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BACKGROUND: Arteriovenous fistulae (AVF) have superior clinical outcomes compared with central venous catheters (CVC) among patients undergoing hemodialysis (HD). Yet, there is increasing recognition that health-related quality of life (HRQoL) may be more important to patients than survival and that differences may exist between AVF and CVCs in this regard. This study compared HRQoL between AVF and CVC in an Irish cohort. METHODS: We conducted a cross-sectional survey among prevalent patients undergoing hemodialysis (N=119) dialyzing with either an AVF or CVC at a regional program. The Short Form 36 (SF-36) and a validated Vascular Access Questionnaire (SF-VAQ) compared QoL between AVF and CVC in domains of physical functioning, social functioning, and dialysis complications. Multivariable logistic regression compared differences between groups for outcomes of physical functioning, social functioning, and dialysis complications expressed as adjusted odds ratios and 95% CI. RESULTS: Mean age was 66.6 years; 52% were using an AVF and 48% had a CVC. Patients dialyzing with an AVF were more satisfied with their access when asked directly (6.2 versus 5.0; P

The aim of this research was to assess a selection of radiopaque filler compounds for increasing radiopacity in a resin suitable for Polyjet multi-material 3D printing. A radiopaque resin has potential applications in medicine to produce patient-specific anatomical models with realistic radiological properties, training aids, and skin contacting components such as surgical or procedural guides that require visibility under fluoroscopy. The desirable filler would have a high level of radiopacity under ionising imaging modalities, such as X-ray, CT, fluoroscopy or angiography. Nine potential filler compounds were selected based on atomic number and handling risk: barium sulphate, bismuth oxide, zirconium oxide, strontium oxide, strontium fluoride, strontium carbonate, iodine, niobium oxide and tantalum oxide. The fillers were evaluated using selected criteria. A weighted material selection matrix was developed to prioritise and select a filler for future 3D printing on a multi-material 3D printer. Zirconium oxide was the highest scoring filler compound in the material selection matrix, scoring 4.4 out of a maximum of 5. MED610TM resin doped with zirconium oxide was shown to be UV curable, and when cured is non-toxic, environmentally friendly, and has the ability to display antimicrobial properties. In terms of radiopacity, a sample with thickness 1.5 mm of MED610™ resin doped with 20 wt.% zirconium oxide produced X-ray radiopacity equivalent to 3 mm of aluminium. Zirconium oxide was selected using the material selection matrix. This radiopaque resin can be used to produce anatomical models with accurate radiological properties, training aids or skin contacting devices that require visibility under ionising imaging modalities. The 3D printing validation run successfully demonstrated that the material selection matrix prioritised a filler suitable for radiopaque multi-material 3D printing.

BackgroundThree-dimensional printing (3DP) enables the production of highly customised, cost-efficient devices in a relatively short time, which can be particularly valuable to clinicians treating patients with palliative care intent who are in need of timely and effective solutions in the management of their patients’ specific needs, including the relief of distressing symptoms.MethodFour online databases were searched for articles published by December 2020 that described studies using 3DP in palliative care. The fields of application, and the relevant clinical and technological data were extracted and analysed.ResultsThirty studies were reviewed, describing 36 medical devices, including anatomical models, endoluminal stents, navigation guides, obturators, epitheses, endoprostheses and others. Two-thirds of the studies were published after the year 2017. The main reason for using 3DP was the difficulty of producing customised devices with traditional methods. Eleven papers described proof-of-concept studies that did not involve human testing. For those devices that were tested on patients, favourable clinical outcomes were reported in general, and treatment with the use of 3DP was deemed superior to conventional clinical approaches. The most commonly employed 3DP technologies were fused filament fabrication with acrylonitrile butadiene styrene and stereolithography or material jetting with various types of photopolymer resin.ConclusionRecently, there has been a considerable increase in the application of 3DP to produce medical devices and bespoke solutions in the delivery of treatments with palliative care intent. 3DP was found successful in overcoming difficulties with conventional approaches and in treating medical conditions requiring highly customised solutions.

Background Oscillating Positive Expiratory Pressure (OPEP) devices are important adjuncts to airway clearance therapy in patients with cystic fibrosis (CF). Current devices are typically reusable and require daily, or often more frequent, cleaning to prevent risk of infection by acting as reservoirs of potentially pathogenic organisms. In response, a daily disposable OPEP device, the UL-OPEP, was developed to mitigate the risk of contamination and eliminate the burdensome need for cleaning devices. Methods A convenience sample of 36 participants, all current OPEP device users, was recruited from a paediatric CF service. For one month, participants replaced their current OPEP device with a novel daily disposable device. Assessment included pre- and post-intervention lung function by spirometry, as well as Lung Clearance Index. Quality of life was assessed using the Cystic Fibrosis Questionnaire – Revised, while user experience was evaluated with a post-study survey. Results 31 participants completed the study: 18 males; median age 10 years, range 4–16 years. Lung function (mean difference ± SD, %FEV1 = 1.69 ± 11.93; %FVC = 0.58 ± 10.04; FEV1: FVC = 0.01 ± 0.09), LCI (mean difference ± SD, 0.08 ± 1.13), six-minute walk test, and CFQ-R were unchanged post-intervention. Participant-reported experiences of the device were predominantly positive. Conclusions The disposable OPEP device maintained patients’ lung function during short term use (≤ 1 month), and was the subject of positive feedback regarding functionality while reducing the risk of airway contamination associated with ineffective cleaning. Registration The study was approved as a Clinical Investigation by the Irish Health Products Regulatory Authority (CRN-2209025-CI0085).

