ORTHOPEDIC PROSTHETICS AND ORTHOTICS IN REHABILITATION UNIT V

Orthotics (Greek means "to straighten" or "align") is a specialty within the medical field concerned with the design, manufacture and application of orthosis. An orthopaedic orthosis is a device that augments a function of the skeletomotor system by controlling motion or altering the shape of body tissue. It supports or corrects the function of a limb or the torso. An orthopaedic device is used to:

Control, guide, limit and/or immobilize an extremity, joint or body segment for a particular reason To restrict movement in a given direction To assist movement generally To reduce weight bearing for a particular purpose To aid rehabilitation from fractures after the removal of a cast To otherwise correct the shape and/or function of the body, to provide easier movement capability or reduce pain

It combines disciplines of study within the health and physical sciences; mathematics and materials engineering, gait analysis, anatomy and physiology, biomechanics and psychology. Patients benefiting from an orthosis have sustained a physical impairment such as a stroke, spinal cord injury or a congenital abnormality like cerebral palsy. Corrective shoe inserts are popularly known as orthotics. A shoe insert is a removable insole which, is used for foot and joint pain relief from arthritis, orthopedic correction, daily wear comfort smell reduction, and to correct discrepancies in leg length. Orthotic devices are classified by acronyms that describe the joint which they cross. AFO is an ankle-foot orthosis CO is a cervical orthosis (neck brace or collar) TLSO is a thoracolumbosacralorthosis (spinal brace or jacket). The main categories are braces for the cervix (neck), upper limb, trunk, lower limb, and foot. Orthosis are generally simpler devices than prostheses, but because orthosis are constrained by the existing body shape and function, they can present an equally demanding design challenge. Certainly the interaction with body function is more critical, and successful application demands an in-depth appreciation of both residual function and the probable reaction to external interference. External orthotics are often classified as structural or functional Structural/Static orthosis - These devices do not allow motion. They provide rigid support for fractures, inflammatory conditions of tendons and soft tissue, and nerve injuries Functional/Dynamic orthosis - These devices permit motion, on which their effectiveness depends. These are used to correct alignment of the joints during dynamic functioning and to

assist movement of weak muscles. An alternative orthotic approach utilizes functional electrical stimulation (FES) of the patients own muscles to generate appropriate forces for joint motion. Upper-limb (extremity) orthosis are devices a applied externally to restore or improve functional and structural characteristics of the musculoskeletal and nervous systems. In general, musculoskeletal problems include those resulting from trauma, sports, and work-related injuries. Types of upper-limb orthosis 1. Upper-arm orthosis a. Shoulder orthosis b. Arm orthosis c. Functional arm orthosis d. Elbow orthosis 2. Forearm-wrist orthosis 3. Forearm-wrist-thumb orthosis 4. Forearm-wrist-hand orthosis 5. Hand orthosis 6. Upper-extremity orthosis (with special functions) A lower-limb orthosis is an external device applied (or attached) to a lower-body segment to improve function by controlling motion, providing support through stabilizing gait, reducing pain through transferring load to another area, correcting flexible deformities, and preventing progression of fixed deformities. Types of lower-limb orthosis 1. Foot orthotics shoe insert 2. Ankle-foot orthosis (AFOs) are orthosis or braces (usually plastic, used to control position and motion of the ankle. 3. A knee-ankle-foot orthosis (KAFO) is an orthosis that encumbers the knee, ankle and foot. 4. A knee orthosis (KO) or knee brace is a brace worn to strengthen the knee. It supports the knee, and provides the stability needed to perform daily activities. Knee braces may also help to properly align the knee to help reduce osteoarthritis pain. An orthopedic prosthesis(Greek: "addition") is an internal or external device that replaces lost parts or functions of the neuroskeletomotor system. An artificial leg or hand is a prosthesis. It is part of the field of biomechatronics, the science of using mechanical devices with human muscle, skeleton, and nervous systems to assist or enhance motor control lost by trauma, disease, or defect. Prosthesis are typically used to replace parts lost by injury (traumatic) or missing from birth (congenital) or to supplement defective body parts.The complete prosthesis would consist of the stump attachment system - usually a "socket", and all the attachment hardware parts all the way down to and including the foot.

