Plantar shear stress in the diabetic foot: A systematic review and meta-analysis.

AIMS: Diabetic foot ulceration (DFU) is a multifactorial process involving undetected, repetitive trauma resulting in inflammation and tissue breakdown. Shear stress forms a major part of plantar load, the aim of this review is to determine whether elevated shear stress results in ulceration. METHODS: A systematic review of the Ovid Medline, EMBASE, CINAHL and Cochrane library databases was performed. Studies involving patients with diabetes who underwent plantar shear stress assessment were included. The primary outcome was plantar shear stress in patients with diabetes who had a current/previous DFU compared with those with no prior ulceration. Meta-analysis was performed comparing shear stress between those with a current or previous DFU and those without, and those with diabetes and healthy controls. RESULTS: The search strategy identified 1461 potentially relevant articles, 16 studies met the inclusion criteria, involving a total of 597 patients. Comparing shear stress between the current/previous DFU group and those without: Standardised mean difference (SMD) 0.62 (95% CI -0.01 to 1.25), in favour of greater shear stress within the DFU group, p = 0.05. Comparing shear stress between people with diabetes and healthy controls: 0.36 (95% CI -0.31 to 1.03), in favour of greater shear stress within the diabetes group, p = 0.29. CONCLUSION: This review suggests that that patients with diabetes and a history of ulceration exhibit greater shear stress than their ulcer-free counterparts. This strengthens the premise that development of systems to measure shear stress may be helpful in DFU prediction and prevention.

Design and Evaluation of Magnetic Hall Effect Tactile Sensors for Use in Sensorized Splints.

Splinting techniques are widely used in medicine to inhibit the movement of arthritic joints. Studies into the effectiveness of splinting as a method of pain reduction have generally yielded positive results, however, no significant difference has been found in clinical outcomes between splinting types. Tactile sensing has shown great promise for the integration into splinting devices and may offer further information into applied forces to find the most effective methods of splinting. Hall effect-based tactile sensors are of particular interest in this application owing to their low-cost, small size, and high robustness. One complexity of the sensors is the relationship between the elastomer geometry and the measurement range. This paper investigates the design parameters of Hall effect tactile sensors for use in hand splinting. Finite element simulations are used to locate the areas in which sensitivity is high in order to optimise the deflection range of the sensor. Further simulations then investigate the mechanical response and force ranges of the elastomer layer under loading which are validated with experimental data. A 4 mm radius, 3 mm-thick sensor is identified as meeting defined sensing requirements for range and sensitivity. A prototype sensor is produced which exhibits a pressure range of 45 kPa normal and 6 kPa shear. A proof of principle prototype demonstrates how this can be integrated to form an instrumented splint with multi-axis sensing capability and has the potential to inform clinical practice for improved splinting.

Hitting the Target: Mathematical Attainment in Children Is Related to Interceptive-Timing Ability.

Interceptive timing is a fundamental ability underpinning numerous actions (e.g., ball catching), but its development and relationship with other cognitive functions remain poorly understood. Piaget suggested that children need to learn the physical rules that govern their environment before they can represent abstract concepts such as number and time. Thus, learning how objects move in space and time may underpin the development of related abstract representations (i.e., mathematics). To test this hypothesis, we captured objective measures of interceptive timing in 309 primary school children (5-11 years old), alongside scores for general motor skill and national standardized academic attainment. Bayesian estimation showed that interceptive timing (but not general motor capability) uniquely predicted mathematical ability even after we controlled for age, reading, and writing attainment. This finding demonstrates that interceptive timing is distinct from other motor skills with specificity in predicting childhood mathematical ability independently of other forms of attainment and motor capability.

An in vivo analysis of safe laparoscopic grasping thresholds for colorectal surgery.

