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Purpose: Use of a lower limb prosthesis generally requires increased cognitive effort to compensate for missing motor and sensory inputs. This study sought to examine how lower limb prosthesis users perceive paying attention to their prosthesis(es) in daily life. Materials and methods: Focus groups with lower limb prosthesis users were conducted virtually using semi-structured questions. Verbatim transcripts were excerpted, coded, and reconciled. Inductive thematic analysis was undertaken to identify experiences shared by participants. Results: Five themes emerged from five focus groups conducted with thirty individuals: Paying attention to my prosthesis is just what I have to do; I pay attention to how my prosthetic socket fits and feels every day; I pay attention because I don't want to fall; I pay attention because I have to learn to do things in a new way; and If I can trust that my prosthesis will do what I want, I can pay less attention to it. Conclusions: Prosthetic attention, including both background and foreground attention, is a shared experience among lower limb prosthesis users. The amount and frequency of prosthetic attention fluctuates throughout the day and changes over time. Measuring attention could inform the evaluation and prescription of technology intended to reduce cognitive effort. IMPLICATIONS FOR REHABILITATION: Walking or performing mobility tasks with a prosthesis requires increased attention and may limit the cognitive resources available for other important activities. Lower limb prosthesis users report paying attention to their prosthesis(ses) to avoid falling, to maintain the fit of their prosthetic socket, and to learn to complete mobility tasks with a prosthesis. Clinicians should discuss prosthetic attention with new prosthesis users and explain how it is expected to decrease over time. Prosthetic technology may affect prosthetic attention but development of a measure to assess prosthetic attention is needed to accurately evaluate this relationship. [ABSTRACT FROM AUTHOR]

Purpose: Little is known about the outcomes that are most important to prosthesis users and funders. A Prosthetic Interventions Core Outcome Set (PI-COS) will help researchers and practitioners measure outcomes that are the most important to prosthesis users and funders. Materials and methods: Prosthesis users and funders rated the importance of 121 International Classification of Functioning, Disability, and Health (ICF) second-level categories using a two-round Delphi survey. A Consensus Meeting using the nominal group technique resolved rating differences between groups. The ICF second-level categories were ranked according to importance and a K-Means Cluster Analysis helped establish the PI-COS. Results: 65 users and 8 funders completed the Delphi surveys, followed by a Consensus Meeting. 26 ICF second-level categories were considered important to prosthesis users and funders and a PI-COS of 14 ICF second-level categories drawn predominantly from five ICF chapters was established: Sensory Functions and Pain (b2), Neuromusculoskeletal and Movement-related Functions (b7), General Tasks and Demands (d2), Mobility (d4), and Products and Technology (e1). Conclusions: The PI-COS describes the outcomes that are most important to prosthesis users and funders. The PI-COS can help focus on the most important outcome measures in clinical practice and research, including future prosthetic health economic evaluations. [ABSTRACT FROM AUTHOR]

Purpose: Life after any amputation can be significantly altered and can have a significant impact on quality of life (QoL). However, most of the evidence base involves older aged amputees, therefore there is a lack of understanding about the impact of amputation on QoL and the factors that predict QoL in younger amputees. The aim of this review is to identify the factors that predict QoL in young amputees. Methods: MEDLINE, CINAHL, EMBASE, PsycINFO, Web of Science were searched to identify articles that measured QoL in young amputees. Articles were independently assessed by two assessors. Data was extracted from the selected articles and a narrative synthesis performed. Results: 18 articles were included in this review. QoL outcome measures varied between studies. The quality of evidence was generally low. This review identified, gender, age, cause of amputation, level of amputation, phantom pain, ability to use a prosthesis, physical function, depression, anxiety, body image, type of prosthesis as predictors of QoL. Conclusion: This review identified modifiable and non-modifiable predictors of QoL in young amputees. Future research needs to focus on exploring the modifiable predictors of QoL as these are the aspects that can be improved to enhance QoL. IMPLICATIONS FOR REHABILITATION: Life after any amputation can be significantly altered and can have a significant impact on quality of life (QoL). Gender, age, cause of amputation, level of amputation, phantom pain, ability to use a prosthesis, physical function, depression and anxiety, body image and type of prosthesis were identified as predictors of QoL. The ability to use a prosthesis and access to advanced prosthetic technology are important predictors of QoL as they allow for improved mobility, which in turn increases independence and therefore QoL. [ABSTRACT FROM AUTHOR]

Objective: The purpose of this study was to qualitatively assess the first-hand lived experiences of patients with amputation who had transitioned from a traditional socket (TS) to Osseointegration (OI) to impact their overall quality of life (QOL) and function. Methods: This was a qualitative phenomenological study. Participants who had a unilateral transfemoral amputation and fit the study's inclusion criteria were interviewed in a semi-structured format regarding their quality of life and function before and after transitioning from a traditional socket (TS) to Osseointegration (OI). Responses were then analyzed through line-by-line coding to determine themes that were relevant to QOL outcomes for this study. Results: Eleven participants were interviewed in this study. The qualitative analysis demonstrated an emergence of 6 main themes consisting of "Improved Quality of Life," "Supportive Community," "Previous Ill-fitting Socket," "Greater Function," "Improved Osseo-perception," and "Promotion of Community Accessibility". Strengths included the use of an OI-specific quality of life assessment with adapted questions from validated outcome measures, international participants, and use of thematic analysis for data analysis. Weaknesses included sample size, niche participant population, and OI as a revision procedure only. More research is still necessary to explore/determine the benefits and detriments of Osseointegration as an alternative to traditional sockets for prosthetic devices. Conclusion: Individuals who have undergone Osseointegration procedure discuss being more satisfied with their prosthesis and quality of life when compared to their previous experience of a traditional socket. Impact Statement: This is a first of its kind study reporting on the lived experiences of those who have undergone OI. The field of amputation rehabilitation is expanding rapidly and knowing how this procedure impacts quality of life is important for healthcare professionals to understand as new frontiers are explored in this field. [ABSTRACT FROM AUTHOR]

Introduction: While each of the 44 National Health Service commissioned artificial limb clinics in the United Kingdom record information about their own prosthetic limb users, these are not collated to give a national picture of amputee epidemiology. The requirement to respond to Freedom of Information (FoI) requests within 20 working days offers another way of extracting data from all centres, and this study describes a first attempt to use this method to update national epidemiological data. Methods: Questions were sent to the FoI email addresses of all 44 centres, requesting numbers of adult unilateral below-knee amputees, adult unilateral above or through-knee amputees and child unilateral above or through-knee amputees (all of K2 level mobility), numbers of people consistently using a prosthesis with a single axis myoelectric hand, and access to an occupational therapist with skills to teach someone to use a myoelectric hand. A FoI request was sent to NHS England seeking release of data that they collect every month from all the prosthetic services which they commission in England. Results: All but one of the UK centres responded, the great majority within 31 days. Incomplete results were generally due to centres finding the questions ambiguous and many did not record mobility levels consistently. While 33 centres had access to skilled occupational therapy, only 4 reported more than 10 patients who constantly used a single axis myoelectric hand. Eighteen centres were unable to provide complete data, and the remainder reported a ranges of 5 to 992 below-knee amputees, 7 to 574 adult above-knee amputees and 0 to 137 child above-knee amputees, suggesting different approaches to managing missing mobility level data. Conclusions: Freedom of Information requests are an inexpensive way of gathering data from NHS prosthetic clinics, which can identify age, sex, level of amputation but not activity levels or use of a prosthesis and hence only gives limited demographic information of the amputee cohort. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this study was to explore healthcare professionals' (HCPs) perceptions and experiences related to 3D scanning and 3D printing for fabricating lower limb prosthetic sockets. Materials and methods: This study used a qualitative descriptive approach. Participants were recruited through HCPs' professional associations, social media posts, and snowball sampling. Purposive sampling was used to attain variation in provider type. One-on-one telephone interviews were conducted using a semi-structured interview guide. Inductive thematic analysis was performed to identify the main themes. Results: Three themes were identified: (1) 3D scanning of the residual limb for designing prosthetic sockets is perceived as clean, quick, and convenient; (2) concerns about the strength and safety of 3D printed sockets for long-term use; (3) Adoption of 3D scanning and 3D printing technology for fabricating prosthetic sockets. Conclusion: We identified perceived benefits and challenges with digital technologies for fabricating prosthetic sockets. To increase adoption, more research demonstrating its efficacy compared to conventional methods, increasing 3D printing material quality, and improving software training programs are needed. Implications for Rehabilitation: 3D printing and 3D scanning are emerging digital technologies that can be used as alternative methods for prosthetic socket manufacturing in the field of rehabilitation. Our research identified perceived benefits of using digital technologies for fabricating prosthetics sockets (3D scanning is perceived as clean, quick, and convenient) and perceived challenges (concerns about the strength and safety of 3D printed sockets for long-term use and a prolonged learning curve). To increase adoption of these digital technologies, more training should be provided to prosthetists and support provided to integrate new processes into staff workloads. [ABSTRACT FROM AUTHOR]

