Areas of Research

• Co-Investigators: Stefania Fatone, PhD, Steven A. Gard, PhD, Kathryn Waldera, MS
• Students/Interns: Margaret Parker, MS, Elisah Pietersma, BS
• Project Director: Craig Heckathorne, MS
• Collaborators: The National AgrAbility Project
• Funded by: National Institute on Disability and Rehabilitation Research (NIDRR)
• Status: Completed

Farming and ranching are important occupations in the United States, offering many people both valuable employment and a satisfying life style. However, these occupations also expose workers to many dangers. In 2012, the U.S. Bureau of Labor Statistics ranked farming and ranching as having the 9th highest fatality rate of U.S. occupational categories with the 2nd highest number of fatalities in that year. Generally, in occupations with many fatalities, there also are many more non-fatal injuries. The National Safety Council reported that among persons employed in agriculture "one out of every ten of these workers will suffer an amputation while on the job" (Kircher 2003). Many of these amputations will involve part or all of a finger or toe, but it is estimated that 5 to 6 percent (about 1 out of every 200 agricultural workers) will have a major limb amputation involving complete loss of a hand or foot or more of a limb (Brown 2003).

Many farmers and ranchers with major limb amputation are geographically isolated, working in remote settings far from prosthetic clinics. Farmers and ranchers have unique needs that often are not met by standard prosthetic devices. Furthermore, farmers and ranchers who use prostheses are at risk of experiencing secondary injuries due to falls, prosthetic entanglement, overuse injury to the intact limbs, and injuries to the residual limb (Wilkomm and Novak 2007). Lacking are objective data and rigorous engineering analyses of components that could explain why prosthetic devices are not meeting the needs of farmers and ranchers with amputations. 

Purpose

The ultimate goals of this project are to promote appropriate application of prosthetic components for farmers and ranchers; to reduce prosthetic device failure and resultant secondary injuries; and to suggest improved prosthetic designs.

Specific Objectives

1. Identify activities where prosthetic devices either help or hinder farm-related activities by surveying farmers and ranchers with amputations and the prosthetists who provide services to them.
2. Promote appropriate clinical designs by developing educational materials and tutorials for prosthetists who work with farmers and ranchers.
3. Improve the design of prosthetic componentry by analyzing failed devices, identifying specific deficiencies and/or needs, and engaging in development projects.

Progress 

The first objective was addressed through a two-stage process. The first stage involved a series of telephone and in-person interviews to define prosthetic issues pertinent to farmers and ranchers. The results of these interviews were reported in the journal Disability and Rehabilitation: Assistive Technology (Waldera et al. 2012. Copy and paste this link into your browser: http://www.ncbi.nlm.nih.gov/pubmed/22779443) and in a webinar, Prosthetics for Farmers and Ranchers: What Is Used and What is Needed, available on the website of the National AgrAbility Project (Heckathorne et al. 2012). Issues explored in the interviews included current and past prostheses used, prosthetic failures, and the ability to complete farm tasks using a prosthesis. Prosthetists who provide services to this population were also interviewed to gain knowledge of specific devices and practices used in their geographic region.

Interviews with 40 farmers (in 12 states) and 26 prosthetists (in 14 states) revealed several common themes related to prostheses and their use. 

The interviews confirmed that farmers and ranchers with amputations have prosthetic needs distinct from the needs of the general population. Also, it was clear that post-amputation farming or ranching can be facilitated by creating more durable, affordable, and adaptable prosthetic components.

The interview results guided the second stage: the design of two surveys, one specifically for farmers and ranchers with upper-limb amputations and another for those with lower-limb amputations. The objective of these surveys was to obtain more specific information about the concerns of farmers and ranchers with limb amputations in order to establish priorities for improvements. The surveys also provided an opportunity to increase the representation of different types and levels of amputation, different farming and livestock operations, and additional geographic regions. The surveys were available online and in print format.

The survey was conducted from February 2013 through March 2014. During that time, 27 farmers and ranchers completed the survey online and one farmer completed a paper survey. Of the 28 respondents, 20 identified themselves as farmers, 7 as ranchers, and one as an agricultural worker. Fourteen of the 28 had upper-limb amputations and fourteen had lower-limb amputations. Using photographs incorporated in the survey, respondents identified the types of prosthetic components and systems they were using. Also, using a four-point scale from "not a problem" to a "very big problem", respondents rated a variety of factors related to problems they experienced with their prostheses. These included design factors (of the prosthesis), functional factors (how the prosthesis performed in farm and ranch work), service factors (service provided by prosthetists), and cost factors (including direct costs of purchasing the prosthesis and paying for repairs and indirect costs that affected productivity).

The survey results were organized into a webinar intended to inform prosthetists about the prosthetic needs of agricultural workers with amputations. The webinar, “Prostheses for Farmers and Ranchers: What Is Used, What Is Needed” (2014), is available to view free of charge (or with a fee to receive Continuing Education Credit if desired) on the Paul E. Leimkuehler Online Learning Center. (Accessibility Option: This webinar is accessible to individuals with a hearing impairment. Downloading the PowerPoint file using the “Resource Link” at the top right corner of the streaming video enables slide views that show transcription of the narrator's oral presentation in the Notes pane.) This webinar addresses our second objective, education. Content focuses on the types of prostheses used by farmers and ranchers in their work and the problems they encountered. Topics include respondents’ specific components, device construction, durability, maintainability, ease of cleaning and decontaminating, use in adverse weather conditions, prosthetic services, and ranking in order of importance the problems they identified.

Our third objective was to develop ideas to improve prosthetic components. We planned to acquire and analyze failed components obtained from farmers and ranchers. However, collection of failed components proved to be impractical because farmers wanted to keep their parts as spares for future use; had repaired the damaged parts by themselves; or had left the failed parts with their prosthetist to make repairs.