During the first surge of the coronavirus disease 2019 (COVID-19) there was a tremendous global response from three-dimensional (3D) printing communities and individuals to support local health care systems and staff. The responses involved a range of 3D printer users from amateur makers to conglomerate manufacturers creating personal protective equipment (PPE) and other supplies of which there were shortages. These new supply chains resulted from the democratization of 3D printing, open source file sharing, mass production of desktop machines, and the relatively cheap cost of 3D printers. The democratized state of 3D printing facilitated an altruistic movement of makers with ranging experience, to work alongside traditional manufacturers to make medical supplies. With the critical nature of the shortages and the sharp increase in COVID-19 infections, many standards and regulations were bypassed, and good manufacturing processes disregarded, in cases. The outcomes from this article is a set of six lessons learned from the authors perspective regarding the use of 3D printing during the initial phase of the COVID-19 pandemic. We note challenges experienced around volume manufacturing, infection control requirements of produced parts and the cleanability of devices, mechanical strength considerations, good manufacturing practices, product and intellectual property (IP) liability, and the role of involving clinical stakeholders.

Objective The aim was to develop a means of predicting interface pressure from cuff inflation pressure during circumferential compression at the lower limb, in order to inform the design of soft exoskeletons. Background Excessive mechanical loading of tissues can cause discomfort and soft tissue injury. Most ergonomic studies on exoskeletons are of interface pressure, but soft exoskeletons apply circumferential pressures similar to tourniquet cuffs by way of cuff inflation pressure. This study details the relationship between interface and cuff inflation pressures for pneumatic tourniquet cuffs. Method Pneumatic cuffs of different widths were inflated to target pressures on (A) a rigid cylinder, (B) the dominant thigh and calf, and (C) knee of healthy participants standing still. Interface pressures were measured under the cuffs using a pressure-sensing mat. Average interface pressures were then compared to cuff inflation pressures. The influence of cuff width, cuff inflation pressure, and participants’ anthropometric data on pressure transmission was assessed. Results A strong linear relationship between cuff inflation pressures and interface pressures was observed. Interface pressures were generally higher than cuff inflation pressures. The efficiency of pressure transmission to the lower limb depended on assessment site, adipose tissue thickness, cuff size, cuff inflation pressure, and possibly limb circumference. Regression equations were developed to predict interface pressures at the thigh, calf, and knee. Conclusion Interface pressures under pneumatic cuffs are influenced by the cuff size, cuff inflation pressure, and tissue compressibility. Predicted interface pressure from cuff inflation pressure and vice versa can be used to aid the design of soft exoskeletons.

Until recently, three-dimensional (3D) printing/additive manufacturing has not been used extensively to create medical devices intended for actual clinical use, primarily on patient safety and regulatory grounds. However, in recent years there have been advances in materials, printers, and experience, leading to increased clinical use. The aim of this study was to perform a structured systematic review of 3D-printed medical devices used directly in patient treatment. A search of 13 databases was performed to identify studies of 3D-printed medical devices, detailing fabrication technology and materials employed, clinical application, and clinical outcome. One hundred and ten papers describing one hundred and forty medical devices were identified and analyzed. A considerable increase was identified in the use of 3D printing to produce medical devices directly for clinical use in the past 3 years. This is dominated by printing of patient-specific implants and surgical guides for use in orthopedics and orthopedic oncology, but there is a trend of increased use across other clinical specialties. The prevailing material/3D-printing technology used were titanium alloy/electron beam melting for implants, and polyamide/selective laser sintering or polylactic acid/fused deposition modeling for surgical guides and instruments. A detailed analysis across medical applications by technology and materials is provided, as well as a commentary regarding regulatory aspects. In general, there is growing familiarity with, and acceptance of, 3D printing in clinical use.

Background Extrinsic warming of contrast media (CM) to 37 °C before angiographic procedures is performed to improve bolus kinetics and avoid potential adverse effects. Extrinsically warmed CM readily loses temperature after removal from the warming cabinet, but the extent of its cooling has not been previously investigated. Purpose To assess temperature loss of extrinsically warmed CM in tubing of traditional angiographic manifolds during simulated angiography. Material and Methods In total, 35 scheduled diagnostic angiographic procedures were observed in a hospital setting. Relevant time points of CM use during the procedures were recorded. The shortest, median, and longest procedures were then simulated in the experimental laboratory to measure CM temperatures at specific times at three locations along the tubing system. Results The angiographic procedures lasted 7.0–26.6 min (median = 11.7 min), with the total duration dependent primarily on the time from contrast being removed from the warming cabinet to the commencement of imaging. During the simulated procedures, consistent patterns of temperature loss were observed. By the last simulated angiographic run, injected CM temperature decreased by 7.4–16.4 °C, depending on procedure length. Most of the heat loss occurred in the tubing between the CM bottle and coronary control syringe. Conclusion During angiographic procedures, prewarmed CM loses its temperature rapidly with the duration of exposure to ambient room temperature. If no additional measures are employed to maintain its temperature outside of the warming cabinet, extrinsic warming has limited impact on injected CM temperature.

Background Handheld oscillating positive expiratory pressure (OPEP) devices have been a mainstay of treatment for patients with hypersecretory conditions such as cystic fibrosis (CF) and chronic obstructive pulmonary disease (COPD) since the 1970s. Current devices are reusable and require regular cleaning and disinfection to prevent harbouring potentially pathogenic organisms. Adherence to cleaning regimens for respiratory devices is often poor and in response to this, a prototype disposable OPEP device—the ‘UL-OPEP’ (University of Limerick—Oscillating Positive Expiratory Pressure device)—was developed to mitigate the risk of contamination by pathogens. The device was previously evaluated successfully in a group of paediatric CF patients. The aim of the current study was to initially evaluate the safety of the prototype in patients with COPD over a period of 1 month to ensure no adverse events, negative impacts on lung function, exercise tolerance, or quality of life. Data on user experience of the device were also collected during post-study follow-up. Methods A sample of 50 volunteer participants were recruited from pulmonary rehabilitation clinics within the local hospital network. The patients were clinically stable, productive, and not current or previous users of OPEP devices. Participants were invited to use a prototype disposable OPEP device daily for a period of 1 month. Pre- and post-study lung function was assessed with standard spirometry, and exercise tolerance with the 6-min-walk-test (6MWT). Quality of life was assessed using the St. George’s Respiratory Questionnaire (SGRQ), and user experience of the prototype device evaluated using a post-study questionnaire. Results 24 Participants completed the study: 9 were female. Overall median age was 67.5 years, range 53–85 years. Lung function, 6-min walk test, and SGRQ scores showed no significant change post-study. User feedback was positive overall. Conclusions The results indicate that the UL-OPEP is safe to use in patients with COPD. No adverse events were recorded during the study or in the follow-up period of 2 weeks. The device did not negatively impact patients’ lung function, exercise tolerance, or quality of life during short term use (1 month), and usability feedback received was generally positive. Larger, longer duration studies will be required to evaluate efficacy. Registration The study was approved as a Clinical Investigation by the Irish Health Products Regulatory Authority (CRN-2209025-CI0085).

