Design of an Ankle Foot Orthotic Christopher Sullivan 1 Abstract The Ankle Foot Orthotic (AFO) has been around for centuries, created to substitute functionality of an ankle that had been lost to injury or disease. A common reason a patient might be prescribed an AFO is a condition called foot-drop, a disorder involving lack of ability to dorsiflex the foot. Foot-drop can be caused by many factors, but most have to do with diseases and injury to the nervous system. People who have had a stroke, for example, may retain the ability to “push off,” but have no ability to raise their toe during swing. Hard plastic AFOs that hold a patient’s foot in a neutral position are the current standard for combating foot-drop. Unfortunately the restrictive nature of the AFO can cause unnatural movements in the patient’s stride. The purpose of this project is to create a prototype active AFO that will still support the foot, but aid in the ability to regulate rotation of the ankle during sections of the gait cycle. Adding the ability to rotate to the brace should increase the comfort level of the brace, while still replacing the lost functionality of the ankle. To accomplish this, a prototype will be created, and its ability to support the foot will be assessed in both lab and in clinical testing. 2 Background information: Foot Drop Foot drop is only a symptom; it is the inability to dorsiflex the foot. Without dorsiflexion the foot can drag on the ground which inevitably leads to tripping and over exertion of the hip and knee in attempts to compensate for the new height that the foot must reach to clear the ground. Foot drop can be caused by many different diseases, such as polio, multiple sclerosis, cerebral palsy, and stroke (1), all of which effect neurological functions or are muscular disorders. There are 6.5 million stroke survivors each year and out of them 20% suffer from a lasting symptom of foot drop (2). Basics of the Gait Cycle Walking is the cyclical motion of our legs as we shift our weight from one foot to the other in an attempt to make a forward progression. This cyclical process as viewed from a single foot is called the gait cycle. The gait cycle can be split into two major functions; the stance phase, where the foot is initially planted and then pushes off; and the swing phase, where the toe is pulled up towards the shin and hovers over the ground while swinging to its next destination (3). The foot has two kinds of motion during this cycle, dorsiflexion and plantar flexion. Dorsiflexion is anytime the foot is being brought closer to the shin; plantarflexion is any movement when the foot is being pointed towards the ground (3). The gait cycle, although complicated, has been studied extensively. The average angles of the limbs have been compiled in many different papers (4, 5, 6, 7) using many different techniques. Data from (4) was collected by recording the movements of a subject who had been outfitted with an assortment of markers indicating joint angles. The angle of the pelvis was taken with respect to the ground and all other angles were measured relative to the pelvis angle, allowing for any angle to be determined with respect to the ground. This data has been used for initial calculations of the torque that is generated by the center of mass of the foot, without inertial forces. Stance Initial DoubleLimb Support Periods % of Cycle Foot Strike Swing Second DoubleLimb Support Single-Limb Stance Opposite Toe-Off Opposite Foot Strike Initial Swing Toe-Off 62% 0% Figure 1. Gait Cycle Graphic Explanation 3 Foot Clearance Terminal Swing MidSwing Tibia Vertical Foot Strike 100% Hip Flexion Extension θH Pelvic Tilt θP Angle Data Opposite Toe-Off Opposite Foot Strike Toe-Off 20 10 Angle Data Opposite Toe-Off Opposite Foot Strike Toe-Off 60 Angle(Degrees) Angle (Degree) 30 40 20 0 0 0 20 40 60 80 0 100 20 60 80 Angle Data Opposite Toe-Off Opposite Foot Strike Toe-Off 30 60 Angle (Degree) Angle Data Opposite Toe-Off Opposite Foot Strike Toe-Off 40 20 10 -10 0 20 -30 0 0 20 40 60 100 Plantar Dorsi Flexion θF Knee Flexion-Extension θK Angle (Degree) 40 % of Cycle % of Cycle 80 40 60 80 100 % of Cycle 100 % of Cycle Angle of Foot to Ground θBC Torque at the Ankle TR 1.00 -15 -35 0.80 0 20 40 60 Angle Data Opposite Toe-Off Opposite Foot Strike Toe-Off 80 100 Torque (Nm) Angle (Degree) 5 -55 -75 