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Prosthetics/Orthotics Research for the Twenty-first Century: Summary 1992 Conference Proceedings

John W. Michael, MEd, CPO
John H. Bowker, MD

ABSTRACT

This article summarizes the findings from a 1992 conference sponsored by the National Center for Medical Rehabilitation Research (NCMRR), which brought together a multidisciplinary group of scientists, clinicians and consumers from the United States and abroad. Participants reported on current prosthetic and orthotic practice and developed recommendations for research initiatives to advance the state of the art. The conference's text, Prosthetic/Orthotic Research for the twenty-first Century: Proceedings of an NCMRR Conference, is available from the NCMRR.

Introduction

The National Center for Medical Rehabilitation Research sponsored an historic conference in 1992 in which leading clinicians, scientists and consumers presented their viewpoints on present clinical prosthetic and orthotic practice and recommended productive areas for research to advance the state of the art. One important goal was to highlight areas where research results were expected to be clinically relevant, thereby directly benefiting people who have a physical disability. This article highlights the key findings presented at the conference.

Applying Science to O&P

Prosthetic and orthotic practice is an empirical field. Present advances have come primarily from practical experience and clinical experiments rather than from theory.

However, a science of prosthetics and orthotics could be developed from the present knowledge base that would provide a theoretical framework allowing the field to advance in an accelerated, more orderly fashion. Although the field is currently in a relatively high state of clinical development, most advances in recent decades have been technical. Little or no advances in fundamental principles have occurred since the termination of significant governmental funding for O&P research and development in the 1960s.

The period from 1945-1965 is now viewed as a time of unparalleled scientific and technical advances in O&P. Key findings from this era still provide the conceptual basis for virtually all contemporary techniques. Although many factors have contributed to the long-term successes of this era, two key aspects were the coordination of research and evaluation efforts and the long-term commitment of significant governmental funding.

Many engineering advances have come from results that were originally considered "mistakes." One essential of successful research is allowing time for enough "mistakes" to discover the successful spin-offs. Other key factors that could contribute to success in O&P research would include: multidisciplinary teams, incremental improvements and proper systems planning. The goal is to provide a practical balance of performance, reliability and economy in all new developments.

Physicians' Perspective on Clinical O&P

The goals of amputation surgery are to remove the irreparably damaged limb segment and then to fashion a residual limb that interfaces effectively with the prosthesis. Limb length preservation fosters independence in activities of daily living. It is therefore important that infected wounds are left open and treated aggressively because it is often then possible to select a lower level of amputation.

In general, the higher the amputation level, the greater the functional loss for the amputee. Disarticulations, despite having a less cosmetic appearance, typically offer greater functional capabilities than the more proximal diaphyseal level. Ironically, amputation simultaneously represents both the failure of previous treatment as well as the definitive effort to restore lost function.

Unfortunately, we know very little about fundamental issues in upperlimb amputee management. The infrequent nature of this level of limb loss results in a dearth of experienced clinicians, whether prosthetists, physicians, therapists or psychologists.

Despite technical advances in myoelectric control, the long-term use rate for most upper-limb prostheses is less than 50 percent. The body-powered alternative, virtually identical to what would have been provided 40 years ago, is no more successful. It may be the quality of the rehabilitation experience has more impact on prosthetic acceptance than the componentry or other technical criteria.

It is important to design new devices to meet the specific needs of amputees rather than designing simply because the technology is available. The foundation for such patient-directed developments is gathering more basic knowledge about this area of rehabilitation.

In lower-limb prosthetics, five critical clinical problems that need further research and development are

• treating fluctuating residual limb volume
• defining "optimal" alignment
• attaching the prosthesis to the body
• creating cosmesis (particularly in the amputee's judgment)
• controlling the high cost of state-of-the-art restoration.

Practitioners' Perspective on Clinical O&P

Clinical management principles are very similar in orthotics and prosthetics. The initial clinical examination of the person with a disability tries to answer such questions as:

• What are the diagnosis, etiology and prognosis for this condition?
• What is the functional deficit?
• What compensatory functions might be enhanced or improved'?
• What are the client's personal, vocational and avocational goals?
• What would be the "ideal" technical solution for this client?

The most common measurement tool today is the plaster-of-paris negative impression, which gathers three-dimensional data from the affected and contralateral body segments. The design process involves rectification of the positive model to apply a biomechanical force to the skeleton that is sufficient in direction and magnitude to accomplish the desired results without harming the interposing soft tissues. Alternate techniques, such as ultrasonic measurement and digital rectification on the computer monitor, are being investigated.