Background: The benefits of travel for the wellbeing of people of all ages and abilities are well known, though travellers with prostheses have so far been excluded. Limb loss, due to trauma, vascular disease, cancer, or infections requires a prosthesis for cosmesis and functionality. The life-changing event of losing a limb and the considerable psychological adjustment to accept an altered body image influence rehabilitation and self-management as well as the participation in social activities, such as sport and travel. The challenge of travel lies not only in transferring practical impediments encountered at home to another location; familiar coping strategies may require unexpected adjustments. After presenting background information on limb loss and prostheses, the purpose of this paper was to review literature on health advice for travellers with prosthetic limbs. Method: All major data bases were searched for peer-reviewed literature using a variation of keyword combinations around travel and prosthetics. Relevant journals were searched individually, and selected authors and university departments contacted. No evidence-based results were obtained. The search then moved to grey literature including documents from relevant organisations, professional bodies, government websites, manufacturers, airlines, prosthetic/physiotherapy clinics, sport organisations to approaching amputees, including veterans and athletes, directly. Result: The list of collated travel advice for people with artificial limbs relates to (1) trip preparation, (2) packing (especially considering the mechanical and/or electrical requirements of the prosthesis), (3) travelling by plane as the most covered mode of travel, and (4) navigating airports and airport security, which may be used by travel health practitioners while awaiting evidence-based guidelines. Conclusion: This is the first paper on travel with a prosthetic limb in any field, including travel medicine. Therefore, travel health practitioners have no evidence-based guidelines at their disposal required for high-quality care for this neglected population. Preliminary recommendations for clinical practice, advice for required updates in education, and suggestions for urgently needed research are provided to replace current hints and tips with evidence so that travellers with prostheses are no longer 'out on a limb'. [ABSTRACT FROM AUTHOR]

Phantom limb pain, a common challenge for amputees, lacks effective treatment options. Vibration therapy is a promising non-pharmacologic intervention for reducing pain intensity, but its efficacy in alleviating phantom limb pain requires further investigation. This study focused on developing prosthesis liners with integrated vibration motors to administer vibration therapy for phantom limb pain. The prototypes developed for this study addressed previous issues with wiring the electronic components. Two transfemoral amputees participated in a four-week at-home trial, during which they used the vibration liner and rated their initial and final pain intensity on a numeric rating scale each time they had phantom pain. Semi-structured interviews were conducted to gather feedback following the at-home trial. Both participants described relaxing and soothing sensations in their residual limb and phantom limb while using vibration therapy. One participant reported a relaxation of his phantom limb sensations, while both participants noted a decrease in the intensity of their phantom limb pain. Participants said the vibration liners were comfortable but suggested that the vibration could be stronger and that aligning the contacts could be easier. The results of this study highlight the potential effectiveness of using vibration therapy to reduce the intensity of phantom limb pain and suggest a vibration liner may be a feasible mode of administering the therapy. Future research should address optimizing the performance of the vibration liners to maximize their therapeutic benefits. [ABSTRACT FROM AUTHOR]

To explore barriers and facilitators to community reintegration experienced by people following traumatic upper limb amputation (ULA). An exploratory qualitative study was conducted with ten adults with major ULA due to trauma. Data from individual, semi-structured interviews was analysed using Braun and Clarke's reflexive thematic analysis. Underlying and influencing community reintegration for participants, was a process of adjustment to the impacts of amputation on everyday function and re-establishing their identity. Participants felt social networks and peer support facilitated the return to social and community activities, as did drawing on personal attributes such as positivity, resilience and self-belief. Prosthetic devices were facilitative for community reintegration by minimising visible differences and unwanted attention through restored cosmesis and in the performance of functional tasks to fulfil social norms and meaningful roles despite issues with comfort and function. Despite the adaptation and evolution of abilities, perspectives and identities, the functional impact of ULA on everyday community activities was an ongoing challenge for all participants. ULA has a significant and lifelong impact on an individual's ability to complete tasks and fulfil meaningful roles in the community. Recommendations based on the study's findings will inform clinicians to support community reintegration for people following traumatic ULA. Rehabilitative environments and interventions that promote self-efficacy, positivity, problem-solving skills and resilience may support adjustment and community reintegration following upper limb amputation. Facilitating appropriate peer support and the strengthening of existing social supports may assist social and community reintegration. The facilitative effects of prosthetics on community participation and reintegration may be enhanced through client-centred, goal-directed and timely prosthetic provision and training. Ongoing barriers and challenges with community participation may indicate the need for ongoing therapeutic intervention and support. [ABSTRACT FROM AUTHOR]

The ankle joint is pivotal in prosthetic feet, especially in Energy-Storing-and-Releasing feet, favoured by individuals with moderate to high mobility (K3/K4) due to their energy efficiency and simple construction. ESR feet, mainly designed for sagittal-plane motion, often exhibit high stiffness in other planes, leading to difficulties in adapting to varied ground conditions, potentially causing discomfort or pain. This study aims to present a systematic methodology for modifying the ankle joint's stiffness properties across its three motion planes, tailored to individual user preferences, and to decouple the sagittal-plane behaviour from the frontal and transverse ones. To integrate the multi-axial ankle inside the MyFlex-η, the designing of experiments using finite element analysis was conducted to explore the impact of geometric parameters on the joint's properties with respect to design constraints and to reach the defined stiffness targets on the three ankle's motion planes. A prototype of the multi-axial ankle joint was then manufactured and tested under FEA-derived load conditions to validate the final configuration chosen. Composite elastic elements and complementary parts of the MyFlex-η, incorporating the multi-axial ankle joint, were developed, and the prosthesis was biomechanically tested according to lower limb prosthesis ISO standards and guidelines from literature and the American Orthotic and Prosthetic Association (AOPA). Experimental tests showed strong alignment with numerical predictions. Moreover, implementing the multi-axial ankle significantly increased frontal-plane compliance by 414% with respect to the same prosthesis with only one degree of freedom on the sagittal plane without affecting the main plane of locomotion performance. [ABSTRACT FROM AUTHOR]

Sensors commonly used to record sub-bandage pressures may be less reliable than is commonly believed. The techniques employed for the calibration or validation of these devices can sometimes produce a highly inaccurate prediction of their performance in vivo. In this review, the various calibration methods referenced in the literature are briefly described and the limitations of each discussed. The significance of these limitations is illustrated by reference to the results of published studies cited in a systematic review which report widely different values for the accuracy of one particular device, the Kikuhime pressure measuring system (ZiboCare, Denmark). The use of inappropriate calibration techniques therefore casts serious doubt upon the pressure values quoted historically in many published scientific and clinical studies in which these particular instruments have been employed. It is proposed that an international standard method be developed to ensure that all sensors intended for the measurement of sub-bandage pressure are characterised using a validated, clinically relevant technique. A programme of education is also required to correct some of the widely held misconceptions often expressed in the literature concerning the use of the Laplace equation to calculate sub-bandage pressure. [ABSTRACT FROM AUTHOR]

Congenital or acquired hand differences, including unilateral below-elbow deficiencies, present complex challenges in pediatric rehabilitation. Surgical management and prosthetic provision represent a big challenge to find a good balance for guaranteeing optimal hand function. There is no specific assessment tool for measuring these aspects in the Italian context. The present study investigates the psychometric properties of the ABILHAND-Kids in children with congenital unilateral below-elbow deficiencies and acquired amputation of the upper limb. We measure internal consistency using Cronbach coefficient alpha and the intraclass correlation coefficient (ICC) for measuring test-retest reliability. Differences in hand function in both children with acquired or congenital diseases were also investigated. Participants to the study were 107 (49 F and 58 M) children, with a mean (SD) age of 8.88 (4.25). For test retest reliability, conducted on a sub-sample of 58 children, the ICC was 0.92, while for internal consistency, the Cronbach coefficient alpha was 0.90. We did not find statistically significant differences in scoring (p = 0.33) in the use (mean 29.25 SD 6.58) or non-use of a prosthetic device (mean 30.74 SD 7.43), while statistically significant differences were found in hand function (p < 0.01) for children who had a congenital impairment (mean 31.87 SD 6.49) and children who had an acquired amputation (mean 27.77 SD 6.60). In conclusion, the ABILHAND-Kids showed good internal consistency and reliability and can capture differences in hand function in children with both congenital and acquired hand disorders. [ABSTRACT FROM AUTHOR]