Unable to acquire failed components, we shifted our developmental focus to a prevalent problem identified by farmers and ranchers in both the interviews and the survey, namely heat and perspiration buildup in the prosthetic socket during summer months. Agricultural workers routinely remove their prosthesis several times a day to alleviate the discomfort from heat and sweat and to dry the socket and limb, thus preventing injury to the skin of the residual limb. Having to remove their prosthesis interrupted their work and reduced their productivity.

We reviewed empirical designs for alternative frame-type sockets that could improve heat and moisture dissipation. We developed a conceptual procedure for designing and fabricating a frame-type transradial socket based on pressure measurements at the socket-limb interface and measurements of the heat dissipation characteristics of the frame.

Clinical Implications

The information gathered during this project can impact the design of prostheses for agricultural workers and the way prosthetic services may be tailored to the particular work and life requirements of this population. Areas for future work include the development of prostheses that are more durable, less costly, and more maintainable by the farmer or rancher. It was clear that far more robust and functional prostheses are needed in particular for persons with arm amputations proximal to the elbow, the majority of whom generally choose not to use prostheses while continuing to farm or ranch. Developments in these areas also may benefit persons with amputations who work in other physically demanding occupations such as construction, forestry, mining, and manufacturing. Such improvements may also serve the physical demands of soldiers with amputations who are deployed in combat situations. Furthermore, new developments that address common concerns can be transferred to all prosthesis users.

References

• Bureau of Labor Statistics (2012). National Census of Fatal Occupational Injuries in 2011 (Preliminary Results). USDL-12-1888. News Release, September 20, 2012.
• Brown J. (2003). Amputations: A Continuing Workplace Hazard. http://www.bls.gov/opub/mlr/cwc/amputations-a-continuing-workplace-hazard.pdf. Access Date: 03/21/12.
• Kircher R. (2003). Farming with an Arm Amputation, Oklahoma AgrAbility Newsletter, 2(2):1-8.
• Wilkomm T and Novak M. (2007). Assistive Technology and Secondary Injuries Experienced by Farmers, Proceedings of the RESNA Annual Conference, Phoenix, AZ, June 15-19.

Related Presentations and Publications

• Waldera K. (2009). Improving Prosthetic Options for Farmers and Ranchers: NU RERC Collaboration with the National AgrAbility Project. Midwest Chapter American Academy of Orthotists and Prosthetists (AAOP) Annual Summer Session, Lake Geneva, WI, June 12-13.
• Waldera KE and Heckathorne CW. (2009). Assessing and Responding to the Prosthetic Needs of Farmers and Ranchers. Presented at the AgrAbility National Training Workshop, Grand Rapids, MI, October 5-8.
• Waldera K and Heckathorne C. (2010). Utilization of Lower-limb and Upper-limb Prostheses by Farmers and Ranchers in the U.S. 13th ISPO World Congress; May 10-15; Leipzig, Germany.
• Heckathorne C and Waldera K. (2011). The Prosthetic Needs of Farmers and Ranchers with Upper-limb Amputations. MEC '11 Symposium; August 17-19; University of New Brunswick.
• Waldera K, Heckathorne CW, Parker M, Fatone S. (2012). Assessing the Needs of Farmers with Amputation. The 38th American Academy of Orthotists and Prosthetists Annual Meeting and Scientific Symposium. March 21-24; Atlanta GA.
• Waldera KE, Heckathorne CW, Parker M, Fatone S. (2012). Assessing the prosthetic needs of farmers and ranchers with amputations. Disability and Rehabilitation: Assistive Technology, 8(3): 204-212, http://www.ncbi.nlm.nih.gov/pubmed/?term=waldera
• Murphy C. (2012). Prosthetic Limbs Inadequate for Farmer, Rancher Use. O&P Business News, 21(10): 31-32.
• Heckathorne C. (2012). Prosthetics for Farmers and Ranchers: What Is Used and What Is Needed. Webinar for the National AgrAbility Project Virtual National Training Workshop, November 27-29. 
  (Available at: http://agrability.org/Online-Training/archived/2012virtualntw.cfm.)
• Waldera K, Heckathorne C, Parker M, Fatone S. (2013). Assessing the Prosthetics Needs of Farmers and Ranchers in the USA: Interview Results. The 14th World Congress of the International Society of Prosthetics and Orthotics, February 4-7, Hyderabad, India.
• Heckathorne C. (2013). Prostheses in Physically Demanding Work. O&P Edge, 12(10):96.
• Craig Heckathorne was interviewed on RFD Radio Network morning program with Alan Jarand and Rita Frazer on 11/21/13.
• Eveleth R (2014) The Future of Farmer Prosthetics. Modern Farmer, January 2, 2014.
  http://modernfarmer.com/2014/01/future-farmer-prosthetics/. 
• Beilharz N (2014) Farmers struggle with prosthetic limbs. ABC Rural Radio, South Australia Country Hour, aired on January 30, 2014. http://www.abc.net.au/news/2014-01-30/prosthetic-farming/5228084. Listen to the hour long program at http://www.abc.net.au/news/2014-01-30/sa-country-hour-30-january/5228064.
• Eveleth R (2014) When State-of-the-Art is Second Best. NovaNEXT, March 5, 2014. http://www.pbs.org/wgbh/nova/next/tech/durable-prostheses/?utm_source=facebook&utm_medium=pbsofficial&utm_campaign=nova_next 
• Heckathorne C, Waldera K, Parker M, Fatone S and Gard S  (2014). Prostheses: What do Farmers and Ranchers Use; What do They Want? Webinar for the National AgrAbility Project Virtual National Training Workshop, December 2-4. (Available at: http://agrability.org/Online-Training/virtualntw/index.cfm)
• Prosthetics and Agriculture: A Marriage of Necessity. AgrAbility Harvest, 2015:6(1)2-3.
• Stefania Fatone was interviewed by Kristoff Husted for KBIA Mid-Missouri Public Radio. "Amputee Farmers Struggle with Available Prosthetics" aired on 6/3/2015. 
• NARIC, News and Notes from the NIDILRR Community and Beyond picked up the KBIA radio interview that aired on 6/3/2015, "Farmers with Prosthetics Face Durability Challenges", and disseminated the link on June 17, 2015. 