Today there are fewer than 2,800 American-Board-Certified practitioners, roughly divided among certified orthotists, certified prosthetists and certified prosthetists/orthotists. The largest group is 26 to 35 years old. Although O&P schools can theoretically graduate 202 students per year, the average is closer to 180. Overall, those with a bachelor's degree dominate the field. A small percentage holds master's or higher-level degrees.

The orthotist/prosthetist is trained to recognize and analyze dynamic pathomechanical conditions and to recommend, design, fabricate, fit and critique the device on the basis of function and tissue pressure tolerance. Rather than focusing on the obvious impairment to the musculoskeletal system, the practitioner must strive instead to overcome the resulting disability. Every profession has a unique set of idioms that characterizes its body of knowledge. Orthotics and prosthetics' idioms would include "Assist swing phase motion and restrain stance phase motion,""There is no such thing as an average-sized person," and "Success occurs when the device provides a desired function or outcome that cannot be obtained any other way."

The O&P clinical laboratory can be an excellent setting for research, but a partnership with experienced academic researchers is necessary to supplement the practitioner's skills. Throughout the country, isolated pockets of expertise can be identified, evaluated and promulgated when appropriate.

There are five major steps in research and technology transfer:

• fundamental studies
• design and development
• clinical evaluation
• education and training
• service delivery

Currently, the field is proficient in approximately half of these areas. Although fundamental studies are generally best done by established scientists, a stable long-term funding source is required. For the most part, good design and development research are being conducted by talented and ingenious people in the field although scientific methodology is often missing or weak.

Critical needs exist for sustained financial support for education and training as well as for clinical evaluation of existing options. Both service delivery and commercial availability are generally well done.

Clinical funding is at least as significant as research developments. Unless reimbursement is available for new developments, these developments remain unavailable to the people with disabilities who can benefit from them, and the research has little practical value. For maximum patient benefit, research should strive for developments that can ultimately culminate in clinically practical, integrated and affordable techniques.

Perspectives on Occupational and Physical Therapy Training in O&P

Present training of occupational therapists (OTs) is typically limited to experience in areas such as laboratory exposure to fabricating splints (average 20 classroom hours) and didactic lectures-demonstrations on prosthetic fundamentals (average four classroom hours). Studies of electric prostheses, pediatric principles and actual patient evaluation or training averages 30 minutes or less. Most OT students have no direct contact with actual prosthetic or orthotic users even though therapy is a crucial factor in O&P use and acceptance. Such limited training results in only a small number of experienced, knowledgeable therapists, usually working in only a few specialty centers.

The situation could be improved significantly by having experienced, expert occupational therapists conduct intensive one- to two-day workshops at the various schools. Continuing education programs specifically devoted to preprosthetic and prosthetic training programs would be useful. Perhaps certification courses, under the auspices of the American Occupational Therapy Association, can ultimately be organized to provide a model for essential skills in this area.

The strong interest of physical therapists (PTs) in O&P topics is not fully mirrored in their basic education. This situation is partially due to the need to expose students to the full scope of the profession compounded by the time constraints of a full curriculum. Although most institutions do not expose students to upper-limb devices, selected master's-level PT programs demonstrate all levels of O&P intervention.

The biomechanical deficits of commonly encountered lower-limb pathologies are emphasized most. Exposure to individuals using a variety of O&P devices is often provided. It is expected that the licensed therapist will supplement this basic training with on-the-job experience and lifelong continuing education.

Current Research Topics

Most advances in orthotic management of the sequelae to spinal cord injury (SCI) were developed in the decade immediately following World War II when the government supported O&P research significantly. Such devices as the wrist-driven wrist-hand orthosis, ratchet wrist-hand orthosis and linear mobile arm supports are now routinely used to increase upper-limb function for this population. Although developed in the 1950s, externally powered orthoses have not been widely used. Recent explorations using Functional Electric Stimulation (FES) to restore quadriplegic grasp show promise and may be more effective than complex electromechanical solutions.

Development of the halo-vest apparatus in the 1960s had a profound impact on the management of SCI by permitting early ambulation and active participation in rehabilitation soon after injury. Further development of more secure trunk fixation would improve the effectiveness of this group of devices.