Background: Transtibial prosthetic sockets are often grouped into patella tendon bearing (PTB) or total surface bearing (TSB) designs, but many variations in rectifications are used to apply these principles to an individual’s personalised socket. Prosthetists currently have little objective evidence to assist them as they make design choices. Aims: To compare rectifications made by experienced prosthetists across a range of patient demographics and limb shapes to improve understanding of socket design strategies. Methodology: 163 residual limb surface scans and corresponding CAD/CAM sockets were analysed for 134 randomly selected individuals in a UK prosthetics service. This included 142 PTB and 21 TSB designs. The limb and socket scans were compared to determine the location and size of rectifications. Rectifications were compiled for PTB and TSB designs, and associations between different rectification sizes were assessed using a variety of methods including linear regression, kernel density estimation (KDE) and a Naïve Bayes (NB) classification. Results: Differences in design features were apparent between PTB and TSB sockets, notably for paratibial carves, gross volume reduction and distal end elongation. However, socket designs varied across a spectrum, with most showing a hybrid of the PTB and TSB principles. Pairwise correlations were observed between the size of some rectifications (e.g., paratibial carves; fibular head build and gross volume reduction). Conversely, the patellar tendon carve depth was not associated significantly with any other rectification, indicating its relative design insensitivity. The Naïve Bayes classifier produced design patterns consistent with expert clinician practice. For example, subtle local rectifications were associated with a large volume reduction (i.e., a TSB-like design), whereas more substantial local rectifications (i.e., a PTB-like design) were associated with a low volume reduction. Clinical implications: This study demonstrates how we might learn from design records to support education and enhance evidence-based socket design. The method could be used to predict design features for newly presenting patients, based on categorisations of their limb shape and other demographics, implemented alongside expert clinical judgement as smart CAD/CAM design templates. [ABSTRACT FROM AUTHOR]

AbstractPurposeMethodsResultsConclusions\nIMPLICATIONS FOR REHABILITATIONEvaluate specific elements of previously proposed fall and near-fall definitions to determine whether they fully capture lower limb prosthesis (LLP) users’ lived experiences.Semi-structured interviews were conducted with 24 LLP users. Interview transcripts were reviewed, coded, and analyzed using deductive thematic analysis to identify shared experiences and inform revisions to previously reported definitions.Four major themes emerged: a fall can be initiated by more than just a loss of balance, loss of balance and losing balance are considered similar, falls are not limited to landing on the ground or floor, and catching yourself and recovering your balance are distinct responses to a loss of balance.Two revisions were made to previous definitions to better align with LLP users’ experiences and historically overlooked fall circumstances. A fall is defined as a loss of balance or sudden loss of support where your body lands on the ground, floor, or another object. A near-fall was defined as a loss of balance where you caught yourself or recovered your balance without landing on the ground, floor, or another object. Implementation of these new definitions will aid the collection of accurate, consistent, and meaningful fall data, enhancing aggregation and comparison across studies.Falls are a top health concern for lower limb prosthesis users.Understanding how lower limb prosthesis users experience falls helps build meaningful fall definitions.Standardized definitions allow clinicians to document fall events with greater consistency and justify fall prevention interventions.Falls are a top health concern for lower limb prosthesis users.Understanding how lower limb prosthesis users experience falls helps build meaningful fall definitions.Standardized definitions allow clinicians to document fall events with greater consistency and justify fall prevention interventions. [ABSTRACT FROM AUTHOR]

Introduction: There are numerous ways to transfer the alignment of a lower-limb prosthesis that have been used and adapted over the last several decades. The proposed glass tracing alignment method (GTAM) allows for a convenient and rapid transfer of prosthetic alignment in the coronal and sagittal planes with minimal equipment requirements. Objective: The aim of this article is to share a novel method for coronal and sagittal plane prosthetic alignment transfer, which may be done with minimal time, materials, and expense. Materials and Methods: Prosthetic alignment may be transferred in part or in whole by tracing the prosthesis in both the coronal and sagittal planes. The prosthesis must first be stabilized on a surface that allows for the prosthetic foot to be traced and is adjacent to a wall surface that allows for tracing of the prosthesis proximal to the foot. The line of progression (LOP) of the prosthesis should be parallel to the edge of the table it is traced upon and in a vertical orientation when tracing the entire prosthesis in the sagittal plane. When tracing the coronal plane alignment, the foot should be oriented vertically and placed in the LOP. Sagittal and coronal tracings should include as much of the prosthesis as possible to insure the most accurate alignment transfer of components. The GTAM was developed to be a clinical complement to traditional alignment transfer methods, which may include use a vertical or horizontal prosthetic alignment transfer jig. Results: Use of the described alignment tracing technique allows for the rapid alignment transfer of prosthetic componentry for a variety of applications. Conclusions: The GTAM proposed is an easy way for a busy practitioner to certify that alignment transfers have been performed correctly or to preserve alignment when replacing elements of a prosthesis for clinical and/or research applications. [ABSTRACT FROM AUTHOR]

Introduction: To choose a suitable prosthesis, clients need to experience both the weight and the control of a prosthesis. A few years ago, De Hoogstraat Rehabilitation Center developed the Xperience Prosthesis for children and adults with a transradial congenital or acquired limb deficiency. Because of the positive effects, we developed a reusable test prosthesis for the transhumeral level. Xperience Prosthesis Transhumeral is an innovative test prosthesis and an essential tool in managing expectations when providing clients with a suitable upper-limb prosthesis. Xperience Prosthesis Transhumeral is a 3D-printed, reusable adjustable socket system with a passive elbow unit and the possibility to fit and experience myoelectric, static, and passive terminal devices. Conclusions: Xperience Prosthesis Transhumeral is a practical and easy-to-handle tool for professionals. For clients, this tool is a unique way to experience the weight, function, and control of a prosthesis before making a final choice. [ABSTRACT FROM AUTHOR]

Introduction: Body-powered prostheses are still essential in practice. There are two types of mechanisms to manipulate bodypowered prostheses: voluntary closing (VC) and voluntary opening (VO). However, there are no studies investigating which is better suited for what type of movement in daily life. Materials and Methods: The participants were eight right-handed, able-bodied adults. They were divided into two groups: a VC-to-VO group, in which the VC type was practiced first and then the VO type, and a VO-to-VC group, in which they practiced in the opposite order. VC/VO-type terminal device (EquiluxTM) was attached to a body-powered prosthesis simulator for the left hand, and the Southampton Hand Assessment Procedure (SHAP) tasks were practiced repeatedly. We compared the VC type and VO type for the number of practices to reach a plateau, Index of Functionality (IOF) score, the six prehensile pattern scores, and the time required for the 26 SHAP tasks. Scores were also compared before and after practice. In addition, changes in IOF and scores for each of the six patterns with proficiency were compared between VC type and VO type. Results: Significant improvements were observed with manipulation practice for both types of devices. The mean SHAP scores at the plateau were 82.6 for VO type and 92.0 for VC type, with VC type significantly higher than VO type. In the six prehensile pattern scores, only two patterns, Tripod and Power, showed significant differences. When comparing the time required, Food Cutting task was an exception and significantly faster in the VC type, while there were no significant differences for the other tasks. Conclusions: It was suggested that the VC type is more suitable for tasks requiring grip strength [ABSTRACT FROM AUTHOR]

Problem Statement: Despite the recent advancements in technology, many individuals with upper-limb loss struggle to achieve stable control over multiple degrees of freedom in a prosthesis. There is an ongoing need to develop noninvasive prosthesis control modalities that could improve functional patient outcomes. Proposed Solution: Ultrasound-based sensing of muscle deformation, known as sonomyography, is an emerging sensing modality for upper-limb prosthesis control with the potential to significantly improve functionality. Sonomyography enables spatiotemporal characterization of both superficial and deep muscle activity, making it possible to distinguish the contributions of individual muscles during functional movements and derive a large set of independent prosthesis control signals. Using sonomyography to control a prosthesis has shown great promise in the research literature but has not yet been fully adapted for clinical use. This article describes the implementation of sonomyography for upper-limb prosthesis control, ongoing technological development, considerations for deploying this technology in clinical settings, and recommendations for future study. [ABSTRACT FROM AUTHOR]

Introduction: In a hand laterality judgment task, participants determine whether rotated images depict a left or a right hand. It is believed that people use motor imagery (imagining their own body moving) to complete this task. This is evidenced by a biomechanical constraints effect (BCE), whereby people take longer to respond to hands shown at biologically awkward angles. It is unknown whether this extends to artificial hands. This study investigated whether prosthetic hands are processed differently when mentally manipulated, potentially due to their perceived eeriness. Materials and Methods: In two online studies, participants completed a hand laterality judgment task containing real and artificial hands (realistic and mechanical prosthetics). Results: All three hand types produced a BCE, evidencing motor imagery, although this was weaker in mechanical hands. Reaction time and slope (effect of angular rotation on reaction time) also varied between the hand types. Conclusions: Our findings indicate that people use motor imagery to process artificial hands, although possible differences in processing between the hands should be followed up [ABSTRACT FROM AUTHOR]