• Co-investigators: Steven A. Gard, PhD, and Matthew Major, PhD
• Project Director: Stefania Fatone, PhD, BPO(Hons)
• Funded by: National Institute on Disability and Rehabilitation Research (NIDRR)
• Status: Completed

Collaboration between clinicians and researchers is essential for addressing clinically-relevant research and development problems and providing improved quality of life to prosthesis and orthosis users. As the recipients of the current RERC for P&O, we place a high priority on collaborating with clinicians and users in order to identify and address research issues of practical concern.

Prosthetists and orthotists often find that their ability to achieve treatment goals is limited by commercial componentry, by commonly employed fabrication methods, evaluation tools, and by relative absence of guidelines and documentation of clinical successes. We believe that direct collaboration between an engineering-based research laboratory, such as ours, and clinical providers of prosthetic and orthotic services can overcome many of these limitations. By bringing analytical tools, machining capabilities, research experience, and mechanical and electronic design expertise to the clinical environment, an engineering research laboratory can augment the clinical service and help explore novel approaches to the design, fitting and evaluation of prostheses and orthoses.

Specific Objectives/Performance Goals

Our general goal is to respond to problems that are identified in the course of clinical care that can be addressed through the knowledge and tools available to engineers and researchers. An engineering-based research team can complement the clinical practitioner in several ways: (1) adapt and customize commercial components to improve their performance or expand their application; (2) document and analyze users' performance with specific prosthetic and orthotic systems using motion analysis equipment; (3) determine the means of component failure to promote improved commercial design and manufacturing; (4) develop evaluation tools, and (5) promote improved methods for constructing, fitting and evaluating prostheses and orthoses through our publications, presentations, and Website.

Collaborations

Dr. Fatone collaborated with Brian Arndt, CPO, and Ryan Caldwell, CP, from Suburban O&P in Des Plaines, Illinois, in a small clinical case study. This work formed the basis of Brian's NCOPE required prosthetics residency project. [Arndt B, Caldwell R, Fatone S (2011) Use of a Partial Foot Prosthesis with Vacuum-Assisted Suspension: A Case Study. Journal of Prosthetics and Orthotics, 23(2):82-88.]

At the request of orthotist, Keith Smith, CO, at Orthotic & Prosthetics Lab, Inc. in St. Louis, Missouri, Dr. Fatone and Rebecca Stine collaborated with Laura Hartung, CO, on her NCOPE required orthotic residency project, a case study of different ankle joint configurations for a child with cerebral palsy. This work has been presented multiple times:

1. Fatone S, Hartung L, Stine R (2011) Effects of Different Orthotic Ankle Joint Conditions on Lower Limb Gait Parameters in a Subject with Crouch Gait (poster). Gait and Clinical Movement Analysis Society, April 26-29, Bethesda, Maryland.
2. Fatone S, Hartung L, Stine R (2011) Effects of Different Orthotic Ankle Joint Conditions on Lower Limb Gait Parameters in a Subject with Crouch Gait. Midwest Chapter of the American Academy of Orthotists and Prosthetists, June 3-4, Grand Geneva Resort, Wisconsin.

Dr. Fatone collaborated with NUPOC orthotics instructor, Christopher Robinson, MBA, CPO, ATC, FAAOP, on an invited expert clinical viewpoint for Prosthetics and Orthotics International. This work formed the basis of an independent study project that Mr. Robinson completed as part of his Master's degree. [Robinson C, Fatone S (2013) Expert Clinical Viewpoint: You've Heard about Outcome Measures, So How Do You Use Them? Implementing Clinically Relevant Outcome Measures in Orthotic Management of Stroke. Prosthetics and Orthotics International, 37(1):30-42.]

During 2011, at the invitation of RIC physician, Dr. Deborah Gaebler-Spira, Dr. Fatone provided research mentorship to Joycie Eulah Abiera, MD, during her Fellowship in Pediatric Orthotics and Prosthetics, at the Rehabilitation Institute of Chicago. Dr. Abiera worked on two clinically-relevant projects: (1) A cross-sectional study of the variability in solid ankle foot orthosis design and fabrication among children with Cerebral Palsy; and (2) The reliability and validity of using 2D video based observational gait analysis to assess knee motion. This latter project is complementary to our RERC project D1.

