Individuals with limb loss present significant challenges to testing and evaluating prosthetic devices, such as medical approval processes and participant availability. Prosthesis simulators, designed for mimicking prosthesis use with able-bodied individuals, offer an alternative to conducting controlled experiments and enhancing the development of prosthetic technologies. This review examines the design features, applications, and limitations of lower limb prosthesis simulators. A literature search identified 73 studies that have used lower limb prosthesis simulators. Most studies have focused on transfemoral prosthesis simulators (TFsims) and testing prosthetic designs and control mechanisms. The most frequently assessed movement was walking, while other movements, were explored only sporadically. The findings reveal significant variability in simulator configurations, training protocols, and the range of movements assessed. Additionally, a notable research gap exists in evaluations of the effect of transtibial prosthesis simulators (TTsims) and hip disarticulation prosthesis simulators (HDsims) on gait. Despite these challenges, prosthesis simulators offer promising potential for accelerating and improving prosthesis development while putting less stress on the relatively small target group of individuals with limb loss. Further research is needed to standardize methodologies and better understand the effects of simulator design and training on gait performance to facilitate advancements in prosthetic research.

This scoping review provides an overview of studies comparing the (cost-)effectiveness of shape capture and socket design techniques for transtibial and transfemoral prostheses. The review compares manual, hybrid, and digital methods, identifies the measurement tools used, and assesses their methodological quality. Effectiveness refers to clinical and functional outcomes such as socket fit, comfort, and user function, whereas cost-effectiveness reflects the balance between resource use and these outcomes. Following Preferred Reporting Items for Systematic Reviews and Meta-analysis guidelines, 5 databases (PubMed, Embase, Web of Science, CINAHL, and Cochrane) were systematically searched. Studies involving humans with transtibial or transfemoral prostheses that compared at least 2 of the 3 methods and reported (cost-)effectiveness outcomes were included. Of 556 articles screened, 20 met the inclusion criteria (497 participants). Sixteen studies evaluated transtibial prostheses and 4 transfemoral prostheses. Manual and hybrid methods were compared in 14 studies, and digital and manual methods in 6, whereas none compared hybrid and digital methods. Eighteen studies were rated as low quality, 2 as moderate, and none as high. Effectiveness constructs mainly covered the International Classification of Functioning, Disability and Health domains “Body functions & Body structures” and “Activities and participation, ” but many were not clearly defined within this framework. Reported outcomes most often addressed production time, number of socket attempts, and socket fit or comfort. Overall, evidence remains limited and inconsistent, with a clear lack of direct comparisons between digital and hybrid techniques. Tentatively, hybrid and digital approaches may improve efficiency and comfort compared with manual methods, but robust, standardized research is needed to confirm these effects.

Introduction: Bone fractures represent a global health problem with the incidence of fractures on the rise each year. The predominant method for addressing bone fractures involves immobilization. Worldwide, many initiatives have sought to develop innovative fracture immobilization designs, and numerous solutions have been patented. However, a comprehensive overview and systematic classification of these patented designs is lacking. Areas covered: In pursuit of these patented immobilization designs, the Espacenet database, recognized as the largest global repository of patents, served as the principal investigative tool. Using a search string, patent classifications and inclusion criteria a total of 71 patents were identified. These can be classified into four unique design groups: (1) fixed and partly enclosed, (2) fixed and fully enclosed, (3) adjustable and partly enclosed and (4) adjustable and fully enclosed designs. The designs that are commercially available are predominantly situated within groups 3 and 4. Expert opinion: Advances in 3D scanning and additive manufacturing could improve comfort, personalization, and monitoring in fracture immobilization, but clinical adoption is hindered by slow production times, workflow misalignment, and regulatory barriers. Key improvements are needed in scanning accuracy, adjustment protocols, and integration into hospital logistics to ensure both technical feasibility and clinical usability.