Summary Background Positive expiratory pressure (PEP) devices are an important element of the management of cystic fibrosis, and of other respiratory diseases. Whereas there have been reports in the literature of contamination of airway clearance devices and their surfaces by microbial pathogens, there is little evidence available regarding such contamination and its contribution to respiratory infection. Aim To establish whether pathogenic bacteria can contaminate PEP devices in the context of normal cleaning and maintenance practices. Methods Patients' home-use clearance devices were brought to a routine clinic appointment and collected for microbiology sampling and analysis. The patients were provided with replacement devices. Nineteen such devices were collected from 17 patients, reflecting use of multiple devices by some patients. Swabs were taken and cultured from each patient's used device, the patient's airway, as well as from new unopened and unused devices that acted as controls. Results Seven of 19 devices (37%) tested positive for presence of pathogenic bacteria. Device-cleaning methods varied among patients and non-sterilization methods were found to be ineffective at removing pathogens. Microbial species found on the devices did not correlate with those identified from airway swabs. Conclusion This study demonstrates the presence of pathogens on positive expiratory pressure devices. The potential for transmission of these pathogens to the patient's airway and the risk of infection remains unclear and requires further study.

The aim of this study was to quantify laparoscopic instrument use and actions of both limbs during a sample of common colorectal surgical procedures. A method was devised using Observer XT software to code video recordings. Anonymised HD video recordings of nine laparoscopic colorectal procedures performed by a single surgeon were analysed. We determined the percentage and frequency of instrument use and limb actions throughout the total laparoscopic surgical duration, as well as the duration of instrument inactivity. Seven instruments and seven actions were studied across nine surgical procedures. Manoeuvring, blunt dissection, and tenting up tissues accounted for the longest amount of total surgical time (non-dominant hand (NDH) 29%, dominant hand (DH) 39%), followed by grasping (NDH 33%, DH 9%), and cauterising (NDH

Peristomal skin complications are a common problem for persons with an ileostomy. PURPOSE The purpose of this pilot study was to solicit user feedback and perform an initial assessment of the performance of a new barrier seal designed to decrease the risk of chemical-induced dermatitis. METHODS Seven (7) potential participants who were at least 18 years of age, >6 months post surgery, with an end or loop ileostomy and unbroken peristomal skin, and who were capable of changing their appliance themselves or had the availability of care assistance were identified and recruited by the stoma care nurse at the University Hospital, Limerick, Ireland. At the initial visit and after 1 and 2 weeks, participants were asked to rate device comfort, security, and handling; skin condition was assessed by the research nurse using the Ostomy Skin Tool. Descriptive statistics were used to tabulate the results. RESULTS Five (5) participants completed the study. Discoloration, erosion, and tissue overgrowth scores improved in 3 of 5 patients, and the mean Ostomy Skin Tool score decreased from 5.4 ± 2.19 at the initial assessment to 4 ± 1.87 at the week 2 visit. Comfort, handling, and security ratings increased from a median of 8 at the beginning of the study to 10 at week 2. CONCLUSION Initial patient feedback regarding the new product was positive, and skin assessment results suggest the new seal may help improve peristomal skin condition. Larger studies with longer patient follow-up are needed to confirm the results of this pilot evaluation.

The large-scale adoption of occupational exoskeletons (OEs) will only happen if clear evidence of effectiveness of the devices is available. Performing product-specific field validation studies would allow the stakeholders and decision-makers (e.g., employers, ergonomists, health, and safety departments) to assess OEs’ effectiveness in their specific work contexts and with experienced workers, who could further provide useful insights on practical issues related to exoskeleton daily use. This paper reviews present-day scientific methods for assessing the effectiveness of OEs in laboratory and field studies, and presents the vision of the authors on a roadmap that could lead to large-scale adoption of this technology. The analysis of the state-of-the-art shows methodological differences between laboratory and field studies. While the former are more extensively reported in scientific papers, they exhibit limited generalizability of the findings to real-world scenarios. On the contrary, field studies are limited in sample sizes and frequently focused only on subjective metrics. We propose a roadmap to promote large-scale knowledge-based adoption of OEs. It details that the analysis of the costs and benefits of this technology should be communicated to all stakeholders to facilitate informed decision making, so that each stakeholder can develop their specific role regarding this innovation. Large-scale field studies can help identify and monitor the possible side-effects related to exoskeleton use in real work situations, as well as provide a comprehensive scientific knowledge base to support the revision of ergonomics risk-assessment methods, safety standards and regulations, and the definition of guidelines and practices for the selection and use of OEs.

