Assessment of Socket Pressure during Walking in Rapid Fit Prosthetic Sockets.
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ABSTRACT:
SUBMITTER: Sasaki K
PROVIDER: S-EPMC9319515 | biostudies-literature | 2022 Jul
REPOSITORIES: biostudies-literature
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Assessment of Socket Pressure during Walking in Rapid Fit Prosthetic Sockets.
Sasaki Kazuhiko K Guerra Gary G Lei Phyu Win W Chaisumritchoke Sirarat S Sutdet Prawina P Kaewtip Sirintip S
Sensors (Basel, Switzerland) 20220713 14
(1) Background: A sustainable casting system that combines the use of a polystyrene bag, a prosthetic liner and a vacuum system was developed to reduce fabrication time while maintaining comfort for the trans-tibial prosthesis user. (2) Methods: Eight prosthetists (28.7 ± 8.25 years old) fit ten trans-tibial prosthesis wearers (46 ± 12.4 years old) with two types of total surface bearing (TSB) prostheses; a polystyrene bead (PS) prosthesis and a plaster of paris (POP) prosthesis. Duration of cas ...[more]
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Project description:IntroductionA challenge in the engineering of auto-adjusting prosthetic sockets is to maintain stable operation of the control system while users change their bodily position and activity. The purpose of this study was to test the stability of a socket that automatically adjusted socket size to maintain fit. Socket release during sitting was conducted between bouts of walking.MethodsAdjustable sockets with sensors that monitored distance between the liner and socket were fabricated. Motor-driven panels and a microprocessor-based control system adjusted socket size during walking to maintain a target sensed distance. Limb fluid volume was recorded continuously. During eight sit/walk cycles, the socket panels were released upon sitting and then returned to position for walking, either the size at the end of the prior bout or a size 1.0% larger in volume.ResultsIn six transtibial prosthesis users, the control system maintained stable operation and did not saturate (move to and remain at the end of the actuator's range) during 98% of the walking bouts. Limb fluid volume changes generally matched the panel position changes executed by the control system.ConclusionsStable operation of the control system suggests that the auto-adjusting socket is ready for testing in users' at-home settings.
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Project description:The prosthetic socket, which transfers load from the residual limb to the prosthesis, is an integral part of the prosthesis. 3D printing has emerged as a potentially viable alternative to traditional fabrication for producing sockets that effectively transfer loads. We conducted a systematic review to better understand the current state of this newer fabrication method, with a focus on the structural integrity of 3D printed sockets and factors that can affect the strength of 3D printed sockets when tested using ISO 10328 standards. Literature searches were carried out in five databases (PubMed, Scopus, CINAHL, Web of Science and Google Scholar). Two reviewers independently performed the literature selection, quality assessment, and data extraction. A total of 1023 unique studies were screened in accordance with inclusion and exclusion criteria. Of 1023 studies, 12 studies met all inclusion criteria, with failure data for 15 3D-printed sockets and 26 standard laminated sockets. Within 3D printed sockets, the addition of composite materials such as carbon fiber particles and distal reinforcement using a compositing infill technique appears to improve socket strength. In light of the considerable amount of heterogeneity between studies in terms of materials and alignment used, the absolute values for failure could not be established for 3DS nor directly compared between 3DS and LCS. However, there is some evidence that the probability of a failure at a given load may be comparable between 3DS and LCS up to the P8 level. For all sockets, whether a laminated composite socket or a 3D printed socket, failure mainly occurred at the distal end of the socket or the pyramid attachment, which is consistent with the ISO testing protocol. Improving the strength of the 3D printed sockets through design modifications at the distal end and implementing emerging printing technologies could help to promote 3D printed sockets as a viable option, particularly when cost or access to care is limited.
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Project description:BackgroundAmong the different factors affecting socket comfort, the pressure applied on residual limb tissues is a crucial parameter for the success or failure of any prosthetic device. However, only a few incomplete data are available on people with transfemoral amputation, in this regard. This work aims at filling this gap in the literature.MethodsTen people with transfemoral amputation wearing 3 different socket designs were recruited in this study: 2 ischial containment sockets featured by proximal trim lines that contain the ischial tuberosity and ramus and greater trochanter, 2 subischial sockets with proximal trim lines under the ischium level, and 6 quadrilateral sockets with proximal trim lines that contain the greater trochanter and create a horizontal seat for the ischial tuberosity. The pressure values at the anterior, lateral, posterior, and medial areas of the socket interface were recorded during 5 locomotion tasks (ie, horizontal, ascent, and descent walking, upstairs and downstairs) by using an F-Socket System (Tekscan Inc., Boston, MA). Gait segmentation was performed by exploiting plantar pressure, which was acquired by an additional sensor under the foot. Mean and standard deviation of minimum and maximum values were calculated for each interface area, locomotion task, and socket design. The mean pressure patterns during different locomotion tasks were reported, as well.ResultsConsidering all subjects irrespective of socket design, the mean pressure range resulted 45.3 (posterior)-106.7 (posterior) kPa in horizontal walking; 48.3 (posterior)-113.8 (posterior) kPa in ascent walking; 50.8 (posterior)-105.7 (posterior) kPa in descent walking; 47.9 (posterior)-102.9 (lateral) kPa during upstairs; and 41.8 (posterior)-84.5 (anterior) kPa during downstairs. Qualitative differences in socket designs have been found.ConclusionsThese data allow for a comprehensive analysis of pressures acting at the tissue-socket interface in people with transfemoral amputation, thus offering essential information for the design of novel solutions or to improve existing ones, in this field.