Introduction: Upper-limb prostheses have undergone substantial technological improvements in the last two decades, but user complaints and abandonment rates have hardly changed. This may follow from the use of laboratory-based tests when assessing new technology instead of measuring prosthesis use in at-home situations. Serious games might be used to assess prosthesis use at home. Objectives: The aim of this study was to assess the feasibility, validity, and reliability of using serious games to measure myocontrol in at-home situations. Study Design: The design of this study is a cohort study with repeated measurements. Methods: All 10 participants (five males; seven transradial and three transhumeral defects) used pattern recognition (PR) to control their prosthesis. Two serious games were included in the PR software: Simon Says and In-The-Zone. Participants were instructed to use their prosthesis as they normally would for 2 weeks with the additional instruction to play at least 18 serious games (±90 minutes in total). Outcome measures for aspects of prosthesis use were wear time, months of prosthesis use, and user experiences, and serious games outcomes were success rate and completion time. Results: For feasibility, all but one participant completed the minimum of 18 games, and user experiences were mostly positive. For validity, no relationships were found between the aspects of prosthesis use and performance in the serious games. For reliability, testretest reliability for success rate was high (intraclass correlation [ICC], 0.79), but low for completion time (ICC, 0.18) in both games. Conclusions: Feasibility and reliability of using serious games as an assessment instrument for prosthesis control in at-home situations appeared to be good; however, validity could not be established. The serious games should be improved to increase validity. Furthermore, more outcome measures that reveal aspects of prosthesis use should be considered. [ABSTRACT FROM AUTHOR]

To describe admission and discharge characteristics of participants admitted to prosthetic rehabilitation following a lower limb amputation and determine changes in participant characteristics including if the population has gotten older over time at admission. A retrospective chart audit of consecutive admissions to an amputee rehabilitation program. Study criteria were transtibial level LLA and above and ≥ 18 years old. Admission characteristics included: age, Montreal Cognitive Assessment (MoCA), Functional Comorbidity Index (FCI) and days between amputation surgery and admission. Discharge characteristics included the L -Test of Functional Mobility (L-Test), 2-Minute Walk Test (2MWT), 6-Minute Walk Test (6MWT), and Activities-specific Balance Confidence (ABC) scale. Multivariable linear regression modelling quantified the association between participant characteristics and admission time. A total of 601 participants (62.3 ± 14.1 years) were included, 63 were (84.9 ± 3.7 years) aged 80 and over. FCI scores [β = 70.34, (95% CI: 20.93, 119.74), p = 0.005] and days between amputation surgery [β = −0.08, (95% CI: −0.13, −0.02), p = 0.011] were independently associated with admission time. People with an LLA are presenting with a higher number of comorbidities at admission over time while being admitted faster from amputation surgery. Future research should investigate the impact of these changing characteristics on rehabilitation outcomes to better assist this population. It is expected that the rate of inpatient prosthetic rehabilitation admissions due to lower limb amputations will increase amongst those over eighty. An analysis of participant characteristics of people admitted to inpatient prosthetic rehabilitation over time will inform modification and developments to future programs. Future prosthetic rehabilitation programs should consider an increased number of comorbidities when developing prognostic expectations for participants. A shortened interval between amputation surgery and admission should be considered when developing prosthetic rehabilitation programs. [ABSTRACT FROM AUTHOR]

This article addresses products from leading foreign manufacturers of upper limb prostheses with bioelectric control. These were analyzed and compared in terms of the following parameters: method of control, numbers of degrees of freedom and microdrives, method of adduction and abduction of the thumb, type of the wrist joint, use of feedback, and number and types of grip. The study results identified common key parameters characteristic of devices in demand in the current prosthetics and orthopedic equipment market. [ABSTRACT FROM AUTHOR]

Background: Although mechanical properties of running specific prostheses (RSPs) can affect running performance, manufacturers do not consistently report them. This study aimed to review existing literature on RSP mechanical and structural properties and their relationship with running performance. Methods: A comprehensive search was conducted using keywords related to mechanical properties of RSPs and running performance. Search terms included stiffness and hysteresis, as well as performance outcomes including metabolic cost and running speed. Non-peer-reviewed and non-English publications were excluded. Results: Twenty articles were included in the review. Sixteen studies used a material testing machine to measure RSP material properties, and four articles used other techniques including 2D/3D video capture and force platforms. Both measurement techniques and reporting of outcomes were inconsistent, which limits the ability to draw broad conclusions. Additionally, several studies did not report the numerical data for material properties despite measuring them. Relatively few articles measured both material properties and running performance and assessed correlations. Conclusion: Several articles connected prosthesis properties to running performance. However, inconsistent measurement and reporting of mechanical properties, along with the multifactorial nature of the athlete-prosthesis system, limit the ability to draw broad conclusions regarding the relationship between material and structural properties and athlete performance. Current evidence may be useful for clinicians seeking ways to optimize RSP stiffness in a case-by-case basis; however, clinicians would benefit from more consistent and systematic comparisons of the attributes of different RSPs and their role in performance. [ABSTRACT FROM AUTHOR]

For those with upper limb absence, body-powered prostheses continue to be popular for many activities despite being an old technology; these devices can provide both inherent haptic feedback and mechanical robustness. Yet, they can also result in strain and fatigue. Body-powered prosthetic graspers typically consist of a simple lever providing a relatively constant transmission ratio between the input forces from the user's shoulder harness and the grip force of their prosthetic prehensor. In the field of robotic hand design, new continuously varying transmissions demonstrate particular promise in generating a wide range of grasping speeds without sacrificing grip strength. These benefits, if applied to shoulder-driven prosthetic grippers, have the potential to both reduce shoulder exertion and fatigue. This work presents the integration of a continuously variable transmission into a body-powered, voluntary close prosthetic testbed. We introduce the design and validate its performance in a benchtop experiment. We compare constant transmission conditions with a force-dependent, continually varying condition. The device is mounted on a prosthetic emulator for a preliminary wearable demonstration.

Research addressing lower limb amputee gait and prosthetic design often focuses on men, despite female lower limb amputees having different risk factors and lower success with their prosthetics overall. It is widely agreed that sex differences exist in able-bodied gait, but research analyzing sex differences in amputee gait is rare. This study compared male and female transtibial amputee gait to ascertain potential sex differences. Forty-five transtibial amputees were asked to walk at their self-selected speed, and spatiotemporal gait data were obtained. Both the mean and variability metric of parameters were analyzed for 10 male and 10 female participants. For all participants, amputated limbs had a shorter stance time, longer swing time, and larger step length. Females had a 10% shorter stance time and 26% larger normalized step and stride length than males. Female participants also walked over 20% faster than male participants. Finally, significant interactions were found in the mean and variability metric of stride velocity, indicating greater variability in women. These findings suggest that sex differences exist in transtibial amputee gait, offering possible explanations for the different comorbidities experienced by female lower limb amputees. These results have major implications for female amputees and for sex-specific research, rehabilitation, and prosthetic design. [ABSTRACT FROM AUTHOR]

AbstractMedical devices are manmade objects existing at the interface between numerous disciplines. They range from as simple as medical gloves to as complex as artificial limbs. This versatility of medical devices and their inherent interdisciplinary nature means that academic courses on them are attended by cohorts of students from varieties of academic backgrounds, who bring with them similarly broad spectra of interests. To satisfy the learning expectations of each and every student in such diverse classes is a daunting task for the instructor. After many years of teaching medical devices at undergraduate and graduate levels at three different universities in the states of Illinois and California, I have come up with an instructional method that solves this challenge by engaging students in the co-creation of the curriculum via selection of their own medical devices of interest and presentation to the class for collective analysis. The threefold presentations are designed so that they reflect an ascent along the hierarchy of a learning taxonomy extending from foundational concepts to critical assessment of knowledge to creative displays of it. In such a way, the students are acquainted with the ability of critical and creative thinking at the expense of rote memorization or inculcation and are prepared to enter the field of medical devices as innovation-centered individuals. The specifics of this new method of instruction are reported here, with the hope that they will be useful to fellow instructors in any interdisciplinary course that benefits from a balance between the rigorous coverage of the instructional material pertaining to engineering and medicine and the flexible selection of topics that comply with students’ individual interests. [ABSTRACT FROM AUTHOR]