Background: Pneumatic actuators are widely used in applications like (medical) robots, or prostheses. Pneumatic actuators require a complex manufacturing process and are produced in standardized dimensions to reduce costs. Over the last decade 3D-printing has emerged as a cost-effective and efficient production method in medical applications. 3D-printing can also function as a cost-efficient alternative production method for pneumatic actuators. Objective: The goal of this research is to study the possibility of creating a pneumatic linear actuator with 3D-printing. Furthermore, the aim is to use the advantage of 3D-printing to create pneumatic actuators with non-circular cross-sections. Methodology: To evaluate the performance of a 3D-printed pneumatic actuator, a test setup was designed and built to measure the leakage and sliding friction force. Furthermore, two pneumatic actuators with a non-conventional cross-sectional shape were designed and their performance was tested and compared with a 3D-printed cylindrical pneumatic actuator, since these tests only ran once, the results are more a guideline. During the manufacturing of the cylinders, no post-processing techniques were used. Results: The functioning of a 3D-printed circular pneumatic actuator was proven with low static leakage rates of 2.5%, low dynamic leakage rates of approximately 1%, and a maximum friction force of [Formula presented]. Furthermore, the results show that it is possible to print functioning pneumatic cylinders with a non-cylindrical concave cross-section. The non-conventional cylinders were tested up to [Formula presented] with maximum dynamic leakage of [Formula presented]. Conclusion: This study demonstrates a method to create functional pneumatic linear actuators with 3D-printing. It was possible to create 3D-printed actuators with a conventional shape, e.g. circular and unconventional shapes e.g. stadium/oval shape and a kidney shape. The leak rates for conventional and unconventional shapes were in the same range. This opens up the world for more design freedom in pneumatic actuators.

Introduction

The Delft Self-Grasping Hand (SGH) is an adjustable passive hand prosthesis that relies on wrist flexion to adjust the aperture of its grasp. The mechanism requires engagement of the contralateral hand meaning that hand is not available for other tasks. A commercialised version of this prosthesis, known as the mHand Adapt, includes a new release mechanism, which avoids the need to press a release button, and changes to the hand shape. This study is the first of its kind to compare two passive adjustable hand prostheses on the basis of quantitative scoring and contralateral hand involvement.
Methods

10 anatomically intact participants were asked to perform the Southampton Hand Assessment Procedure (SHAP) with the mHand. Functionality and contralateral hand involvement were recorded and compared against SGH data originating from a previous trial involving a nearly identical testing regime.
Results

mHand exhibited higher functionality scores and less contralateral hand interaction time, especially during release-aiding interactions. Additionally, a wider range of tasks could be completed using the mHand than the SGH.
Discussion

Geometric changes make the mHand more capable of manipulating smaller objects. The altered locking mechanism means some tasks can be performed without any contralateral hand involvement and a higher number of tasks do not require contralateral involvement when releasing. Some participants struggled with achieving a good initial grip due to the inability to tighten the grasp once already formed.
Conclusion

The mHand offers the user higher functionality scores with less contralateral hand interaction time and the ability to perform a wider range of tasks. However, there are some design trade-offs which may make it slightly harder to learn to use.

Standing up using one leg is a challenging task for those with a transfemoral amputation, particularly for elderly users with a low activity level. Active prostheses are generally not accessible to this group and available passive prostheses do not support standing up. This article presents the design and evaluation of the “Energy Restoring Intelligent Knee” (ERiK), which stores energy during sit-down in a pneumatic cylinder and returns it during stand-up. We hypothesized that the system would reduce the time needed to perform transitions and also enable higher load sharing by the prosthetic leg. However, the results of an experimental study with seven participants with transfemoral amputation contradict these hypotheses: the participants could neither move faster nor make more use of the prosthetic leg to share their body weight during transitions. We observed that a major obstacle to the useful functionality of the leg was the absence of ankle dorsiflexion – the foot tended to slip during stand-up initiation, such that only low pre-pressures and therefore support levels could be set. The rather binary action of the pneumatics also complicated movement initiation. The lessons learned from this study may be helpful to those seeking to create better designs in the future.