0.60 Torque Data Opposite Toe-Off Opposite Foot Strike Toe-Off 0.40 0.20 0.00 % of Cycle 0 20 40 60 % of Cycle Figure 2. Gait data plots (13) 4 80 100 Gait Mechanics An initial look at a simple free body diagram of the foot has been conducted, with the purpose of benchmarking the amount of torque needed by the ankle to keep the foot aloft. Joint angle data from (4), specifically the pelvic (the only angle that is taken with respect to ground), the hip, the knee, and the foot angles (θP, θH, θN, and θF, respectively) were used to calculate the angle of the foot relative to ground. The Center of Gravity of the foot was calculated from anthropometric data (8). In combination with the angle of the foot with respect to ground; the greatest moment that is required to support a normal average foot (8) during the swing cycle was calculated to be .90 NΞm. This initial analysis does not include inertial effects, and is just a static analysis. The next phase of Figure 3. Angle explanation the project will involve a dynamic analysis of the leg and foot. More data is needed about the patent to determine anything else about the reactions that an AFO would feel when the foot is on the ground, but this is negligible for now because in our design the AFO will be free to move Figure 4. FBD of the Foot during the stance phase. Commercially available AFOs Only in the last two decades have there been real strides made in full replacement of the function of the limb, with a solid brace. These braces are called Ankle Foot Orthotics (AFOs). Most commercially available AFOs are passive, in that they only support the foot and add no energy to the system. Most are 5 Figure 5. Hard Plastic AFO (9) made from thermosetting plastics and are molded to fit the patent’s own leg. These AFOs are light and rigid. This rigidity has been identified as a possible hindrance for patients to adopt their new AFOs, as it can cause un-natural gaits by not emulating the movements of a healthy ankle. In addition to rigid orthotics there are also other solutions that attempt to give small shocks (5V max) to the peroneal nerve, causing dorsiflexion (10). This form of therapy is commonly known as Electrical Stimulation (10). Electrical Stimulation is considered to be a viable replacement for the AFO (10), but the devices are not without their problems; they are expensive, considered Figure 6. Bioness Knee and Foot Electrical Simulation Device (1) an invasive technology, and the long term effects of electrical stimulation are unknown. These devices are also contraindicated in many patients (11). For example, the peroneal nerve is not always in an appropriate spot where electrical stimulation could work without discomfort, electrical stimulation should not be used on anyone with a heart condition or any kind of pacemaker, and the leg itself that is being stimulated to should not have any recent fracture or dislocation. While these types of devices are considered active AFOs, they are outside the planned scope of this project (11). Recently Investigated AFOs Active AFOs that have been created for research are abundant, but most have been hindered by their need to be tethered to a computer or external power supply, and they are usually too complicated to bridge the gap as a commercially viable alternative to the inherently simple passive AFOs. Figure 7. i-AFO Unit (12) An “i-AFO” was constructed in 2010 by researchers at Yamagata University, in Japan (12). Its purpose was to better control the gait of a patient who had flaccid paralysis of the ankles. “i-AFO” used a rotational breaking system to variably dampen the system. This particular AFO was in its 3rd generation and was still too bulky to fit into an unmodified shoe. But it was still useful in that it helped to show the advantages that can be achieved by dampening alone. 