Dr. Fatone has engaged in ongoing clinical collaborations on orthotic management of persons with upper motor neuron lesions with Deborah Gaebler-Spira, MD, at the Rehabilitation Institute of Chicago, Ms. Elaine Owens (PT from Bangor, Wales) and Mr. Donald McGovern (CPO at the Rehabilitation Institute of Chicago) resulting in multiple national and international presentations:

1. Fatone S, McGovern D (2010) Preliminary Experience with AFO-FC Tuning: Challenges and Outcomes. Invited Speaker, Midwest Chapter of the American Academy of Orthotists and Prosthetists, September 17-18, Grand Geneva Resort, Wisconsin.
2. Owen E, McGovern D and Fatone S (2010) The Importance of Being Earnest about Shank and Thigh Kinematics when Designing, Aligning and Tuning Ankle-Foot Orthosis Footwear Combinations. American Academy of Cerebral Palsy and Developmental Medicine, September 22-25, Washington DC.
3. Fatone S, McGovern D, Mangun J (2011) Effect on Gait of Ankle Foot Orthosis-Footwear Combination in an Individual with Post Stroke Hemiplegia. 37th American Academy of Orthotists and Prosthetists Annual Meeting and Scientific Symposium, March 16-19, Orlando, Florida.
4. Owen E, Gaebler D, McGovern D, Fatone S (2011) The Importance of Being Earnest about Shank and Thigh Kinematics when Designing, Aligning and Tuning Ankle-Foot Orthosis Footwear Combinations. Instructional Course, American Academy of Cerebral Palsy and Developmental Medicine, October 12-15, Las Vegas, Nevada.
5. Owen E, Gaebler-Spira D, McGovern D, Fatone S (2012) The Importance of Being Earnest about Shank and Thigh Kinematics when Designing, Aligning and Tuning Ankle-Foot Orthosis Footwear Combinations. Instructional Course, American Academy of Cerebral Palsy and Developmental Medicine, September 12-15, Toronto, Canada.
6. Owen E, Hansen A, Fatone S. (2013) From Stable Standing to "Rock'n'Roll" Walking. Symposium, 14th World Congress of the International Society for Prosthetics and Orthotics, February 4-7, Hyderabad, India.
7. Owen E, Gaebler-Spira D, McGovern D, Fatone S (2013) The Importance of Being Earnest about Shank and Thigh Kinematics when Designing, Aligning and Tuning Ankle-Foot Orthosis Footwear Combinations. Instructional Course, American Academy of Cerebral Palsy and Developmental Medicine, October 16-19, Milwaukee, Wisconsin.
8. Hansen A, Owen E, Fatone S (2014) From Stable Standing to “Rock’n’Roll” Walking. 40th American Academy of Orthotists and Prosthetists Annual Meeting & Scientific Symposium, February 26-March 1, Chicago, Illinois.

Dr. Fatone collaborated with Rob Hoskins, BME, and colleagues at Dayton Artificial Limb in Dayton, Ohio in dissemination of a small clinical case series tracking wound healing during use of prosthetic sockets with vacuum-assisted suspension. [Hoskins R, Sutton E, Kinor D, Schaeffer J, Fatone S. (2014) Using Vacuum-assisted Suspension to Manage Limb Wounds in Persons with Transtibial Amputation: A Case Series. Prosthetics Orthotics International, 38(1):68-74.]

Matthew Major, PhD (post-doctoral fellow at NUPOC) and Dr Fatone collaborated with Elliot Roth, MD, at the Rehabilitation Institute of Chicago to validate the Berg Balance Scale for use with persons with lower limb amputation. [Major M, Fatone S, Roth E (2013) Validity and Reliability of the Berg Balance Scale for Individuals with Lower Limb Amputation. Archives of Physical Medicine and Rehabilitation, 94(11):2194-202.] This work was featured in an article in the Northwestern University Feinberg School of Medicine News Center https://www.feinberg.northwestern.edu/news/2013/09/balance_NUPOC.html and also has been presented at a number of conferences:

1. Major MJ, Liss L, Murray T, Mangla N, Fatone S, EJ Roth EJ (2012) A pilot study: feasibility of using the Berg Balance scale in lower limb prosthesis users. 38th American Academy of Orthotists and Prosthetists Annual Meeting and Scientific Symposium, March 21-24, Atlanta, Georgia.
2. Major M, Fatone S, Roth E (2012) Validation of the Berg Balance Scale for Individuals with Lower Limb Amputation. Midwest Chapter of the American Academy of Orthotists and Prosthetists, September 27-29, Lake Geneva, Wisconsin.
3. Major M, Fatone S. (2013) Validation of the Berg Balance Scale for Individuals with Lower Limb Amputation. Texas Association of Orthotists and Prosthetists Annual Meeting, April 19-20, Dallas, Texas.

Dr. Fatone consulted on a collaborative project with Norman Harden, MD, at the Center for Pain Studies, the Rehabilitation Institute of Chicago, to create an amputee research registry with two goals: (1) to collect epidemiological data on post-amputation pain; and (2) to identify persons with amputation who are interested in participating in research.

Dr. Fatone collaborated with Drs. Katherine Steele and Kristie Bjornson from the University of Washington to explore the effect of orthoses on musculotendon lengths in persons with neurological disorders. This has led to a number of presentations and a publication:

1. Choi H, Bjornson K, Fatone S, and Steele KM (2013) Changes in musculotendon length with AFO tuning after stroke: a musculoskeletal modeling case study. Biomedical Engineering Society (BMES) Annual Meeting, September 25-28, Seattle, Washington.
2. Fatone S (2013) Use of Orthoses in Stroke Rehabilitation – Current Research. Invited Speaker, ISPO UK Annual Scientific Meeting, Orthotic Education and Training Trust Sponsored Lecture, October 4-5, Blackpool, UK.
3. Steele K, Choi H, Bjornson K, Fatone S (2013) Using musculoskeletal modeling to evaluate the effects of tuning ankle foot orthoses. World Congress on Biomechanics, July 6-11, Boston, Massachusetts.
4. Choi H, Bjornson K, Fatone S, Steele K. (2015) Using musculoskeletal modeling to evaluate the impact of ankle foot orthosis footwear combination on musculotendon dynamics. Disability and Rehabilitation Assistive Technology, Early Online: 1–6, DOI: 10.3109/17483107.2015.1005030.

Drs. Major, Fatone and Gard supervised the independent study projects of engineering students, David Kluger and Pooja Raghavan, that led to peer reviewed publications.

