12,5% smaller with the AFO than without it and for the calcaneus, the mean was 12% smaller with the AFO (table 3). For the MTP5, there was a 0,5% higher mean when using the AFO.
Table 2. Shows the paired T-test for the force sensors in Toe off (60% of gait cycle), on MTP1, MTP5 and calcaneus. Also, the stride is included in this figure.
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Table 3. Showing the force from MTP1, MTP5 and calcaneus in the toe off (60%). It also shows the mean from all the subjects.
Gait speed
The gait speed tended to be quite low with an average speed of 3,9km/h (lowest speed at 2,0km/h and highest 4,6km/h) (table 4). There were no common patterns for the subjects between the times of stance phase and swing phase when using the AFO versus when they walked without it (appendix 4). For the stride, all subjects but one had a shorter stride length when using the AFO (table 4). The stride (p=0,47) (table 2), swing time (0,614) and the stance time (p=0,961) did not show any significant difference when walking with the AFO compared to walking without it (table 5).
Table 4. Shows the speed for each subject. It also shows the stride duration for both trials and the total mean from each column.
Subject Stride duration(s )No AFO Stride duration(s) AFO Speed 2 1,35 1,33 3,2 3 1,24 1,27 4 4 1,17 1,27 2 6 1,14 1,16 4,3 7 1,1 1,15 4,5 8 1,06 1,14 4,5 9 1,06 1,06 4,6 Mean 1,16 1,197 3,87
Table 5. Shows the paired T-test for swing time and the stance time when walking with an AFO and without.
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EMG and MMG
EMG and MMG was measured on the rectus femoris muscle on the subjects. EMG was also measured on the biceps femoris muscle during the trials. The results collected from the MMG and EMG was not normally distributed and therefore the Wilcoxon's test was used instead of the paired T-test.
From the EMG on the quadriceps (rectus femoris) muscle, mid swing had a greater difference in the result but was not enough to be significant (p=0,063) (table 6). In mid swing, the muscle activation was 28% smaller when using the AFO (table 9). No significant differences were found between wearing the AFO and walking without it in the initial contact (p=0,237), mid stance (p=0,352), toe off (p=0,249), or terminal swing (p=0,249) (table 6).
No significant differences could be found in the EMG from the hamstrings (biceps femoris) muscle either. Initial contact (p=0,172), mid stance (p=0,176), toe off (p=0,128), mid swing (p=0,345) and terminal swing (0,612) (table 7).
Neither did the MMG show any significant differences when walking with the AFO. Initial contact (p=0,933), mid stance (p=0,612), toe off (p=0,866), mid swing (p=0,310) terminal stance (p=0,398) (table 8).
Table 6. Shows the Wilcoxon´s test for the rectus femoris muscle.
Table 7. Shows the Wilcoxon´s test for the biceps femoris muscle.
21
Table 9. Shows the mean of EMG -and MMG activity for different parts of the gait cycle. The EMG-PF shows the activity from the biceps femoris muscle while the MMG and EMG-DF shows the activity from rectus femoris muscle.
22
Discussion
In this feasibility study, the muscle area changes for when walking with, versus without an AFO was investigated. Plantar force, MMG and EMG were measured and taken in consideration. The study was conducted on healthy subjects.
Muscle area changes
The objective of this study was to examine if there are any quadriceps muscle area changes while walking with an AFO compared to when walking without one. The results presented in the study showed a significant difference in the mid swing phase of the gait cycle for the quadriceps area suggesting that the area is smaller when using an AFO (p=0,023).
Since wearable ultrasound devices like the SMG-system hasn’t existed for very long, no previous studies were found measuring ultrasound in walking.
Though, studies on kinematics have found that AFOs often limits the ankle joint (Daryabor et al, 2018) and that the quadriceps muscle can compensate for inadequate ankle flexion in the mid swing (Bregman 2011) which seems to be coinciding with the results from our study.
Muscle area has also been showed to correlate with muscle strength (Palakshappa et al, 2018) which is why one can assume from the results that the subjects needed to use more strength in the quadriceps muscle in mid swing when using the AFO.