OBJECTIVE: This study aimed to identify clinical measures that have been used to evaluate function, health related quality of life (HRQoL), and/or satisfaction in children who use lower limb prostheses (LLP). The data reported on psychometric properties for children who use LLP were collected for each measure. METHODS: First, PubMed, CINAHL, and Web of Science databases were searched using broad search terms to identify standardized outcome measures of function, HRQoL, and/or satisfaction with treatment used in pediatric LLP research published in 2001 or after. For each of the eligible measures found, a second search was performed to identify psychometric properties (e.g., validity, reliability) assessed with children who use LLP. RESULTS: Forty-four standardized outcome measures were identified from 41 pediatric LLP research articles. Five measures (i.e., Gait Outcomes Assessment for Lower Limb Differences, Functional Mobility Assessment, Child Amputee Prosthetics Project- Prosthesis Satisfaction Inventory, Child Amputee Prosthetics Project- Functional Scale Index, and Lower Limb Function Questionnaire) had data on psychometric properties for children who use LLP. CONCLUSIONS: Few studies report psychometric data for assessing the overall HRQoL, function, and/or satisfaction for children who use LLP. Further research is needed to validate or create new outcome measures that assess the HRQoL, satisfaction, and/or function of children who use LLP. [ABSTRACT FROM AUTHOR]

Prosthetic socket manufacturing is experiencing a revolutionary shift towards using digital methods, such as 3D scanning and 3D printing. However, using digital methods requires the clinician to transfer their skills from making sockets by hand to making sockets with a computer. This shift in practice may change the socket geometry and fit; however, to what extent is unknown. Thus, the aim of this study was to explore the feasibility of analyzing geometric and clinical differences between digitally- and manually-designed sockets. Nine adult inpatients with below-knee amputation were recruited. Two sockets were 3D printed for each participant from 3D socket models that were developed from: (1) 3D scanning a manually-modified hand-casted positive mold of the residuum; and (2) a digitally-modified 3D scan of the residuum. Manual and digital procedures were compared for three measures: final socket geometry, the Socket Comfort Score, and a patient experience survey. Feasibility data were collected to measure protocol implementation fidelity to inform a future larger study. These data revealed that 89% of participants followed the intended protocol, no participants dropped out, and only one adverse event was report. As no significant geometric differences were found and participants experienced similar comfort scores between manually- and digitally-designed sockets, study feasibility was determined to be successful. Thus, a randomized control trial study will be conducted to draw statistically relevant conclusions from these outcome measures that may provide meaningful information for improving digital design procedures. [ABSTRACT FROM AUTHOR]

The demand for affordable prostheses, particularly in low- and middle-income countries (LMICs), is significant. Currently, the majority of prosthetic sockets are manufactured using monolithic thermoplastic polymers such as PP (polypropylene), which lack durability, strength, and exhibit creep. Alternatively, they are reinforced with consumptive thermoset resin and expensive composite fillers such as carbon, glass, or Kevlar fibres. However, there are unmet needs that amputees face in obtaining affordable prosthetic sockets, demanding a solution. This study utilises self-reinforced PET (polyethylene terephthalate), an affordable and sustainable composite material, to produce custom-made sockets. Advancing the development of a unique socket manufacturing technique employing a reusable vacuum bag and a purpose-built curing oven, we tested fabricated sockets for maximum strength. Subsequently, a prosthetic device was created and assessed for its performance during ambulation. The mechanical and structural strength of PET materials for sockets reached a maximum strength of 132 MPa and 5686 N. Findings indicate that the material has the potential to serve as a viable substitute for manufacturing functional sockets. Additionally, TOPSIS analysis was conducted to compare the performance index of sockets, considering decision criteria such as material cost, socket weight, and strength. The results showed that PET sockets outperformed other materials in affordability, durability, and strength. The methodology successfully fabricated complex-shaped patient sockets in under two hours. Additionally, walking tests demonstrated that amputees could perform daily activities without interruptions. This research makes significant progress towards realising affordable prostheses for LMICs, aiming to provide patient-specific affordable prostheses tailored for LMICs. [ABSTRACT FROM AUTHOR]

AbstractPurposeMaterials and methodsResultsConclusions\nIMPLICATIONS FOR REHABILITATIONIn this study, we sought to examine how lower limb prosthesis users define success, what constructs they associate with success, and what barriers and facilitators contribute to achieving success.Purposively sampled lower limb prosthesis users were recruited to participate in a focus group study. Verbatim transcripts from focus groups were analyzed using inductive thematic analysis. Identified constructs were mapped to existing outcome measures, and a conceptual framework for success with a lower limb prosthesis was proposed.Thirty-one lower limb prosthesis users participated in one of five focus groups. Five themes were developed: keep moving forward, despite ups and downs; being able to live MY normal life and do the things I want to do with ease; learning what works for me and how to manage my prosthesis; only I can define my success; and what about my mental health? Several constructs that do not align with existing measures were identified, including prosthetic attention, grief/loss after amputation, and trust in prosthesis. Facilitators for success described by participants included peer connection, finding the right prosthetist, and mental health support.According to lower limb prosthesis users, success must be patient-driven, individually defined, and continually reassessed.According to prosthesis users, success with a lower limb prosthesis should be patient-driven, individually defined, and continually reassessed.Lower limb prosthesis users described facilitators for success to include peer connection, finding the right prosthetist, mental health support, and access to appropriate prosthetic technology.Constructs described by lower limb prosthesis users as relating to success that are currently difficult to measure include prosthetic attention, grief/loss after amputation, prosthesis management, ability to blend in, and trust in the prosthesis.According to prosthesis users, success with a lower limb prosthesis should be patient-driven, individually defined, and continually reassessed.Lower limb prosthesis users described facilitators for success to include peer connection, finding the right prosthetist, mental health support, and access to appropriate prosthetic technology.Constructs described by lower limb prosthesis users as relating to success that are currently difficult to measure include prosthetic attention, grief/loss after amputation, prosthesis management, ability to blend in, and trust in the prosthesis. [ABSTRACT FROM AUTHOR]

Introduction: Bilateral microprocessor-controlled prosthetic knee (MPK) users have unique needs in traversing environmental barriers compared to unilateral users. An enhancement to the GeniumTM/Genium X3TM MPK which included an updated ruleset, hydraulics, and new bilateral parameter presets was made to improve safety while stumbling and the smoothness of gait for all users while also improving the experience of bilateral users. The purpose of the study was to evaluate the effectiveness of the enhancements in a sample with unilateral and bilateral amputation. Methods: A convenience sample of MPK users was recruited from two sites in the USA in two phases. Assessments included the L-Test of Functional Mobility, Activity-specific Balance Confidence Scale, Prosthetic Limb User Survey of Mobility, a study-specific questionnaire, and the Comparative Activities of Daily Living (ADL) Questionnaire. Statistical significance of extracted data was tested with the Wilcoxon Rank-Sum Test for independent data and Wilcoxon Signed-Rank for paired data with an a priori significance level of p < 0.05. Unilateral subjects were age-matched to the group of bilateral subjects for between-groups and within-groups analyses. Results: Twenty-six subjects (n = 26) were enrolled. Stumble frequency reduced 85% from 16.0 ± 39.7 to 2.4 ± 2.3 (p = 0.008) between baseline and final assessment overall. The bilateral group reported 50% (p = 0.009) and 57% (p = 0.009) greater relative improvement in patient-reported ease and safety, respectively, of completing ADLs compared to the unilateral group. The unilateral group reported residual limb pain and low back pain reduced from 2.3 to 1.4 (p = 0.020) and 3.8 to 1.8 (p = 0.027), respectively, whereas the bilateral group did not. Discussion: Substantial reductions in stumbles, residual limb pain, and back pain were shown overall. These reductions were driven by the unilateral group who also showed improvements in comfort, exertion, and concentration while walking. The enhancements to the knee likely reduced some gait asymmetry for unilateral users. Improvements in patient-reported ease and safety of completing ADLs were shown overall and were driven by the bilateral group. This study shows further improvement in patient experience is achievable through innovation in MPK technology even for patients who appear to be functioning well. [ABSTRACT FROM AUTHOR]

There are no reports in the literature of powerlifting success after amputation. We had the unique opportunity to characterize functional outcomes, strength, muscle contractility and size, and corticospinal excitability in an accomplished, competitive powerlifter (best competition squat = 205.0 kg, deadlift = 262.7 kg) with a unilateral, transtibial amputation relative to amputee controls. Four men (age range = 23-49 years) with unilateral, lower-limb amputation (3 transtibial, 1 transfemoral) participated in 1 laboratory visit. We assessed 10-m gait speed, the timed up and go (TUG) test, 5-time sit-to-stand performance (5TSTS), contractile properties of the vastus lateralis (VL) and medial gastrocnemius by tensiomyography, and VL cross-sectional area (CSA) by ultrasonography. Unilateral assessments for the intact limb included isokinetic knee extension and flexion torque and power and transcranial magnetic stimulation derived corticospinal excitability. An interview with the powerlifter provided contextual perspective. Compared with the control subjects, the powerlifter performed the 5TSTS faster (6.8%), exhibited faster VL contraction times (intact limb = 12.2%; residual limb = 23.9%), and showed larger VL CSA for the intact limb (46.7%). The powerlifter exhibited greater knee extension and flexion peak torque and mean power, particularly at 180°·s -1, as well as greater corticospinal excitability for the intact VL (65.6%) and tibialis anterior (79.6%). By contrast, the control subjects were faster in the TUG (18.3%) and comfortable (13.0%) and fast (21.4%) in the 10-m walk test. The major themes of our interview included needing to modify lifting mechanics, persistence, and remarkable pain tolerance. Our findings highlight the impressive neuromuscular adaptations that are attainable after lower-limb amputation. [ABSTRACT FROM AUTHOR]