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Project description:Elevated vacuum (EV) is suggested to improve suspension and limb volume management for lower limb prosthesis users. However, few guidelines have been established to facilitate configuration of EV sockets to ensure their safe and proper function. A benchtop model of an EV socket was created to study how prosthetic liner tensile elasticity, socket fit, and socket vacuum pressure affect liner displacement and subsequent pressure on the residual limb. A domed carbon fiber layup was used to represent an EV socket. Inserts were used to simulate various air gaps between the socket and liner. Various prosthetic liner samples were placed under the carbon fiber layup. Liner displacement and the corresponding pressure change underneath the liner were measured as vacuum was applied between the liner sample and socket wall. Tissue vacuum pressure increased linearly with socket vacuum pressure until the liner contacted the socket wall. Predicted tissue vacuum pressure matched well with experimental results. Findings suggest that the effect of vacuum pressure on the residual limb is primarily determined by air gap distance. The developed model may be used to assess effects of EV on residual limb tissues based on an individual's socket fit, liner characteristics, and applied vacuum. Understanding the physiological effects of EV on the residual limb could help practitioners avoid blister formation and improve EV implementation.
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Project description:Acquisition of surface electromyography (sEMG) from a person with an amputated lower extremity (LE) during prosthesis-assisted walking remains a significant challenge due to the dynamic nature of the gait cycle. Current solutions to sEMG-based neural control of active LE prostheses involve a combination of customized electrodes, prosthetic sockets, and liners. These technologies are generally: (i) incompatible with a subject's existing prosthetic socket and liners; (ii) uncomfortable to use; and (iii) expensive. This paper presents a flexible dry electrode design for sEMG acquisition within LE prosthetic sockets which seeks to address these issues. Design criteria and corresponding design decisions are explained and a proposed flexible electrode prototype is presented. Performances of the proposed electrode and commercial Ag/AgCl electrodes are compared in seated subjects without amputations. Quantitative analyses suggest comparable signal qualities for the proposed novel electrode and commercial electrodes. The proposed electrode is demonstrated in a subject with a unilateral transtibial amputation wearing her own liner, socket, and the portable sEMG processing platform in a preliminary standing and level ground walking study. Qualitative analyses suggest the feasibility of real-time sEMG data collection from load-bearing, ambulatory subjects.
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Project description:People with transtibial amputation often experience skin breakdown due to the pressures and shear stresses that occur at the limb-socket interface. The purpose of this research was to create a transtibial finite element model (FEM) of a contemporary prosthesis that included complete socket geometry, two frictional interactions (limb-liner and liner-socket), and an elastomeric liner. Magnetic resonance imaging scans from three people with characteristic transtibial limb shapes (i.e., short-conical, long-conical, and cylindrical) were acquired and used to develop the models. Each model was evaluated with two loading profiles to identify locations of focused stresses during stance phase. The models identified five locations on the participants' residual limbs where peak stresses matched locations of mechanically induced skin issues they experienced in the 9 months prior to being scanned. The peak contact pressure across all simulations was 98 kPa and the maximum resultant shear stress was 50 kPa, showing reasonable agreement with interface stress measurements reported in the literature. Future research could take advantage of the developed FEM to assess the influence of changes in limb volume or liner material properties on interface stress distributions. Graphical abstract Residual limb finite element model. Left: model components. Right: interface pressures during stance phase.
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Project description:The study was designed to establish a biomechanical assessment platform for the lower limb residuum/socket interface as a function of duration and speed of movement. The approach exploits an interface sensor which measures multi-directional stresses at the interface. The corresponding interface coupling motion was assessed using a 3D motion capture system. A longitudinal study, involving a trans-femoral amputee, was conducted with nine repeated level walking sessions over a 12-month period. The effect of walking speed on interface biomechanics was also assessed. Interface peak pressures and shear stresses in the range of 55-59 kPa and 12-19 kPa were measured, respectively, over all sessions in the 12 months study period at the posterior-proximal location of the residuum. The peak pressure and longitudinal shear values were found to fluctuate approximately 11% and 40% as against its maximum value, respectively, over 12 months. In addition, up to 12° of angular coupling and up to 28 mm of pistoning were recorded over a gait cycle, which was found to change by 29% and 45% respectively over the study period. The variation in walking speed, by altering self-selected cadence, resulted in changes of pressure and shear stresses at mid-stance of the gait cycle. In particular, as compared with self-selected cadence, for fast speed, peak pressure and peak longitudinal shear stress decreased by 5% and 33%, respectively. For slow speed, peak pressure and peak longitudinal shear stress increased by 7% and 17%, respectively. The corresponding angular and pistoning revealed a variation of up to 29% and 45%, respectively. This biomechanical assessment approach shows promise in the quantitative assessment of interface kinematics and kinetics for lower limb prosthetics, the usage of which could assist the clinical assessment of prosthetic socket fit.
