Search Results (29)

Since elevated temperature and humidity may occur at the prosthetic socket–skin interface, it is essential to collect thermal data from the residual limb, as this information serves as an indicator of adverse effects such as irritation, postural problems, and significant damage to health. These data are obtained non-invasively through the execution of a thermal imaging (TI) procedure. However, the precision and repeatability of a TI procedure rely significantly on its execution technique. This work presents the design and implementation of a mechatronic device that automates a thermal imaging technique. The application of the device is in lower-limb prosthetics evaluation. The proposed system improves data acquisition consistency by reducing execution time and minimizing human error, thereby enhancing the reproducibility and reliability of thermal measurements. The introduced device, Thermal Imaging Booth, proposes an automated solution for TI standardization in clinical and research settings. By minimizing inconsistencies, this system improves the diagnostic potential of thermography, facilitating its adoption in biomedical applications. Full article

Background/Objective: Changes in limb volume affect prosthetic socket fit and limb health, which in turn affects the comfort, stability, and usability of a prosthesis. The objective of this research was to identify and evaluate residual limb fluid volume metrics that could be used to identify the need for a prosthetic socket modification or replacement. Methods: A prospective observational study was conducted with transtibial prosthesis users undergoing socket modification or replacement. Participants performed a morning and afternoon 20 min structured activity protocol and self-reported their average socket comfort and other health outcomes before and after their socket was modified or replaced. Limb fluid volume changes across the protocol were recorded using bioimpedance analysis. Results: Anterior region residual limb fluid volume loss was low when the socket comfort score was high. Participants with ESCS_ave increases of ≥2 points pre- to post-modification experienced less limb fluid volume loss post-modification minus pre-modification (mean +0.6%) compared to participants with ESCS_ave increases of <2 points (mean −0.9%) (p = 0.0002). Conclusions: The percentage of fluid volume in the anterior limb may be a useful quantitative metric to explore for the application of bioimpedance monitoring in clinical care, helping to identify when sufficient change has occurred such that a new socket is warranted. Full article

This study investigates strategies to enhance the structural integrity of 3D-printed orthopedic transtibial exoskeleton sockets by integrating non-planar reinforcement with structured prepreg rods composed of continuous carbon fibers, leveraging multi-axis additive manufacturing techniques. A prototype of a cylindrical polyamide 3D-printed exoskeleton socket is examined. Numerical modeling using progressive failure analysis, incorporating material property degradation models, successfully simulated damage accumulation in the studied 3D-printed structures. Numerical simulations revealed that crack formation initiates in the socket’s distal section, aligning with physical test observations. Targeted localized reinforcement with carbon rods effectively strengthened the high-load regions of the prosthetic devices. A method to improve product strength by optimization of the internal architecture of the embedded reinforcements in the local stress concentrator zones is proposed. The results demonstrate a reduction in stress concentrations within prostheses when using carbon fiber reinforcements. Multi-axis dual extrusion non-planar additive manufacturing techniques were used to produce the developed prototypes. Surface morphology was examined, and optimal process parameters were determined to enhance printing quality. The developed approach enables precise reinforcement of custom-shaped sockets with complex geometries. Full article

Standardizing socket design and maintaining a default socket alignment in transtibial prostheses are innovations that aim to simplify fitting procedures and reduce prosthetic service costs, particularly in low-income countries. Objectives: This study evaluated the Mercer Universal Prosthesis (MUP) with a standardized “neutral alignment” against custom-made conventional prostheses (CVPs). Methods: Twenty transtibial amputees (n = 20) completed gait assessments using their CVP and immediately after fitting with an MUP. Temporal–spatial and sagittal plane kinematics (hip, knee, and ankle angles) were analyzed, along with a gait symmetry index. Results: the MUP group reported a significant difference between the prosthetic and the intact limb for both hip and knee kinematics (p < 0.05), but there was no change in the CVP group. When compared with the sound limb in the MUP group, post hoc analysis showed that both hip flexion and the hip range of motion (ROM) in the MUP limb significantly increased by 5.7° and 7.3° (p = 0.002 and p < 0.001, respectively). Spatial and temporal gait parameters were comparable between the MUP and CVP groups, and gait symmetry showed no significant differences. The CVP showed greater symmetry in terms of hip (19%, p = 0.012) and knee flexion (8%, p = 0.026) compared to the MUP, while the MUP had higher plantarflexion symmetry (24.4%, p = 0.013). Conclusions: Immediately post fitting, MUP improved joint mobility in the prosthetic limb, potentially enhancing kinematics. While short-term benefits are evident, further research is needed to assess long-term gait adaptation and quality of life impacts. Full article