That it seems to take more strength from the quadriceps when walking with an AFO could be problematic for people with post stroke since they might not have much strength in the quadriceps muscle (Silvia-Couto et al, 2014).
Plantar forces
The force sensors on the plantar side of the foot showed a significant difference in both the sensor beneath MTP1 (p=0,016) and the one beneath calcaneus (p=0,042). During the push off (60%), the subjects put less force on the MTP1 and calcaneus when walking with the AFO. The stride length for the subjects was shorter for everyone but one when wearing the AFO, but no significant difference was found. Neither was a significant difference found in the swing- or stance time.
Previously studies have shown that walking with an AFO can decrease stride duration (Nikamp 2017). This did not seem to be the case in this study. One reason for this could be that we have used different types of AFOs in the studies, since the stiffness of the AFOs affects the walking pattern (Bregman et al, 2011).
Previous studies have also found that it is harder to push off with an AFO since it is limiting the ankle moment and making it impossible to perform plantar flexion (Daryabor et al, 2018). This could be one explanation to what affected the forces being lower in push off with the AFO.
Another factor for the decreased force under MTP1 could be that the plane of the AFO is flat which makes the push off more even over the forefoot. Instead of pushing of on the side of MTP1, which is most common way to push off the step (Hessert et al, 2005).
EMG activity
The EMG activity from rectus femoris in mid swing was smaller when the subjects was walking with the AFO than when they were walking without it. The results were close to but did not show a significant difference (p=0,063). Other than that, no significant differences were found when measuring EMG activity, neither for the rectus femoris muscle or the bicep femoris muscle. The results from the MMG did not show any significant differences in any phase of the gait cycle either.
An earlier study on the quadriceps muscle activity has showed that there is a difference in the muscle activation when walking with an AFO and that the activity seems to be higher with the AFO. Though, the differences were not significant and did therefore not seem to affect the gait pattern (Costa et al, 2010). The results from this study does not match with our findings, except that the results were not
23 significant, since the activity was smaller when walking with an AFO in our study. This make it seem like it is even more likely no significant difference in muscle activity when walking with the AFO. Further research is needed to clarify this in the future.
Methods
It was probably good to conduct the trial on the treadmill since we were able to control that the speed was the same on both trails. It would have been harder to estimate when walking on the ground. Also, no obstacles such as turns, or walls could interrupt when walking on the treadmill.
The subjects got to choose their own speed when walking on the treadmill which was to ensure that they felt comfortable and walked as they usually do. They got to walk five minutes before starting the tests to find their preferred speed. All the subjects started with a low speed and increased until they thought they had found their normal walking speed. The self-selected speed often tended to be quite low and maybe not an accurate version of how they normally walk. Since studies have shown that men around 40 years old have a normal walking speed on about 5km/h (Bohannon et Andrews, 2011) it is probably safe to assume that some of the subjects in our study normally would walk faster than the speed they chose. In our study the average speed was 3,9 km/h (2,0-4,6). We think that if we would have pushed the subjects to try with a higher speed and then instead lower the speed again if it felt to high, the speed it might would have increased and have been more accurate.
All the parts of the device had to be taped on except the EMG electrodes which had adhesive on them. The tape did not stick well if the subject had a lot of hair on the thigh since it only attached to the hair and not the skin. Subjects who had a great amount of hair on their thighs was shaved on the parts where the ultrasound and EMG were placed but it might would have helped if the whole leg was shaved so that the hair couldn’t affect how well the tape would stick. There was also a problem with subjects that had freshly shaved legs since they were too soft for the tape to stick. The best scenario would have been if all subjects had shaved their whole thighs about two days before the trial, so no hair would be in the way for the parts of the device, but the tape would have something to stick on. Lotion could also be a reason why the tape falls off.