This study is an updated systematic review of papers published in the last 5 years on industrial back-support exoskeletons. The research questions were aimed at addressing the recent findings regarding objective (e.g. body loading, user performance) and subjective evaluations (e.g. user satisfaction), potential side effects, and methodological aspects of usability testing. Thirteen studies of active and twenty of passive exoskeletons were identified. The exoskeletons were tested during lifting and bending tasks, predominantly in laboratory settings and among healthy young men. In general, decreases in participants' back-muscle activity, peak L5/S1 moments and spinal compression forces were reported. User endurance during lifting and static bending improved, but performance declined during tasks that required increased agility. The overall user satisfaction was moderate. Some side effects were observed, including increased abdominal/lower-limb muscle activity and changes in joint angles. A need was identified for further field studies, involving industrial workers, and reflecting actual work situations. Practitioner summary: Due to increased research activity in the field, a systematic review was performed of recent studies on industrial back-support exoskeletons, addressing objective and subjective evaluations, side effects, and methodological aspects of usability testing. The results indicate the efficiency of exoskeletons in back-load reduction and a need for further studies in real work situations. Abbrevaitions: BB: biceps brachii; BF: biceps femoris; CoM: centre of mass; DA: deltoideus anterior; EMG: electromyography; ES: erector spinae; ES-C: erector spinae-cervical; ESI: erector spinae iliocostalis; ESI-L: erector spinae iliocostalis-lumborum; ESL: erector spinae longissimus; ES-L: erector spinae-lumbar; ESL-L: erector spinae longissimus-lumborum; ESL-T: erector spinae longissimus-thoracis; ES-T: erector spinae-thoracic; GM: glutaeus maximus; LBP: low back pain; LD: latissimus dorsi; LPD: local perceived discomfort scale; LPP: local perceived pressure scale; MS: multifidus spinae; MSD: musculoskeletal disorder; M-SFS: modified spinal function sort; NMV: no mean value provided; OA: obliquus abdominis (internus and externus); OEA: obliquus externus abdominis; OIA : obliquus internus abdominis; RA: rectus abdominis; RF: rectus femoris; RoM: range of motion; SUS: system usability scale; T: trapezius (pars Ascendens and Descendens); TA: trapezius pars ascendens; TC: mid-cervical trapezius; TD: trapezius pars descendens; VAS: visual analog scale; VL: vastus lateralis; VM: vastus medialis.

peer-reviewed The full text of this article will not be available in ULIR until the embargo expires on the 16/12/2021 The aim of this study was to develop a 3D printable radiopaque ink and successfully print a finished artifact. Radiopaque 3D printing would be hugely beneficial to improve the visibility of medical devices and implants, as well as allowing more realistic phantoms and calibration aids to be produced. Most 3D printing technologies are polymer based. Polymers are naturally radiolucent, allowing X-rays to pass through, showing up as faint dark gray regions on X-ray detectors, as for soft tissues. During this study, a 3D printable ultraviolet (UV) curable resin containing zirconium oxide (ZrO2) nanoparticles was developed. 5 wt.% ZrO2 was dispersed in a base resin using a high-shear mixer. Particles remained in suspension for 6–8 h at room temperature, allowing time for 3D printing. A model of a hand including radiopaque bones and a test block demonstrating a range of internal radiopaque features were successfully 3D printed. Radiopacity was demonstrated in the 3D-printed models, and there was good dispersion of ZrO2 within the resin matrix. The impregnated resin remained UV curable and viscosity was not compromised. In this study, 3D-printed radiopaque features demonstrated clear radiopacity under X-ray and microcomputed tomography imaging.

peer-reviewed The full text of this article will not be available in ULIR until the embargo expires on the 19/05/2021 The aim of this study was to sample human kinematics and kinetics during simulated tasks to aid the design of industrial exoskeletons. Twelve participants performed two dynamic tasks; a simulated lifting task and an overhead lifting task. Based on the current data, to completely assist a worker with lifting loads up to 15 kg, hip actuators would need to supply up to 111 Nm of extensor torque at speeds up to 139°/s of extension velocity and 26°/s of flexion velocity. The actuators should allow the hip to extend to 11° and flex to 95°, and supply a power of 212 W. To completely assist workers lifting a 3 kg load overhead, actuators assisting shoulder flexion would need to supply up to 20 Nm of flexor torque at speeds up to 21°/s of extension velocity and 116°/s of flexion velocity. The actuators should also allow 67° of shoulder flexion and supply a power of 27 W. Practitioner summary: There is increasing interest in developing exoskeletons for industrial applications. This study details relevant kinetic and kinematic exposures for common production tasks, which can be used to inform functional requirements of industrial exoskeletons. Highlights This study sampled joint kinematic and kinetic activity to inform design of industrial exoskeletons. The study presents sample values to two types of common industrial tasks across the major joints as are often assisted. We also indicate considerations on which joints should be considered to be actively assisted.

Objective To establish the relationship between circumferential compression on the lower limb during simulated ramp and staircase profile loading, and the resultant relationship with discomfort/pain and tissue oxygenation. Background Excessive mechanical loading by exoskeletons on the body can lead to pressure-related soft tissue injury. Potential tissue damage is associated with objective oxygen deprivation and accompanied by subjective perception of pain and discomfort. Method Three widths of pneumatic cuffs were inflated at the dominant thigh and calf of healthy participants using two inflation patterns (ramp and staircase), using a computer-controlled pneumatic rig. Participants rated discomfort on an electronic visual analog scale and deep tissue oxygenation was monitored using near infrared spectroscopy. Results Circumferential compression with pneumatic cuffs triggered discomfort and pain at lower pressures at the thigh, with wider cuffs, and with a ramp inflation pattern. Staircase profile compression caused an increase in deep tissue oxygenation, whereas the ramp profile compression decreased it. Conclusion Discomfort and pain during circumferential compression at the lower limb is related to the width of pneumatic cuffs, the inflation pattern, and the volume of soft tissue at the assessment site. The occurrence of pain is also possibly related to the decrease in deep tissue oxygenation during compression. Application Our findings can be used to inform safe and comfortable design of soft exoskeletons to avoid discomfort and possible soft tissue injury.