Background: Transtibial prosthetic sockets are critical components in the complete assembly of a prosthetic, as they form the major load-bearing parts by housing the residual limb of a prosthesis user. Conventional procedures for manufacturing these sockets require repeated iterations and manual casting, baking, and drying, which often lead to longer processing and waiting times. Additive Manufacturing (AM) enables the creation of bespoke designs with meticulous control over the socket’s shape, thickness, and material composition. Method: To design and propose an optimal socket design to a lower-limb prosthetic user based on their preference of activity such as walking, running, and jumping, we investigated seven materials—Polypropylene (PP) standard material for conventional socket fabrication, Polylactic-acid-plus (PLA+), Polyamide (PA) Natural, Polyamide-6-Glass-Fiber (PA6-GF), Polyamide-copolymer (CoPA), Polyamide-6-Carbon-Fiber (PA6-CF), and Polyamide-12-Carbon-Fiber (PA12-CF)—that have AM compatibility by subjecting them to heavy external loading and evaluating their von Mises stress–strain behavior. Result: Using Finite Element Analysis (FEA), we evaluated a single-material design and a combination design with two materials—one major (low cost) and one minor (higher cost)—to optimize a composition that would bear heavy external loads without yielding. A maximum load-bearing capacity of 3650 N was achieved with the combination of PLA+ and 31.54 vol% PA6-CF (30.23 weight%, 99.13 g), costing about USD 14 for the total socket material. Similarly, a combination of PLA+ with 31.54 vol% PA6-GF (30.76 weight%, 101.67 g) exhibited a maximum load-bearing capacity of 2528.91 N. Conclusions: The presence of high-strength CF and GF in minor compositions and at critical locations within the transtibial socket are the suggested reasons for these enhanced load-bearing capacities, due to which these sockets could be used for undertaking a wider range of activities by the prosthesis users. Full article

Our limb prostheses aim to restore Activities of Daily Living (ADLs) for amputees, with the socket being a critical component of trans-tibial prostheses influencing both comfort and functionality. Despite technological advancements, challenges such as fit, weight, and durability remain. This study investigates an additive manufacturing method for Total Surface Bearing (TSB) sockets, leveraging CT scans to create a Computer-Aided Design (CAD) and finite element (FE) model. Biomechanical behavior under static loading conditions were analyzed using FE analysis and resistive-based pressure sensors. The study found consistent pressure distribution across the residual limb, with deviations of 8.53 kPa and 4.46 kPa between FE analysis and experimental measurements. Mean pressures of 44.6 kPa and 22.11 kPa were observed under Full Body Weight (FBW) and Half Body Weight (HBW) conditions, respectively. The FE analysis demonstrated a uniform stress distribution in the prosthetic socket, with a maximum stress of 0.15 MPa and a deformation of 0.008 mm, highlighting the effectiveness of this approach in enhancing socket design. Full article

