Canadian Prosthetics Orthotics Journal最新文献

A preliminary cost-utility analysis (CUA) of prosthetic care innovations can provide timely information during the early stage of product development and clinical usage. Concepts of preliminary CUAs are emerging. However, several obstacles must be overcome before these analyses are performed routinely. Disparities of methods and high uncertainty make the outcomes of usual preliminary CUAs challenging to interpret, appraise and share. These shortcomings create opportunities for a basic framework of preliminary CUAs. First, I introduced a basic framework of a preliminary CUA built around a series of constructs and hands-on recommendations. Then, I appraised this framework considering the strengths and weaknesses, barriers and facilitators, and return on investment. The design of the basic framework was determined through the review of health economic and prosthetic-specific literature. A preliminary CUA comparing the costs and utilities between usual intervention and an innovation could be achieved through a 15-step iterative process focusing on feasibility, constructs, analysis, and interpretation of outcomes. This CUA provides sufficient evidence to identify knowledge gaps and improvement areas, educate about the design of subsequent full CUAs, and obtain fast-track approval from governing bodies. Like previous CUAs, the main limitations were inherent to the constructs (e.g., narrow perspective, plausible scenarios, mid-term time horizon, substantial assumptions, data mismatch, high uncertainty). Key facilitators potentially transferable across preliminary CUAs of prosthetic care innovations included choosing abided constructs, capitalizing on prior schedules of expenses, and benchmarking baseline or incremental utilities. This new approach with preliminary CUA can simplify the selection of methods, standardize outcomes, ease comparisons between innovations, and streamline pathways for adoption. Further collegial efforts toward validating standard preliminary CUAs will facilitate access to economic prosthetic care innovations, improving the lives of individuals suffering from limb loss worldwide.

The emergence of skeletal prosthetic attachments leaves governmental organizations facing the challenge of implementing equitable policies that support the provision of bone-anchored prostheses (BAPs). In 2013, the Queensland Artificial Limb Service (QALS) started a five-year research project focusing on health service delivery and economic evaluation of BAPs. This paper reflects on the QALS experience, particularly the lessons learned. QALS' jurisdiction and drivers are presented first, followed by the impact of outcomes, barriers, and facilitators, as well as future developments of this work. The 21 publications produced during this project (e.g., reimbursement policy, role of prosthetists, continuous improvement procedure, quality of life, preliminary cost-utilities) were summarized. Literature on past, current, and upcoming developments of BAP was reviewed to discuss the practical implications of this work. A primary outcome of this project was a policy developed by QALS supporting up to 22 h of labor for the provision of BAP care. The indicative incremental cost-utility ratio for transfemoral and transtibial BAPs was approximately AUD$17,000 and AUD$12,000, respectively, per quality-adjusted life-year compared to socket prostheses. This project was challenged by 17 barriers (e.g., limited resources, inconsistency of care pathways, design of preliminary cost-utility analyses) but eased by 18 facilitators (e.g., action research plan, customized database, use of free repositories). In conclusion, we concluded that lower limb BAP might be an acceptable alternative to socket prostheses from an Australian government prosthetic care perspective. Hopefully, this work will inform promoters of prosthetic innovations committed to making bionic solutions widely accessible to a growing population of individuals suffering from limb loss worldwide.

Background: Amputation at the transfemoral (TF) level reduces the rate of successful prosthetic fitting, functional outcome, and quality of life (QoL) compared with transtibial amputation. The TF socket interface is considered the most critical part of the prosthesis, but socket discomfort is still the most common user complaint. Direct Socket for transfemoral prosthesis users is a novel interface fabrication process where the socket is shaped and laminated directly on the residual limb and delivered in a single visit.

Objectives: The aim of this study was to investigate if prosthetic users' quality of life (QoL), comfort, and mobility with a Direct Socket TF interface were comparable to their experience with their previous prostheses.

Methodology: The pre/post design prospective cohort study included 47 subjects. From this cohort, 36 subjects completed the 6-months follow-up (mean age 58 years, 27 males). Outcomes at baseline included EQ-5D-5L^®, PLUS-M™, CLASS, ABC, AMPPRO, and TUG. At 6-weeks and 6-months, subjects repeated all measures. Seven Certified Prosthetist (CP) investigators performed observations and data collection at six different sites (from July 2018 to April 2020).

Findings: Results showed significant improvement in all outcome measures for the 36 subjects that completed both 6-weeks and 6-months follow-ups. CLASS sub-scales showed significantly improved stability, suspension, comfort, and socket appearance. Improvement in K-Level and less use of assistive devices were observed with the AMPPRO instrument, indicating improved user mobility and performance. QoL was also increased, as measured in Quality-Adjusted-Life-Years (QALY) from the EQ-5D-5L.