peer-reviewed The full text of this article will not be available in ULIR until the embargo expires on the 30/03/2021 There is a lack of data and guidance on soft exoskeleton pressure contact with the body. The purpose of this research was to study the relationship between circumferential loading at the knee and discomfort/pain, to inform the design of soft exoskeletons/exosuits. The development of discomfort and pain was studied during standing and walking with circumferential compression using a pneumatic cuff. Our results show higher tolerance for intermittent than continuous compression during standing. Discomfort was triggered at pressures ranging from 13.7 kPa (continuous compression) to 30.4 kPa (intermittent compression), and pain at 52.9 kPa (continuous compression) to 60.6 kPa (intermittent compression). During walking, cyclic compression caused an increase in discomfort with time. Higher cuff inflation pressures caused an earlier onset and higher end intensities of discomfort than lower pressures. Cyclic cuff inflation of 10 kPa and 20 kPa was reasonably well tolerated. Practitioner summary Soft exoskeleton compression of the knee was simulated during static and dynamic compression cycles. The results can be used to understand how users tolerate pressure at the knee, and also to understand the levels at which discomfort and pain are experienced. Abbreviations: BMI: body mass index; DDT: discomfort detection threshold; EndVAS: end of experiment rating on visual analog discomfort scale; PDT: pain detection threshold; SD: standard deviation; SE: standard error; TSP: temporal summation of pain; VAS: visual analogue scale

Aim This study explored and interpreted insights expressed by a cohort of older adults related to their life experience, their experiences using or assisting someone with assistive devices, and their perceptions of robots and robotic assistive devices, including lower limb exoskeletons. Method A grounded theory study was undertaken with 24 older adult participants over five months. Each participant participated in a structured interviewed regarding their experiences with technologies and in particular their perceptions of assistive technologies. Themes from the interviews were coded using Nvivo software. Results Five main themes emerged from this study - (1) Aging & life stage experiences, (2) Quality of Life, (3) Assistive Technologies, (4) Health Conditions & Care, (5) Products & Service Systems. These have influenced new constructs for a hybrid design tool that incorporates stages of Usability and TAMs (Technology Acceptance Models) to gauge (a) Perception, (b) Experience and (c) Perceived Impact by older adults of lower limb exoskeletons. Conclusions: Emerging technologies such as robotic assistive devices require a specific enquiry to understand how best to optimise acceptance by older adults and avoid feelings by them of frustration, embarrassment and ultimately abandonment of these devices. Implications for rehabilitation Older adults frequently require rehabilitation and assistance with ambulation Exoskeletons are forms of assistive technologies for rehabilitation, and they are moving from clinical use to more day care use, including as part of daily living These results help explain factors related to the perception of exoskeletons by older adults, which if considered during exoskeleton design, could improve the technology uptake and compliance with this technology use by these users.

The aim of this study was to assess the elongation of the skin surface of the spine for simulated industrial lifting and lowering tasks to aid the design of industrial exoskeletons worn on the back. Eighteen male participants lifted and lowered a box of varying loads (5 kg, 10 kg, 15 kg) using three techniques (squat, semi-squat, stooped) from the ground to a table. Motion capture sensors attached to the spine from C7 to S1 measured movement. Stoop lifting involved significantly more elongation (mean 71.1 mm; margin of error ±6.9) than squat lifting (mean 36.8 mm; margin of error ±6.9). Load and Task (lift vs. lower) did not have a significant effect on elongation. Elongation of the skin surface of the lumbar spine was greater than for the thoracic spine. These data detail example levels of elongation of the skin surface of the spine, which should be considered in upper body wearable industrial exoskeleton design. Further, exoskeleton design should take into account that the skin surface of the lumbar spine involves greater elongation than the skin surface of the thoracic spine during deep lifting.

There is a paucity of methods to model soft anatomical tissues. Accurate modelling of these tissues can be difficult with current medical imaging technology. The aim of this research was to develop a methodology to model non-intestinal colorectal tissues that are not readily identifiable radiologically to enhance contextual understanding of these tissues and inform medical device design. The models created were used to inform the design of a novel medical device to separate the mesocolon from the retroperitoneum during resection of the colon. We modelled the peritoneum and the mesentery. The mesentery was used to indicate the location of Toldt’s fascia. We generated a point cloud dataset using cryosection images as the target anatomy is more visible than in CT or MRI images. The thickness of the mesentery could not be accurately determined as point cloud data do not have thickness. A denser point cloud detailing the mesenteric boundaries could be used to address this. Expert anatomical and surgical insight and point cloud data modelling methods can be used to model soft tissues. This research enhances the overall understanding of the mesentery and Toldt’s fascia in the human specimen which is necessary for medical device innovations for colorectal surgical procedures.

Additive Manufacturing (AM) facilitates product personalization and iterative design, which makes it an ideal technology for ergonomic product development. In this study, a systematic review was conducted of the literature regarding the use of AM in ergonomic-product design, and methodological aspects of the studies were analyzed. A literature search was performed using the keywords "3D print*," "additive manufacturing," "ergonomic*" and "human factors". Included were studies reporting the use of AM specifically in ergonomic design of products/prototypes including the detailing of an ergonomic testing methodology used for evaluation. Forty studies were identified pertaining to the fields of medicine, assistive technology, wearable technology, hand tools, testing devices and others. The most commonly used technology was fused deposition modeling with polylactic acid, but the overall preferred material was acrylonitrile butadiene styrene. Various combinations of objective/subjective and qualitative/quantitative product evaluation methods were used. Based on the findings, recommendations were developed to facilitate the choice of most suitable AM technologies and materials for specific applications in ergonomics.

Background Musculoskeletal disorders (MSDs) are particularly common in the shoulder/neck region for some tasks that involve low force exertions, for example computer work. It has been demonstrated that muscle activity may be stimulated by cognitively demanding tasks. There is a lack of studies on the relationship between qualitative levels of cognitive loading, level of muscle activity, and muscle fatigue. Aims To investigate the effects of quantitative levels of cognitive loading on conduction velocity changes and isometric endurance times for the upper trapezius. Methods Participants performed a combination of three levels of a cognitively demanding computer task (0, 1.59 and 3 Bits) while simultaneously performing either of two isometric endurance tests (20 and 40% MVC) for the upper trapezius. Results Information load had a significant effect (P < 0.05) on normalized conduction velocity slopes for the 40% but not for the 20% maximum voluntary contraction conditions. Information load had a highly significant effect on endurance times for both exertion levels (P < 0.01). Conclusions This study found that performing a high-difficulty cognitive task while simultaneously performing increasingly higher levels of static isometric shoulder abduction exertions, fatigued the trapezius muscle quicker than performing an equivalent exertion with low cognitive load. This is particularly relevant to workplaces with increasing levels of automation that require high levels of decision making and computer use.