The subjects had a lot of wires that connected the different parts of the device hanging on the leg. We tried to tape them up as good as possible but there was still a lot hanging out. This could be a factor that influenced the walking speed and/or created abnormal walking patterns. We assume that the warm-up walks on five minutes before the trials made them used to the conditions and removed abnormal gait. We had no other measure to make sure they had gotten into their normal gait pattern but their words that they felt comfortable. We asked every subject before ending the warmup if they felt okay and used to the speed. This makes it hard to know if the five minutes was enough or if the time should have been longer.
The toe off AFOs was prefabricated and not individually customized. A common thought through studies are that there is no golden standard for patients in AFOs and that ultimate stiffness should be evaluated for each patient for the most energy efficient push off and gait pattern (Bregman et al, 2011) (Waterval et al, 2019). The result might would have differed and been more accurate if every AFO was individually customized. Due to lack of time and material, customized AFOs would not have been possible in this study and since prefabricated AFOs are such a common choice of treatment method, the results from this study are probably anyway applicable for the field.
Also, to make the customized AFOs, an expertise about stiffness and layers would be needed that we do not possess.
The subjects were wearing their own shoes but were asked to wear sneakers to the trials. Everyone had similar sneakers. The heel height might have differed some between the shoes, but we do not think it affected the results.
Subjects
The group of subjects we used were small. The subjects were all people in their twenties who were all active.Healthy subjects were good for the study since it would be hard to do the test on people which
24 need AFOs on a daily basis, since they would have a hard time walking without it and it would be harder to estimate if it was the AFO affecting the quadriceps muscle or something else, a compensatory movement from the drop foot for example. With the healthy subjects it is clearer that it was the AFO which affected the quadriceps and not the gait pattern itself.
Stroke is more common in elderly (Socialstyrelsen, 2020) and maybe a group of subjects closer in age to that would have been more appropriate than young adults to make the results even more applicable. Though, younger people tend to have a more stable and consistent gait pattern than elderly (Almarwani et al, 2015) which indicates that this kind of study might would have been harder to conduct on older subjects since the data might would have varied too much to be able to draw good enough conclusions for a feasibility study. We therefore think that the young healthy adults were the best way to go. This study has potentially provided some insights regarding the experimental protocol that can be applied on patients with stroke for future studies.
Clinical relevance
A lot of people suffer from post-stroke symptoms and many of the patients in this group are in need for AFOs. This makes studies on how AFOs affect the walking clinically relevant since it affects such a large amount of people.
Though, post stroke patients often have inconsistent walking patterns (Kramer et al, 2016) (Platts et al, 2006) which makes it hard to apply these results on them. This study might have given some insights, but further studies are needed.
Limitations /Sources of error
There are some limitations with this study. At first, there was a limited number of subjects which makes it hard to draw conclusions. Because of economical restrictions we were not able to recruit more subjects.
Two of the subjects had unusable data because we could not manually measure the ultrasound image since the lines of the image was too unclear.
One source of error is that we can´t guarantee that the mobile ultrasound did not move. We had a solution that included tape to hold the ultrasound at its place but since some subjects had a lot of hair or too smooth skin the tape sometimes loosened which might have made the device move.
When analyzing the data in Matlab we had to draw the line manually. In some pictures of the gait cycle it could be difficult to estimate where the line went. The thickness of the muscle edge was also different on every patient which made it hard to place the lines on the same place for every picture.
We do not have any earlier experience of using ultrasound devices which might have resulted in some errors.
Conclusion
This study supports the hypothesis suggesting there is a difference in quadriceps muscle area when walking with an AFO. It indicates that toe off AFOs might not assist the quadriceps muscle in mid swing, creating a less energy consuming walking. A larger study needs to be conducted in the area to make it applicable for clinical use.
The impact from form and stiffness in AFOs might mean that the results from this study is only applicable for the Toe Off Flow 2 ½.
Acknowledgements
Camp Scandinavia did not interact in the study other than lending materials and instruct proper fitting. We would like to thank all the subjects and our supervisor Christina Ma for all the help and support during this study. We would also like to thank Camp Scandinavia AB for lending us equipment.
25
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Appendix
Appendix 1. Information sheet and consent form. Part 1.
Information for subjects participating in the study “In vivo muscle
morphology comparison between walking with and without ankle-foot orthosis in healthy adults.”