Despite encouraging results with paraplegic ambulation for children using lower-limb orthoses, this has been a difficult area in which to demonstrate long-term success with adults. Future research to develop more energy-efficient devices with easier application would benefit adult amputees. Using modern microchip technology to develop "smart" orthoses incorporating closed-loop feedback should be explored.

Gait analysis is now well accepted in the rehabilitation community and is beginning to be applied to orthotic design and prosthetic evaluation. In some cases, these data can provide a scientific rationale for recommendation of one device over another. As gait systems become less expensive and easier to operate, their use will expand.

Also, a pressing need exists for a thorough study of the factors that influence compliance in wearing devices. The specific indications for spinal orthoses are presently subjective with very few exceptions. Basic studies in this area would result in more effective treatment and simultaneously reduce the cost inherent in prescribing ineffective devices.

In the field of limb prosthetics, socket configuration is one of the most crucial elements because it provides the interface between the body and the componentry. Highly advanced hardware has little value if the socket is uncomfortable or ineffective. Present research to develop a socket based on the individual topography and internal morphology of the amputee's tissues has revealed that manual solutions to this problem are too labor intensive to be practical. Application of CAD! CAM principles may overcome this Technical barrier to further advancement.

The Utah Arm illustrates one successful model for a market-driven prosthetic development. A prototype was developed based on a needs assessment for a more sophisticated upperlimb prosthesis for higher-level amputations. Since a commercial product was the intended goal, the entire development process evaluated available choices for manufacturability. Following laboratory and field testing, the initial commercial device was produced. Based on feedback from the first cohort of users, additional modifications and improvements were made to the device.

However, it must be recognized that manufacturers cannot justify developing sophisticated devices for small populations based on projected sales. It was only as a result of limited government research funding that it was possible for the Utah Arm to become an available option for people who have disabilities. The greater the research support available, particularly in the critical field evaluation stage, the more mature and effective the final development becomes. Such research support benefits people with disabilities by providing better devices and benefits society by clearly defining the optimal use of such new developments.

Current Challenges in O&P Practice

Due to the limited number of affected individuals, a disappointingly small number of health professionals are able to develop significant experience and expertise in managing upper-limb deficits. Consequently, the quality of clinical care that upper-limb amputees receive is sporadic and sometimes marginal. Developing regional centers of excellence may be one effective approach to this problem.

One primary clinical need is for a national study of the many complex physiological and psychosocial aspects of upper-limb disability. Technological problems include the need for advancements in structural materials, prosthetic component designs, actuators and control systems. Lighter components and systems, more versatile joint mechanisms and improved exterior appearance are immediate needs.

The common pattern of rejection of upper-limb orthotic devices after one or two years of successful use must be explored. If the gradual return of function can be predicted in specific cases of paralysis, development of inexpensive modular orthoses that encourage greater development of residual function may be appropriate. Present investigations of FES look promising and warrant further research.

As a practical matter, manufacturers need to coordinate upper-limb orthotic research to ensure the final product can be produced economically. Other practical concerns include the necessity for a consistent reimbursement mechanism and a uniform terminology shared by occupational therapists and orthotists when describing upper-limb orthotic devices.

Lower-limb orthotic components have not changed significantly in modern times. Advanced articulations that offer variable motion restraint in a compact and lightweight package are an immediate need. For example, a knee joint that prevents stance phase flexion while allowing stance phase extension would be a significant advance in function particularly if controlled swing phase flexion also is available.

There is a strong need for detailed study of the personalities and behaviors of individuals who sustain a disproportionate percentage of serious traumatic injuries that require orthotic management. The impact of socioeconomic factors also must be better understood and overcome. It is important to understand the natural history of physical disability over the entire life span and to document the effects of aging on the functional capacities of people who have physical losses.

Other practical concerns include better techniques to manage the grossly obese individual, improved external appearance of the devices and consistent reimbursements to permit clinical application of available and future technology. Better education of professionals and prosthetic/orthotic users would improve rehabilitation effectiveness. Scientific evaluation of new and existing concepts or designs is the cornerstone of the rational application of prosthetic/orthotic technology.

Many opportunities exist for developing new materials, techniques and components in lower-limb prosthetics. Examples include creation of engineered plastics offering vastly improved durability and flexibility simultaneously and microchip-controlled knee and ankle mechanisms. Sensory feedback, better control schemes and more versatile pediatric systems are also obvious needs.

