Validation of a Custom Interface Pressure Measurement System to Improve Fitting of Transtibial Prosthetic Check Sockets.

Achievement of fit between the residual limb and prosthetic socket during socket manufacture is a priority for clinicians and is essential for safety. Clinicians have recognised the potential benefits of having a sensor system that can provide objective socket-limb interface pressure measurements during socket fitting, but the cost of existing systems makes current technology prohibitive. This study will report on the characterisation, validation and preliminary clinical implementation of a low cost, portable, wireless sensor system designed for use during socket manufacture. Characterisation and benchtop testing demonstrated acceptable accuracy, behaviour at variable temperature, and dynamic response for use in prosthetic socket applications. Our sensor system was validated with simultaneous measurement by a commercial sensor system in the sockets of three transtibial prosthesis users during a fitting session in the clinic. There were no statistically significant differences between the sensor system and the commercial sensor for a variety of functional activities. The sensor system was found to be valid in this clinical context. Future work should explore how pressure data relates to ratings of fit and comfort, and how objective pressure data might be used to assist in clinical decision making.

Experimental Evaluation of a Hybrid Sensory Feedback System for Haptic and Kinaesthetic Perception in Hand Prostheses.

This study proposes a new hybrid multi-modal sensory feedback system for prosthetic hands that can provide not only haptic and proprioceptive feedback but also facilitate object recognition without the aid of vision. Modality-matched haptic perception was provided using a mechanotactile feedback system that can proportionally apply the gripping force through the use of a force controller. A vibrotactile feedback system was also employed to distinguish four discrete grip positions of the prosthetic hand. The system performance was evaluated with a total of 32 participants in three different experiments (i) haptic feedback, (ii) proprioceptive feedback and (iii) object recognition with hybrid haptic-proprioceptive feedback. The results from the haptic feedback experiment showed that the participants' ability to accurately perceive applied force depended on the amount of force applied. As the feedback force was increased, the participants tended to underestimate the force levels, with a decrease in the percentage of force estimation. Of the three arm locations (forearm volar, forearm ventral and bicep), and two muscle states (relaxed and tensed) tested, the highest accuracy was obtained for the bicep location in the relaxed state. The results from the proprioceptive feedback experiment showed that participants could very accurately identify four different grip positions of the hand prosthesis (i.e., open hand, wide grip, narrow grip, and closed hand) without a single case of misidentification. In experiment 3, participants could identify objects with different shapes and stiffness with an overall high success rate of 90.5% across all combinations of location and muscle state. The feedback location and muscle state did not have a significant effect on object recognition accuracy. Overall, our study results indicate that the hybrid feedback system may be a very effective way to enrich a prosthetic hand user's experience of the stiffness and shape of commonly manipulated objects.

Perioperative pharmacokinetics and pharmacodynamics of meloxicam in emus (Dromaius novaehollandiae) of different age groups using nonlinear mixed effect modelling.

Meloxicam is a widely used nonsteroidal anti-inflammatory drug in avian species. However, variability in pharmacokinetic (PK) and pharmacodynamic (PD) parameters in birds warrants species-specific studies for dose and dosing interval optimization. We performed a perioperative PK study of meloxicam (0.5 mg/kg, intravenously) on emus of three different age groups: 3 chicks (5 weeks old, 3.5 kg), 4 juveniles (26 weeks old, 18.8 kg) and 6 adults (66 weeks old, 38.8 kg). A two-compartment population PK model including weight as a significant covariate on clearance and central volume of distribution (V1) best fitted the data. The typical values (20 kg bird) for clearance and V1 were 0.54 L/kg/h and 0.095 L/kg. Both parameters significantly decreased with increasing weight/age. Meloxicam potency and selectivity for COX-1 and COX-2 were measured in whole blood assays (TxB2 production endpoint). Meloxicam was partially selective in emus (IC50 COX-1:COX-2 = 9.1:1). At the current empirical dose (0.5 mg/kg/24 hr), plasma meloxicam concentration is above IC50 of COX-2 for only 2 hr. PK/PD predicted dose required for 80% COX-2 inhibition over 24 hr were 3.4, 1.4 and 0.95 L/kg/day in chicks, juveniles and adult emus, respectively. The safety, therapeutic efficacy and practicality of modifying the daily dose or dose interval should be considered for dose recommendations in emus.

Transtibial prosthetic socket fitting: Australian prosthetist perspectives on primary challenges, management strategies, and opportunities for workflow and technological innovation.