As United States healthcare transitions from traditional fee-for-service models to value-based care, there is increased need to demonstrate quality care through clinical outcomes. Therefore, the purpose of this study was to create equations to calculate an expected mobility score for lower limb prosthesis users specific to their age, etiology, and amputation level to provide benchmarks to qualify good outcomes. A retrospective cross-sectional analysis of outcomes collected during clinical care was performed. Individuals were grouped based on amputation level (unilateral above-knee (AKA) or below-knee (BKA)) and etiology (trauma or diabetes/dysvascular (DV)). The mean mobility score (PLUS-M® T-score) for each year of age was calculated. AKAs were further stratified into having a microprocessor knee (MPK) or non-microprocessor (nMPK) for secondary analysis. As expected, average prosthetic mobility declined with age. Overall, BKAs had higher PLUS-M T-scores compared to AKAs and trauma etiologies had higher scores compared to DV. For AKAs, those with a MPK had higher T-scores compared to those with a nMPK. Results from this study provide average mobility for adult patients across every year of life. This can be leveraged to create a mobility adjustment factor to qualify good outcomes in lower limb prosthetic care. Normative values of mobility are needed to qualify good outcomes in prosthetic care as healthcare shifts towards value-based care. Understanding where an individual is relative to others with similar characteristics (e.g., age, etiology, gender, amputation level, and device type) can provide clinicians with better benchmarks for individual goal-setting. The ability to generate predicted mobility scores specific to each individual can create a mobility adjustment factor to better qualify good outcomes. [ABSTRACT FROM AUTHOR]

The main objective of this article is to review the current state of the market for bioelectrically controlled upper limb prostheses in the Russian Federation. National standards and legislative norms relating to prosthetics are reviewed, the procedure for obtaining a prosthesis is described step by step, taking into account various methods of payment and recompense, and the products of the leading manufacturers of bioprostheses in Russia are reviewed from the point of view of functionality and management principles. The study results led to conclusions regarding the competitiveness of bionic devices and their availability in the domestic market. [ABSTRACT FROM AUTHOR]

We present here a robotic man-machine system consisting of a bionic hand prosthesis and a force application module which supports the use of tactile feedback to increase the convenience and efficiency of the prosthesis. The structure and operating algorithm of the control system, built using an artificial neural network and providing the prosthesis with controlled movement and force sensation, are also presented. [ABSTRACT FROM AUTHOR]

Purpose: The multistep journey to prosthetic device-enabled functioning following amputation requires a structured approach for optimal care delivery, but such program structures and outcomes are inadequately characterized. The study is responsive by describing an implementation framework for lower limb loss rehabilitation and evaluating its utility. Materials and methods: The lower limb loss rehabilitation continuum framework (LLRC) was developed using literature-based continuum of care and amputation phase concepts as well as input from limb loss rehabilitation stakeholders. LLRC structure includes five sequential steps (Postsurgical Stabilization (PS), Preprosthetic Rehabilitation (PPR), Limb Healing and Maturation (LHM), Prosthetic Fitting (PF), Prosthetic Rehabilitation (PR)) between six touchpoints of patient-healthcare interaction (Surgery, Preprosthetic Rehabilitation Admission and Discharge, Functioning Evaluation and Prescription, Prosthetic Rehabilitation Admission and Discharge). The utility of this framework was evaluated through LLRC program implementation in a semiurban US setting and program functioning and process outcomes assessment from an IRB-approved, retrospective observational study about patients with unilateral lower-limb amputations completing this program. Results: Program functional (FIM gain; efficiency) scores were greater for PPR(32.6(8);3.1) compared with PR(24.3(8.5);3.8). Program completion duration was 149.7(63.4) days. LHM(75.8(58.5) days) and PF(51.4(24.3) days) were the longest steps. PR duration was significantly longer(p = 0.033) for the transfemoral level. Conclusion: The LLRC framework is useful for the design and implementation of structured limb loss rehabilitation programs. The lower limb-loss rehabilitation continuum (LLRC) is a novel implementation framework with a five-step structure from limb loss to completion of prosthetic rehabilitation between six touchpoints of patient-healthcare interaction, with standardized terminology and baseline and outcome metrics. The utility of the program was demonstrated by successful program development in a suburban health setting and actionable process outcomes and superior functioning outcomes compared with literature. The LLRC can be adapted by health systems, institutions, and care providers for program development. Programs can expect high FIM gains and efficiency for Preprosthetic rehabilitation and Prosthetic rehabilitation steps. With an LLRC completion time of 5 months, long Limb healing and maturation and Prosthetic fitting steps present areas of opportunity for improvement. [ABSTRACT FROM AUTHOR]

Introduction: Despite recent technological advances that have led to sophisticated bionic prostheses, attaining embodied solutions still remains a challenge. Recently, the investigation of prosthetic embodiment has become a topic of interest in the research community, which deals with enhancing the perception of artificial limbs as part of users' own body. Surface electromyography (sEMG) interfaces have emerged as a promising technology for enhancing upper-limb prosthetic control. However, little is known about the impact of these sEMG interfaces on users' experience regarding embodiment and their interaction with different functional levels. Methods: To investigate this aspect, a comparison is conducted among sEMG configurations with different number of sensors (4 and 16 channels) and different time delay. We used a regression algorithm to simultaneously control hand closing/opening and forearm pronation/supination in an immersive virtual reality environment. The experimental evaluation includes 24 able-bodied subjects and one prosthesis user. We assess functionality with the Target Achievement Control test, and the sense of embodiment with a metric for the users perception of self-location, together with a standard survey. Results: Among the four tested conditions, results proved a higher subjective embodiment when participants used sEMG interfaces employing an increased number of sensors. Regarding functionality, significant improvement over time is observed in the same conditions, independently of the time delay implemented. Conclusions: Our work indicates that a sufficient number of sEMG sensors improves both, functional and subjective embodiment outcomes. This prompts discussion regarding the potential relationship between these two aspects present in bionic integration. Similar embodiment outcomes are observed in the prosthesis user, showing also differences due to the time delay, and demonstrating the influence of sEMG interfaces on the sense of agency. [ABSTRACT FROM AUTHOR]

Introduction: The intact foot and ankle comprise a complex set of joints that allow rotation in multiple planes of motion. Some of these motions are coupled, meaning rotation in one plane induces motion in another. One such coupling is between the sagittal and transverse planes. For every step, plantarand dorsi-flexion motion is coupled with external and internal rotation of the shank relative to the foot, respectively. There is no prosthetic foot available for prescription that mimics this natural coupling. The purpose of this study was to determine if a sagittal:transverse ankle angle coupling ratio exists that minimizes the peak transverse plane moment during prosthetic limb stance. Methods: A novel, torsionally active prosthesis (TAP) was used to couple sagittal and transverse plane motions using a 60-watt motor. An embedded controller generated transverse plane rotation trajectories proportional to sagittal plane ankle angles corresponding to sagittal:transverse coupling ratios of 1:0 (rigid coupling analogous to the standard-of-care), 6:1, 4:1, 3:1, and 2:1. Individuals with unilateral transtibial amputation were block randomized to walk in a straight line and in both directions around a 2 m circle at their self-selected speed with the TAP set at randomized coupling ratios. The primary outcome was the peak transverse plane moment, normalized to body mass, during prosthetic limb stance. Secondary outcomes included gait biomechanic metrics and a measure of satisfaction. Results: Eleven individuals with unilateral transtibial amputations participated in the study. The 6:1 coupling ratio resulted in reduced peak transverse plane moments in pairwise comparisons with 3:1 and 2:1 coupling ratios while walking in a straight line and with the prosthesis on the outside of the circle (p < .05). Coupling ratio had no effect on gait biomechanic metrics or satisfaction. Discussion: The general pattern of results suggests a quadratic relationship between the peak transverse plane moment and coupling ratio with a minimum at the 6:1 coupling ratio. The coupling ratio did not appear to adversely affect propulsion or body support. Subjects indicated they found all coupling ratios to be comfortable. While a mechatronic prosthesis like the TAP may have limited commercial potential, our future work includes testing a robust, passive prosthetic foot with a fixed coupling ratio. [ABSTRACT FROM AUTHOR]