Graduate student, Angelika Zissimopoulos, completed her doctoral dissertation with support from NIDRR. This work focused on Mediolateral Foot Placement and Related Biomechanical Impairments in Post-Stroke Individuals and has been reported in three peer-reviewed publications.

Graduate student, Erin Boutwell, completed her doctoral dissertation with support from NIDRR. This work focused on the Effect of Prosthesis Stiffness on Impact Forces During In Vivo Step Loads and Gait and has been reported in the journal of Medical Engineering & Physics. See Boutwell E, Stine R, Gard S. (2015) A Novel in vivo Impact Device for Evaluation of Sudden Limb Loading Response. Medical Engineering & Physics, 37:151-155.doi:10.1016/j.medengphy.2014.10.008. The online version of this paper is available here: http://www.sciencedirect.com/science/article/pii/S1350453314002781..

Drs. Major, Fatone and Gard supervised the independent study projects of engineering students, David Kluger and Pooja Raghavan, that led to peer reviewed publications and presentations:

1. Major MJ, Kluger D, Fatone S, Gard SA (2013) The effect of trunk flexion on lower limb kinetics of able-bodied gait (poster). American Society of Biomechanics, September 4-7, Omaha, Nebraska.
2. Major MJ, Kluger D, Fatone S, Gard SA (2014) The effect of trunk flexion on lower limb kinetics of able-bodied gait. 10th Annual Lewis Landsberg Research Day, Northwestern University, April 3, Chicago, Illinois
3. Major M, Raghavan P and Gard S. (2014) Estimating step length of lower limb prosthesis users with a low-cost accelerometer. 40th American Academy of Orthotists and Prosthetists Annual Meeting & Scientific Symposium, February 26-March 1, Chicago, IL.

Graduate student, Sarah Koehler, completed her doctoral dissertation with support from NIDRR. This work focused on A Quantitative Analysis of Transfemoral Prosthetic Alignment and has been reported in the Journal of Biomechanics. See Koehler SR, Dhaher YY, Hansen AH. (2014) Cross-validation of a portable, six-degree-of-freedom load cell for use in lower-limb prosthetics research. J Biomech, 47(6), 1542-1547. 

Anticipated Results

Clinical collaborations will foster closer ties between researchers and clinicians that will benefit the field directly through the conduct of clinically-relevant projects that address a clinical need and indirectly by building networks and relationships between clinicians and research that facilitates future collaboration, stakeholder input, support of other ongoing research, knowledge translation, and research training and exposure.

Publications

• Arndt B, Caldwell R, Fatone S (2011) Use of a Partial Foot Prosthesis with Vacuum-Assisted Suspension: A Case Study. Journal of Prosthetics and Orthotics, 23(2):82-88. 
• Boutwell E, Stine R, Gard S. (2015) A Novel in vivo Impact Device for Evaluation of Sudden Limb Loading Response. Medical Engineering & Physics, 37:151-155. doi:10.1016/j.medengphy.2014.10.008. The online version of this paper is available here: http://www.sciencedirect.com/science/article/pii/S1350453314002781. 
• Choi H, Bjornson K, Fatone S, Steele K. (2015) Using musculoskeletal modeling to evaluate the impact of ankle foot orthosis footwear combination on musculotendon dynamics. Disability and Rehabilitation Assistive Technology, Early Online: 1–6, DOI: 10.3109/17483107.2015.1005030.
• Hoskins R, Sutton E, Kinor D, Schaeffer J and Fatone S (2014) Using Vacuum-assisted Suspension to Manage Residual Limb Wounds in Persons with Transtibial Amputation: A Case Series. Prosthetics and Orthotics International, 38(1):68-74.
• Kluger D, Major MJ, Fatone S, Gard S. (2014) The effect of trunk flexion on lower limb kinetics of able-bodied gait. Human Movement Science, 33:395-403.
• Koehler SR, Dhaher YY, Hansen AH. (2014) Cross-validation of a portable, six-degree-of-freedom load cell for use in lower-limb prosthetics research. J Biomech, 47(6), 1542-1547. 
• Major M, Fatone S, Roth E. (2013) Validity and reliability of the Berg Balance Scale for community-dwelling persons with lower limb amputation. Archives of Physical Medicine and Rehabilitation, 94(11):2194-202. 
• Major MJ, Raghavan P, Gard SA. (in press) Assessing a low-cost accelerometer-based technique to estimate spatial gait parameters of lower-limb prosthesis users. Prosthetics and Orthotics International.
• Robinson C, Fatone S (2013) Expert Clinical Viewpoint: You've Heard about Outcome Measures, So How Do You Use Them? Implementing Clinically Relevant Outcome Measures in Orthotic Management of Stroke. Prosthetics and Orthotics International, 37(1):30-42.
• Zissimopoulos A, Fatone S, Gard S (2014) The effect of ankle-foot orthoses on self-reported balance confidence in persons with chronic post-stroke hemiplegia. Prosthetics Orthotics International, 38(2):148-154.
• Zissimopoulos A, Stine R, Fatone S, Gard SA (2014) Mediolateral foot placement accuracy during ambulation in individuals with chronic post-stroke hemiplegia. Gait and Posture, 39:1097–1102.
• Zissimopoulos A, Fatone S, Gard SA (2014) Effects of an Ankle-Foot Orthosis on Mediolateral Foot Placement Ability during Post-Stroke Gait. Prosthetics Orthotics International, May 30. pii: 0309364614534294. [Epub ahead of print]. 