BACKGROUND: Analysis of safe laparoscopic grasping thresholds for the colon has not been performed. This study aimed to analyse tissue damage thresholds when the colon is grasped laparoscopically, correlating histological changes to mechanical compressive forces. METHODS: An instrumented laparoscopic grasper was used to measure the forces applied to porcine colon, with data captured and plotted as a force-time (f-t) curve. Haematoxylin and eosin histochemistry of tissue subjected to 10, 20, 40, 50 and 70 N for 5, 30 and 60 s was performed, and the area of colonic circular and longitudinal muscle was compared in grasped and un-grasped regions. The area under the f-t curve was calculated as a measure of the accumulated force applied, known as the force-time product (FTP). RESULTS: FTP ranged from 55.7 to 3793 N.s. Significant differences were observed between the muscle area of the grasped and un-grasped regions in both longitudinal and circular muscle at 50 N and above for all grasping times. For the longitudinal muscle, significant differences were observed between grasped and un-grasped areas at 20 N force for 30 s (mean difference = 59 mm2, 95% CI 41-77 mm2, P = 0.04), 20 N force for 60 s (mean difference = 31 mm2, 95% CI 21.5-40.5 mm2, P = 0.006) and 40 N force for 30 s (mean difference 37 mm2, 95% CI 27-47 mm2, P = 0.006). Changes in histology correlated with mechanical forces applied to the longitudinal muscle at a FTP over 300 N s. CONCLUSIONS: This study characterizes the grasping forces that result in histological changes to the colon and correlates these with a mechanical measurement of the applied force. The findings will contribute to the development of smart laparoscopic graspers with active constraints to prevent excessive grasping and tissue injury.

Real-Time Measurement of the Tool-Tissue Interaction in Minimally Invasive Abdominal Surgery: The First Step to Developing the Next Generation of Smart Laparoscopic Instruments.

Introduction Analysis of force application in laparoscopic surgery is critical to understanding the nature of the tool-tissue interaction. The aim of this study is to provide real-time data about manipulations to abdominal organs. Methods An instrumented short fenestrated grasper was used in an in vivo porcine model, measuring force at the grasper handle. Grasping force and duration over 5 small bowel manipulation tasks were analyzed. Forces required to retract gallbladder, bladder, small bowel, large bowel, and rectum were measured over 30 seconds. Four parameters were calculated-T(hold), the grasp time; T(close), time taken for the jaws to close; F(max), maximum force reached; and F(rms), root mean square force (representing the average force across the grasp time). Results Mean F(max) to manipulate the small bowel was 20.5 N (±7.2) and F(rms) was 13.7 N (±5.4). Mean T(close) was 0.52 seconds (±0.26) and T(hold) was 3.87 seconds (±1.5). In individual organs, mean F(max) was 49 N (±15) to manipulate the rectum and 59 N (±13.4) for the colon. The mean F(max) for bladder and gallbladder retraction was 28.8 N (±7.4) and 50.7 N (±3.8), respectively. All organs exhibited force relaxation, the F(rms) reduced to below 25 N for all organs except the small bowel, with a mean F(rms) of less than 10 N. Conclusion This study has commenced the process of quantifying tool-tissue interaction. The static measurements discussed here should evolve to include dynamic measurements such as shear, torque, and retraction forces, and be correlated with evidence of histological damage to tissue.

The ontogeny of visual-motor memory and its importance in handwriting and reading: a developing construct.

Humans have evolved a remarkable ability to remember visual shapes and use these representations to generate motor activity (from Palaeolithic cave drawings through Jiahu symbols to cursive handwriting). The term visual-motor memory (VMM) describes this psychological ability, which must have conveyed an evolutionary advantage and remains critically important to humans (e.g. when learning to write). Surprisingly, little empirical investigation of this unique human ability exists--almost certainly because of the technological difficulties involved in measuring VMM. We deployed a novel technique for measuring this construct in 87 children (6-11 years old, 44 females). Children drew novel shapes presented briefly on a tablet laptop screen, drawing their responses from memory on the screen using a digitizer stylus. Sophisticated algorithms (using point-registration techniques) objectively quantified the accuracy of the children's reproductions. VMM improved with age and performance decreased with shape complexity, indicating that the measure captured meaningful developmental changes. The relationship between VMM and scores on nationally standardized writing assessments were explored with the results showing a clear relationship between these measures, even after controlling for age. Moreover, a relationship between VMM and the nationally standardized reading test was mediated via writing ability, suggesting VMM's wider importance within language development.

A cross sectional pilot study utilising STrain Analysis and Mapping of the Plantar Surface (STAMPS) to measure plantar load characteristics within a healthy population.