Study information
This study is only for bachelor thesis purpose.
This study aims to investigate muscle area changes when walking with an ankle-foot orthosis and not. A mobile SMG device will be fixed to the leg to measure muscle area while walking through ultrasound. A clinical examination of the participant will be conducted on the subjects in preparation for the study and each subject will get some questions about general information before starting the trial (Such as gender, height etc.). A code will be assigned for each subject, replacing the name for the data analyses to avoid showing identity. There is no knowledge of any health risks associated to this trial.
Denna studie görs enbart I syftet för en C-uppsats.
Denna studie ämnar undersöka muskelareaförändringar när man går med en ankel-fot ortos jämfört med att gå självständigt. Ett SMG-system kommer fästas på benet för att mäta muskelarea I gångcykeln genom ett ultraljud. En klinisk undersökning kommer genomföras av deltagarna som förberedelse för studien och varje deltagare kommer få svara på några allmänna frågor innan mätningarna påbörjas (så som kön, längd osv). Varje deltagare kommer tillges en kod som ersättning till namn inför dataanalyser för att undvika röjda identiteter. Det finns ingen vetskap om några möjliga hälsorisker associerade till denna studie.
As a subject
You are required to be healthy (no injuries which can affect walking abilities). This is a totally voluntarily trial. You are as a participant free to leave or cancel the trial whenever you want without questions being asked. Your personal information will be handled anonymously. The information will only be used in the purpose of this study. The information will be protected by the school´s server. After the study, your information will be deleted.
Du behöver vara frisk (inga skador som förhindrar din gång). Det är helt frivilligt att vara med I studien. Du som deltar har tillåtelse att avbryta studien när som helst utan skäl. Din personliga information kommer att behandlas anonymt och informationen kommer endast användas I syfte för den här studien. Informationen är skyddad av skolans servrar. Efter att studien är avslutat så kommer all personlig information att raderas.
Preparation
For this trial you will have to have an area of your leg shaved in order for the device to stick. If possible, you can shave your LEG before arriving and if not, we will do it before start. Wear comfortable walking shoes to the trial (sneakers) and preferably with removable soles. Estimated time for the trial will be approximately two hours for each participant, including a fika break. If you are unavailable to attend on agreed time, please inform us as soon as possible!
30
Appendix 1. Information sheet and consent form. Part 2.
För den här studien kommer du att behöva raka bort hår från en del av ditt ben för att tillåta apparaten att fästa bättre. Om det är möjligt kan du raka benet själv innan, om inte så gör vi det på plats. Ha på dig bekväma skor (sneakers) med borttagbar sula. Den uppskattade tiden för undersökning och test-tid kommer att bli ca: två timmar. Det kommer att bjudas på fika. Om du inte kan komma på din bokade tid måste du höra av dig så snart som möjligt!
Contact information
Anna Jansson Vilma Thunberg 076-817 29 79 070-597 78 35 Jaan1717@student.ju.se thvi1700@student.ju.se
31
Appendix 1. Information sheet and consent form. Part 3.
Shows the information and the form which had to be read and filled out by every participant before any trial was started.
Consent form for: “In vivo muscle morphology comparison between
walking with and without ankle-foot orthosis in healthy adults.”
By signing this form, I allow that my personal information can be used for the purpose of this study. I am aware of my rights in this study and that I can cancel my participation at any time without further questions being asked.
Genom att signera den här blanketten godkänner jag att min personliga information kan användas i studiens syfte. Jag är medveten om mina rättigheter och att jag kan avbryta studien när som helst utan frågor.
Date/city: ____________________
Name: ______________________
32
Appendix 2. Consent form photography management.
Shows the form which had to be filled out by the participants who was going to be filmed or photographed before any filming or photography could be made.
Kodnummer: …………..