• Co-Investigators: Rebecca Stine, MS
• Project Director: Stefania Fatone, PhD
• Funded by: National Institute on Disability and Rehabilitation Research (NIDRR)
• Status: Completed

The NU-RERC State of the Science Conference conducted in 2006 highlighted the need for the evaluation of functional outcomes that can be collected in the P&O clinic and combined from multiple facilities to create sufficient sample size for the resulting data to be meaningfully utilized to support clinical practice. The evaluation of functional outcomes provides information that empowers clinicians, patients, payers and policy makers, and facilitates patient care based on identifying the most effective interventions. Outcomes are an important component of evidence based practice and quality patient care.

Many clinical questions regarding function with P&O devices are spatially planar and could be addressed with 2D motion analysis. Although relatively simple, many such questions have only expert opinion to support them. For example, the 2003 ISPO Consensus Conference on the Orthotic Management of Stroke recommended that both nonarticulated AFOs and articulated AFOs with plantar flexion stops could be used to control knee recurvatum following stroke. However, these recommendations were only supported by low level evidence or expert opinion. Insufficient evidence exists for the functional outcome of many P&O interventions.

We propose that the functional outcome of P&O interventions could be determined in a sufficiently large sample to be statistically meaningful if a simple tool to measure motion could be deployed and used in multiple P&O facilities. Two-dimensional motion analysis has been used successfully in the past and, with improvements in digital camera technology and marker tracking software, can be used effectively today. The advantages of such systems are that the equipment required is relatively inexpensive, data collection protocols can be simple, and data can be centrally processed. As with any measurement tool, there are also limitations, the main one being that more complex questions regarding 3D movement cannot be easily addressed.

Specific Objectives

Our objectives for this project include (1) developing a simple two-dimensional (2D) motion analysis tool; (2) developing training materials to assist in deployment of the tool at clinical sites; (3) deploying the tool for use at several P&O clinical sites and calibrating the set-up; (4) conducting a pilot investigation of the effectiveness of ankle foot orthoses (AFO) at controlling knee recurvatum at mid stance in persons following stroke; and (5) evaluating the utility of the tool and application to the pilot study.

Results and Discussion

This project explored the feasibility of performing multicenter functional outcome studies using relatively low-cost video cameras and centralized data processing. This feasibility study is important for developing future research projects that involve making measurements of persons using prostheses and orthoses in a clinical setting, but this information could also be used in other fields of rehabilitation to address clinical questions regarding movement pathologies.

Our experience conducting a small multicenter clinical trial collecting videos in orthotic practices suggested that guidance was needed regarding the recording of quality videos for 2D motion analysis (Fatone & Stine, 2015). Conditions that affect video quality include:

• Illumination - a bright image is needed to track the joints or segments,
• Image size - camera should be positioned as close as possible to the image field while maintaining sufficient space to view the activity,
• Camera position and steadiness - the camera needs to be held steady, level, and placed perpendicular to the image field,
• Marker placement on the patient - correct marker placement on the joints of interest improves measurement of joint angles (Baker et al., 2013). 

A good quality clinical video can produce data that are comparable to that of instrumented motion analysis systems, especially for sagittal plane motion of large joints like the knee (Grunt et al., 2010). We processed pilot data from 3 able-bodied subjects in 2D using a single Casio video camera and MaxTraq software (Innovision Systems Inc., Columbiaville, MI, USA), again in 2D using an 8-camera digital motion analysis system and Cortex software (Motion Analysis Corporation, Santa Rosa, CA, USA), and in 3D using the same 8-camera system and OrthoTrak software (Motion Analysis Corporation) (Fatone & Stine 2015). For each of these techniques, reflective markers were placed on the subjects using a modified Helen Hayes model (Kadaba et al. 1990) with an extra marker on the greater trochanter for use in the 2D calculations of sagittal plane knee kinematics. Variations in knee angle between the 2D approaches were smaller than between the 2D and 3D approaches. This was likely due to 3D angle calculations using an embedded coordinate system to calculate Euler rotations rather than 2D included angles. Sagittal plane knee angles calculated from hand-digitized video using MaxTraq were comparable to 2D calculations using the computerized motion analysis system with automatic digitization of reflective markers (Fatone & Stine. 2015). Our results confirm the work of other authors who reported that 2D video-based systems can provide valid gait data assuming good quality videos are used (Churchill et al., 2002 and Nielsen and Daugaard, 2008).

Care must be taken during the setup process and during data capture to ensure that the resulting video is recorded in a manner that is appropriate with respect to patient privacy concerns.

References Cited

• Baker R, Harvey A, Rodda J. Clinical video. In: Baker R, (Ed.) Measuring Walking: A Handbook of Clinical Gait Analysis. London: Mac Keith Press; 2013.
• Churchill AJ, Halligan PW, Wade DT. RIVCAM: a simple video-based kinematic analysis for clinical disorders of gait. Comput Methods Programs Biomed 2002;69:197-209.
• Grunt S, van Kampen PJ, van der Krogt MM, et al. Reproducibility and validity of video screen measurements of gait in children with spastic cerebral palsy. Gait Posture 2010;31:489-494.
• Kadaba MP, Ramakrishnan HK, Wootten ME. Measurement of lower extremity kinematics during level walking. J Orthop Res 1990;8:383-392.
• Nielsen D, Daugaard M. Comparison of Angular Measurements by 2D and 3D Gait Analysis [dissertation]. Jonkoping: Orthopaedic Technology, Jonkoping University; 2008.

Publications

• Fatone S, Stine R. (2015) Capturing Quality Clinical Videos for Two-Dimensional Motion Analysis. Journal of Prosthetics and Orthotics, (1)27-32. 