Conclusions: Evidence from the findings demonstrate that the Direct Socket TF system and procedure can be a good alternative to the traditional method of prosthetic interface delivery.

Background: Lab-based simulators can help to reduce variability in prosthetics research. However, they have not yet been used to investigate the effects of sweating at the residuum-liner interface. This work sought to create and validate a simulator to replicate the mechanics of residual limb perspiration. The developed apparatus was used to assess the effects of perspiration and different liner designs.

Methodology: By scanning a cast, an artificial residuum was manufactured using a 3D-printed, transtibial bone model encased in silicone, moulded with pores. The pores allowed water to emit from the residuum surface, simulating sweating. Dry and sweating cyclic tests were performed by applying compressive and tensile loading, while measuring the displacement of the residuum relative to the socket. Tests were conducted using standard and perforated liners.

Findings: Although maximum displacement varied between test setups, its variance was low (coefficient of variation <1%) and consistent between dry tests. For unperforated liners, sweating increased the standard deviation of maximum displacement approximately threefold (0.04mm v 0.12mm, p<0.001). However, with the perforated liner, sweating had little effect on standard deviation compared to dry tests (0.04mm v 0.04mm, p=0.497).

Conclusions: The test apparatus was effective at simulating the effect of perspiration at the residual limb. Moisture at the skin-liner interface can lead to inconsistent mechanics. Perforated liners help to remove sweat from the skin-liner interface, thereby mitigating these effects.

Background: Interventions to resolve thermal discomfort as a common complaint in amputees are usually chosen based on the residual limb skin temperature while wearing prosthesis; whereas, less attention has been paid to residual limb skin temperature while outside of the prosthesis. The objective of this study was to explore the localized and regional skin temperature over the transtibial residual limb (TRL) while outside of the prosthesis.

Methodology: Eight unilateral transtibial adults with traumatic amputation were enrolled in this cross-sectional study. Participants sat to remove their prostheses and rested for 30 minutes. Twelve sites were marked circumferentially in four columns (anterolateral, anteromedial, posteromedial, and posterolateral) and longitudinally in three rows (proximal, middle, and distal) over the residual limb and used for attachment of analog thermistors. Skin temperature was recorded and compared for 11 minutes. Furthermore, the relationship of skin temperature with participants' demographic and clinical characteristics was explored.

Findings: The whole temperature of the TRL was 27.73 (SD=0.83)°C. There was a significant difference in skin temperature between anterior and posterior columns. Likewise, the distal row was significantly different from the proximal and middle rows. The mean temperature at the middle and distal zones of the anteromedial column had the highest and lowest skin temperatures (29.8 and 26.3°C, p<0.05), respectively. The mean temperature of the whole TRL had no significant relationships (p>0.05) with participants' demographic and clinical characteristics.

Conclusions: An unequal distribution of temperature over the TRL was found with significantly higher and lower temperatures at its anterior column and distal row, respectively. This temperature pattern should be considered for thermoregulation strategies. Further investigation of the residual limb temperature with and without prosthesis, while considering muscles thickness and blood perfusion rate is warranted.

Background: Balance impairment is a contributing factor to falls. Falls are a leading cause of injury and death in older adults. An ankle-foot orthosis (AFO) is a device that can be prescribed as an intervention to help individuals with compromised balance to ambulate safely.

Objective: The purpose of this review was to investigate the role ankle-foot orthoses have in affecting balance in community-dwelling older adults.

Methodology: A scoping review was conducted searching MEDLINE, CINAHL, EMBASE, and REHABDATA databases to obtain the appropriate literature to meet the following criteria: 1) quantitative research design; 2) studies with participants over age 65; 3) studies with participants with drop-foot or sensory deficits in the lower extremity; 4) the treatment intervention was unilateral or bilateral AFOs; 5) the outcome measure was balance or stability. The retrieved articles were assessed based on the internal validity, external validity, objectivity, and reliability of the study design and the interpretation of results.

Findings: 11 articles were identified that met the inclusion criteria. Four major themes emerged in the analysis about the impact that ankle-foot orthoses have on balance in older adults: (1) AFOs improved lateral stability, (2) AFOs improved balance under static conditions, (3) AFOs provided a reduction in postural sway and (4) AFOs increased walking speed in community-dwelling older adults.

Conclusions: The evidence from the findings of the review indicate that ankle-foot orthoses have a generally positive affect on balance in older adults. Clinicians can consider the ankle-foot orthosis an effective intervention that can improve balance in some older adult patient populations.