However, one of the most pressing needs is for scientific evaluation of new and existing devices by independent researchers. Gait studies and ambulatory physiological monitoring may be useful tools in this process. For maximum effectiveness, research needs must be carefully prioritized based on their benefits to people with disabilities.

Consumers' Perspective on Research Priorities

The Americans with Disabilities Act (ADA) is both a significant advance in protecting the civil rights of people with disabilities and a reflection of the new, more active involvement of American citizens in their medical treatment. Consumers no longer blindly accept the advice of professionals.

For research to have maximum effectiveness, all professionals involved must come to regard the person with a disability as an equal offering a unique and invaluable perspective to the rehabilitation process. The same attitude should prevail in clinical application of research results.

In addition to basic science investigations, consumers with a physical disability want applied research with reasonably prompt results. Aggressive investigation of available materials from other disciplines, for example, may quickly identify a ready source for improved results in O&P. CAD/CAM shows some promise and should be further explored. Cooperation between funding agencies will accelerate the pace of advances by minimizing duplicate efforts.

Sensory feedback, better control systems, improved suspension and cosinesis, and more energy-efficient devices are strongly needed. Objective comparisons between alternative devices would help consumers choose wisely to best meet their needs.

Consumers with disabilities want uniform, high-quality services available nationwide and, therefore, support the development and dissemination of a curriculum for prosthetists and orthotists that emphasizes state-of-the-art techniques and devices. Service delivery models must also be studied and improved.

The creation of centers of excellence, groups of multidisciplinary researchers focusing on O&P problems, will undoubtedly lead to further improvements. It is important, however, that such centers not be funded to the detriment of individual researchers.

One of the most pressing needs is for a comprehensive national study to quantify and understand the population of O&P users. The O&P field is suited for financial support due to the high likelihood of demonstrable clinical results from applied research.

One of the greatest demographic concerns is the correlation between advanced age and poverty level income with physical disabilities. Women with disabilities are often "doubly disabled" by their gender and impairment. The disability movement in the United States is one positive force to address these concerns. As an example, the United Cerebral Palsy Association has a 10-point consumer-driven national agenda that focuses on

• equal opportunity laws
• employment
• elimination of work disincentives
• prevention
• transportation
• housing
• access to health care
• educating children with disabilities
• personal assistance
• assistive technology.

Successful use of assistive technologies depends on choice and access. Research to increase communication and consumer education and to remove reimbursement barriers can have a very positive impact. An actively involved consumer population is essential for any short- or long-term successes in rehabilitation research and can greatly accelerate the pace and effectiveness of new developments.

The highly active person with a disability can be a very positive force in improving the state of the art by demanding designs that permit unlimited participation in all types of normal activities, including high-performance athletics. Others with disabilities also will ultimately benefit from the improved devices and mobility.

Another need is for definitive studies to distinguish between a poorly designed or fitted device and an individual who is unwilling or unable to accept rehabilitation efforts. Scientific definition of a "properly fitting" device is sorely needed. Increased communication between consumers and professionals is one venue to explore this area.

There is little point in developing advanced designs when it is already difficult to fund existing technology. In addition to concerted efforts to educate third par ties about the effectiveness of O&P rehabilitation, it may be necessary to use selective legal action to set precedents for coverage of advanced options.

A number of factors have been identified that can enhance the quality of life for O&P users. Examples include

• a high level of comfort
• cosmesis, sometimes at the expense of some function
• vocational and recreational activities
• development of self-esteem overcoming challenges
• personal involvement in one's own prosthesis or orthosis design.

Many opportunities exist for effective cooperation between professionals and consumers, including financial assistance for purchasing devices and for training in proper delivery of advanced services as well as for dissemination of information via joint meetings. One of the most urgent needs is for a standard that can objectively measure clinical services.

Group discussions, production of appropriate written materials and short conferences are useful mechanisms to achieve these goals. The special needs of all members of the disabled community must also be taken into account.

Integrating Neural Prosthetic Concepts into O&P

Considerable progress has been made in developing neural prostheses to restore hand and arm function of individuals who have sustained spinal cord injuries. A prosthesis wearer is faced with a similar challenge, and some of the same concepts and hardware may apply to both groups. Despite their technical complexity, such techniques as multiple degrees of freedom control and closed sensory feedback loops can be made transparent through careful engineering design.