The socket is the most important, patient-specific element of a prosthesis. Conventionally, the process of making a custom socket involves manually rectifying a plaster model of the residual limb. This process is time-consuming and often inconsistent among prosthetists because it is based on implicit knowledge. Hence, the aim of this work was to describe a novel process of generating a prosthetist-specific, digital “global” template and to illustrate that it can be automatically applied to rectify the shape of a transtibial residual limb. The process involved (1) the acquisition of a “training” dataset of unrectified and rectified positive models through manual data collection and digital 3D scanning, and (2) the unsupervised learning of the prosthetist’s rectifications by an artificial intelligence (AI) algorithm. The assessment of the process involved (1) evaluating whether the rectification rule learned by the AI was consistent with the prosthetist’s expectations, and (2) evaluating the template feasibility by applying the AI rectification process to a new residual limb and comparing the results to the prosthetist’s manual rectification for the same residual limb. The results suggest that the AI-rectified positive was consistent with the approach described by the prosthetist, with only small radial and angle errors and similar dimensions (volume and cross-sectional perimeters) as the hand-rectified positive. This study provides a proof-of-concept of the ability to integrate an AI algorithm into the fabrication process for transtibial prosthetic sockets. Once refined, this approach may provide a time-saving tool for prosthetists by automatically implementing typical rectifications and providing a good starting socket fit for individuals with amputation. Full article

Background: The company Ethnocare has developed the Overlay, a new pneumatic solution for managing volumetric variations (VVs) of the residual limb (RL) in transtibial amputees (TTAs), which improves socket fitting. However, the impact of the Overlay during functional tasks and on the comfort and pain felt in the RL is unknown. Methods: 8 TTAs participated in two evaluations, separated by two weeks. We measured compensatory strategies (CS) using spatio-temporal parameters and three-dimensional lower limb kinematics and kinetics during gait and sit-to-stand (STS) tasks. During each visit, the participant carried out our protocol while wearing the Overlay and prosthetic folds (PFs), the most common solution to VV. Between each task, comfort and pain felt were assessed using visual analog scales. Results: While walking, the cadence with the Overlay was 105 steps/min, while it was 101 steps/min with PFs (p = 0.021). During 35% and 55% of the STS cycle, less hip flexion was observed while wearing the Overlay compared to PFs (p = 0.004). We found asymmetry coefficients of 13.9% with the Overlay and 17% with PFs during the STS (p = 0.016) task. Pain (p = 0.031), comfort (p = 0.017), and satisfaction (p = 0.041) were better with the Overlay during the second visit. Conclusion: The Overlay’s impact is similar to PFs’ but provides less pain and better comfort. Full article

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

Achieving a comfortable socket residual limb interface is crucial for effective prosthetic rehabilitation, depending on the precise characterisation and fluctuations in the shape and volume of residual limbs. Clinicians rely on subjective and iterative methods for shaping sockets, often involving a trial-and-error approach. This study introduces a framework for measuring, analysing, and comparing residual limb shape and volume using scanned data to facilitate more informed clinical decision-making. Surface scans of 44 transtibial residual limb casts of various sizes and lengths were examined. All scans were spatially aligned to a mid-patella and subjected to analysis using a shape analysis toolbox. Geometric measurements were extracted, with particular attention to significant rectified regions during the cast rectification process. Following PTB guidelines, our analysis revealed substantial alterations, primarily in the mid-patella region, followed by the patellar tendon area. Notably, there was a significant volume change of 6.02% in the region spanning from mid-patella to 25% of the cast length. Beyond this point, linear cast modifications were observed for most amputees up to 60% of the cast length, followed by individual-specific deviations beyond this region. Regardless of residual limb size and length, the modifications applied to positive casts suggested categorising patients into five major groups. This study employs the AmpScan shape analysis tool, to comprehend the cast rectification process used for capturing and assessing the extent of rectification on patients’ residual limb casts. The clinical implications of our research are threefold: (a) the comparison data can serve as training resources for junior prosthetists; (b) this will aid prosthetists in identifying specific regions for rectification and assessing socket fit; (c) it will help in determining optimal timing for prosthetic fitting or replacement. Full article

Monitoring and controlling the microclimate at the skin–socket interface of limb prostheses is an important, yet unresolved, clinical problem. Phase-change materials (PCMs) represent a promising biosensor technology that holds the potential to both detect and alter (i.e., stabilize) changes in the temperature of a hybrid biological/mechanical system, such as a prosthesis. The biologically inspired sensor capabilities of PCMs can enhance the internal socket conditions and offer improved comfort and suspension while minimizing skin injuries for prosthesis users. This study investigated how prosthetic liners equipped with PCM biosensors affected the long-term outcomes for prosthesis users. In this double-blinded longitudinal crossover study, a cohort of transtibial prosthesis users wore regular conventional liners for six months and PCM liners for another six months. Prosthesis utilization, physical performance, and gait symmetry were studied using Modus StepWatch, the 2-minute walk test, and the TekScan F-Scan gait test, respectively. Measured parameters from these various tests, acquired at multiple timepoints during the study, were compared pairwise between the two liners per individual. While the obtained quantitative data trends, such as the gait symmetry, favored the PCM liners, no statistically significant differences were found between the PCM and conventional gel liners in any of the study parameters. Full article