BACKGROUND: Following transtibial amputation, a custom-built socket is the most common interface between the prosthesis and residual limb. Desire from both prosthetists and prosthesis users for improved socket fitting processes have been well documented. However, there is currently limited information available about prosthetists' experiences of how prosthetic manufacturing workflow can contribute to socket fit problems. OBJECTIVES: This study aims to determine how socket fit problems are currently detected and managed by prosthetists and to identify challenges, management strategies, and opportunities for workflow and technological innovation during prosthesis manufacture and socket fitting. STUDY DESIGN: Mixed-method (quantitative and qualitative) survey. METHODS: An online survey was developed and piloted in consultation with members of the Australian Orthotic Prosthetic Association. The final 25-question survey was distributed through their membership database. Mixed methods were used to analyze survey items. Qualitative items were grouped and coded under themes relating to challenges, management strategies, and opportunities. Quantitative data were analyzed using nonparametric descriptive methods. RESULTS: Twenty-three respondents with a range of experience completed the survey. Seven of eight major Australian states/territories were represented. Primary workflow stages presenting challenges with limited strategies/solutions available to the prosthetists were roll-on liner selection, mold or cast modifications, communication with the client, and check socket fitting. Suggested solutions included improved socket-limb interface monitoring technology. CONCLUSIONS: This study provides the first insights into prosthetist-identified challenges and limitations at different stages of the socket workflow and presents a starting point for more targeted research into innovation that may assist in these processes.

Assessment of biomedical engineering knowledge using true-false questions.

The COVID-19 pandemic has caused a shift from on-campus to remote online examinations, which are usually difficult to invigilate. Meanwhile, closed-ended question formats, such as true-false (TF), are particularly suited to these examination conditions, as they allow automatic marking by computer software. While previous studies have reported the score characteristics in TF questions in conventional supervised examinations, this study investigates the efficacy of using TF questions in online, unsupervised examinations at the undergraduate level of Biomedical Engineering. We examine the TF and other question-type scores of 57 students across three examinations held in 2020 under online, unsupervised conditions. Our analysis shows significantly larger coefficient of variance (CV) in scores in TF questions (42.7%) than other question types (22.3%). The high CV in TF questions may be explained by different answering strategies among students, with 13.3 ± 17.2% of TF questions left unanswered (zero marks) and 16.4 ± 11.5% of TF questions guessed incorrectly (negative marks awarded). In unsupervised, open-book examination where sharing of answers among students is a potential risk; questions that induce a larger variation in responses may be desirable to differentiate among students. We also observed a significant relationship (r = 0.64, p < 0.05) between TF scores and the overall subject scores, indicating that TF questions are an effective predictor of overall student performance. Our results from this initial analysis suggests that TF questions are useful for assessing biomedical-theme content in online, unsupervised examinations, and are encouraging for their ongoing use in future assessments.

The Impact of Limited Prosthetic Socket Documentation: A Researcher Perspective.

The majority of limb prostheses are socket mounted. For these devices, the socket is essential for adequate prosthetic suspension, comfort, and control. The socket is unique among prosthetic components as it is not usually mass-produced and must instead be custom-made for individual residual limbs by a prosthetist. The knowledge of what constitutes "good" socket fit is gained by expert prosthetists and technicians over years of experience, and rarely documented. The reliance on tacit knowledge makes it difficult to standardize the criteria for a well-fitting socket, leading to difficulties understanding the impact of socket fit. Despite its importance, the workflow for socket fitting is often overlooked in literature. Due to the customized nature of sockets, if information is provided in literature, generally only the type of socket and suspension mechanism is noted, with information regarding the fitting and manufacturing processes omitted. In this article, the concerns, issues and consequences arising from lack of upper and lower limb socket documentation are discussed from a researcher perspective, supported by healthcare professionals and socket fabrication specialists. Key changes are proposed to the way socket manufacturing and evaluation are documented to assist future research.

Human-device interface pressure measurement in prosthetic, orthotic and exoskeleton applications: A systematic review.

This study aimed to investigate normal and shear load sensor technology that has been characterised and used at the human-device interface in prosthetic, orthotic and exoskeleton applications. In addition to taking a cross-disciplinary view, this study expands on previous reviews by considering recently published papers, clinical translation of sensors, and development of the sensor technology itself. A search of MEDLINE, INSPEC, SCOPUS and Web of Science was performed up to 26 January 2021. A total of 33 studies were assessed for quality and their data extracted. The review found variable quality of published papers, with normal load being most commonly measured, and resistive sensor technology most commonly used. The translation to clinical environments was indicated in most studies, though the study population was not always made up of the target users. Studies could benefit from more direct comparison with clinically relevant load thresholds and by ensuring clinical testing is performed in the most realistic and representative way possible. Additionally, more focus on developing sensors that measure shear loads would enable further insights into conditions at the human-device interface. Finally, all researchers would benefit from better and more widespread anonymous data sharing practices to facilitate further experimentation.

Clinical utility of pressure feedback to socket design and fabrication.

