A quantitative comparison between the mHand Adapt passive adjustable hand prosthesis and its predecessor, the Delft Self-Grasping Hand.

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.

Adjustable prosthetic sockets: a systematic review of industrial and research design characteristics and their justifications.

BACKGROUND: The 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. METHODS: Systematic 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. RESULTS: 50 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. DISCUSSION: There 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.

Evidencing the effectiveness of upper limb prostheses: a multi-stakeholder perspective on study requirements.

The provision of upper limb prosthetic devices through the National Health Services (NHS) within the United Kingdom is driven by national policies. NHS England have recently published a new policy to provide multi-grip myoelectric hands. The policy highlighted that there was limited evidence to support its deployment and it will be reviewed should new information arise. The clear identification of the evidence gap provides an opportunity for the academic research community to conduct studies that will inform future iterations of this and other upper limb prosthetic related policies. This paper presents a summary of findings and recommendations based on two multi-stakeholder workshops held in June 2022 and July 2022, which explored the design requirements for policy-driven research studies. The workshops involved people from a broad range of stakeholder groups: policy, academia, NHS clinical and management, industry, and a person with upper limb absence. The workshop discussions focused on the research questions that NHS England identified in the policy evidence review: (1) Clinical Effectiveness; (2) Cost Effectiveness; (3) Safety; and (4) Patient Subgroups. The recommendations based on stakeholder discussions included the need to gather qualitative and quantitative research evidence, use goal-based outcome measures, and conduct longitudinal studies. Future research studies also need to address the complexities of conducting national and international policy-driven research, such as clinical resource capacity and participant involvement.

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.

State of the art of prosthesis simulators for the upper limb: A narrative review.

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.

An evaluation of contralateral hand involvement in the operation of the Delft Self-Grasping Hand, an adjustable passive prosthesis.

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-to-day life and development of suitable training methods.

Evaluating Reachable Workspace and User Control Over Prehensor Aperture for a Body-Powered Prosthesis.

Using a shoulder harness and control cable, a person can control the opening and closing of a body-powered prosthesis prehensor. In many setups the cable does not pass adjacent to the shoulder joint center allowing shoulder flexion on the prosthetic side to be used for prehensor control. However, this makes cable setup a difficult compromise as prosthesis control is dependent on arm posture; too short and the space within which a person can reach may be unduly restricted, too long and the user may not be able to move their shoulder sufficiently to take up the inevitable slack at some postures and hence have no control over prehensor movement. Despite the fundamental importance of reachable workspace to users, to date there have been no studies in prosthetics on this aspect. Here, a methodology is presented to quantify the reduction in the reachable volume due to the harness, and to record the range-of-motion of the prehensor at a series of locations within the reachable workspace. Ten anatomically intact participants were assessed using a body-powered prosthesis simulator. Data was collected using a 3D motion capture system and an electronic goniometer. The harnessed reachable workspace was 38-85% the size of the unharnessed volume with participants struggling to reach across the body and above the head. Across all arm postures assessed, participants were only able to achieve full prehensor range-of-motion in 9%. The methodologies presented could be used to evaluate future designs of both body-powered and myoelectric prostheses.

Technology for monitoring everyday prosthesis use: a systematic review.

BACKGROUND: Understanding how prostheses are used in everyday life is central to the design, provision and evaluation of prosthetic devices and associated services. This paper reviews the scientific literature on methodologies and technologies that have been used to assess the daily use of both upper- and lower-limb prostheses. It discusses the types of studies that have been undertaken, the technologies used to monitor physical activity, the benefits of monitoring daily living and the barriers to long-term monitoring, with particular focus on low-resource settings. METHODS: A systematic literature search was conducted in PubMed, Web of Science, Scopus, CINAHL and EMBASE of studies that monitored the activity of prosthesis users during daily-living. RESULTS: Sixty lower-limb studies and 9 upper-limb studies were identified for inclusion in the review. The first studies in the lower-limb field date from the 1990s and the number has increased steadily since the early 2000s. In contrast, the studies in the upper-limb field have only begun to emerge over the past few years. The early lower-limb studies focused on the development or validation of actimeters, algorithms and/or scores for activity classification. However, most of the recent lower-limb studies used activity monitoring to compare prosthetic components. The lower-limb studies mainly used step-counts as their only measure of activity, focusing on the amount of activity, not the type and quality of movements. In comparison, the small number of upper-limb studies were fairly evenly spread between development of algorithms, comparison of everyday activity to clinical scores, and comparison of different prosthesis user populations. Most upper-limb papers reported the degree of symmetry in activity levels between the arm with the prosthesis and the intact arm. CONCLUSIONS: Activity monitoring technology used in conjunction with clinical scores and user feedback, offers significant insights into how prostheses are used and whether they meet the user's requirements. However, the cost, limited battery-life and lack of availability in many countries mean that using sensors to understand the daily use of prostheses and the types of activity being performed has not yet become a feasible standard clinical practice. This review provides recommendations for the research and clinical communities to advance this area for the benefit of prosthesis users.

Upper limb activity of twenty myoelectric prosthesis users and twenty healthy anatomically intact adults.