6 In 2008 A more complex AFO was created by Svensson, and Holmberg from Halmstad University. The AFO was created to help patients walk up an inclined surface, stairs, or flat ground. They used a magneto rheological type dampener. This is type of dampener is variable, that provides various levels of dampening based of a voltage. During the swing phase the AFO would lock up holding up the foot, and Figure 8. Variable Dampening AFO for Inclined Surfaces (13) during the stance phase the AFO would release its hold. This AFO was important because its goal was to recreate a normal gait cycle, even when being used on inclined surfaces. The power supply for this AFO is not mentioned in the paper, so the practical effectiveness of this kind of damper is hard to measure. Air muscles are not new, but their excellent strength to weight ratio has renewed interest in the technology during recent years. In 2005 air muscles were used by university of Michigan researchers to create an AFO (14). It tackled the problem of plantar flexion, which is the motion opposite typical foot drop. The AFO was successful in that it did generate plantar flexion but it was never tested on patients and the AFO had to be tethered because of computational and air supply limitations. The AFO was later adapted to include dorsiflexion, but the added air muscles made it impossible to wear a shoe at all. Researchers at UIUC recently developed an AFO that used a bladder to Figure 9. Air Muscle AFO (14) generate all the air pressure needed for the AFO calling it the Pneumatic Power Harvesting Ankle-foot Orthosis (15). This AFO used a very small piston to mechanically lock the foot into a preferable position. This AFO is self-contained, and runs purely on the mechanical action of walking to trigger the different states that it had. Unfortunately the design was bulky and there was no variability to it: the device was either on or off. Models of the foot are invaluable in the design of an AFO. Using a simplified 2-D approach, approximate models of the ankle-foot joint, Figure 10. Pneumatic Power Harvesting AFO (15) as well as simple actuators, have been made in the past. The effects of drop foot on the gait cycle have also been simulated. By generating an accurate model of the injured system it should be possible to add on simplified models of an AFO. The effects on the gait could be predicted. So far this has only been done to illustrate how a pre decided actuator would have to work, and has not been used for comparison. (3) 7 Gap in Research The research that has been done in the past relied heavily on an assumed actuator, and because of this there has been no investigation to seek the best actuator for the AFO, or the best means to apply this actuation. This project will go through a process similar to senior design; initially, interviews with medical professionals and patients will be held, and after this modeling of a healthy leg and an injured leg can be done. The information gathered from the interviews and from the simulations will help to determine the appropriate actuator for the job. There has yet to be a serious look into the different pros and cons of the actuators as applied to an AFO, such as other forms of dampeners, Air muscles, variable material stiffness, combination springs and dampeners, or even electric motors. Couple these with self-generating power from, either a bladder or some kind of piezoelectric plate, harvesting of the energy of the stride can be carried out. Opening the design process to more than one possibility promise to provide an AFP that is self-contained, untethered, and can fit inside a shoe. Characterization of Actuators and Energy Storage/Conversion Devices In the past it has been necessary to pick actuators based on their inherent abilities in comparison to each other. Tables and plots of different physical and mechanical properties, as well as operating characteristics, of these devices are readily available, and excerpts have been provided (16, 17, 18, 19). This data is very important, but are only useful when coupled with the needs specified by the customer. The devices identified as being key to the system architecture are energy storage, energy conversion, and an actuator. The important indices to characterize these devices are power density, strain, density, and efficiency. Some of the power generation devices, such as piezoelectric elements are fabricated as thin plates, and their energy density is calculated in terms of energy generated per unit area. Efficiency Density Energy or Power Density Energy Storage Energy Conversion Actuator ππ = πΈππ’π‘ ⁄πΈππ ππ = πππ’π‘ ⁄πππ ππ = πππ’π‘ ⁄πππ ππ = π⁄π ππ = π⁄π ππ = π⁄π πΈπ = πΈππ’π‘ ⁄π ππ = πππ’π‘ ⁄π ππ = πππ’π‘ ππ ⁄π π = βπΏ⁄πΏπππ Strain 8 Energy Storage and Conversion Potential Energy Storage Energy Density 50-100 Wh/kg 40-175 Wh/kg 150-250 Wh/kg 140-300 Wh/kg