BACKGROUND: The clinical utility of measuring pressure at the prosthetic socket-residual limb interface is currently unknown. OBJECTIVES: This study aimed to identify whether measuring interface pressure during prosthetic design and fabrication results in closer agreement in pressure measurements between sockets made by different clinicians, and a reduction in pressure over areas of concern. It also investigated whether clinicians value knowing the interface pressure during the fabrication process. STUDY DESIGN: Mixed methods. METHODS: Three prosthetists designed a complete prosthetic system for a transtibial residual limb surrogate. Standardised mechanical testing was performed on each prosthetic system to gain pressure measurements at four key anatomical locations. These measurements were provided to the clinicians, who subsequently modified their sockets as each saw fit. The pressure at each location was re-measured. Each prosthetist completed a survey that evaluated the usefulness of knowing interface pressures during the fabrication process. RESULTS: Feedback and subsequent socket modifications saw a reduction in the pressure measurements at three of the four anatomical locations. Furthermore, the pressure measurements between prosthetists converged. All three prosthetists found value in the pressure measurement system and felt they would use it clinically. CONCLUSIONS: Results suggest that sensors measuring pressure at the socket-limb interface has clinical utility in the context of informing prosthetic socket design and fabrication. If the technology is used at the check socket stage, iterative designs with repeated measurements can result in increased consistency between clinicians for the same residual limb, and reductions in the magnitudes of pressures over specific anatomical landmarks. CLINICAL RELEVANCE: This study provides new information on the value of pressure feedback to the prosthetic socket design process. It shows that with feedback, socket modifications can result in reduced limb pressures, and more consistent pressure distributions between prosthetists. It also justifies the use of pressure feedback in informing clinical decisions.

Reliability and validity of the iSense optical scanner for measuring volume of transtibial residual limb models.

BACKGROUND:: Residual limb volume is often measured as part of routine care for people with amputations. These measurements assist in the timing of prosthetic fitting or replacement. In order to make well informed decisions, clinicians need access to measurement tools that are valid and reliable. OBJECTIVES:: To assess the reliability and criterion validity of the iSense optical scanner in measuring volume of transtibial residual limb models. STUDY DESIGN:: Three assessors performed two measurements each on 13 residual limb models with an iSense optical scanner (3D systems, USA). Intra-rater and inter-rater reliability were calculated using intraclass correlation coefficients. Bland Altman plots were inspected for agreement. Criterion validity was assessed using a steel rod of known dimensions. Ten repeated measurements were performed by one assessor. A t-test was used to determine differences between measured and true rod volume. RESULTS:: Intra-rater reliability was excellent (range of intraclass correlation coefficients: 0.991-0.997, all with narrow 95% confidence intervals). While the intraclass correlation coefficients suggest excellent inter-rater reliability between all three assessors (range of intraclass correlation coefficients: 0.952-0.986), the 95% confidence intervals were wide between assessor 3 and the other two assessors. Poor agreement with assessor 3 was also seen in the Bland-Altman plots. Criterion validity was very poor with a significant difference between the mean iSense measurement and the true rod volume (difference: 221.18 mL; p < 0.001). CONCLUSIONS:: Although intra-rater reliability was excellent for the iSense scanner, we did not find similar results for inter-rater reliability and validity. These results suggest that further testing of the iSense scanner is required prior to use in clinical practice. CLINICAL RELEVANCE: The iSense offers a low cost scanning option for residual limb volume measurement. Intra-rater reliability was excellent, but inter-rater reliability and validity were such that clinical adoption is not indicated at present.

Reliability and Validity of Measurement Tools for Residual Limb Volume in People With Limb Amputations: A Systematic Review.

BACKGROUND: Measurements of residual limb volume often guide decisions on the type and timing of prosthetic prescription. To help inform these decisions, it is important that clinicians use measurement tools that are reliable and valid. PURPOSE: The aim of this systematic review was to investigate the reliability and validity of measurement tools for residual limb volume in people with limb amputations. DATA SOURCES: A comprehensive search on MEDLINE, EMBASE, CINAHL, Scopus, and Web of Science was performed on July 11, 2016. STUDY SELECTION: Studies were included if they examined the reliability or validity of measurement tools for residual limb volume, were conducted on humans, and were published in English. DATA EXTRACTION: Data were extracted from 11 reliability and 4 validity studies and included study characteristics, volumetric estimates, and reliability and validity estimates. The quality of the studies was also rated. DATA SYNTHESIS: Data from 2 studies (38 participants) indicated good to excellent intrarater (intraclass correlation coefficient [ICC] ≥0.88) and interrater (ICC ≥0.88) reliability and high between-session reliability (coefficient of variation [CV] = 10%) for water displacement volumetry. One study (28 participants) reported excellent intrarater and interrater reliability (ICC ≥0.93) for the circumferential method, and data from 2 studies (19 participants) indicated high between-session reliability for the optical surface scanner (CV ≤9.8%). Three studies (26 participants) indicated good to excellent between-session reliability results for computed tomography (CV = 9.2%-10.9%). One study (7 participants) showed moderate within-session reliability (CV = 50%). Using water displacement volumetry as the gold standard, 2 studies (79 participants) indicated excellent validity for the circumferential method ( r ≥0.92; ICC ≥0.92). All studies reporting measures of reliability or validity were performed with people who had transtibial amputations. LIMITATIONS: Only studies published in English and in which water displacement volumetry was used as the gold standard were included in this review. The reliability and validity of the quality rating scale used in this review have not been tested. CONCLUSIONS: On the basis of a limited number of moderate- to high-quality studies with small sample sizes, circumferential and water displacement methods were found to be reliable, and the circumferential method was found to be valid in people with transtibial amputations. There are inadequate data for drawing conclusions about volume measurement methods in people with other types of limb amputations.