Performing precise, repetitive motions is essential in many robotic and automation systems. Iterative learning control (ILC) allows determining the necessary control command by using a very rough system model to speed up the process. Functional iterative learning control is a novel technique that promises to solve several limitations of classic ILC. It operates by merging the input space into a large functional space, resulting in an over-determined control task in the iteration domain. In this way, it can deal with systems having more outputs than inputs and accelerate the learning process without resorting to model discretizations. However, the framework lacks so far a validation in experiments. This paper aims to provide such experimental validation in the context of robotics. To this end, we designed and built a one-link flexible arm that is actuated by a stepper motor, which makes the development of an accurate model more challenging and the validation closer to the industrial practice. We provide multiple experimental results across several conditions, proving the feasibility of the method in practice.

Industrial automation calls for precise tasks with cycle times reduced to the minimum. At the same time, when handling delicate products such as fruits and vegetables, accelerations must be kept low to keep interaction forces under a certain threshold to avoid damage. This trade-off hinders the penetration of automation in many relevant application fields. This paper investigates using soft technology to solve this challenge. We propose the FinFix gripper, a non-anthropomorphic soft gripper capable of handling delicate objects at high acceleration using a contact-reactive grasping approach. This gripper has two entirely passive sensorized fingers that establish contact and two active fingers that are actuated pneumatically through a rigid mechanism allowing for rapid closure. We provide exhaustive experimental validation by connecting the gripper to a delta robot. The system can reliably execute pick-and-place cycles in ∼1 s when the distance between the pick and the place locations is 400 mm, resulting in a peak speed of ∼10ms . None of the fragile objects used during the experiments showed any damage. The only information needed is a rough estimation of the object's position to be grasped and a contact event to trigger the reflex. The test results show that the gripper can hold fragile objects during lateral accelerations of 10g.

In laparoscopy, a small incision size improves the surgical outcome but increases at the same time the rigidity of the instrument, with consequent impairment of the surgeon’s maneuverability. Such reduction introduces new challenges, such as the loss of wrist articulation or the impossibility of overcoming obstacles. A possible approach is using multi-steerable cable-driven instruments fully mechanical actuated, which allow great maneuverability while keeping the wound small. In this work, we compared the usability of the two most promising cable configurations in 3D printed multi-steerable instruments: a parallel configuration with all cables running straight from the steerable shaft to the handle; and a multi configuration with straight cables in combination with helical cables. Twelve participants were divided into two groups and asked to orient the instrument shaft and randomly hit six targets following the instructions in a laparoscopic simulator. Each participant carried out four trials (two trials for each instrument) with 12 runs per trial. The average task performance time showed a significant decrease over the first trial for both configurations. The decrease was 48% for the parallel and 41% for the multi configuration. Improvement of task performance times reached a plateau in the second trial with both instruments. The participants filled out a TLX questionnaire after each trial. The questionnaire showed a lower burden score for the parallel compared to multi configuration (23% VS 30%). Even though the task performance time for both configurations was comparable, a final questionnaire showed that 10 out of 12 participants preferred the parallel configuration due to a more intuitive hand movement and the possibility of individually orienting the distal end of the steerable shaft

(1) Background: This study investigated the feasibility of conducting a two-week “real-world” trial of the Self Grasping Hand (SGH), a novel 3D printed passive adjustable prosthesis for hand absence; (2) Methods: Single-group pilot study of nine adults with trans-radial limb absence; five used body-powered split-hooks, and four had passive cosmetic hands as their usual prosthesis. Data from activity monitors were used to measure wear time and bilateral activity. At the end of the two-week trial, function and satisfaction were measured using the Orthotics and Prosthetics Users’ Survey Function Scale (OPUS) and the prosthesis satisfaction sub-scales of the Trinity Amputations and Prosthesis Experience Scale (TAPES). Semi-structured interviews captured consumer feedback and suggestions for improvement; (3) Results: Average SGH wear time over 2 weeks was 17.5 h (10% of total prosthesis wear time) for split-hook users and 83.5 h (63% of total prosthesis wear time) for cosmetic hand users. Mean satisfaction was 5.2/10, and mean function score was 47.9/100; (4) Two-week real-world consumer testing of the SGH is feasible using the methods described. Future SGH designs need to be more robust with easier grasp lock/unlock.