This position paper outlines the important role of academia in shaping the orthotics and prosthetics (O&P) profession and preparing for its future. In the United States, most healthcare professions including O&P are under intense pressure to provide cost effective treatments and quantifiable health outcomes. Pivotal changes are needed in the way O&P services are provided to remain competitive. This will require the integration of new technologies and data driven processes that have the potential to streamline workflows, reduce errors and inform new methods of clinical care and device manufacturing. Academia can lead this change, starting with a restructuring in academic program curricula that will enable the next generation of professionals to cope with multiple demands such as the provision of services for an increasing number of patients by a relatively small workforce of certified practitioners delivering these services at a reduced cost, with the expectation of significant, meaningful, and measurable value. Key curricular changes will require replacing traditional labor-intensive and inefficient fabrication methods with the integration of newer technologies (i.e., digital shape capture, digital modeling/rectification and additive manufacturing). Improving manufacturing efficiencies will allow greater curricular emphasis on clinical training and education - an area that has traditionally been underemphasized. Providing more curricular emphasis on holistic patient care approaches that utilize systematic and evidence-based methods in patient assessment, treatment planning, dosage of O&P technology use, and measurement of patient outcomes is imminent. Strengthening O&P professionals' clinical decision-making skills and decreasing labor-intensive technical fabrication aspects of the curriculum will be critical in moving toward a digital and technology-centric practice model that will enable future practitioners to adapt and survive.

The Sabolich family had made a unique contribution to both the clinical practice of Prosthetics and Orthotics as well as the business of prosthetics and orthotics. In preparing for this Special Edition, as Co-Editor-in-Chief, I felt it important to include the story of the Sabolich vision for prosthetic clinical practice and their experiences in achieving that vision. Their story is an important part of the history of prosthetic clinical practice in the United States. Their rethinking of what a clinical practice could look like and function as was far-sighted. Achieving it required both risk taking, as well as a new business model. The reaction from other Prosthetic and Orthotic practitioners was strong. Some saw the new model as visionary while others found it provocative. The model was based on a concierge style practice, which provided a premium service to a patient from first appointment to providing and maintaining of their device. They then went further than that by incorporating in-house research into their facility to develop new and innovative prosthetic approaches that would make them leaders in the field of socket design and fit. Their vision was to be a Center of Excellence for Prosthetics and Orthotics Practices, a vison that many people within the sector would likely agree was achieved. I invited current CEO of Scott Sabolich Prosthetics and Research to reflect back on the history of his family's business and how multiple generations of his family were able to see gaps and create opportunities where others could not see beyond the status quo and even fought hard to maintain the status quo. The evolution of this company provides insight into the successful development of novel business practices and economics in Prosthetics and Orthotics, while staying true to core service principles. The result was a business model that, in hind sight, had future-proofed the company in the face of the global economic challenges that impacted the sector in 2008-9 and beyond. It is also an indicator of what opportunities there are, at the business, clinical and technical levels, for those who take the risk of breaking from the status quo. Because of time and capacity constraints on the part of Mr. Scott Sabolich, it was agreed that his professional opinions and insights would be done in an interview format.

Background: Pressure sensing at the body-device interface can help assess the quality of fit and function of assistive devices during physical activities and movement such as walking and running. However, the dynamic performance of various pressure sensor configurations is not well established.

Objectives: Two common commercially available thin-film pressure sensors were tested to determine the effects of clinically relevant setup configurations focusing on loading areas, interfacing elements (i.e. 'puck') and calibration methods.

Methodology: Testing was performed using a customized universal testing machine to simulate dynamic, mobility relevant loads at the body-device interface. Sensor performance was evaluated by analyzing accuracy and hysteresis.

Findings: The results suggest that sensor calibration method has a significant effect on sensor performance although the difference is mitigated by using an elastomeric loading puck. Both sensors exhibited similar performance during dynamic testing that agree with accuracy and hysteresis values reported by manufacturers and in previous studies assessing mainly static and quasi-static conditions.

Conclusion: These findings suggest that sensor performance under mobility relevant conditions may be adequately represented via static and quasi-testing testing. This is important since static testing is much easier to apply and reduces the burden on users to verify dynamic performance of sensors prior to clinical application. The authors also recommend using a load puck for dynamic testing conditions to achieve optimal performance.

Digitalisation is the megatrend in healthcare, not only since the pandemic. We are two European digital health experts and industry leaders in the field of orthotics and prosthetics (O&P) and in this article we explored what are the underlying trends driving the adoption of digitalisation for customisation of prosthetics & orthotics. We showed that several trends in 3D image capture (input step), 3D modelling (processing step) and 3D printing (output step) currently converge and thus fuel the rapid transformation of the O&P industry. In short outlooks, we rated the probability and timing of adoption rates across the upcoming couple of years. We furthermore reviewed the impact of boundary conditions set by regulators as well as the reimbursement system. Towards the end of this article, we outlined a digital scenario of the near future by following around an orthotist during her work. We finished with a call-to-action targeting regulators, payors, prosthetists/orthotists, and patients to enable such a desirable future.