The degree of compliance of a limb influences its postural stability in the face of varying loads. For example, the legs function somewhat like the suspension system in an automobile: They support the body at a fixed height regardless of loading and also accommodate terrain changes.

Current artificial joints do not match the compliance of normal limbs very well since they are typically either completely stiff (locked) or completely free (unlocked). Development of variable stiffness O&P joints may result in more effective and more natural-looking devices. Combined force and position feedback is one mechanism to regulate stiffness of a given segment.

The importance of sensory and proprioceptive feedback is just now being fully appreciated. Despite impressive technical advances in myoelectric control, for example, it is presently necessary for amputees to use visual information for position feedback. Although the challenge is complex, the addition of more effective feedback mechanisms is expected to improve the clinical effectiveness of available devices.

In addition to choosing a stimulus of the correct type, it also must be modulated similarly to the intact system it attempts to replace. For example, perceived grasp force is a power function with an exponent of about 1.7. Electrotactile psychophysiological function is also nonlinear with a power function exponent that begins at 1.8. Investigation of this modality would seem to be productive.

There is also a strong need for basic studies to establish the psychophysics of human sensory modalities and to determine how best to artificially represent tactile information based on these studies. Far more effective clinical evaluation protocols than the present anecdotal reports of a small cohort of subjects are also necessary. Significant research into neuroprosthetic feedback is essential for significant advances to occur.

In the field of paraplegic gait, the hybrid combination of FES and external orthoses seems to offer significant potential, particularly for adults with SCI. Individuals with lower-level lesions may be able to use special floor-reaction orthoses combined with surface FES to the quadriceps (as has been demonstrated in the laboratory). For those with higher level involvement, a microcomputer-controlled hip orthosis has been tested on a limited number of subjects with encouraging results.

With improvements in the control scheme, it may be possible to offer an FES-assisted swing-through gait that is no more energy consuming than RGO-assisted reciprocal gait. With further development, such cybernetic orthoses literally may represent the next step forward in paraplegic rehabilitation.

Cosmesis and Skin Coverings

Based on patient demands, clinical investigations of improved methods for supplying a life-like external appearance have identified medical grade silicone elastomers as a particularly promising material for technical development. Several investigators are actively working to improve the practicality of techniques based on this material. Likely applications include a more durable and life-like covering for upper and lower-limb devices and development of all-silicone designs for selected areas such as partial-hand and partial foot ablation or absence.

One unmet need is for a cost-effective technique to provide individual coloration to match basic skin tones and detailed anatomic structures, ideally with the ability to "tan" in response to the summer sun and to "fade" automatically in the absence of sun. Technical factors affecting the realistic appearance of simulated skin that need further investigation include the color, heterogeneity, translucency and texture of human skin. Due to the high cost of present developments, only limited access is currently available. If reduction in cost is not possible through manufacturing innovations, then a concerted effort to convince professionals and third parties that a much higher minimum standard for the realistic appearance of external prostheses is necessary.

Database Needs for Research and

Development in gap Of the more than 6,000 medical and 8,000 engineering and applied science databases publicly accessible in the United States, only four contain information primarily relevant to O&P: RECAL, Rehabdata, NU-REP and Abledata/HyperAbledata. Containing primarily device-oriented information, these existing resources should be both supported and expanded.

Other database functions that would be useful to researchers include a database tabulating the mechanical, chemical, electrical, thermal and biocompatibility of presently used material, valid patient statistics, and a comprehensive database of past and present research and development efforts. A hierarchical database of patient organizations, support groups and potential funding sources would be beneficial. As O&P developments proliferate, the need for a concise mechanism to organize essential findings will increase.

Current O&P Research

Most present research in O&P involves applied clinical investigations. Many are preliminary or pilot studies. Clinical case reports are common but offer little objective data.

Numerous commercial successes of recent decades have been cited as examples of prosthetic research, including the Flex-Foot, CAT/CAM ischial containment socket design and the Endo-Flex monolithic thermoplastic prosthetic construction. However, these are primarily technical advances. What is conspicuously missing is the collaboration with trained researchers in these developments. While a more disciplined approach is needed for O&P problems, it is generally believed that close collaboration between clinical practitioners and quality researchers will result in the most rapid advances.