Presentations

• Stine R and Fatone S (2017) Capturing Quality Clinical Videos for Two-Dimensional Motion Analysis. In the Symposium “Improving Patient Care with Smart Data.” The 43rd Academy Annual Meeting & Scientific Symposium of the American Academy of Orthotists & Prosthetists (AAOP), March 1-4, Chicago, IL.
• Fatone S and Stine R (2016) Capturing Quality Clinical Videos for Two-Dimensional Motion Analysis, as part of the Gait Society and Lower Limb Society Forum Technological Advancements That Promote Practical Application of Outcome Measures, 42nd American Academy of Orthotists and Prosthetists Annual Meeting & Scientific Symposium, March 9-11, Orlando, FL. 
• Fatone S. (2012) 2D video based assessment of gait. Invited Speaker, 3rd Annual Convention in Prosthetics and Orthotics, July 6-8, Manila, Philippines.

• Co-Project Leaders: A. Heinemann, PhD, and L. Ehrlich-Jones, PhD
• Project Manager: L. Connelly, MS
• Consultants: M. Brncick, Northwestern University Prosthetics-Orthotics Center (NUPOC); D. Hart, Focus on Therapeutic Outcomes (FOTO); C. Carter, American Board for Certification in Prosthetics, Orthotics and Pedorthics (ABC)
• Funded by: National Institute on Disability and Rehabilitation Research (NIDRR)
• Status: Completed

Despite the availability of standard measures to assess functional status, quality of life and satisfaction with services and devices, provider enthusiasm for routine outcomes monitoring and improvement is diminished by the time and expense. We proposed to work with the American Board for Certification in Prosthetics, Orthotics and Pedorthics (ABC) and Focus on Therapeutic Outcomes (FOTO) to develop an outcomes monitoring, data collection and reporting service and education program that gives providers the information they need to improve patient care quality. We worked with FOTO to develop a scannable paper and Web-based data entry system that provides secure and confidential outcomes information to ABC-accredited programs. We evaluated the utility of this system and developed a quality improvement education curriculum in collaboration with NUPOC in terms of the actions providers take to enhance the quality of their patient outcomes.

The ABC accreditation standards are designed to enhance quality healthcare in P&O practices and to help increase efficiency and support initiatives that improve patient outcomes. Facility accreditation helps ABC achieve specific goals including promoting the welfare of persons with disabilities by establishing standards for those engaged in the fitting of prostheses and orthoses. ABC defines six categories of standards including quality assessment and improvement. We have learned from providers that they perceive outcomes data collection and monitoring as time consuming and expensive. While they acknowledge the value of data collection, they do not have access to data management systems that allows them to compare their patient outcomes with other providers. We hypothesized that compliance with ABC's Performance Management and Improvement Standards related to use of quality indicators will improve from baseline through a three-year implementation process.

Purpose/Specific Objectives

(1) Develop a database of process and outcome indicators that are useful in guiding clinical practice improvement activities;(2) Develop an educational curriculum that enhances clinicians' ability to integrate process and outcome information in improving P&O care delivery quality;(3) Analyze facility compliance with ABC's Performance Management and Improvement Standards;(4) Evaluate and refine the curriculum on use of quality indicators to improve clinical practice and outcomes.

Clinical Implications

This project was designed to improve clinical practice favorably. The Centers for Medicare and Medicaid Services (CMS) requires facilities to achieve accreditation in order to be eligible for Medicare reimbursement. Still, wide variations in performance management exist, in part because facilities have few examples of how to monitor and improve their services. This project was developed to promote "best practices" to a wide audience.

Related Presentations and Publications

• Heinemann A, Ehrlich-Jones L, Williams D. Enhancing Quality of Prosthetic Services with Process and Outcome Information. Paper presented at: 13th ISPO World Congress; May 10-15, 2010; Leipzig, Germany.
• Connelly L, Heinemann A, Ehrlich-Jones L. Enhancing Quality of Prosthetic and Orthotic Services with Process and Outcome Information. Midwest Chapter of the American Academy of Orthotists and Prosthetists; June 3-4, 2011; Grand Geneva Resort, WI.
• Heinemann A. Ehrlich-Jones L, Connelly L, Fatone S. Enhancing Quality of Prosthetic and Orthotic Services with Process and Outcome Information. in 38th American Academy of Orthotists and Prosthetists Annual Meeting and Scientific Symposium. March 21-24, 2012. Atlanta GA.
• Heinemann A, Ehrlich-Jones L, Connelly L, Fatone S (2013) Improving the quality of prosthetic and orthotic services with process and outcome information. 14th World Congress of the International Society of Prosthetics and Orthotics, February 4-7, Hyderabad, India.
• Heinemann A, Connelly L, Ehrlich-Jones L, Fatone S (2014) Outcome Instruments for Prosthetics: Clinical Applications. Invited Paper, Physical Medicine and Rehabilitation Clinics of North America, 25(1):179-198. PMID: 24287247.
• Heinemann A, Connelly L, Ehrlich-Jones L, Fatone S (in press) Enhancing Quality of Prosthetic Services with Process and Outcome Information. Prosthetics Orthotics International.
• Ehrlich-Jones, Linda. Quality Improvement: What Is It and How Do We Use It? Online Educational Module for Orthotists and Prosthetists, 2014.
• Wong AWK, Heinemann AW, Ehrlich-Jones L, Connelly L, Semik P, Fatone S (2014) Comparison of the Orthotics and Prosthetics Users’ Survey (OPUS) and Orthotics and Focus on Therapeutic Outcomes (FOTO) Functional Status Measures for Persons with Lower Limb Amputation. American Congress of Rehabilitation Medicine, October 7-11, Toronto, ON, Canada. 
• Heinemann A, Ehrlich-Jones L, Connelly L, Semik P and Fatone S (2016) Enhancing Quality of Prosthetic Services with Process and Outcome Information. Prosthetics and Orthotics International 1-7. DOI: 10.1177/0309364616637957. 