Background: Research into prosthesis training and design puts a burden on the small population of people with upper-limb absence who can participate in these studies. One solution is to use a prosthetic hand simulator, which allows for attaching a hand prosthesis to an intact limb. However, whether the results of prosthesis simulator studies can be translated to people with upper-limb absence using a hand prosthesis is unclear. Objective: To review the literature on prosthetic hand simulators, provide an overview of current designs, and highlight the differences and similarities between prosthesis simulators and traditional prostheses. Methods: A Boolean combination of keywords was used to search 3 electronic databases: PubMed, Scopus and Web of Science. Relevant articles in English were selected. Results: In total, 52 papers were included in the review, and an overview of the state of the art was presented. We identified the key differences between prosthesis simulators and traditional prostheses as the position of the terminal device and the available degrees of freedom of the arm and (prosthetic) wrist. Conclusions: This paper provides an overview of prosthesis simulator designs over the past 27 years and an overview of the similarities and differences between prosthesis simulators and prostheses. The literature does not provide enough evidence to establish whether the results obtained from simulator studies could be translated to prostheses. A recommendation for future simulator design is to constrain pro- and supination of the forearm of anatomically intact participants and add a prosthetic wrist that can pro- and supinate. Additional research is required to find the ideal terminal device position for a prosthesis simulator with respect to the person's hand.

The Delft Self-Grasping Hand is an adjustable passive prosthesis operated using the concept of tenodesis (where opening and closing of the hand is mechanically linked to the flexion and extension of the wrist). As a purely mechanical device that does not require harnessing, the Self-Grasping Hand offers a promising alternative to current prostheses. However, the contralateral hand is almost always required to operate the mechanism to release a grasp and is sometimes also used to help form the grasp; hence limiting the time it is available for other purposes. In this study we quantified the amount of time the contralateral hand was occupied with operating the Self-Grasping Hand, classified as either direct or indirect interaction, and investigated how these periods changed with practice. We studied 10 anatomically intact participants learning to use the Self-Grasping Hand fitted to a prosthesis simulator. The learning process involved 10 repeats of a feasible subset of the tasks in the Southampton Hand Assessment Procedure (SHAP). Video footage was analysed, and the time that the contralateral hand was engaged in grasping or releasing was calculated. Functionality scores increased for all participants, plateauing at an Index of Functionality of 33.5 after 5 SHAP attempts. Contralateral hand involvement reduced significantly from 6.47 (first 3 attempts) to 4.68 seconds (last three attempts), but as a proportion of total task time remained relatively steady (increasing from 29% to 32%). For 9/10 participants most of this time was supporting the initiation of grasps rather than releases. The reliance on direct or indirect interactions between the contralateral hand and the prosthesis varied between participants but appeared to remain relatively unchanged with practice. Future studies should consider evaluating the impact of reliance on the contralateral limb in day-today life and development of suitable training methods.

Stumbling during gait is commonly encountered in patients who suffer from mild to serious walking problems, e.g., after stroke, in osteoarthritis, or amputees using a lower leg prosthesis. Instead of self-reporting, an objective assessment of the number of stumbles in daily life would inform clinicians more accurately and enable the evaluation of treatments that aim to achieve a safer walking pattern. An easy-to-use wearable might fulfill this need. The goal of the present study was to investigate whether a single inertial measurement unit (IMU) placed at the shank and machine learning algorithms could be used to detect and classify stumbling events in a dataset comprising of a wide variety of daily movements. Ten healthy test subjects were deliberately tripped by an unexpected and unseen obstacle while walking on a treadmill. The subjects stumbled a total of 276 times, both using an elevating recovery strategy and a lowering recovery strategy. Subjects also performed multiple Activities of Daily Living. During data processing, an event-defined window segmentation technique was used to trace high peaks in acceleration that could potentially be stumbles. In the reduced dataset, time windows were labelled with the aid of video annotation. Subsequently, discriminative features were extracted and fed to train seven different types of machine learning algorithms. Trained machine learning algorithms were validated using leave-one-subject-out cross-validation. Support Vector Machine (SVM) algorithms were most successful, and could detect and classify stumbles with 100% sensitivity, 100% specificity, and 96.7% accuracy in the independent testing dataset. The SVM algorithms were implemented in a user-friendly, freely available, stumble detection app named Stumblemeter. This work shows that stumble detection and classification based on SVM is accurate and ready to apply in clinical practice

