Exploring the mechanical properties of 3D-printed multilayer lattice structures for use in accommodative insoles.

Full-contact insoles fabricated from multilayer foams are the standard of care (SoC) for offloading and redistributing high plantar pressures in individuals with diabetes at risk of plantar ulceration and subsequent lower limb amputation. These devices have regional variations in total thickness and layer thickness to create conformity with a patient's foot. Recent work has demonstrated that metamaterials can be tuned to match the mechanical properties of SoC insole foams. However, for devices fabricated using a multilayer lattice structure, having regional variations in total thickness and layer thickness may result in regional differences in mechanical properties that have yet to be investigated. Three lattices, two dual-layer and one uniform-layer lattice structure, designed to model the mechanical properties of SoC insoles, were 3D-printed at three structure/puck thicknesses representing typical regions seen in accommodative insoles. The pucks underwent cyclic compression testing, and the stiffness profiles were assessed. Three pucks at three structure/puck thicknesses fabricated from SoC foams were also tested. Initial evaluations suggested that for the latticed pucks, structure thickness and density inversely impacted puck stiffness. Behaving most like the SoC pucks, a dual-layer lattice that increased in density as structure thickness increased demonstrated consistent stiffness profiles across puck thicknesses. Identifying a lattice with constant mechanical properties at various structure thicknesses may be important to produce a conforming insole that emulates the standard of care from which patient-specific/regional lattice modulations can be made.

Circumstances of falls among older adult walker users in long-term care and the associated walker design deficits.

Falls are the leading cause of fatal and non-fatal injuries in older adults. Walkers are often used by and prescribed to this population to reduce fall risk, however, walker users and walker non-users alike experience similar fall incidence rates. The role of walkers in preventing falls is unclear as some studies suggest walkers may be a fall-inciting factor. The purpose of this study was to analyze walker deficits by evaluating the circumstances and causes of falls in older adult walker users residing in long-term care facilities. Videos capturing 34 real-life falls involving wheeled walkers (rollators and two-wheeled walkers) in two retirement facilities were analyzed for 3 themes: walker type, fall direction, and activity at the time of fall. A frequency analysis of these themes was performed to determine common fall mechanisms. The results of this study suggest two-wheeled walker and rollator users most often fall sideways while turning and backward during weight transfer, respectively. Poor maneuverability, lateral stability, and wheel velocity control of the walkers contributed to the falls. Device improvements addressing these areas of deficiency may be necessary to mitigate falls occurring in older adult walker users.

Full body musculoskeletal model for simulations of gait in persons with transtibial amputation.

This paper describes the development, properties, and evaluation of a musculoskeletal model that reflects the anatomical and prosthetic properties of a transtibial amputee using OpenSim. Average passive prosthesis properties were used to develop CAD models of a socket, pylon, and foot to replace the lower leg. Additional degrees of freedom (DOF) were included in each joint of the prosthesis for potential use in a range of research areas, such as socket torque and socket pistoning. The ankle has three DOFs to provide further generality to the model. Seven transtibial amputee subjects were recruited for this study. 3 D motion capture, ground reaction force, and electromyographic (EMG) data were collected while participants wore their prescribed prosthesis, and then a passive prototype prosthesis instrumented with a 6-DOF load cell in series with the pylon. The model's estimates of the ankle, knee, and hip kinematics comparable to previous studies. The load cell provided an independent experimental measure of ankle joint torque, which was compared to inverse dynamics results from the model and showed a 7.7% mean absolute error. EMG data and muscle outputs from OpenSim's Static Optimization tool were qualitatively compared and showed reasonable agreement. Further improvements to the muscle characteristics or prosthesis-specific foot models may be necessary to better characterize individual amputee gait. The model is open-source and available at (https://simtk.org/projects/biartprosthesis) for other researchers to use to advance our understanding and amputee gait and assist with the development of new lower limb prostheses.

Design and Evaluation of a Knee Flexion Assistance Exoskeleton for People with Transtibial Amputation.

People with below-knee amputation walk with asymmetric gaits that over time can lead to further musculoskeletal disorders and decreased quality of life. While prosthesis technology is improving, prosthetic ankles may be fundamentally limited in their ability to restore healthy walking patterns because they do not assist the residual knee joint. The knee on the residual limb has muscular deficits due to the loss of the gastrocnemius, a biarticular muscle that crosses both the ankle and knee. Here we present the design, development, and preliminary evaluation of a robotic knee exoskeleton for people with transtibial amputation. The device is intended to restore gastrocnemius-like flexion moments to the knee on the residual limb. The exoskeleton uses a custom offboard actuation and control system to allow for a simple and lightweight design with high torque capabilities. A preliminary walking experiment with one person with transtibial amputation was conducted. The exoskeleton provided a range of knee flexion torque profiles and had an RMS tracking error of 1.9 Nm across four assistance conditions. This device will be used in future studies to explore the effects of providing knee flexion assistance to people with transtibial amputation during walking. Long term, findings from studies with this exoskeleton could motivate future assistive device designs that improve walking mechanics and quality of life for people with limb loss.

