A scoping review of digital fabrication techniques applied to prosthetics and orthotics: Part 1 of 2-Prosthetics.

BACKGROUND: Traditionally, the manufacture of prostheses is time-consuming and labor-intensive. One possible route to improving access and quality of these devices is the digitalizing of the fabrication process, which may reduce the burden of manual labor and bring the potential for automation that could help unblock access to assistive technologies globally. OBJECTIVES: To identify where there are gaps in the literature that are creating barriers to decision-making on either appropriate uptake by clinical teams or on the needed next steps in research that mean these technologies can continue on a pathway to maturity. STUDY DESIGN: Scoping literature review. METHODS: A comprehensive search was completed in the following databases: Allied and Complementary Medicine Database, MEDLINE, Embase, Global Health Archive, CINAHL Plus, Cochrane Library, Web of Science, Association for Computing Machinery, Institute of Electrical and Electronics Engineers, and Engineering Village, resulting in 3487 articles to be screened. RESULTS: After screening, 130 lower limb prosthetic articles and 117 upper limb prosthetic articles were included in this review. Multiple limitations in the literature were identified, particularly a lack of long-term, larger-scale studies; research into the training requirements for these technologies and the necessary rectification processes; and a high range of variance of production workflows and materials which makes drawing conclusions difficult. CONCLUSIONS: These limitations create a barrier to adequate evidence-based decision-making for clinicians, technology developers, and wider policymakers. Increased collaboration between academia, industry, and clinical teams across more of the pathway to market for new technologies could be a route to addressing these gaps.

Activity, socket fit, comfort and community participation in lower limb prosthesis users: a Cambodian cohort study.

BACKGROUND: After amputation, many people become less active, feel lonely and lose independence. Understanding the factors associated with low physical activity levels and participation could contribute to defining key interventions which can support prosthesis users so they can live a more active and socially included lifestyle. This longitudinal observational study aims to assess relationships between physical activity, community participation, prosthetic fit, comfort and user satisfaction using actimetry, 3D scans and questionnaires in a Cambodian cohort of established lower limb prosthesis users. METHODS: Twenty participants (5F:15M, nine transfemoral, eleven transtibial, 24-60 years old and 3-43 years since amputation) were recruited. They completed a questionnaire which included their demographics, community participation, prosthesis satisfaction and comfort at the start of the study, and between three and six months later. Their prosthetic sockets and residual limbs were 3D scanned at the start and end of the study. Accelerometers were embedded under the cosmesis on the shank of the prosthesis, to collect ten weeks of activity data. RESULTS: Participants averaged 4470 steps/day (743-7315 steps/day), and wore their prosthesis for most waking hours, averaging 13.4 h/day (4.5-17.6 h/day). Self-reported measures of activity and hours of wear correlated with these accelerometer data (Spearman's rho rs = 0.59, and rs = 0.71, respectively). Participants who were more active wore their prosthesis for more hours/day (Pearson r = 0.73) and were more satisfied with socket fit (rs = 0.49). A longer residual limb correlated with better community participation (rs = 0.56) and comfort (rs = 0.56). Self-reported community participation did not correlate with a person's activity level (rs = 0.13), or their prosthesis comfort (rs = 0.19), and there was only weak correlation between how important the activity was to an individual, and how often they participated in it (rs = 0.37). A simple 0-10 scale of overall comfort did not provide enough detail to understand the types and severity of discomfort experienced. CONCLUSION: Associations between perceived and measured activity levels correlated with socket satisfaction in this cohort of people with established lower limb amputations. The small sample size means these correlations should be interpreted with caution, but they indicate variables worthy of further study to understand barriers to community engagement and physical activity for prosthesis users in Cambodia, and potentially in other settings.

A Machine Learning Classification Model for Monitoring the Daily Physical Behaviour of Lower-Limb Amputees.