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Project description:In recent years, numerous prosthetic ankle-foot devices have been developed to address the demands of sloped walking for individuals with lower-limb amputation. The goal of this study was to compare the performance of a passive, hydraulic ankle-foot prosthesis to two related, non-hydraulic ankles based on their ability to minimize the socket reaction moments of individuals with transtibial amputation during a range of sloped walking tasks. After a two-week accommodation period, kinematic data were collected on seven subjects with a transtibial amputation walking on an instrumented treadmill set at various slopes. Overall, this study was unable to find significant differences in the torque at the distal end of the prosthetic socket between an ankle-foot prosthesis with a hydraulic range-of-motion and other related ankle-foot prosthesis designs (rigid ankle, multiaxial ankle) during the single-support phase of walking. In addition, socket comfort and perceived exertion were not significantly different for any of the ankle-foot prostheses tested in this study. These results suggest the need for further work to determine if more advanced designs (e.g., those with microprocessor control of hydraulic features, powered ankle-foot designs) can provide more biomimetic function to prosthesis users.
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Project description:BackgroundThe prosthetic socket is a key component that influences prosthesis satisfaction, with a poorly fitting prosthetic socket linked to prosthesis abandonment and reduced community participation. This paper reviews adjustable socket designs, as they have the potential to improve prosthetic fit and comfort through accommodating residual limb volume fluctuations and alleviating undue socket pressure.MethodsSystematic literature and patent searches were conducted across multiple databases to identify articles and patents that discussed adjustable prosthetic sockets. The patents were used to find companies, organisations, and institutions who currently sell adjustable sockets or who are developing devices.Results50 literature articles and 63 patents were identified for inclusion, representing 35 different designs used in literature and 16 commercially available products. Adjustable sockets are becoming more prevalent with 73% of publications (literature, patents, and news) occurring within the last ten years. Two key design characteristics were identified: principle of adjustability (inflatable bladders, moveable panels, circumferential adjustment, variable length), and surface form (conformable, rigid multi-DOF, and rigid single DOF). Inflatable bladders contributed to 40% of literature used designs with only one identified commercially available design (n = 16) using this approach. Whereas circumferential adjustment designs covered 75% of identified industry designs compared to only 36% of literature devices. Clinical studies were generally small in size and only 17.6% of them assessed a commercially available socket.DiscussionThere are clear differences in the design focus taken by industry and researchers, with justification for choice of design and range of adjustment often being unclear. Whilst comfort is often reported as improved with an adjustable socket, the rationale behind this is not often discussed, and small study sizes reduce the outcome viability. Many adjustable sockets lack appropriate safety features to limit over or under tightening, which may present a risk of tissue damage or provide inadequate coupling, affecting function and satisfaction. Furthermore, the relationship between design and comfort or function are rarely investigated and remain a significant gap in the literature. Finally, this review highlights the need for improved collaboration between academia and industry, with a strong disconnect observed between commercial devices and published research studies.
| S-EPMC10626671 | biostudies-literature
Project description:BACKGROUND:There are many studies that have investigated biomechanical differences among prosthetic feet, but not changes due to adaptation over time. There is a need for objective measures to quantify the process of adaptation for individuals with a transtibial amputation. Mechanical power and work profiles are a primary focus for modern energy-storage-and-return type prostheses, which strive to increase energy return from the prosthesis. The amount of energy a prosthesis stores and returns (i.e., negative and positive work) during stance is directly influenced by the user's loading strategy, which may be sensitive to alterations during the course of an adaptation period. The purpose of this study was to examine changes in lower limb mechanical work profiles during walking following a three-week adaptation to a new prosthesis. METHODS:A retrospective analysis was performed on 22 individuals with a unilateral transtibial amputation. Individuals were given a new prosthesis at their current mobility level (K3 or above) and wore it for three weeks. Kinematic and kinetic measures were recorded from overground walking at 0, 1.5, and 3 weeks into the adaptation period at a self-selected pace. Positive and negative work done by the prosthesis and sound ankle-foot were calculated using a unified deformable segment model and a six-degrees-of-freedom model for the knee and hip. RESULTS:Positive work from the prosthesis ankle-foot increased by 6.1% and sound ankle-foot by 5.7% after 3 weeks (p?=?0.041, 0.036). No significant changes were seen in negative work from prosthesis or sound ankle-foot (p?=?0.115, 0.192). There was also a 4.1% increase in self-selected walking speed after 3 weeks (p?=?0.038). Our data exhibited large inter-subject variations, in which some individuals followed group trends in work profiles while others had opposite trends in outcome variables. CONCLUSIONS:After a 3-week adaptation, 14 out of 22 individuals with a transtibial amputation increased energy return from the prosthesis. Such findings could indicate that individuals may better utilize the spring-like function of the prosthesis after an adaptation period.
| S-EPMC5787280 | biostudies-literature