When a human limb is lost through disease or trauma, the integrity of the body is compromised in so many ways that an engineer may well feel daunted by the design requirements for a prosthetic replacement. The losses from a lower limb amputation - Gone is the structural support for the upper body in standing - the complex joint articulations and muscular motor system involved in walking - Loss of the multimode sensory feedback, from inter alia pressure sensors on the sole of the foot, length and force sensors in the muscles, and position sensors in the joints, which closed the control loop around the skeletomotor system - Loss of a significant percentage of body weight and the body is now asymmetrical and unbalanced. It is desirable to attempt to replace all these losses with like-for-like components, using powerful motors and sensors connected to the wearers residual neuromuscular system. Or, to accept the losses and redefine the optimal functioning of the new unit of person-plus-technology. Even if engineering could provide a solution, there remain additional problems inherent to prosthetic replacements to consider - the unnatural mechanical interface between the external environment and the human body is one of the most difficult problem - load transfer (transferred to the skeletal structures via intimate contact between the surface of residual limb and prosthesis) - the exact distribution of load To overcome these problems, an alternative direct transcutaneous fixation to the bone has been attempted in limited experimental trials, but this brings its own problems of materials biocompatability and prevention of infection around the opening through the skin

FUNDMENTALS
Designers of orthotic and prosthetic devices are aware of the three cardinal considerations I. II. III. Function Structure Cosmesis

I. FUNCTION a) Understanding the clinical conditions The objective of the treatment must be clear. The medical practitioner specifies the requirements, leaving the implementation of this instruction to the rehabilitation technologist. b) Knowledge of biomechanics The dysfunction in the patient and the function of proposed device to be coupled to the patient should be understood. Kinematics, dynamics, energy considerations, and control all enter into this understanding of function.

II. STRUCTURE Structure is the means of carrying the function, and finally both function and structureare combined into a design that is cosmetically acceptable. Some of the fundamental issues in these concepts are discussed here. 1. Shape - To function well, the device needs an effective coupling to the human body. There is often some part of the device that is molded to the contours of the wearer. Achieving a satisfactory mechanical interface of a molded component depends primarily on the shape. The internal dimensions of such components are not made an exact match to the external dimensions of the limb segment, but by a process of rectification, the shape is adjusted to relieve areas of skin with low load tolerance. The Shapes are also evolved to achieve appropriate load distribution for stability of coupling between prosthetic socket and limb or, in orthotic design, a system of usually three forces that generates a moment to stabilize a collapsing joint (Fig. 1). Rectification is adjustment of a model of body shape to achieve a desirable load distribution in a prosthesis or orthosis.

FIGURE 1 Three-force system required in an orthosis to control a valgus hindfoot due to weakness in the hindfoot supinators.

2. Alignment Alignment is a factor influencing the interface loading. The alignment of the molded socket to the remainder of the structural components also will be critical in determining the moments and forces transmitted to the interface. Adjustability may be important, particularly for children or progressive medical conditions. Functional components that enable desirable

motions are largely straight-forward engineering mechanisms such as hinges or dampers, although the specific design requirements for their dynamic performance may be quite complex because of the biomechanics ofthe body. An example of the design of knee joints is expanded below. These motions may be driven from external power sources but more often are passive or body-powered mechanisms. In orthoses where relatively small angular motions are needed, these may be provided by material flexibility rather than mechanisms. 3. Design and choice of materials should ensure a controlled slow yielding, not brittle fracture. 4. The ability of the complete structure to absorb shock loading, either the repeated small shocks of walking at the heel strike or rather more major shocks during sports activities or falls. This minimizes the shock transmitted through the skin to the skeleton, known to cause both skin lesions and joint degeneration. 5. Hygiene- the user must be able to clean the orthosis or prosthesis adequately without compromising its structure or function.

III. COSMOSIS Appearance can be of great psychological importance to the user, and technology has its contribution here, too. Optical shape scanning linked to three-dimensional (3D) computer-aided design, and CNC machining can be pressed into service to generate customized shapes to match a contralateral remaining limb. In providing cosmesis, the views of the user must remain important. The wearer will often choose an attractive functional design in preference to a life like design that is not felt to be part of his or her body. Externally powered devices have been attempted using various power sources with degrees of success. a) Pneumatic power in the form of a gas cylinder is cheap and light, but recharging is a problem that exercised the ingenuity of early suppliers: where supplies were not readily available, even schemes to involve the local fire services with recharging were costly. b) Hydraulic servos were largely unsuccessful because of power supply and actuator weight and oil leakage. c) Electric actuation, heavy and slow at first, has gradually improved to establish its premier position. Input control to these powered devices can be from surface electromyography or by mechanical movement of, for example, the shoulder. Feedback can be presented as skin pressure, movement of a sensor over the skin, or electric stimulation. Control strategies range from position control around a single joint or group of related joints through combined position and force control for hand grip to computerassisted coordination of entire activities such as feeding.