Introduction: Bone-anchored prostheses (BAP) are an advanced reconstructive surgical approach for individuals who had transfemoral amputation and are unable to use the conventional socket-suspension systems for their prostheses. Access to this technology has been limited in part due to the lag between the start of a new procedure and the availability of evidence that is required before making decisions about widespread provision. This systematic review presents as a single resource up-to-date information on aspects most relevant to decision makers, i.e., clinical efficacy, safety parameters, patient experiences, and health economic outcomes of this technology. Methods: A systematic search of the literature was conducted by an information specialist in PubMed, MEDLINE, Embase, CINAHL, Cochrane Library, the Core Collection of Web of Science, CADTH's Grey Matters, and Google Scholar up until May 31, 2023. Peer-reviewed original research articles on the outcomes of clinical effectiveness (health-related quality of life, mobility, and prosthesis usage), complications and adverse events, patient experiences, and health economic outcomes were included. The quality of the studies was assessed using the Oxford Centre for Evidence-Based Medicine Levels of Evidence and ROBINS-I, as appropriate. Results: Fifty studies met the inclusion criteria, of which 12 were excluded. Thirty-eight studies were finally included in this review, of which 21 reported on clinical outcomes and complications, 9 case series and 1 cohort study focused specifically on complications and adverse events, and 2 and 5 qualitative studies reported on patient experience and health economic assessments, respectively. The most common study design is a single-arm trial (pre-/post-intervention design) with varying lengths of follow-up. Discussion: The clinical efficacy of this technology is evident in selected populations. Overall, patients reported increased health-related quality of life, mobility, and prosthesis usage post-intervention. The most common complication is a superficial or soft-tissue infection, and more serious complications are rare. Patient-reported experiences have generally been positive. Evidence indicates that bone-anchored implants for prosthesis fixation are cost-effective for those individuals who face significant challenges in using socket-suspension systems, although they may offer no additional advantage to those who are functioning well with their socket-suspended prostheses. [ABSTRACT FROM AUTHOR]

Background: This video article describes the use of bone-anchored prostheses for patients with transtibial amputations, most often resulting from trauma, infection, or dysvascular disease. Large studies have shown that about half of all patients with a socket-suspended artificial limb experience limited mobility and limited prosthesis use because of socket-related problems. These problems occur at the socket-residual limb interface as a result of a painful and unstable connection, leading to an asymmetrical gait and subsequent pelvic and back pain. In almost all of these cases, a bone-anchored prosthesis may result in substantial improvements in mobility and quality of life. Description: This technique is preferably performed in a single-stage procedure. Preoperative implant planning is imperative when designing the custom-made implant. These images should be visible on screen in the operating room throughout the procedure to guide the surgeon. The patient is positioned with the knee on a silicone cushion. The planned soft-tissue resection is marked, after which the resection of all layers is performed, including large nerves and neuromas, with high cuts performed under traction. Exposure of the residual bone following revision osteotomy is carried out according to the design. The medullary canal is prepared and perpendicular cutting of the tibial and fibular remnant are performed, with the latter cut at a level 1 to 2 cm higher than the former. The intramedullary component is inserted under fluoroscopic guidance, after which the distal end of the tibia is prepared utilizing the typical drop shape. Two transverse locking screws are inserted with the standard "freehand" technique. The soft tissues are contoured and closed over the implant, after which the stoma is created and the dual cone is mounted. Finally, pressure bandages are applied, and postoperative imaging is performed. After the surgical procedure, most patients stay 1 or 2 nights in the hospital, depending on the magnitude of the surgery (e.g., bilateral implantation of a bone-anchored implant) and the patient's comorbidities. Alternatives: Simultaneous major leg amputation and bone-anchored prosthesis implantation is not advocated as treatment. First, a rehabilitation program with a socket-suspended prosthesis should be completed before patients can apply for a bone-anchored prosthesis. After rehabilitation, satisfaction with a prosthetic socket may be adequate, thereby not indicating the need for a bone-anchored prosthesis. Contraindications for bone-anchored implant surgery include severe diabetes (with complications), severe bone deformity, immature bones, bone diseases (i.e., chronic infection or metastasis), current chemotherapy, severe vascular diseases, pain without a clear cause, obesity (body mass index >30 kg/m2), and smoking. Rationale: Approximately half of patients who undergo a major lower-limb amputation are able to utilize an artificial leg acceptably well with a socket-suspended prosthesis. However, the other half of patients experience limitations resulting in reduced prosthesis use, mobility, and quality of life. Limb-to-prosthesis energy transfer is poor because of the so-called "pseudojoint" (i.e., the soft-tissue interface), and gross mechanical malalignment is common. Furthermore, transtibial amputees may experience irritation from pistoning and suction at the residual limb-socket interface. These issues result in skin problems and difficulties with socket fit because of fluctuation in the size of the residual limb size, resulting in a decrease in overall satisfaction and confidence in mobility. An osseointegration implant creates a direct skeletal connection between the residual limb and artificial leg, in which energy transfer is optimal and mechanical alignment is radically improved. Expected Outcomes: In an unpublished prospective study performed at our center with a 5-year follow-up, a total of 21 patients with a transtibial amputation received a titanium tibial osseointegration implant with additional proximal transverse locking screw fixation for primary stability. Most patients were male (71%), had a traumatic amputation (67%), and underwent a 2-stage surgical procedure (64%). Prosthesis wearing time was measured with use of the Questionnaire for Persons with a Transfemoral Amputation (Q-TFA) Prosthetic Use Score (PUS), and health-related quality of life was measured using the Q-TFA Global Score (GS). Both measurements improved significantly comparing preoperative baseline values using a socket-suspended prosthesis to all follow-up moments after bone-anchored prosthesis treatment: Q-TFA PUS baseline 53, 6-month 90, 1-year 88, 2-years 91, 5-years 89; Q-TFA GS baseline 38, 6-month 71, 1-year 80, 2-year 77, 5-year 78. The third question of the Global Score was separately assessed. This question asks, "How would you summarize your overall situation as an amputee?" A clear tendency for improvement was observed as 43% stated their situation to be "extremely poor" or "poor" at baseline, while only 19% stated their situation to be "good" or "extremely good", which changed at 5-year follow-up to 6% stating the situation to be "poor" and 94% stating the situation to be "good" or "extremely good". An implant survival of 95.5% was achieved at 5-year follow-up. One individual experienced progressive septic implant loosening resulting in a through-knee amputation. The individual had undergone primary transtibial amputation due to dysvascular problems, and preoperative duplex ultrasonography had shown no signs of aortoiliac occlusive disease. However, repeat examination displayed dysvascular disease progression, with the patient admitting having refrained from nicotine cessation. No bone infection, periprosthetic fracture, intramedullary stem breakage, or aseptic loosening occurred. Nine individuals experienced 12 events of low-grade soft-tissue infections all successfully treated with oral antibiotics. Nine individuals also experienced 12 events of high-grade soft-tissue infections, successfully treated with oral antibiotics 8 times, and requiring parenteral antibiotics or surgical treatment in 1 and 3 cases, respectively. This resulted in an infection/implant-year used ratio of 0.24. Hypergranulation tissue and stoma tissue redundancy occurred 2 and 4 times, respectively. We concluded that the mid-term results of this type of treatment were acceptable, especially in patients with nonvascular amputations. Since 2020, we have performed the surgery using a single-stage procedure as the standard choice, based on cost and convenience factors, and the results seem to be no different from our previous 2-stage strategy (unpublished data). Important Tips: Preoperative implant planning: the procedure should be guided by comprehensive surgical instructions and use a custom-made implant design, with the aim of performing the procedure in a single stage. Patient positioning and setup: a knee cushion support may be beneficial. Soft-tissue marking: plan the resection area liberally, and plan the stoma anterior to the surgical approach (if not possible, directly in the wound). Soft-tissue correction and exposure of residual bone: liberally resect soft-tissue redundancy. Revision osteotomy with guided shortening: utilize water-cooled power sawing. Medullary canal preparation and the perpendicular osteotomy plane: use fluoroscopy to guide drilling. Insertion of the intramedullary component: in case of little resistance, use bone morphogenetic protein-2 (InductOs; Medtronic) and bone impaction grafting for augmentation. Use transverse locking screws for primary stabilization of the implant Soft-tissue contouring and closure: do not close the muscle fascia over the implant. Aperture creation and dual-cone insertion: perform a 2-stage procedure only in cases with bone reconstruction, with the second stage performed after a 10 to 12-week interval. Bandage: leave the bandage applied for 48 hours. Postoperative imaging and follow-up: our institutional follow-up schedule is 6 months, then 1, 2, 5, and 10 years postoperatively. Introduction rehabilitation protocol: The standard program is 4 weeks and starts 3 weeks after a single-stage surgery. Patients may fully load the prosthesis at the start of the rehabilitation, provided the pain score does not exceed a 5 on a scale from 0 to 10. Rehabilitation: make videos to compare patient mobility at postoperative time points and to assess progression. Results and conclusions: implant loosening is rare, and soft-tissue infections typically occur often in the first 2 years and require nonoperative treatment. Acronyms and Abbreviations: BAP = bone-anchored prosthesis BMI = body mass index CT = computed tomography OTI = osseointegration tibia implant K-wire = Kirschner wire DCA = dual-cone adapter BIG = bone impaction grafting [ABSTRACT FROM AUTHOR]