BACKGROUND: No in-shoe systems, measuring both components of plantar load (plantar pressure and shear stress) are available for use in patients with diabetes. The STAMPS (STrain Analysis and Mapping of the Plantar Surface) system utilises digital image correlation (DIC) to determine the strain sustained by a deformable insole, providing a more complete understanding of plantar shear load at the foot-surface interface. RESEARCH QUESTIONS: What is the normal range and pattern of strain at the foot-surface interface within a healthy population as measured by the STAMPS system? Is STAMPS a valid tool to measure the effects of plantar load? METHODS: A cross-sectional study of healthy participants was undertaken. Healthy adults without foot pathology or diabetes were included. Participants walked 20 steps with the STAMPS insole in a standardised shoe. Participants also walked 10 m with the Novel Pedar® plantar pressure measurement insole within the standardised shoe. Both measurements were repeated three times. Outcomes of interest were global and regional values for peak resultant strain (SMAG) and peak plantar pressure (PPP). RESULTS: In 18 participants, median peak SMAG and PPP were 35.01 % and 410.6kPa respectively. The regions of the hallux and heel sustained the highest SMAG (29.31 % (IQR 24.56-31.39) and 20.50 % (IQR 15.59-24.12) respectively) and PPP (344.8kPa (IQR 268.3 - 452.5) and 279.3kPa (IQR 231.3-302.1) respectively). SMAG was moderately correlated with PPP (r= 0.65, p < 0.001). Peak SMAG was located at the hallux in 55.6 % of participants, at the 1st metatarsal head (MTH) in 16.7 %, the heel in 16.7 %, toes 3-5 in 11.1 % and the MTH2 in 5.6 %. SIGNIFICANCE: The results demonstrate the STAMPS system is a valid tool to measure plantar strain. Further studies are required to investigate the effects of elevated strain and the relationship with diabetic foot ulcer formation.

No frugal innovation without frugal evaluation: the Global IDEAL Sub-Framework.

Objective: The Global IDEAL Sub-Framework Study aimed to combine the intended effects of the 2009/2019 IDEAL (Idea, Development, Exploration, Assessment, Long-term study) Framework recommendations on evaluating surgical innovation with the vision outlined by the 2015 Lancet Commission on Global Surgery to provide recommendations for evaluating surgical innovation in low-resource environments. Design: A mixture of methods including an online global survey and semistructured interviews (SSIs). Quantitative data were summarized with descriptive statistics and qualitative data were analyzed using the Framework Method. Participants: Surgeons and surgical researchers from any country. Main outcome measures: Findings were used to suggest the nature of adaptations to the IDEAL Framework to address the particular problems of evaluation in low-resource settings. Results: The online survey yielded 66 responses representing experience from 40 countries, and nine individual SSIs were conducted. Most respondents (n=49; 74.2%) had experience evaluating surgical technologies across a range of life cycle stages. Innovation was most frequently adopted based on colleague recommendation or clinical evaluation in other countries. Four themes emerged, centered around: frugal innovation in technological development; evaluating the same technology/innovation in different contexts; additional methodologies important in evaluation of surgical innovation in low/middle-income countries; and support for low-income country researchers along the evaluation pathway. Conclusions: The Global IDEAL Sub-Framework provides suggestions for modified IDEAL recommendations aimed at dealing with the special problems found in this setting. These will require validation in a stakeholder consensus forum, and qualitative assessment in pilot studies. From assisting researchers with identification of the correct evaluation stage, to providing context-specific recommendations relevant to the whole evaluation pathway, this process will aim to develop a comprehensive and applicable set of guidance that will benefit surgical innovation and patients globally.

STrain Analysis and Mapping of the Plantar Surface (STAMPS): A novel technique of plantar load analysis during gait.