There are currently limited data on how prosthetic devices are used to support lower-limb prosthesis users in their free-living environment. Possessing the ability to monitor a patient's physical behaviour while using these devices would enhance our understanding of the impact of different prosthetic products. The current approaches for monitoring human physical behaviour use a single thigh or wrist-worn accelerometer, but in a lower-limb amputee population, we have the unique opportunity to embed a device within the prosthesis, eliminating compliance issues. This study aimed to develop a model capable of accurately classifying postures (sitting, standing, stepping, and lying) by using data from a single shank-worn accelerometer. Free-living posture data were collected from 14 anatomically intact participants and one amputee over three days. A thigh worn activity monitor collected labelled posture data, while a shank worn accelerometer collected 3-axis acceleration data. Postures and the corresponding shank accelerations were extracted in window lengths of 5-180 s and used to train several machine learning classifiers which were assessed by using stratified cross-validation. A random forest classifier with a 15 s window length provided the highest classification accuracy of 93% weighted average F-score and between 88 and 98% classification accuracy across all four posture classes, which is the best performance achieved to date with a shank-worn device. The results of this study show that data from a single shank-worn accelerometer with a machine learning classification model can be used to accurately identify postures that make up an individual's daily physical behaviour. This opens up the possibility of embedding an accelerometer-based activity monitor into the shank component of a prosthesis to capture physical behaviour information in both above and below-knee amputees. The models and software used in this study have been made open source in order to overcome the current restrictions of applying activity monitoring methods to lower-limb prosthesis users.

A Personal Respirator to Improve Protection for Healthcare Workers Treating COVID-19 (PeRSo).

Introduction: SARS-CoV-2 infection is a global pandemic. Personal Protective Equipment (PPE) to protect healthcare workers has been a recurrent challenge in terms of global stocks, supply logistics and suitability. In some settings, around 20% of healthcare workers treating COVID-19 cases have become infected, which leads to staff absence at peaks of the pandemic, and in some cases mortality. Methods: To address shortcomings in PPE, we developed a simple powered air purifying respirator, made from inexpensive and widely available components. The prototype was designed to minimize manufacturing complexity so that derivative versions could be developed in low resource settings with minor modification. Results: The "Personal Respirator - Southampton" (PeRSo) delivers High-Efficiency Particulate Air (HEPA) filtered air from a battery powered fan-filter assembly into a lightweight hood with a clear visor that can be comfortably worn for several hours. Validation testing demonstrates that the prototype removes microbes, avoids excessive CO2 build-up in normal use, and passes fit test protocols widely used to evaluate standard N95/FFP2 and N99/FFP3 face masks. Feedback from doctors and nurses indicate the PeRSo prototype was preferred to standard FFP2 and FFP3 masks, being more comfortable and reducing the time and risk of recurrently changing PPE. Patients report better communication and reassurance as the entire face is visible. Conclusion: Rapid upscale of production of cheaply produced powered air purifying respirators, designed to achieve regulatory approval in the country of production, could protect healthcare workers from infection and improve healthcare delivery during the COVID-19 pandemic.

Technology for monitoring everyday prosthesis use: a systematic review.

BACKGROUND: Understanding how prostheses are used in everyday life is central to the design, provision and evaluation of prosthetic devices and associated services. This paper reviews the scientific literature on methodologies and technologies that have been used to assess the daily use of both upper- and lower-limb prostheses. It discusses the types of studies that have been undertaken, the technologies used to monitor physical activity, the benefits of monitoring daily living and the barriers to long-term monitoring, with particular focus on low-resource settings. METHODS: A systematic literature search was conducted in PubMed, Web of Science, Scopus, CINAHL and EMBASE of studies that monitored the activity of prosthesis users during daily-living. RESULTS: Sixty lower-limb studies and 9 upper-limb studies were identified for inclusion in the review. The first studies in the lower-limb field date from the 1990s and the number has increased steadily since the early 2000s. In contrast, the studies in the upper-limb field have only begun to emerge over the past few years. The early lower-limb studies focused on the development or validation of actimeters, algorithms and/or scores for activity classification. However, most of the recent lower-limb studies used activity monitoring to compare prosthetic components. The lower-limb studies mainly used step-counts as their only measure of activity, focusing on the amount of activity, not the type and quality of movements. In comparison, the small number of upper-limb studies were fairly evenly spread between development of algorithms, comparison of everyday activity to clinical scores, and comparison of different prosthesis user populations. Most upper-limb papers reported the degree of symmetry in activity levels between the arm with the prosthesis and the intact arm. CONCLUSIONS: Activity monitoring technology used in conjunction with clinical scores and user feedback, offers significant insights into how prostheses are used and whether they meet the user's requirements. However, the cost, limited battery-life and lack of availability in many countries mean that using sensors to understand the daily use of prostheses and the types of activity being performed has not yet become a feasible standard clinical practice. This review provides recommendations for the research and clinical communities to advance this area for the benefit of prosthesis users.