Worldwide, a significant interest in wearable robots or exoskeletons does exist, also from an industrial background. This paper provides an overview of assistive exoskeletons that have specifically been developed for industrial purposes. It discusses their potential in increasing performance and flexibility on one hand and in reducing the mechanical loads on workers involved in manual work on the other. From this it is concluded that exoskeletons have the potential to increase performance under specific conditions and to reduce physical loads significantly. However, several technical issues hinder mainstay practical use of exoskeletons in industry until now. One main issue concerns the human-machine interaction which stands in the way of acceptance. This issue and its linkage to ethics and standardization will be discussed during the conference.

We report a case of three-dimensional (3D) printing being used to solve a difficult bedside clinical problem and avoidance of substantial risk associated with alternative solutions. A 15-year-old male with advanced cystic fibrosis developed a small (~1mm) linear tear in his Percutaneous Endoscopic Gastrostomy (PEG) tube, approximately 40 mm from the skin surface. The patient’s advanced condition precluded replacement of the PEG tube under general anaesthetic. Attempts to manage the tear with adhesive tapes yielded limited success. 3D printing was used to create a bespoke sealing device overnight, rectifying the leak and allowing enteral feeding to recommence unimpeded. The device is functioning well, several months post-discharge of the patient.

BACKGROUND Cognitive demands in the form of sustained attention are prevalent in automated manufacturing where operators undertake monitoring tasks for prolonged periods. Sustained attention tasks are stressful and could have potential health consequences for employees including contributing to Work Related Musculoskeletal Disorders (WRMSDs). OBJECTIVE The study investigates if lowered task engagement (low task motivation/focus) is a mediator of the relationship between sustained attention and musculoskeletal complaints. METHOD A structural equation modelling technique was used to determine if task engagement mediates the relationship between attention demand/attention supply and self-reported musculoskeletal complaints (MSCs) in manufacturing employees (n = 235). RESULTS Study participants were 5.16 times (OR, odds ratio) more likely to have neck complaints, 7.27 (OR) times more likely to have upper back complaints and 3.9 (OR) times more likely to report lower back complaints (OR 2.05) when attention demands were high and task engagement was low. When task engagement was introduced as a mediator between attention supply and MSCs, odds ratios decreased for neck (from 1.01 to 0.60), shoulder (from 0.95 to 0.47) (p

Methods: A convenience sample of 36 participants, all current OPEP device users, was recruited from a paediatric CF service. For a period of one month, participants replaced their current OPEP device (used daily for up to 6 months) with the SoloPep device (daily disposable). Lung function was assessed immediately before and after adopting the new device using Spirometry. Lung Clearance Index (LCI) was assessed via multiple-breath nitrogen washout. User experience of SoloPep was evaluated with a post-study questionnaire, rated on five-point Likert scales. All participants were trained at the first clinic visit to use the SoloPep device. This was performed using a proprietary software program. Results: 31 participants completed the study: 13 females; median age 10 years, range 4-16 years. Lung function (%FEV1, mean ± SD; baseline = 83.26 ± 19.63, follow-up = 86.31 ± 20.95) and LCI (mean ± SD; baseline = 10.05 ± 2.86, follow-up = 9.66 ± 2.10) were unchanged post-intervention. The majority of participants believed that SoloPep was easy to use (72% Strongly Agree; 24% Agree; 4% Neutral), dealt with issues they had with cleaning of their current OPEP device (72% Strongly Agree; 16% Agree; 12% Neutral), and encouraged them to perform OPEP therapy more regularly (52% Strongly Agree; 28% Agree; 16% Neutral, 4% Strongly Disagree). All agreed that they would adopt SoloPep as their usual OPEP device (76% Strongly Agree; 24% Agree). No adverse device-related events were reported during SoloPep use. Conclusion: SoloPep demonstrated equivalence to existing OPEP devices in this cohort and may be a useful adjunct to aid airway clearance, reducing risk of cross-contamination.

peer-reviewed The full text of this article will not be available in ULIR until the embargo expires on the 28/03/2022 Soft exoskeletons apply compressive forces at the limbs via connection cuffs to actuate movement or stabilise joints. To avoid excessive mechanical loading, the interface with the wearer's body needs to be carefully designed. The purpose of this study was to establish the magnitude of circumferential compression at the lower limb during walking that causes discomfort/pain. It was hypothesized that the thresholds differ from those during standing. A cohort of 21 healthy participants were tested using two sizes of pneumatic cuffs, inflated at the thigh and calf in a tonic or phasic manner. The results showed lower inflation pressures triggering discomfort/pain at the thigh, with tonic compression, and wider pneumatic cuffs. The thresholds were lower during walking than standing still. Deep tissue oxygenation increased during phasic compression and decreased during tonic compression. According to the findings, circumferential compression by soft exoskeletons is preferably applied at anatomical sites with smaller volumes of soft tissue, using narrow connection cuffs and inflation pressures below 14 kPa. peer-reviewed