Efficiency 85-90% Lead Acid battery 90-95% NiCad battery 90-95% NiMH battery 90-95% Li-ion battery 40-70% Compressed Air 2.78 Wh/kg 90% Super-capacitor Table 1. Data from tables was collected from (16,17) Power Generation Electromagnetic generator Piezo element Power Density Efficiency 200-300 W/kg 20-70% 2 .01-.02 W/m 2 0.17 W/km .5-5% 2-5% Seebeck elements Table 2. Data from tables was collected from (16,17) Actuators Actuator Type Muscle Power Power Density 0.5 MW/m3 Actuator Strain Density Efficiency .3-.7 1000-1100 kg/m3 20-25% Piezo Electric Low Strain 100-1000 MW/m3 5E-6 - 3E-5 2600-4700 kg/m3 98% Piezo Electric High Strain 90-500 MW/m3 5E-5 - 2E-4 7500-7800 kg/m3 90-98% 100-700 MW/m3 .0006-.002 6500-9100 kg/m3 80-98% .7-100 MW/m3 .007-.07 6400-6600 kg/m3 1-2% .01-.04 MW/m3 .1-.4 3800-4400 kg/m3 50-80% 3 .1-1 3 30-40% 5 MW/m3 .1-1 180-250 kg/m3 90-98% 3 32-50% Magnetostrictor Shape memory alloy solenoid hydraulic piston pneumatic piston 500 MW/m 3 1 MW/m 0.35 Air muscle Table 3. Data for table was collected from (16, 17, 18, 19) 9 1600-2000 kg/m 500-1000 kg/m Budget The funding for the project has already been acquired. A full time Co-op Block during the summer of 2011 and part time work have been approved for this project. $1000 has been allocated for the construction and testing of a prototype. This money will be put towards any materials that are needed to construct a prototype, as well as any specialized manufacturing that might need to take place (due to the natural geometry involved in the human body). External sensors not meant to be permanently attached to the AFO can be purchased; these sensors will be necessary for almost any kind of clinical testing that could take place. Statement of Work The Following is a statement of the work that will be completed throughout the course of this project. 1. Customer needs must be set, and associated with design criteria. This information will be gathered by interviewing local medical professionals, orthopedic specialists, and patients. 2. An analytical model of the foot is to be created. The model is going to be used for benchmarking, and approximation. The model should help push the design process in an appropriate direction. 3. Create a System level design, of what the AFO needs to accomplish, and how each part of the design could be tested. 4. Follow up with stakeholders to receive feedback on initial design ideas, as well as informing the stakeholders of progress made so far. Feedback will be incorporated as the project moves into the detailed design phase. 5. Perform detailed design and analysis of the AFO to be constructed. 6. Present final design to stakeholders. This will constitute, at a minimum, a CAD package, bill of materials, and a proposed test plan. The test plan should encompass how the design will be qualified, and how it will be tested in a clinical setting. 7. The AFO will be built and tested in the lab according to the test plan. 8. Once lab test results are within specifications, the AFO will be tested with a group of patients with foot drop, under the supervision of their clinical providers. 10 Timeline: Winter 2010 ο· Project identified ο· Initial literature search Begun ο· Thesis Proposal Started ο· Rapid Prototyping Taken Spring 2011 9hr/week ο· Finish up Undergraduate Required Courses ο· Thesis Proposal Finished ο· Finish Literature search ο· Quasi-Static modeling of foot Summer 2011 full-time ο· Co-Op working on project ο· Dynamic modeling of foot ο· Interviews Patients and Clinicians o ο· Proof of Concept prototypes created o ο· Information gathered and added to model Preliminary Design o ο· Review of Data Collected Present design concept to stakeholders (patients, clinicians, and thesis committee) Detailed Analysis and Design o Presentation to stakeholders (patients, clinicians, and thesis committee) ο· Building AFO Started ο· Writing Thesis Fall 2011 9hr/week ο· Take Senior Design 1, Math 1, and Controls Systems ο· Finish Building AFO ο· Bench Testing of AFO ο· Writing Thesis Winter 2011 9hr/week ο· Take Senior Design 2, Math 2 11 ο· Finish Bench Testing ο· Clinical Testing ο· Compile Work ο· Writing Thesis Spring 2012 9hr/week ο· Finish Clinical Testing o Compare Results with Model and Bench Testing ο· Finish Writing Thesis ο· Thesis Defense 12 Bibliography 1. 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