Wearable robots assist individuals with sensorimotor impairment in daily life, or support industrial workers in physically demanding tasks. In such scenarios, low mass and compact design are crucial factors for device acceptance. Remote actuation systems (RAS) have emerged as a popular approach in wearable robots to reduce perceived weight and increase usability. Different RAS have been presented in the literature to accommodate for a wide range of applications and related design requirements. The push toward use of wearable robotics in out-of-the-lab applications in clinics, home environments, or industry created a shift in requirements for RAS. In this context, high durability, ergonomics, and simple maintenance gain in importance. However, these are only rarely considered and evaluated in research publications, despite being drivers for device abandonment by end-users. In this paper, we summarize existing approaches of RAS for wearable assistive technology in a literature review and compare advantages and disadvantages, focusing on specific evaluation criteria for out-of-the-lab applications to provide guidelines for the selection of RAS. Based on the gained insights, we present the development, optimization, and evaluation of a cable-based RAS for out-of-the-lab applications in a wearable assistive soft hand exoskeleton. The presented RAS features full wearability, high durability, high efficiency, and appealing design while fulfilling ergonomic criteria such as low mass and high wearing comfort. This work aims to support the transfer of RAS for wearable robotics from controlled lab environments to out-of-the-lab applications.

We present a novel approach to estimate the relative sensor orientation from inertial sensors placed on connected body segments. Drift in the relative orientation estimates obtained by integrating the gyroscope measurements is corrected solely by incorporating common information in the inertial sensor measurements due to the connection of the body segments. We solve the estimation problem using a complementary filtering implementation to reduce the computational complexity. We study its robustness under common real-world model violations, e.g., soft tissue artifacts and spikes in the acceleration signals due to impacts. The efficacy of the method is illustrated with numerical simulations and is compared to a multiplicative extended Kalman filter implementation, both with and without outlier rejection. In addition, a human experiment strengthened the simulation results under realistic sensor errors.

Positioning and stabilizing a catheter at the required location inside a vessel or the heart is a complicated task in interventional cardiology. In this review we provide a structured classification of catheter stabilization mechanisms to systematically assess their challenges during cardiac interventions. Commercially available, patented, and experimental prototypes of catheters were classified with respect to their stabilizing mechanisms. Subsequently, the classification was used to define requirements for future cardiac catheters and persisting challenges in catheter stabilization. The classification showed that there are two main stabilization mechanisms: surface-based and volume-based. Surface-based mechanisms apply attachment through surface anchoring, while volume-based mechanisms make use of locking through shape or force against the vessel or cardiac wall. The classification provides insight into existing catheter stabilization mechanisms and can possibly be used as a tool for future design of catheter stabilization mechanisms to keep the catheter at a specific location during an intervention. Additionally, insight into the requirements and challenges for catheter stabilization inside the heart and vasculature can lead to the development of more dedicated systems in the future, allowing for intervention- and patient-specific instrument manipulation.