For example, prior to the availability of gait analysis laboratories, physical therapy gait training for transfemoral amputees was based on clinicians' subjective impressions of gait parameters based on visual cues. Investigation of 69 subjects. at the Mayo Clinic using objective gait analysis data revealed that an extended stance phase on the prosthetic side was characteristic of many recent amputees despite physical therapy intervention. A training aid providing audio cuing was developed to address this need. Using this biofeedback 'device, all 10 subjects were able to develop a more symmetrical gait while none in the control group who received conventional gait training was able to do so.

Another common gait defect identified was a positive Trendelenburg or gluteus medius limp. Work is presently underway to develop a feedback device to address this concern. Thus far, conventional physical therapy gait training has been shown to be largely ineffective in correcting this gait anomaly.

Over the past decade or so, significant interest has arisen in the application of computer-aided manufacturing principles to O&P. Although the original work simply applied commercial CNC-controlled milling to model production, later investigations have explored more efficient strategies.

Dudley Childress' group at Northwestern University has demonstrated the potential value of rapid prototyping by directly creating the socket from a bead of molten thermoplastic in a process dubbed "Squirt Shape" and through using commercial processes such as stereolithography and laminated object manufacturing. Since each prosthetic socket is fundamentally a prototype, further exploration of this technology is appropriate. If the manufacturing costs were low enough, it might be possible to develop disposable sockets.

Implications for Developing Countries

Many areas of the world, particularly developing countries, have large populations of young, healthy individuals with major amputations but no available prosthetic services. It has been estimated that it would require training up to 100,000 new prosthetists if conventional production methods are to meet the worldwide need.

In addition to funding training, the cost to supply hand-crafted prostheses to so many individuals is likely to be cost prohibitive. It is possible that CAD/CAM may be able to reduce the costs of both training and supply due to the volume of devices that one skilled prosthetist can produce using such systems. An experiment is presently underway in Vietnam to investigate the application of CAD/CAM to developing world prosthetic needs. One of the fundamental problems in addressing the health needs of developing countries is the near total lack of reliable statistics, particularly in rural areas. Treatment possibilities are usually several decades outdated in urban areas and totally absent in rural areas. In addition to the obvious need for upgrade training of existing urban clinicians, it may be useful to develop community-based rehabilitation programs for the rural areas. Diseases that result in insensate, at-risk feet, such as Hansen's Disease and diabetes mellitus, may be effectively managed via such community-based programs.

India is a good example of a rapidly developing country. The number of people with physical disabilities increases each year. Amputation is most commonly caused by traumatic injury, predominantly to working-age males.

The percentage of the population with financial independence can secure reasonably high-level rehabilitation either domestically or abroad. The financially dependent majority is restricted to the very basic devices the government can afford. Cultural and geographic factors influence the specific O&P designs that are accepted. For example, the need to sit on the ground cross-legged and to ambulate without shoes while indoors require different components than for the Western world.

Key characteristics of successful rehabilitation devices for developing countries such as India include

• low cost
• local availability
• manual fabrication
• adaptability to climate and working conditions
• high durability without frequent repairs
• simple to repair locally
• good function
• biomechanically sound
• light weight
• acceptable cosmesis
• reproducible by trained personnel.

Recommendations

Prosthetics and Orthotics

A system of multidisciplinary research groups or centers, broadly based with checks and balances, should be established. A laboratory for testing and evaluating the safety, efficacy and indications for newly developed devices should be developed. Factors that affect acceptance of specific devices need investigation.

Advances in upper-limb control schemes and feedback are needed. Basic research into fitting criteria and energy consumption are crucial. Computer modeling of the musculoskeletal system may help generate new concepts in prosthetic and orthotic design. Reviewing developments from other fields may reveal useful materials and techniques for incorporation into existing devices. Long-term financial support must be found for a postgraduate level training program in O&P.

Therapy

Regional centers of excellence with different research emphases would accelerate progress. Critical developments include a national database on amputee demographics and validation of functional assessment tools. Present treatment guidelines are typically subjective and lack scientific verification. A training program based on the team approach would help disseminate presently known information and improve the effectiveness of rehabilitation.

Research

Concrete needs include a "smart" upper-limb orthotic sensor, improved cosmesis, adjustable sockets, improved ulcer treatments and established general databases. The optimal use of presently available and future devices needs to be objectively determined. In addition to a network of centers of excellence, individually funded research must continue. Such basic investigations as the relationship between different surgical techniques and prosthesis design or development of a functional assessment tool for children with cerebral palsy also are necessary.