Objectives To evaluate use of a novel disposable Oscillating Positive Expiratory Pressure (OPEP) device (SoloPep) by children with CF. Methods A convenience sample of 36 participants, all current OPEP device users, was recruited from a paediatric CF service. For one month, participants replaced their current OPEP devices (typically used daily for up to 6 months) with the SoloPep device (daily disposable), and followed their existing OPEP regimen. Lung function was assessed on the day that use of the new device was adopted and following completion of the test period using the EasyOne Air Spirometer (NDD Medzintechnik AG, Switzerland). Lung Clearance Index (LCI) was assessed via multiple-breath nitrogen washout (Exhalyser D, Eco Medics, Switzerland). User experience of SoloPep was evaluated with a post-study questionnaire, rated on five-point Likert scales. All participants were trained at the first clinic visit to use the SoloPep device utilising a proprietary software program. Results 31 participants completed the study: 13 females; median age 10 years, range 4–16 years. Lung function (mean ± SD;%FEV1, baseline = 83.26 ± 19.63, follow-up = 86.31 ± 20.95;%FVC, baseline = 92.65 ± 16.02, follow-up = 94.32 ± 16.82; FEV1: FVC, baseline = 0.79 ± 0.11, follow-up = 0.80 ± 0.10) and LCI (mean ± SD; baseline = 10.05 ± 2.86, follow-up = 9.66 ± 2.10) were unchanged post-intervention. Most participants felt that SoloPep was easy to use (72% Strongly Agree; 24% Agree; 4% Neutral), addressed issues they had with cleaning their current OPEP device (72% Strongly Agree; 16% Agree; 12% Neutral), and encouraged them to perform their OPEP therapy more regularly (52% Strongly Agree; 28% Agree; 16% Neutral, 4% Strongly Disagree). All participants agreed that they would like to use SoloPep as their usual OPEP device (76% Strongly Agree; 24% Agree). No adverse device-related events were reported during SoloPep use. Conclusion SoloPep was developed as a daily disposable OPEP device to reduce the risk of infection due to poor device cleaning. It is a convenient, user-friendly alternative to currently available OPEP devices. Over the course of the study, lung function was maintained, no adverse events were reported, and positive user experiences of the device were reported. Therefore, SoloPep may be a useful adjunct to aid airway clearance in children with CF.

BACKGROUND: Oscillating positive expiratory pressure devices aid removal of excess secretions and reduce gas trapping in patients with hypersecretory pulmonary diseases, for example, cystic fibrosis. Oscillating positive expiratory pressure works when the patient exhales actively against a fixed resistor, which generates mean intrapulmonary pressures of 10–20 cm H 2 O with rapid fluctuations of at least 1 cm H 2 O from the mean. In this study, we evaluated the performance of oscillating positive expiratory pressure therapy by pediatric subjects with cystic fibrosis to determine adherence to target therapeutic pressures. METHODS: Twenty-one pediatric subjects were recruited. Each had a history of using an oscillating positive expiratory pressure device twice daily and had received standardized training and instructions from the same specialist physiotherapist. Performance was evaluated by using a flow and pressure sensor placed in-line between the participant9s mouth and the device. The participants performed expirations as per their normal routine. RESULTS: None of the participants achieved target therapeutic pressure ranges during expiration. The mean ± SD pressure generated was 16.2 ± 6.8 cm H 2 O, whereas mean ± SD flow was 31.3 ± 8.9 L/min. The mean ± SD expiration length was 2.5 ± 1.4 s. CONCLUSIONS: Despite standardized instruction, the results demonstrated considerable variation among the participants and overall poor technique during use. Outcomes of this study indicated that airway clearance effects of oscillating positive expiratory pressure were compromised due to poor technique.

Peristomal skin complications are a common problem for persons with an ileostomy.The purpose of this pilot study was to solicit user feedback and perform an initial assessment of the performance of a new barrier seal designed to decrease the risk of chemical-induced dermatitis.Seven (7) potential participants who were at least 18 years of age,6 months post surgery, with an end or loop ileostomy and unbroken peristomal skin, and who were capable of changing their appliance themselves or had the availability of care assistance were identified and recruited by the stoma care nurse at the University Hospital, Limerick, Ireland. At the initial visit and after 1 and 2 weeks, participants were asked to rate device comfort, security, and handling; skin condition was assessed by the research nurse using the Ostomy Skin Tool. Descriptive statistics were used to tabulate the results.Five (5) participants completed the study. Discoloration, erosion, and tissue overgrowth scores improved in 3 of 5 patients, and the mean Ostomy Skin Tool score decreased from 5.4 ± 2.19 at the initial assessment to 4 ± 1.87 at the week 2 visit. Comfort, handling, and security ratings increased from a median of 8 at the beginning of the study to 10 at week 2.Initial patient feedback regarding the new product was positive, and skin assessment results suggest the new seal may help improve peristomal skin condition. Larger studies with longer patient follow-up are needed to confirm the results of this pilot evaluation.

Wearable devices are fast evolving to address mobility and autonomy needs of elderly people whowould benefit from physical assistance. Recent developments in soft robotics provide importantopportunities to develop soft exoskeletons (also called exosuits) to enable both physical assistanceand improved usability and acceptance for users. The XoSoft EU project has developed a modularsoft lower limb exoskeleton to assist people with low mobility impairments. In this paper, we presentthe design of a soft modular lower limb exoskeleton to improve person’s mobility, contributing toindependence and enhancing quality of life. The novelty of this work is the integration of quasi-passive elements in a soft exoskeleton. The exoskeleton provides mechanical assistance for subjectswith low mobility impairments reducing energy requirements between 10% and 20%. Investigationof different control strategies based on gait segmentation and actuation elements is presented. A firsthip–knee unilateral prototype is described, developed, and its performance assessed on a post-strokepatient for straight walking. The study presents an analysis of the human–exoskeleton energy pat-terns by way of the task-based biological power generation. The resultant assistance, in terms ofpower, was 10.9% ±2.2% for hip actuation and 9.3% ±3.5% for knee actuation. The control strat-egy improved the gait and postural patterns by increasing joint angles and foot clearance at specificphases of the walking cycle., This work has received funding from the European Union’s Horizon 2020 framework programme forresearch and innovation under grant agreement no. 688175.