ADDRESS: School of Health and Welfare, P.O Box 1026, SE-551 11, Jönköping, Sweden VISIT: Barnarpsgatan 39, Campus, Building G
PHONE: +46 (0)36 10 10 00 WEB: www.ju.se Samtycke till hantering av fotografier, film, ljud, rörelseanalyser (III)
Vid Avdelningen för rehabilitering, Hälsohögskolan, Jönköping University
Detta är ett formulär för att dokumentera individens frivilliga samtycke till att angiven personlig information hanteras. Det övergripande ändamålet för att hantera dessa personuppgifter är att bedriva undervisning med stark koppling till klinisk verksamhet under ordnade och kontrollerade former för både studenter och patienter/personer. Mer information ges i separat dokument, som individen får en kopia av.
Ifyllda Samtyckesformulär förvaras på Hälsohögskolan i säkerhetsklassad förvaring, med tillgång endast för behörig personal.
Om du samtycker svarar du genom att kryssa i ruta för respektive del, fyller i namn och kontaktuppgifter och bekräftar med din underskrift, datum och ort.
Delar som du inte samtycker till fylls inte i.
________________________________________________________________________________ □ Jag har tagit del av den skriftliga informationen och har förstått att mitt deltagande är helt frivilligt och kan avbrytas när som helst utan någon förklaring samt att jag när som helst kan återkalla mitt samtycke och kan begära att uppgifterna förstörs eller avidentifieras.
Jag samtycker till att bli
□ Fotograferad □ Filmad
□ Ljudinspelad □ Rörelseanalys registrerad Jag samtycker till att dessa material sparas och kan användas till
□ Undervisning
□ Presentationer, föreläsningar inom Jönköping University □ Presentationer, föreläsningar externt utanför Jönköping University
□ Jag samtycker till att bli kontaktad för separat samtycke till annan då beskriven användning.
För- och efternamn: ………. Födelseår:………… Telefon-nummer:………. Ort, datum: ………. Underskrift: ………
33
Appendix 3. Mean area, p-value and percentage difference.
Gait
phase No AFO AFO P value Percentage difference
0% 518,255 526,557 0,858 1,6% 30% 681,921 679,255 0,838 0,3% 60% 726,208 716,539 0,482 1,4% 80% 676,690 625,937 0,023* 7,5% 100% 529,812 524,497 0,554 1,1%
Shows the mean area of the rectus femoris muscle with and without AFO in mm², the P-value and the percentage difference between walking with the AFO and without.
34
Appendix 4. Stance time, swing time and stride.
Subject Speed Stance time, Swing time & stride.
Subject 2 no AFO 3,2 stance(s), 0.67, swing(s), 0.68, stride(s), 1.35 Subject 2 with AFO 3,2 stance(s), 0.64, swing(s), 0.69, stride(s), 1.33 Subject 3 no AFO 4,0 stance(s), 0.77, swing(s), 0.47, stride(s), 1.24 Subject 3 with AFO 4,0 stance(s), 0.88, swing(s), 0.39, stride(s), 1.27 Subject 4 no AFO 2,0 stance(s), 0.90, swing(s), 0.27, stride(s), 1.17 Subject 4 with AFO 2,0 stance(s), 0.65, swing(s), 0.62, stride(s), 1.27 Subject 6 no AFO 4,3 stance(s), 0.55, swing(s), 0.59, stride(s), 1.14 Subject 6 with AFO 4,3 stance(s), 0.49, swing(s), 0.66, stride(s), 1.16 Subject 7 no AFO 4,5 stance(s), 0.56, swing(s), 0.54, stride(s), 1.10 Subject 7 with AFO 4,5 stance(s), 0.61, swing(s), 0.54, stride(s), 1.15 Subject 8 no AFO 4,5 stance(s), 0.50, swing(s), 0.56, stride(s), 1.06 Subject 8 with AFO 4,5 stance(s), 0.72, swing(s), 0.42, stride(s), 1.14 Subject 9 no AFO 4,6 stance(s), 0.53, swing(s), 0.54, stride(s), 1.06 Subject 9 with AFO 4,6 stance(s), 0.51, swing(s), 0.55, stride(s), 1.06
Shows the stance time, swing time and stride duration for every subject, both with the AFO and without.