Consumers

Much more demographic data and clearer consensus on the best currently available practices are needed. Improved education of surgeons, prosthetists, orthotists and people with physical disabilities will significantly enhance rehabilitation outcomes. The amputee advocacy model exemplified by the War Amputations of Canada is worthy of study and perhaps emulation by other groups for people with disabilities.

Neuroprostheses

Many possibilities exist for clinical advances based on further research in this area. Examples include "bridging to reinnervate" peripheral injuries, direct connection of nerves to prostheses and orthoses and direct skeletal attachment of devices. More knowledge of the physiology of the hand, particularly the nondominant hand, is needed as is a better understanding of the cortical implications of amputation of the peripheral nervous system.

Proprioception is probably one of the most critical forms of sensory feedback; the role of auditory feedback also should be investigated. Gripping devices that automatically increase their prehension when slipping occurs are a logical development. In the long run the goal should be to create "smart" devices that alter their characteristics as the patient learns how to use them. Support for the evaluation of existing devices and techniques, rather than simply the proliferation of new devices, would be most effective.

Cosmesis

Cosmesis should be considered one aspect of function and is probably better termed "realistic appearance." Further study of the effect of appearance on the psychosocial interactions of the user is necessary.

Development of up-to-date criteria or prosthetic skin, continuing conferences for professionals and review of available literature should accelerate he development of improved cosmetic coverings.

Database Needs

Readily accessible databases containing information about O&P issues would be valuable to diverse populations, including consumers, researchers, clinicians, manufacturers and administrators. The general contents should include demographics, publications and audiovisual materials, consumer reactions and cross references to other databases. Additional information might include reimbursement rates, available products and services, recreational opportunities, sources of reimbursement funding, and accessible hotels, offices and other public buildings.

The database should be accessible at any time, easy to use and available for a modest fee. Sources for data presently include the Centers for Disease Control, U.S. Population Census, National Health Survey and the Department of Veterans Affairs.

Conclusion

For maximum return on investment, a comprehensive national plan for O&P research and development is recommended. This should include both a network of multidisciplinary centers of excellence focusing on different aspects of the work as well as individual researchers. A priority list of well-defined areas for research and development, perhaps generated in a series of consensus conferences, would be useful.

The plan should include a multicenter evaluation program, independent of the research and development centers, to

• ensure safety and efficacy of new techniques and devices
• provide objective indications and contraindications
• accelerate the introduction from research findings to clinical application.

To increase efficiency, a formal method for coordinating and correlating activities within the field is required. The former Committee on Prosthetics Research and Development might be a useful model.

Fundamental studies also are urgently needed to provide the foundation for further advances in the field. Examples would include

• effect of pressure, shear, etc. on soft and hard tissues
• control of the human neuromuscular system
• three-dimensional computer modeling of the human neuromuscular system.

Concurrently, investigations should be made into applied science opportunities. A concerted effort to review past work demonstrating sound ideas that failed due to inadequate materials, manufacturing, etc. might generate rapid results. Examples of high priority applied research includes

• fitting and alignment principles, including socket designs
• prevention and treatment of pressure sores
• improved cosmesis (more realistic appearance)
• advanced control and feedback systems.

Because O&P is an empirical field that may be on the threshold of developing a scientific foundation, this is a particularly appropriate time for concerted research. Partly as a result of the technically advanced state of general practice, certain developments such as transfer of materials technology from other fields are likely to be successfully implemented soon. Meanwhile, present laboratory demonstrations such as FES-assisted ambulation can be developed into practical clinical systems. In the long run, basic studies in critical areas will be essential to develop the next generation of insights leading to fundamental advances in O&P rehabilitation.

People coping with a disability want readily accessible and consistently effective rehabilitation. Focused, coordinated and sustained research in O&P can result in significant advances toward achieving this goal.

JOHN W. MICHAEL, MEd, CPO, is director of professional and technical services for Otto Bock USA, 3000 Xenium Lane N., Minneapolis, NM 55441. At the time of the conference, he was an assistant clinical professor at Duke University Medical Center.

References:

1. Bowker JH, Michael JW. Prosthetic/Orthotic Research for the Twenty-First Century: Proceedings of an NCMRR Conference, 1994 (accepted for publication). Available from: National Center for Medical Rehabilitation Research, Building 61E Room 2A03, 9000 Rockville Pike, Bethesda, MD 20892.