Objective This pilot study proposed and performs initial testing with Exoscore, a design evaluation tool to assess factors related to acceptance of exoskeleton by older adults, during the technology development and testing phases. Background As longevity increases and our aging population continues to grow, assistive technologies such as exosuits and exoskeletons can provide enhanced quality of life and independence. Exoscore is a design and prototype stage evaluation method to assess factors related to perceptions of the technology, the aim being to optimize technology acceptance. Method In this pilot study, we applied the three-phase Exoscore tool during testing with 11 older adults. The aims were to explore the feasibility and face validity of applying the design evaluation tool during user testing of a prototype soft lower limb exoskeleton. Results The Exoscore method is presented as part of an iterative design evaluation process. The method was applied during an exoskeleton research and development project. The data revealed the aspects of the concept design that rated favorably with the users and the aspects of the design that required more attention to improve their potential acceptance when deployed as finished products. Conclusion Exoscore was effectively applied to three phases of evaluation during a testing session of a soft exoskeleton. Future exoskeleton development can benefit from the application of this design evaluation tool. Application This study reveals how the introduction of Exoscore to exoskeleton development will be advantageous when assessing technology acceptance of exoskeletons by older adults.

The objective of this research was to apply a user-centered design approach to the development of a soft exoskeleton for lower limb assistance. There has been a clear shift from hard to soft robotic exoskeletons in recent years. Soft exoskeleton technologies typically comprise sensors and actuators embedded in fabric/technical textiles. This approach to physical assistance offers benefits in usability for wearers, but also presents challenges e.g. how the concepts are put on/off and worn for long durations considering the personal needs of the wearer. Presented is a structured three-cycle development approach which considers user-centered design principles, but also a participatory user-driven design-test-redesign methodology. Target users for the concept (older adults, individuals post-stroke or incomplete spinal cord injury) were involved in concurrent design evaluation and development throughout the design process.

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BackgroundWe report a case of using 3D printing to create a bespoke eye cover for an 18-year-old man with left maxillary alveolar rhabdomyosarcoma. Further, the patient had proptosis causing chemosis and subsequent conjunctival abrasions. This had been managed by taping a large dressing around the eye for a number of weeks previously.MethodsA 3D scanner was used to capture the surface topography of the patients face. The data were imported into a CAD package and used as a guide to create a bespoke eye cover. The final design was 3D printed in a biocompatible material for use by the patient.ResultsThe scan, modelling, and printing of the bespoke cover was completed successfully in less than 72 hours.Conclusion3D printing offers a method to create bespoke solutions for patients in palliative care to meet rare and difficult clinical challenges.

BACKGROUND Within the international literature, no studies have been identified that compare prevalence rates of low back pain (LBP) in chartered physiotherapists, physical and athletic therapists and those in the national working population, making it unclear whether such therapists are an occupational group at high risk of developing LBP. AIMS To establish the prevalence of LBP among therapists (both employed and self-employed) in Ireland, to compare the employment status-, gender- and age-specific LBP prevalence rates between therapists and the national working population and to estimate the adjusted odds of developing LBP among therapists relative to the national working population. METHODS An analysis of data from the Health In Hand Intensive Tasks and Safety (HITS) study and the third national Survey on Lifestyle, Attitudes and Nutrition (SLAN). The HITS study was a cross-sectional study investigating work-related musculoskeletal disorders in practising therapists. The SLAN 2007 was a face-to-face interview study of adults. RESULTS LBP prevalence in therapists was 49% with no significant difference by employment status. Therapists had a much higher prevalence compared with the national working population across all demographic strata, with therapists nearly five times more likely to suffer from LBP than the national working population after careful adjustment for differences in sociodemographic factors. CONCLUSIONS Therapists in Ireland are an occupational group at high risk of developing LBP, warranting further research into their physical and psychosocial work-related risk factors.

This paper presents the design and preliminary testing of a full-body assistive exoskeleton AXO-SUIT for older adults. AXO-SUIT is a system of modular exoskeletons consisting of lower-body and upper-body modules, and their combination as full body as well to provide flexible physical assistance as needed. The full-body exoskeleton comprises 27 degrees of freedom, of which 17 are passive and 10 active, which is able to assist people in walking, standing, carrying and handling tasks. In the paper, design of the AXO-SUIT is described. End-user testing results are presented to show the effectiveness of the exoskeleton in providing flexible physical assistance.

Background: OPEP devices are indicated to remove excess secretions and reduce gas trapping in patients with hypersecretory pulmonary diseases e.g. Cystic Fibrosis (CF), bronchiectasis, chronic bronchitis. OPEP works by actively exhaling to functional residual capacity via a fixed resistor, to generate mean pressures of 10-20 cmH2O at a flow rate of 10-20 L/min, with an Inspiration: Expiration (I:E) ratio of 1:3 or 1:4. The current study sought to evaluate user behaviour during OPEP therapy in paediatric CF patients. Methods: 21 paediatric patients were recruited at the CF unit in University Hospital Limerick, Ireland. Each subject used an OPEP device twice daily and received standardised training and instructions from the same specialist physiotherapist. Use behaviour was evaluated using a flow and pressure sensor placed in-line between the subject’s mouth and OPEP device. Each subject was asked to perform ten expirations as per their normal routine. Each expiration was recorded separately for analysis. Results: None of the subjects achieved the specified therapeutic ranges during expiration (Figure 1). Mean pressure = 16.19 cmH2O [SD=6.78], with a mean flow = 31.28 L/min [SD=8.85]. Mean Expiration length = 2.53s [SD=1.36], with mean I:E ratio = 1:1.24 [range: 1:0.36 – 1:2.42]. Interpretation: Despite standardised instruction and good adherence to twice daily OPEP therapy, subjects demonstrated poor technique and large variance during use. Multiple cofounding factors may contribute to this phenomenon.

This paper presents the design of a modular full-body assistive exoskeleton (FB-AXO) for older adults which was developed with funding under the AAL funded AXO-SUIT project. Processes used to formulate a prioritized set of functional and design requirements via close end-user involvement are outlined and used in realising the exoskeleton. Design of the resulting mechanics and electronics details for the lower- and upper-body subsystems (LB-AXO and (UB-AXO)) are described. Innovative designs of shoulder and spine mechanisms are presented. The FB-AXO system comprises 27 degrees of freedom, of which 17 are passive and 10 active. The exoskeleton assists full-body motions such as walking, standing, bending, as well as performing lifting and carrying tasks to assist older users performing tasks of daily living.