Materials used for prosthetic and orthotic devices In the first part of the twentieth century, orthosis were constructed primarily of metal, leather and fabric and prostheses were manufactured from wood and leather.The sockets of artificial limbs have always been fashioned to suit the individual patient, historically by carving wood, shaping leather, or beating sheet metal. In the last 50 years, tremendous technological advancements have been made in the material sciences. The demand for strong and lightweight components in the aerospace and marine industries has produced a variety of new materials that possess mechanical properties suitable for use in the construction of orthosis and prosthesis. New plastics have led to revolutionary advancements in the profession, permitting increases durability and strength and significant cosmetic improvements. The rehabilitation team, the orthotist and prosthetist are responsible for choosing the appropriate materials and components for fabrication because their experience and training are quite specialized in this area. The following characteristics of materials are considered 1. Strength, the maximum external load that the material can support or sustain. Strength is especially important in lower limb devices. 2. Stiffness, the amount of bending or compression that occurs on loading. The stiffer a material, the less flexible or less likely it is that deformation will occur during wear. 3. Durability, the ability of a material to withstand repeated cycles of loading or unloading during functional activities. Repeated loading compromises the materials strength and increases risk of failure or fracture of the material. 4. Density, a materials weight per unit volume. This is one of the prime determinants of energy cost during functional activities while wearing a prosthetic or orthotic device. Although the goal is to provide as lightweight a device as possible, the need for strength, durability, and fatigue resistance may require that a denser material be chosen. 5. Corrosion resistance, the degree to which the material is susceptible to chemical degradation. Many of the materials used for orthoses or prosthesis retain heat, so that perspiration becomes a problem. The ease of fabrication of materials is also an important consideration. Certain materials can be easily molded or adjusted for a custom fit; others require special equipment or techniques to shape the materials as desired. The materials used are leather, metals (Steels and its alloys, Aluminum, Titanium and Magnesium), wood and plastics. Because plastics can be molded easily and readily formed, they are very popular and widely used material for orthosis and prosthesis.Following the introduction of thermosetting fiber-reinforced plastics, polypropylene is favoured material. Carbon fiber composites substituted for metal have improved the performance of structural components such as limb shanks.

APPLICATIONS
COMPUTER-AIDED ENGINEERING IN CUSTOMIZED COMPONENT DESIGN Fabrication Process The traditional fabrication process is composed of a series of steps. 1. Making accurate measurements of the residual limb. 2. Negative Mold is a mold taken of an actual body part that is used to create the 3D positive cast or model necessary for fabrication of the orthosis or prosthesis. This negative impression is most often taken using plaster of paris bandage or a fiber resin tape. 3. Fabricating the positive model plaster of paris is poured into the negative mold and once the positive model is set, the negative impression if stripped away and discarded. 4. Manual rectification The positive model is modified manually to incorporate the desired controls. 5. Fabrication The orthosis or prosthetic socket is then created around the positive. Fabrication process used with the positive model is dependent on the material selected for the device. Thermoforming is a common production method used. 6. Fitting the device to the patient. This procedure is time consuming. Since the traditional way of fabrication is time consuming, computer-aided engineering has been used in the process of design of customized components to match to body shape. The prosthetic particularly seek is the ability to produce a well-fitting socket during the course os single patient consultation. By using advanced technology, residual limb shapes are captured in a computer rectified by computer algorithms produce the rectified cast is produced by using a computer numerically controlled (CNC) machine

All this can be done in an hour. In addition, by using a vacuum-formed machinery to pull a socket rapidly over the cast, the socket can be ready for trial fitting in one session. Computer algorithms used for rectification permit the clinician to modify the 3D body segment to incorporate the desired biomechanical controls into an orthosis or prosthesis. The amount of force applied to a specific area is dependent in part on manipulation of the 3D model. The clinician can incorporate reliefs for bony prominences of the limb or can change

the geometry of the shape to enhance structural strength characteristics in final orthosis or prosthesis. A series of rectification maps can be held as templates, each storing the appropriate relief or buildup to be applied over a particular anatomic area of the limb. Advantages of computer-aided design Fast and efficient the shape is now stored in digital form in the computer and can be reproduced or adjusted whenever and wherever desired economic

Requirements for orthosis design are considerably different from those of standard engineering, - relaxation in the accuracies required (millimeters, not microns); - a need to measure limb or trunk parts that are attached to the body, which may resist being orientated conveniently in a machine and which will certainly distort with the lightest pressure; - a need to reproduce fairly bulky items Instrumentation for body shape scanning has been developed by - using methods of silhouettes, - contact probes measuring contours of plaster casts, - light triangulation.