The upper limb activity of twenty unilateral upper limb myoelectric prosthesis users and twenty anatomically intact adults were recorded over a 7-day period using two wrist worn accelerometers (Actigraph, LLC). This dataset reflects the real-world activities of the participants during their normal day-to-day routines. Participants included students, working adults, and retirees recruited from across the United Kingdom. This dataset offers a potential wealth of knowledge into a poorly understood cohort. The raw unprocessed data files and the activity count data exported from the Actilife software are provided. We also provide a non-wear algorithm developed for the removal of prosthesis non-wear periods and resulting activity count data corresponding to prothesis wear periods. Finally, we have included the transposed activity diaries provided by the participants. Analysis to date has primarily involved assessment of the symmetry of upper limb activity, however, there is potential to undertake additional analysis such as understanding the differences in the way a prosthesis is used compared to an anatomical arm.

Upper- and lower-limb amputees show reduced levels of eeriness for images of prosthetic hands.

The "uncanny phenomenon" describes the feeling of unease associated with seeing an image that is close to appearing human. Prosthetic hands in particular are well known to induce this effect. Little is known, however, about this phenomenon from the viewpoint of prosthesis users. We studied perceptions of eeriness and human-likeness for images of different types of mechanical, cosmetic, and anatomic hands in upper-limb prosthesis users (n=9), lower-limb prosthesis users (n=10), prosthetists (n=16), control participants with no prosthetic training (n=20), and control participants who were trained to use a myoelectric prosthetic hand simulator (n=23). Both the upper- and lower-limb prosthesis user groups showed a reduced uncanny phenomenon (i.e., significantly lower levels of eeriness) for cosmetic prosthetic hands compared to the other groups, with no concomitant reduction in how these stimuli were rated in terms of human-likeness. However, a similar effect was found neither for prosthetists with prolonged visual experience of prosthetic hands nor for the group with short-term training with the simulator. These findings in the prosthesis users therefore seem likely to be related to limb absence or prolonged experience with prostheses.

Corrigendum: The Reality of Myoelectric Prostheses: Understanding What Makes These Devices Difficult for Some Users to Control.

[This corrects the article on p. 7 in vol. 10, PMID: 27597823.].

Visualisation of upper limb activity using spirals: A new approach to the assessment of daily prosthesis usage.

BACKGROUND: Current outcome measures used in upper limb myoelectric prosthesis studies include clinical tests of function and self-report questionnaires on real-world prosthesis use. Research in other cohorts has questioned both the validity of self-report as an activity assessment tool and the relationship between clinical functionality and real-world upper limb activity. Previously,1 we reported the first results of monitoring upper limb prosthesis use. However, the data visualisation technique used was limited in scope. STUDY DESIGN: Methodology development. OBJECTIVES: To introduce two new methods for the analysis and display of upper limb activity monitoring data and to demonstrate the potential value of the approach with example real-world data. METHODS: Upper limb activity monitors, worn on each wrist, recorded data on two anatomically intact participants and two prosthesis users over 1 week. Participants also filled in a diary to record upper limb activity. Data visualisation was carried out using histograms, and Archimedean spirals to illustrate temporal patterns of upper limb activity. RESULTS: Anatomically intact participants' activity was largely bilateral in nature, interspersed with frequent bursts of unilateral activity of each arm. At times when the prosthesis was worn prosthesis users showed very little unilateral use of the prosthesis (≈20-40 min/week compared to ≈350 min/week unilateral activity on each arm for anatomically intact participants), with consistent bias towards the intact arm throughout. The Archimedean spiral plots illustrated participant-specific patterns of non-use in prosthesis users. CONCLUSION: The data visualisation techniques allow detailed and objective assessment of temporal patterns in the upper limb activity of prosthesis users. Clinical relevance Activity monitoring offers an objective method for the assessment of upper limb prosthesis users' (PUs) activity outside of the clinic. By plotting data using Archimedean spirals, it is possible to visualise, in detail, the temporal patterns of upper limb activity. Further work is needed to explore the relationship between traditional functional outcome measures and real-world prosthesis activity.

The Reality of Myoelectric Prostheses: Understanding What Makes These Devices Difficult for Some Users to Control.

Users of myoelectric prostheses can often find them difficult to control. This can lead to passive-use of the device or total rejection, which can have detrimental effects on the contralateral limb due to overuse. Current clinically available prostheses are "open loop" systems, and although considerable effort has been focused on developing biofeedback to "close the loop," there is evidence from laboratory-based studies that other factors, notably improving predictability of response, may be as, if not more, important. Interestingly, despite a large volume of research aimed at improving myoelectric prostheses, it is not currently known which aspect of clinically available systems has the greatest impact on overall functionality and everyday usage. A protocol has, therefore, been designed to assess electromyographic (EMG) skill of the user and predictability of the prosthesis response as significant parts of the control chain, and to relate these to functionality and everyday usage. Here, we present the protocol and results from early pilot work. A set of experiments has been developed. First, to characterize user skill in generating the required level of EMG signal, as well as the speed with which users are able to make the decision to activate the appropriate muscles. Second, to measure unpredictability introduced at the skin-electrode interface, in order to understand the effects of the socket-mounted electrode fit under different loads on the variability of time taken for the prosthetic hand to respond. To evaluate prosthesis user functionality, four different outcome measures are assessed. Using a simple upper limb functional task prosthesis users are assessed for (1) success of task completion, (2) task duration, (3) quality of movement, and (4) gaze behavior. To evaluate everyday usage away from the clinic, the symmetricity of their real-world arm use is assessed using activity monitoring. These methods will later be used to assess a prosthesis user cohort to establish the relative contribution of each control factor to the individual measures of functionality and everyday usage (using multiple regression models). The results will support future researchers, designers, and clinicians in concentrating their efforts on the area that will have the greatest impact on improving prosthesis use.