The design and fitting of prosthetic sockets can significantly affect the acceptance of an artificial limb by persons with lower limb amputations. Clinical fitting is typically an iterative process, which requires patients’ feedback and professional assessment. When feedback is unreliable due to the patient’s physical or psychological conditions, quantitative measures can support decision-making. Specifically, monitoring the skin temperature of the residual limb can provide valuable information regarding unwanted mechanical stresses and reduced vascularization, which can lead to inflammation, skin sores and ulcerations. Multiple 2D images to examine a real-life 3D limb can be cumbersome and might only offer a partial assessment of critical areas. To overcome these issues, we developed a workflow for integrating thermographic information on the 3D scan of a residual limb, with intrinsic reconstruction quality measures. Specifically, workflow allows us to calculate a 3D thermal map of the skin of the stump at rest and after walking, and summarize this information with a single 3D differential map. The workflow was tested on a person with transtibial amputation, with a reconstruction accuracy lower than 3 mm, which is adequate for socket adaptation. We expect the workflow to improve socket acceptance and patients’ quality of life. Full article

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. Full article

Lower-limb prosthesis design and manufacturing still rely mostly on the workshop process of trial-and-error using expensive unrecyclable composite materials, resulting in time-consuming, material-wasting, and, ultimately, expensive prostheses. Therefore, we investigated the possibility of utilizing Fused Deposition Modeling 3D-printing technology with inexpensive bio-based and bio-degradable Polylactic Acid (PLA) material for prosthesis socket development and manufacturing. The safety and stability of the proposed 3D-printed PLA socket were analyzed using a recently developed generic transtibial numeric model, with boundary conditions of donning and newly developed realistic gait cycle phases of a heel strike and forefoot loading according to ISO 10328. The material properties of the 3D-printed PLA were determined using uniaxial tensile and compression tests on transverse and longitudinal samples. Numerical simulations with all boundary conditions were performed for the 3D-printed PLA and traditional polystyrene check and definitive composite socket. The results showed that the 3D-printed PLA socket withstands the occurring von-Mises stresses of 5.4 MPa and 10.8 MPa under heel strike and push-off gait conditions, respectively. Furthermore, the maximum deformations observed in the 3D-printed PLA socket of 0.74 mm and 2.66 mm were similar to the check socket deformations of 0.67 mm and 2.52 mm during heel strike and push-off, respectively, hence providing the same stability for the amputees. We have shown that an inexpensive, bio-based, and bio-degradable PLA material can be considered for manufacturing the lower-limb prosthesis, resulting in an environmentally friendly and inexpensive solution. Full article

The well-established finite element method (FEM) has been used successfully to evaluate and develop medical devices for lower-limb prosthetics over recent decades. Most numerical models are based on a specific 3D geometry, which, although allowing for an accurate analysis of a specific case, may differ significantly from the target group that is often geometrically closer to the average residual limb. In order to address this issue, a generic numerical transtibial model was developed with the corresponding definitive socket and silicone liner. Three load cases were performed to analyse the applicability of the model: donning, single-leg stance, and the static P5 test according to ISO 10328. While the first two cases were used commonly in previous studies, the ISO test was only used in physical tests and not in a numerical environment. The results of the simulations in terms of contact pressure, as well as the relative deformation of the socket, fit into the range reported in the literature for similar boundary conditions, thus verifying the model in biomechanical terms. The generic transtibial model serves as a numerical tool for the relative comparison of different socket-liner designs prior to the fabrication, providing insights into results that are otherwise difficult to obtain. Full article