• Principal Investigators: Allen Heinemann, PhD, and Dudley Childress, PhD
• Funded by: National Institute on Disability and Rehabilitation Research (NIDRR) of the U.S. Department of Education under Grant No. H133E030030. 
• Status: Completed 

The need to measure and evaluate rehabilitation practice in general and P&O practice specifically has received growing recognition in the past several years. Fuhrer (1995) outlined recommendations for medical rehabilitation outcomes research generated at a 1994 conference organized by the National Center for Medical Rehabilitation Research (NCMRR). Critical to NCMRR's agenda, and reiterated throughout the report, is the need for valid, reliable and change-sensitive outcome measures to evaluate the efficacy and effectiveness of rehabilitation practices. The American Board for Certification in Prosthetics, Orthotics and Pedorthics (ABC) echoes this call for certification by encouraging outcomes measurement and clinical pathways within the context of a continuous quality improvement process (Hoxie, 1995, 1996).

Patient perspectives on devices and services as well as satisfaction with services are widely recognized as important areas of rehabilitation and in healthcare generally. However, the greatest challenge is the lack of standardization in measures that would allow outcomes to be compared across programs. Outcome measurement has been the subject of several articles in P&O trade publications (American Orthotics and Prosthetics Association, 1998; Otto, 1999). A recurring concern is the industry's need to quantify outcomes as a means of justifying the cost of services to payers and of responding to growing pressure from consumer groups. The industry would benefit from a set of instruments that can accurately and conveniently measure important and relevant outcomes. Such an assessment could provide many benefits: assist the field develop evidence-based practice and clinical pathways, assure client satisfaction, supplement earnings reports, enhance payer relations, and provide a means of implementing program accreditation.

During a previous RERC funding cycle, we developed a set of outcome measures to ascertain the effectiveness of rehabilitation care for patients who receive prosthetic services. We developed a prototype database that describes wearer characteristics, device characteristics, outcomes, and costs in order to help providers document and evaluate the benefits of their services and improve user outcomes. We disseminated the database to service providers across the U.S., Canada and Australia. We also developed a set of self-report instruments that assess functional status, quality of life, and satisfaction with devices and services that can be used within a P&O clinic: the Orthotics and Prosthetics Users' Survey (OPUS) (Heinemann et al., 2003). OPUS includes four instruments that differentiate patients with varying levels of lower extremity function, quality of life, and satisfaction.

The four components of OPUS provide clinicians with a useful tool to evaluate individual client and program outcomes. The psychometric properties are promising as the instrument demonstrates the ability to detect a wide range of function, quality of life, and satisfaction and possesses good internal consistency and construct validity. The development of the OPUS allows providers to monitor and improve their services and to fulfill accreditation requirements developed by ABC. Despite the availability of standard measures to assess functional status, quality of life and satisfaction with services and devices, the expense of outcomes monitoring diminishes provider enthusiasm for routine outcomes monitoring and improvement. We propose to develop an outcomes monitoring, data collection and reporting service that gives providers the information they need to improve patient care. We will establish a data entry system that provides secure and confidential outcomes information to ABC accredited programs. We will evaluate the utility of this system and the actions providers take to enhance the quality of their patient outcomes. The data entry and reporting system is likely to be of considerable value to P&O facilities. We will explore the possibility of licensing the software so as to assure that a consistent data reporting system is available after the completion of this project. We have worked with Northwestern University's Technology Transfer Program (NU-TTP) to assure a copyright for OPUS and have gained familiarity with the procedures involved.

References

• Fuhrer, M.J. (1995). Conference report: an agenda for medical rehabilitation outcomes research. American Journal of Physical Medicine & Rehabilitation, 74:243-248.
• Hoxie, L.O. (1995). Outcome measurement: a primer for orthotic and prosthetic care. Journal of Prosthetics and Orthotics, 7:132-136.
• Hoxie, L.O. (1996). Outcome measurement and clinical pathways. Journal of Prosthetics and Orthotics, 8:93-95.
• American Orthotic and Prosthetic Association (1998). Outcomes in the prosthetics and orthotics profession. O & P Almanac, December.
• Otto, J. (1999). Outcomes insights: a current perspective Parts 1 and 2. O & P Business News Dec. 15, 1999 and Jan. 1, 2000.

Related Publications

• Burger, H, Franchignoni, F, Heinemann, AW, Kotnik, S, Giordano, A. (2008). Validation of the orthotics and prosthetics user survey upper extremity functional status module in people with unilateral upper limb amputation. J. Rehabilitation Medicine, 40(5):393-9.
• Heinemann, AW, Fisher, W, Gershon, R (2006a). Improving Healthcare Quality with Outcomes Management. Proceedings of the American Academy of Orthotists and Prosthetists State of the Science Conference 6: Outcome Measures in Lower Limb Prosthetics, Chicago, IL, September 7-9, 2005. Journal of Prosthetics and Orthotics, 18(1S):46-50.
• Heinemann, AW, Gershon, R, Fisher, W (2006b). Development and Application of the Orthotics and Prosthetics User Survey: Applications and Opportunities for Healthcare Quality Improvement. Proceedings of the American Academy of Orthotists and Prosthetists State of the Science Conference 6: Outcome Measures in Lower Limb Prosthetics, Chicago, IL, September 7-9, 2005. Journal of Prosthetics and Orthotics, 18(1S):80-5.
• Heinemann, AW, Bode, R, O'Reilly, C (2003). Development and Measurement Properties of the Orthotics and Prosthetics Users' Survey (OPUS): A Comprehensive Set of Clinical Outcome Instruments. Prosthetics Orthotics Int, 27(3):191-206.