Diabetic foot ulceration is driven by peripheral neuropathy, resulting in abnormal foot biomechanics and elevated plantar load. Plantar load comprises normal pressure and tangential shear stress. Currently, there are no in-shoe devices measuring both components of plantar load. The STAMPS (STrain Analysis and Mapping of the Plantar Surface) system was developed to address this and utilises digital image correlation (DIC) to determine the strain sustained by a plastically deformable insole, providing an assessment of plantar load at the foot-surface interface during gait. STAMPS was developed as a multi-layered insole, comprising a deformable mid-layer, onto which a stochastic speckle pattern film is applied. A custom-built imaging platform is used to obtain high resolution pre- and post-walking images. Images are imported into commercially available DIC software (GOM Correlate, 2020) to obtain pointwise strain data. The strain and displacement data are exported and post-processed with custom analysis routines (MATLAB, Mathworks Inc.), to obtain the resultant global and regional peak strain (SMAG), antero-posterior strain (SAP) and medio-lateral strain (SML). To validate the core technique an experimental test process used a Universal Mechanical Tester (UMT) system (UMT TriboLab, Bruker) to apply controlled vertical and tangential load regimes to the proposed multi-layer insole. A pilot study was then conducted to assess the efficacy of using the STAMPS system to measure in-shoe plantar strain in three healthy participants. Each participant walked 10 steps on the STAMPS insole using a standardised shoe. They also walked 10 m in the same shoe using a plantar pressure measurement insole (Novel Pedar®) to record peak plantar pressure (PPP) as a gold-standard comparator. The results of the experimental validation tests show that with increased normal force, at a constant shear distance, SMAG increased in a linear fashion. Furthermore, they showed that with increased shear distance, at a constant force, SMAG increased. The results of the pilot study found participant 1 demonstrated greatest SMAG in the region toes 3-5 (15.31%). The highest mean SMAG for participant 2 was at the hallux (29.31%). Participant 3 exhibited highest strain in the regions of the first and second metatarsal heads (58.85% and 41.62% respectively). Increased PPP was strongly associated with increased SMAG with a Spearman's correlation coefficient 0.673 (p < 0.0001). This study has demonstrated the efficacy of a novel method to assess plantar load across the plantar surface of the foot. Experimental testing validated the sensitivity of the method to both normal pressure and tangential shear stress. This technique was successfully incorporated into the STAMPS insole to reliably measure and quantify the cumulative degree of strain sustained by a plastically deformable insole during a period of gait, which can be used to infer plantar loading patterns. Future work will explore how these measures relate to different pathologies, such as regions at risk of diabetic foot ulceration.

MiGut: A scalable in vitro platform for simulating the human gut microbiome-Development, validation and simulation of antibiotic-induced dysbiosis.

In vitro models of the human colon have been used extensively in understanding the human gut microbiome (GM) and evaluating how internal and external factors affect the residing bacterial populations. Such models have been shown to be highly predictive of in vivo outcomes and have a number of advantages over animal models. The complexity required by in vitro models to closely mimic the physiology of the colon poses practical limits on their scalability. The scalable Mini Gut (MiGut) platform presented in this paper allows considerable expansion of model replicates and enables complex study design, without compromising on in vivo reflectiveness as is often the case with other model systems. MiGut has been benchmarked against a validated gut model in a demanding 9-week study. MiGut showed excellent repeatability between model replicates and results were consistent with those of the benchmark system. The novel technology presented in this paper makes it conceivable that tens of models could be run simultaneously, allowing complex microbiome-xenobiotic interactions to be explored in far greater detail, with minimal added resources or complexity. This platform expands the capacity to generate clinically relevant data to support our understanding of the cause-effect relationships that govern the GM.

Looking at the task in hand impairs motor learning.

"Visual capture" is the term used to describe vision being afforded a higher weighting than other sensory information. Visual capture can produce powerful illusory effects with individuals misjudging the size and position of their hands. The advent of laparoscopic surgical techniques raises the question of whether visual capture can interfere with an individual's rate of motor learning. We compared adaptation to distorted visual feedback in two groups: the Direct group appeared to have the advantage of directly viewing the input device, while the Indirect group used the same input device but viewed their movements on a remote screen. Counterintuitively, the Indirect group adapted more readily to distorted feedback and showed enhanced performance. The results show that visual capture impairs adaptation to distorted visual feedback, suggesting that surgeons need to avoid viewing their hands when learning laparoscopic techniques.

Reduced motor asymmetry in older adults when manually tracing paths.