In the field of medical instruments, additive manufacturing allows for a drastic reduction in the number of components while improving the functionalities of the final design. In addition, modifications for users’ needs or specific procedures become possible by enabling the production of single customized items. In this work, we present the design of a new fully 3D-printed handheld steerable instrument for laparoscopic surgery, which was mechanically actuated using cables. The pistol-grip handle is based on ergonomic principles and allows for single-hand control of both grasping and omnidirectional steering, while compliant joints and snap-fit connectors enable fast assembly and minimal part count. Additive manufacturing allows for personalization of the handle to each surgeon’s needs by adjusting specific dimensions in the CAD model, which increases the user’s comfort during surgery. Testing showed that the forces on the instrument handle required for steering and grasping were below 15 N, while the grasping force efficiency was calculated to be 10–30%. The instrument combines the advantages of additive manufacturing with regard to personalization and simplified assembly, illustrating a new approach to the design of advanced surgical instruments where the customization for a single procedure or user’s need is a central aspect.

Various upper-limb prostheses have been designed for 3D printing but only a few of them are based on bio-inspired design principles and many anatomical details are not typically incorporated even though 3D printing offers advantages that facilitate the application of such design principles. We therefore aimed to apply a bio-inspired approach to the design and fabrication of articulated fingers for a new type of 3D printed hand prosthesis that is body-powered and complies with basic user requirements. We first studied the biological structure of human fingers and their movement control mechanisms in order to devise the transmission and actuation system. A number of working principles were established and various simplifications were made to fabricate the hand prosthesis using a fused deposition modelling (FDM) 3D printer with dual material extrusion. We then evaluated the mechanical performance of the prosthetic device by measuring its ability to exert pinch forces and the energy dissipated during each operational cycle. We fabricated our prototypes using three polymeric materials including PLA, TPU, and Nylon. The total weight of the prosthesis was 92 g with a total material cost of 12 US dollars. The energy dissipated during each cycle was 0.380 Nm with a pinch force of ≈16 N corresponding to an input force of 100 N. The hand is actuated by a conventional pulling cable used in BP prostheses. It is connected to a shoulder strap at one end and to the coupling of the whiffle tree mechanism at the other end. The whiffle tree mechanism distributes the force to the four tendons, which bend all fingers simultaneously when pulled. The design described in this manuscript demonstrates several bio-inspired design features and is capable of performing different grasping patterns due to the adaptive grasping provided by the articulated fingers. The pinch force obtained is superior to other fully 3D printed body-powered hand prostheses, but still below that of conventional body powered hand prostheses. We present a 3D printed bio-inspired prosthetic hand that is body-powered and includes all of the following characteristics: adaptive grasping, articulated fingers, and minimized post-printing assembly. Additionally, the low cost and low weight make this prosthetic hand a worthy option mainly in locations where state-of-the-art prosthetic workshops are absent.

Background: Current body-powered hands have very low acceptance rates. They also require high activation forces. In the past, a high acceptance rate was reported for the then-available Hüfner hand, a hand which could be controlled by relatively low activation forces. Objective: The aim of this study was to measure and quantify the mechanical performance of the Hüfner hand. Study design: Mechanical evaluation. Methods: Two versions of the Hüfner hand were tested using a mechanical test bench. Forces and displacements were measured under four different glove conditions (no glove, leather, polyvinyl chloride (PVC), silicone). The measured results were compared to data from currently available voluntary-closing hands. Results: The Hüfner hand required 132–170 Nmm of work and 78–104 N cable force to pinch 15 N. The overall mechanical performance of the Hüfner hands is better than currently available body-powered hands. Conclusion: The mechanical performance of the Hüfner hand was measured and quantified. Mechanical testing results show that the Hüfner hand has better mechanical performance than current body-powered hands. This may have contributed to its reported high acceptance rates. The design of the Hüfner hand, combined with data presented in this study, can serve as guidelines for the design of a new generation of body-powered hands.

The large interest in robot hands and active hand prostheses has in recent years been joined by that in active hand orthoses. Despite the differences in intended uses, these three categories of artificial hand devices share key characteristics. Examination of the commonalities could stimulate future design. Thus, in this article, we undertook a comparative review of publications describing robot hands, active prostheses, and active orthoses, with a focus on mechanical structure, actuation principle, and transmission. Out of a total of 510 papers identified through the literature search, 72 publications were included in a focused examination. We identified trends in the design of artificial hands and gaps in the literature. After comparing their mechanical aspects, we propose recommendations for future development.