CASD Computer-aided Socket Design (CASD) is a computer-aided system for the design of prosthetic sockets. It uses advantageous features of computer graphics and calculation. CASD has two components 1. A software program to design the socket. 2. A computer-controlled milling machine to carve the finished design. The starting point is the unmodified shape of the patient stump. The shape is obtained by measuring the inside surface of a plaster wrap cast which has been taken of the stump. The cast is rotated about a longitudinal axis as the measuring arm whose tip rests on the inside of the cast moves along this axis. The tip of the probe therefore traces a helical path round the inside of the cast and its displacement from the axis is measured. The resulting data file then represents the shape of the stump with each data point being the polar coordinate of a point on the surface, relative to an arbitrary axis through the stump. This shape is then modified by the programme to fit the patient.

There are various ways in which the prosthetic can determine the shape of the final socket He can modify the initial shape by moulding the plaster on the stump to preshape the cast. He can select a particular rectification process He can modify the amount of pressure or relief provided,

The shape of the socket is stored as a numeric file on a computer. The data is stored as slices and strips (Figure 2). When the shape is altered in any way, the effect is that some radii are changed, and the new shape is stored as a new set of radial values. In practice, the angular spacing between the strips and the regular spacing between slices is 100 and 6.35mm (1/4).

Fig. 2 (a) A slice consists of the radial values of points spaced at regular angular intervals about an axis. (b) A strip of the data consists of the points lying in a vertical plane through the axis.

The file containing the shape data for the socket is sent to a numerically controlled 3-axis milling machine which carves the shape out of a plaster bank. The carved shape is removed and placed in a Rapidform oven where a pre-heated polypropylene sheet is lowered over the plaster and conformed to the shape by use of a vacuum pump. Then cooled the plaster is broken out and the plastic trimmed so that the desired socket shape remains. This is then fitted to the patient with the necessary fittings and attachments.

Design of orthopaedic shoe Computer-aided design (CAD) techniques are also finding application in the design of bespoke (modified or custom made) orthopaedic footwear, using CAD techniques from the volume fashion trade modified to suit the one-off nature of bespoke work. Bespoke footwear is made to fit an individual patients foot measurements. Orthopaedic footwear should take into account fit, comfort and cosmesis. Orthopaedic footwear should be As light as possible Have adequate thermal conductivity Be permeable to moisture Not produce excess pressure Prevent excessive movement of the foot in the shoe

3D surface scanning technologies are used to produce digitised representation of the foot. Following foot measurements are required The outline of the foot when the patient is standing The height over prominent toes or bony features should be indicated Sites of skin lesions Girth of the foot Long and short heel Foot length

A model of the shoe last is made from the measurements.Shoe Last is the solid form around which a shoeis molded. The fit of a shoe depends on the design, shape and volume of the Shoe Last. Shoe lasts specifically designed to the proportions of individual customers' feet are used to design bespoke orthopedic footwear. Shoemaster system is used for design of footwear. Shoemaster is CAD/CAM system for the shoemaking industry. In this system, library of reference last shapes are held, and a suitable one is selected both to match the clients foot shape and to fulfill the shoemaking needs for the particular style and type of a shoe. The schematic of the process followed in development is shown in fig. 3. Here, the digitized customers last model is compared with the basis last catalog and the customer last library.The resulting last is output as 3D data to a CNC machine to make a last. The last is given to the customer for trial fit and necessary changes are made till a perfect last is obtained. The final customers last goes to the next step of pattern design and pattern engineering. This includes pattern constructions like size, fit grading features and design of patterns for shoe uppers. The custom style is selected from the database of styles in the software. The custom style output is given to a plotter or cutter to generate the required patterns of the orthopedic shoe.

Figure 3 Schematic of operation of the Shoemaster shoe design.

Design of shoe inserts is another related application, with systems to capture, manipulate, and reproduce underfoot contours now in commercial use. An example is the Ampfit system, where the foot is placed on a platform where the foot shape is captured by impressing the sole into a bed of closely packed cylindrical rods. The matrix of round-ended cylinders is then forced up by gas pressure through both platform and supports, supporting the foot over most of the area with an even load distribution. The shape is captured from the cylinder locations and fed into a computer, where rectification can be made similar to that described for prosthetic sockets. The output of the computer is given to a CNC machine and the machine mills the shoe inserts from the preform while the client waits.