Handedness, a preference towards using the right or left hand, is established in early childhood. Such specialisation allows a higher level of skill to be maintained in the preferred hand on specific tasks through continuous practice and performance. Hand asymmetries might be expected to increase with age because of the time spent practising with the preferred hand. However, neurophysiological work has suggested reduced hemispheric function lateralisation in the ageing brain, and behavioural studies have found reduced motor asymmetries in older adults (Przybyla et al., in Neurosci Lett 489:99-104, 2011). We therefore tested the predictions of behavioural change from reduced hemispheric function by measuring tracing performance (arguably one of the most lateralised of human behaviours) along paths of different thickness in a group of healthy young and older adults. Participants completed the task once with their preferred (right) hand and once with their non-preferred (left) hand. Movement time (MT) and shape accuracy (SA) were dependant variables. A composite measure of MT and SA, the speed accuracy cost function (SACF) provided an overall measure of motor performance. Older participants were slower and less accurate when task demands were high. Combined analyses of both hands revealed reduced asymmetries in MT and SACF in the older group. The young were significantly faster when tracing with their preferred hand, but older participants were equally slow with either hand. Our results are consistent with the growing literature reporting decreased hemispheric function lateralisation in the ageing brain.

HAILO: A Sensorised Hand Splint for the Exploration of Interface Forces.

This study presents the design and development of an instrumented splint for measuring the biomechanical effects of hand splinting and for assessing interface loading characteristics for people with arthritis. Sixteen multi-axial soft load-sensing nodes were mounted on the splint-skin interface of a custom 3D printed thumb splint. The splint was used to measure the interface forces between splint and hand in 12 healthy participants in 6 everyday tasks. Forces were compared between a baseline relaxed hand position and during states of active use. These data were used to generate a measure of sensor activity across the splint surface. Through direct comparison with a commercial splint, the 3D printed splint was deemed to provide similar levels of support. Observation of the activity across the 16 sensors showed that 'active' areas of the splint surface varied between tasks but were commonly focused at the base of the thumb. Our findings show promise in the ability to detect the changing forces imparted on the hand by the splint surface, objectively characterising their behaviour. This opens the opportunity for future study into the biomechanical effects of splints on arthritic thumbs to improve this important intervention and improve quality of life.

Exploring structural learning in handwriting.

Structural learning suggests that the human nervous system learns general rules that can be applied when controlling actions involving similar structures (e.g. using a variety of bicycles when learning to ride). These general rules can then facilitate skill acquisition in novel but related situations (e.g. a new bicycle). We tested this concept by investigating whether learned asymmetries in handwriting (greater ease in moving the hand rightwards and downwards within Western-educated populations) are present in the non-preferred hand as predicted by structural learning. We found these asymmetries in both hands of a right-handed population when tracing abstract shapes. We then ruled out biomechanical explanations by finding the same results with a left-handed population. These findings provide support for structural learning and explain: (1) the rapidity with which individuals can learn to write with their non-preferred hand; (2) the presence of a higher abstract (effector independent) level within voluntary motor control organisation.

A biomechanical model of the human defecatory system to investigate mechanisms of continence.

This article presents a method to fabricate, measure and control a physical simulation of the human defecatory system to investigate individual and combined effects of anorectal angle and sphincter pressure on continence. To illustrate the capabilities and clinical relevance of the work, the influence of a passive-assistive artificial anal sphincter (FENIXTM) is evaluated. A model rectum and associated soft tissues, based on geometry from an anonymised computed tomography dataset, was fabricated from silicone and showed behavioural realism to the biological system and ex vivo tissue. Simulated stool matter with similar rheological properties to human faeces was developed. Instrumentation and control hardware were used to regulate injection of simulated stool into the system, automate balloon catheter movement through the anal canal, define the anorectal angle and monitor stool flow rate, intra-rectal pressure, anal canal pressure and puborectalis force. Studies were conducted to examine the response of anorectal angles at 80°, 90° and 100° with simulated stool. Tests were then repeated with the inclusion of a FENIX device. Stool leakage was reduced as the anorectal angle became more acute. Conversely, intra-rectal pressure increased. Overall inclusion of the FENIX reduced faecal leakage, while combined effects of the FENIX and an acute anorectal angle showed the greatest resistance to faecal leakage. These data demonstrate that the anorectal angle and sphincter pressure are fundamental in maintaining continence. Furthermore, it demonstrates that use of the FENIX can increase resistance to faecal leakage and reduce anorectal angles required to maintain continence. Physical simulation of the defecatory system is an insightful tool to better understand, in a quantitative manner, the effects of the anorectal angle and sphincter pressure on continence. This work is valuable in helping improve our understanding of the physical behaviour of the continence mechanism and facilitating improved technologies to treat severe faecal incontinence.