Comparing thermal discomfort with skin temperature response of lower-limb prosthesis users during exercise.

BACKGROUND: Thermal discomfort is prevalent among prosthesis users. This observational study of thirty unilateral lower-limb prosthesis users compared their skin temperatures and the thermal discomfort experienced during exercise between their residual and contralateral limbs. METHODS: Participants performed a 2-minute interval cycling exercise test. Skin temperature was measured at matched locations on each leg during the 1-minute rest intervals. Average rate-of-change in skin temperature was compared between legs using a repeated measures analysis of variance. Participants rated thermal discomfort on each leg before and after exercise, and a Wilcoxon signed-rank test was used to compare legs. Ordinal regression evaluated the relationship between the rate-of-change in temperature on the residual limb and the perceived thermal discomfort. FINDINGS: After exercise, thermal discomfort ranked higher on the amputated side (P = 0.007). On average, both legs cooled during exercise (P = 0.002), but the difference between legs was not significant. The rate-of change in skin temperature on the residual limb during exercise did not relate to the thermal discomfort experienced (odds ratio of 0.357). INTERPRETATION: These findings indicate that in this patient population, skin temperature does not explain the thermal discomfort experienced, and subjective thermal discomfort is inadequate for detecting thermoregulatory issues, with potential implications for long-term tissue health.

Three-dimensional printed upper-limb prostheses lack randomised controlled trials: A systematic review.

BACKGROUND: Three-dimensional printing provides an exciting opportunity to customise upper-limb prostheses. OBJECTIVE: This review summarises the research that assesses the efficacy and effectiveness of three-dimensional printed upper-limb prostheses. STUDY DESIGN: Systematic review. METHODS: PubMed, Web of Science and OVID were systematically searched for studies that reported human trials of three-dimensional printed upper-limb prostheses. The studies matching the language, peer-review and relevance criteria were ranked by level of evidence and critically appraised using the Downs and Black Quality Index. RESULTS: After removing duplicates, 321 records were identified. Eight papers met the inclusion criteria. No studies used controls; five were case studies and three were small case-series studies. All studies showed promising results, but none demonstrated external validity, avoidance of bias or statistically significant improvements over conventional prostheses. The studies demonstrated proof-of-concept rather than assessing efficacy, and the devices were designed to prioritise reduction of manufacturing costs, not customisability for comfort and function. CONCLUSION: The potential of three-dimensional printing for individual customisation has yet to be fully realised, and the efficacy and effectiveness to be rigorously assessed. Until randomised controlled trials with follow-up are performed, the comfort, functionality, durability and long-term effects on quality of life remain unknown. Clinical relevance Initial studies suggest that three-dimensional printing shows promise for customising low-cost upper-limb prosthetics. However, the efficacy and effectiveness of these devices have yet to be rigorously assessed. Until randomised controlled trials with follow-up are performed, the comfort, functionality, durability and long-term effects on patient quality of life remain unknown.

Clinical efficacy and effectiveness of 3D printing: a systematic review.