Introduction: The study presents the design and manufacturing of a custom silicone distal cup, with a high spatial resolution, to fit inside the prosthetic liner for the treatment of irregular morphology at the distal residual limb of a patient with lower-limb amputation. This distal cup for the inside of the prosthetic liner has intricate interior features matching the shape of the distal residual limb to prevent localized high-pressure regions. Methods: High-resolution 3D optical scanning, computer-aided design (CAD), and material extrusion (MEX) process for additive manufacturing of molds are three key techniques for designing and manufacturing this custom distal cup. A three-part mold for molding the distal cup with matching features was designed by CAD and fabricated by MEX. The subject evaluated the distal cup by walking using the distal cup before wearing the prosthetic liner in the lower-limb prosthesis. Results: A custom silicone distal cup was fabricated using a 3D-printed mold and evaluated using a Prosthetic User's Survey. Based on the survey, the insert has an acceptable comfort, suspension requirement, and ease of use. Conclusions: The scan by high spatial resolution Space Spider optical scanner could capture detailed features of the distal residual limb. The resulting distal cup had the protrusion that functioned to separate the invaginations. The subject was satisfied with the distal cup based on the Prosthetic User's Survey. Clinical Relevance: The approach to fabricate the custom silicone distal cup using a high-resolution 3D optical scanner and a 3D-printed mold can be applied to fabricate the distal cup with intricate features for a patient with irregular morphology at the distal residual limbs. [ABSTRACT FROM AUTHOR]

Introduction: No prior studies have examined the prevalence of unmet prosthesis need among prosthesis nonusers. Objectives: The aim of this study was to describe the prevalence of unmet need for an upper-limb prosthesis and identify independent covariates associated with unmet need for a prosthesis. Study Design: This study is a telephone survey of 742 persons with upper-limb amputation (ULA). Methods: Differences between users and nonusers and between nonusers with and without an unmet need were compared statistically. Covariates associated with unmet need P ≤ 0.2 in bivariate analyses were included in a multivariate logistic regression model predicting unmet need. Results: Odds of unmet need were higher for those who stopped using a prosthesis within the past year compared with 20 years or more ago (odds ratio [OR], 4.30; 95% confidence interval [CI], 1.28–14.51) and those on disability (OR, 4.01; 95% CI, 0.95–16.85). Odds of unmet need were lower for those with higher upper-limb function scores (OR, 0.94; 95% CI, 0.96–1.00), who were unemployed versus employed/student (OR, 0.15; 95% CI, 0.02–0.98), and those who had abandoned a prior prosthesis because it was "too much fuss" (OR, 0.41; 95% CI, 0.18–0.92). Conclusions: Unmet need was prevalent, impacting approximately 50% of persons with upper-limb amputation who were not using a device and 14% who reported never having used a prosthesis. Independent correlates of greater unmet included worse upper-limb function, prosthesis use within the prior year, and disability status. Correlates of lesser unmet need included being unemployed and having abandoned a prosthesis because it was perceived as an undue burden. Further studies are needed to understand barriers to prosthesis use among nonusers with an unmet need. Clinical Relevance: Persons with ULA who do not use a prosthesis should be reevaluated regularly to identify unmet needs. Our findings suggest recent prosthesis users, those with poorer upper-limb function, and those who are employed or on disability are more likely to have unmet needs. [ABSTRACT FROM AUTHOR]

Introduction: Modular prosthetic ankle components have been shown to improve walking in transtibial prosthesis users, but they may reduce stability during standing. Therefore, the stiffness of the prosthetic foot-ankle components may need to be appropriately tuned to provide a balance between walking mobility and standing balance. The present research investigates both concepts to improve our knowledge about how prosthetic ankle stiffness influences standing and walking performance. Methods: Ten individuals with unilateral transtibial amputation and categorized as minimum K3-level ambulators participated. Standing balance and gait analyses at three self-selected speeds were performed at three different levels of ankle dorsiflexion stiffness (Soft, Medium, and Firm) using the College Park Venture foot (College Park Industries, Warren, MI, USA). Repeated-measures analyses of variance (ANOVAs) were performed on relevant standing balance, gait spatiotemporal, and roll-over shape (ROS) outcomes. Gait kinetic and kinematic data were analyzed using a one-dimension statistical parametric analysis. Results: Ankle dorsiflexion stiffness influenced balance and gait. Overall, the Firm dorsiflexion stiffness provided a smaller body sway on standing balance, a ROS radius close to the one of able-bodied individuals, and reduced step length asymmetry while walking. Furthermore, walking speed had an influence on ROS radii, resulting in a larger radius for slow walking speeds and a smaller one for fast walking speeds. Discussion: The Firm stiffness appeared to offer the most advantages for balance and gait. The radius of ROS under the Firm condition, close to the radius of able-bodied individuals, could have caused the improvement in step length symmetry by a greater progression of the center of pressure, resulting in further progression of the prosthetic side. This information, in addition to the observed walking speed effect on ROS radii, encourages us to develop studies to examine the effect of walking speed on foot performance and improve prosthetic foot design to maintain the same gait characteristics under different walking speeds. Clinical Relevance: These results improve our understanding of how a specific prosthetic ankle dorsiflexion stiffness affects standing balance and gait, which supports the prosthetist's evaluation process to determine specific individual stiffness for each prosthesis user. [ABSTRACT FROM AUTHOR]

Purpose Cobalt metallosis is a rare but dangerous complication of total joint arthroplasty resulting from deterioration of the joint leading to metal-on-metal friction and breakdown. Potential manifestations vary in severity and include dilated cardiomyopathy, thyroid dysfunction, cognitive disturbances, neuropathy, fatigue, and weakness. The therapeutic role of N -acetylcysteine in metallosis has been investigated due to its ability to chelate with heavy metal ions, such as cobalt and chromium. Summary Here we report the case of a 71-year-old female who presented with suspected metallosis diagnosed in the outpatient setting due to symptoms of significant weight loss and failure to thrive. This metallosis was secondary to the hardware breakdown of a left knee revision roughly 6 years previously. The patient was not a surgical candidate due to her poor nutrition status and was started on nasojejunal tube feeds along with N -acetylcysteine 600 mg by mouth twice daily for 45 days. The patient's serum cobalt levels decreased from 61.7 µg/L on admission to 16.2 µg/L prior to her undergoing proper revision of the left knee roughly 2 months after admission to the hospital. The patient tolerated treatment well and was able to be discharged the day after surgery, with no further complaints or complications. Conclusion This case report contributes to the body of literature suggesting that administration of N -acetylcysteine can reduce serum cobalt concentrations, without notable adverse effects, in the context of prosthetic knee–associated metallosis. [ABSTRACT FROM AUTHOR]

To perform a detailed psychometric Rasch analysis of the Prosthesis Embodiment Scale (PEmbS) administered in adults with lower limb amputation (LLA). A convenience sample of German-speaking adults with LLA (n = 150), recruited from German state agencies' databases, was asked to complete the PEmbS, a 10-item patient-reported scale assessing prosthesis embodiment. The local dependency between two items was resolved by keeping for the global score only the lower score of these two items (#9 and #10). Collapsing the seven response categories to four (two expressing disagreement and two agreement) eliminated disordered thresholds. After that, the PEmbS demonstrated unidimensionality, acceptable item fit, and good reliability indices. A keyform plot was created to transform raw scores into linear measures of prosthesis embodiment, making it possible to compare the individual's item responses with those expected by the Rasch model, and to manage missing responses. The PEmbS is useful for assessing prosthesis embodiment in people with LLA, both for research and clinical purposes. We propose a revised version of the PEmbS for lower limb amputees; its appropriateness in other LLA contexts requires further investigation. Prosthesis embodiment has been empirically related to positive clinical outcomes in limb amputees. The Prosthesis Embodiment Scale (PEmbS) is a patient-reported scale that has been recently recommended for use in research on prosthesis embodiment. Rasch analysis showed that the revised version of the German PEmbS is a psychometrically sound instrument for the assessment of prosthesis embodiment in lower limb amputees. The PEmbS thus also allows reliable and valid diagnosis of prosthesis embodiment in clinical and rehabilitation contexts. [ABSTRACT FROM AUTHOR]