Real-Time Assessment of Mechanical Tissue Trauma in Surgery.

OBJECTIVE: This work presents a method to assess and prevent tissue trauma in real-time during surgery. BACKGROUND: Tissue trauma occurs routinely during laparoscopic surgery with potentially severe consequences. As such, it is crucial that a surgeon is able to regulate the pressure exerted by surgical instruments. We propose a novel method to assess the onset of tissue trauma by considering the mechanical response of tissue as it is loaded in real-time. METHODS: We conducted a parametric study using a lab-based grasping model and differing load conditions. Mechanical stress-time data were analyzed to characterize the tissue response to grasps. Qualitative and quantitative histological analyses were performed to inspect damage characteristics of the tissue under different load conditions. These were correlated against the mechanical measures to identify the nature of trauma onset with respect to our predictive metric. RESULTS: Results showed increasing tissue trauma with load and a strong correlation with the mechanical response of the tissue. Load rate and load history also showed a clear effect on tissue response. The proposed method for trauma assessment was effective in identifying damage. The metric can be normalized with respect to loading rate and history, making it feasible in the unconstrained environment of intraoperative surgery. SIGNIFICANCE: This work demonstrates that tissue trauma can be predicted using mechanical measures in real-time. Applying this technique to laparoscopic tools has the potential to reduce unnecessary tissue trauma and its associated complications by indicating through user feedback or actively regulating the mechanical impact of surgical instruments.

Sensorimotor control dynamics and cultural biases: learning to move in the right (or left) direction.

The nativist hypothesis suggests universal features of human behaviour can be explained by biologically determined cognitive substrates. This nativist account has been challenged recently by evolutionary models showing that the cultural transmission of knowledge can produce behavioural universals. Sensorimotor invariance is a canonical example of a behavioural universal, raising the issue of whether culture can influence not only which skills people acquire but also the development of the sensorimotor system. We tested this hypothesis by exploring whether culture influences the developing sensorimotor system in children. We took kinematic measures of motor control asymmetries in adults and children from differing cultures where writing follows opposite directions. British and Kuwaiti adults (n = 69) and first grade (5-6 year old) children (n = 140) completed novel rightward and leftward tracing tasks. The Kuwaitis were better when moving their arm leftward while the British showed the opposite bias. Bayesian analysis techniques showed that while children were worse than adults, they also showed asymmetries-with the asymmetry magnitude related to accuracy levels. Our findings support the idea that culture influences the sensorimotor system.

Laparoscopic Motor Learning and Workspace Exploration.

BACKGROUND: Laparoscopic surgery requires operators to learn novel complex movement patterns. However, our understanding of how best to train surgeons' motor skills is inadequate, and research is needed to determine optimal laparoscopic training regimes. This difficulty is confounded by variables inherent in surgical practice, for example, the increasing prevalence of morbidly obese patients presents additional challenges related to restriction of movement because of abdominal wall resistance and reduced intra-abdominal space. The aim of this study was to assess learning of a surgery-related task in constrained and unconstrained conditions using a novel system linking a commercially available robotic arm with specialised software creating the novel kinematic assessment tool (Omni-KAT). METHODS: We created an experimental tool that records motor performance by linking a commercially available robotic arm with specialized software that presents visual stimuli and objectively measures movement outcome (kinematics). Participants were given the task of generating aiming movements along a horizontal plane to move a visual cursor on a vertical screen. One group received training that constrained movements to the correct plane, whereas the other group was unconstrained and could explore the entire "action space." RESULTS: The tool successfully generated the requisite force fields and precisely recorded the aiming movements. Consistent with predictions from structural learning theory, the unconstrained group produced better performance after training as indexed by movement duration (p < 0.05). CONCLUSION: The data showed improved performance for participants who explored the entire action space, highlighting the importance of learning the full dynamics of laparoscopic instruments. These findings, alongside the development of the Omni-KAT, open up exciting prospects for better understanding of the learning processes behind surgical training and investigate ways in which learning can be optimized.