OBJECTIVE: To evaluate the clinical efficacy and effectiveness of using 3D printing to develop medical devices across all medical fields. DESIGN: Systematic review compliant with Preferred Reporting Items for Systematic Reviews and Meta-Analyses. DATA SOURCES: PubMed, Web of Science, OVID, IEEE Xplore and Google Scholar. METHODS: A double-blinded review method was used to select all abstracts up to January 2017 that reported on clinical trials of a three-dimensional (3D)-printed medical device. The studies were ranked according to their level of evidence, divided into medical fields based on the International Classification of Diseases chapter divisions and categorised into whether they were used for preoperative planning, aiding surgery or therapy. The Downs and Black Quality Index critical appraisal tool was used to assess the quality of reporting, external validity, risk of bias, risk of confounding and power of each study. RESULTS: Of the 3084 abstracts screened, 350 studies met the inclusion criteria. Oral and maxillofacial surgery contained 58.3% of studies, and 23.7% covered the musculoskeletal system. Only 21 studies were randomised controlled trials (RCTs), and all fitted within these two fields. The majority of RCTs were 3D-printed anatomical models for preoperative planning and guides for aiding surgery. The main benefits of these devices were decreased surgical operation times and increased surgical accuracy. CONCLUSIONS: All medical fields that assessed 3D-printed devices concluded that they were clinically effective. The fields that most rigorously assessed 3D-printed devices were oral and maxillofacial surgery and the musculoskeletal system, both of which concluded that the 3D-printed devices outperformed their conventional comparators. However, the efficacy and effectiveness of 3D-printed devices remain undetermined for the majority of medical fields. 3D-printed devices can play an important role in healthcare, but more rigorous and long-term assessments are needed to determine if 3D-printed devices are clinically relevant before they become part of standard clinical practice.

Comparing surgical experience with performance on a sinus surgery simulator.

BACKGROUND: This study evaluates whether surgical experience influences technical competence using the Flinders sinus surgery simulator, a virtual environment designed to teach nasal endoscopic surgical skills. METHODS: Ten experienced sinus surgeons (five consultants and five registrars) and 14 novices (seven resident medical officers and seven interns/medical students) completed three simulation tasks using haptic controllers. Task 1 required navigation of the sinuses and identification of six anatomical landmarks, Task 2 required removal of unhealthy tissue while preserving healthy tissue and Task 3 entailed backbiting within pre-set lines on the uncinate process and microdebriding tissue between the cuts. RESULTS: Novices were compared with experts on a range of measures, using Mann-Whitney U -tests. Novices took longer on all tasks (Task 1: 278%, P < 0.005; Task 2: 112%, P < 0.005; Task 3: 72%, P < 0.005). In Task 1, novices' instruments travelled further than experts' (379%, P < 0.005), and provided greater maximum force (12%, P < 0.05). In Tasks 2 and 3 novices performed more cutting movements to remove the tissue (Task 2: 1500%, P < 0.005; Task 3: 72%, P < 0.005). Experts also completed more of Task 3 (66%, P < 0.05). CONCLUSIONS: The study demonstrated the Flinders sinus simulator's construct validity, differentiating between experts and novices with respect to procedure time, instrument distance travelled and number of cutting motions to complete the task.

A detachable electronic device for use with a long white cane to assist with mobility.

Vision-impaired individuals often use a long white cane to assist them with gathering information about their surroundings. However, these aids are generally not used to detect obstacles above knee height. The purpose of this study is to determine whether a low-cost, custom-built electronic device clipped onto a traditional cane can provide adequate vibratory warning to the user of obstacles above knee height. Sixteen normally sighted blindfolded individuals participated in two mobility courses which they navigated using a normal white cane and a white cane with the electronic device attached. Of the 16 participants, 10 hit fewer obstacles, and 12 covered less ground with the cane when the electronic device was attached. Ten participants found navigating with the electronic device easier than just the white cane alone. However, the time taken on the mobility courses, the number of collisions with obstacles, and the area covered by participants using the electronic device were not significantly different (p > 0.05). A larger sample size is required to determine if the trends found have real significance. It is anticipated that additional information provided by this electronic device about the surroundings would allow users to move more confidently within their environment.