Evaluation of novel plantar pressure-based 3-dimensional printed accommodative insoles - A feasibility study.

BACKGROUND: Custom insoles are commonly prescribed to patients with diabetes to redistribute plantar pressure and decrease the risk of ulceration. Advances in 3D printing have enabled the creation of 3D-printed personalized metamaterials whose properties are derived not only from the base material but also the lattice microstructures within the metamaterial. Insoles manufactured using personalized metamaterials have both patient-specific geometry and stiffnesses. However, the safety and biomechanical effect of the novel insoles have not yet been tested clinically. METHODS: Individuals without ulcer, neuropathy, or deformity were recruited for this study. In-shoe walking plantar pressure at baseline visit was taken and sensels with pressure over 200 kPa was used to define offloading region(s). Three pairs of custom insoles (two 3D printed insoles with personalized metamaterials (Hybrid and Full) designed based on foot shape and plantar pressure mapping and one standard-of-care diabetic insole as a comparator). In-shoe plantar pressure measurements during walking were recorded in a standardized research shoe and the three insoles and compared across all four conditions. FINDINGS: Twelve individuals were included in the final analysis. No adverse events occurred during testing. Maximum peak plantar pressure and the pressure time integral were reduced in the offloading regions in the Hybrid and Full but not in the standard-of-care compared to the research shoe. INTERPRETATION: This feasibility study confirms our ability to manufacture the 3D printed personalized metamaterials insoles and demonstrates their ability to reduce plantar pressure. We have demonstrated the ability to modify the 3D printed design to offload certain parts of the foot using plantar pressure data and a patient-specific metamaterials in the 3D printed insole design. The advance in 3D printed technology has shown its potential to improve current care.

A novel workflow to fabricate a patient-specific 3D printed accommodative foot orthosis with personalized latticed metamaterial.

Patients with diabetes mellitus are at elevated risk for secondary complications that result in lower extremity amputations. Standard of care to prevent these complications involves prescribing custom accommodative insoles that use inefficient and outdated fabrication processes including milling and hand carving. A new thrust of custom 3D printed insoles has shown promise in producing corrective insoles but has not explored accommodative diabetic insoles. Our novel contribution is a metamaterial design application that allows the insole stiffness to vary regionally following patient-specific plantar pressure measurements. We presented a novel workflow to fabricate custom 3D printed elastomeric insoles, a testing method to evaluate the durability, shear stiffness, and compressive stiffness of insole material samples, and a case study to demonstrate how the novel 3D printed insoles performed clinically. Our 3D printed insoles results showed a matched or improved durability, a reduced shear stiffness, and a reduction in plantar pressure in clinical case study compared to standard of care insoles.

Evaluation of a quasi-passive biarticular prosthesis to replicate gastrocnemius function in transtibial amputee gait.

Lower limb amputees experience gait impairments, in part due to limitations of prosthetic limbs and the lack of a functioning biarticular gastrocnemius (GAS) muscle. Energy storing prosthetic feet restore the function of the soleus, but not GAS. We propose a transtibial prosthesis that implements a spring mechanism to replicate the GAS. A prototype Biarticular Prosthesis (BP) was tested on seven participants with unilateral transtibial amputation. Participants walked on an instrumented treadmill with motion capture, first using their prescribed prosthesis, then with the BP in four different spring stiffness conditions. A custom OpenSim musculoskeletal model, including the BP, was used to estimate kinematics, joint torques, and muscle forces. Kinematic symmetry was evaluated by comparing the amputated and intact angles of the ankle, knee, and hip. The BP knee and ankle torques were compared to the intact GAS. Finally, work done by the BP spring was calculated at the ankle and knee. There were no significant differences between conditions in kinematic symmetry, indicating that the BP performs similarly to prescribed prostheses. When comparing the BP torques to intact GAS, higher spring stiffness better approximated peak GAS torques, but those peaks occurred earlier in the gait cycle. The BP spring did positive work on the knee joint and negative work on the ankle joint, and this work increased as BP spring stiffness increased. The BP has the potential to improve amputee gait compensations associated with the lack of biarticular GAS function, which may reduce their walking effort and improve quality of life.

A novel walking cane with haptic biofeedback reduces knee adduction moment in the osteoarthritic knee.

Knee osteoarthritis is a leading cause of ambulatory disability in adults. The most prescribed mobility aid, the walking cane, is often underloaded and therefore fails to reduce knee joint loading and provide symptomatic relief. For this study, a novel walking cane with haptic biofeedback was designed to improve cane loading and reduce the knee adduction moment (KAM). To determine; 1) the short-term efficacy of a novel walking cane using haptic biofeedback to encourage proper cane loading and 2) the effects of the novel cane on KAM. Cane loading and KAM, peak knee adduction moment (PKAM), and knee adduction angular impulse (KAAI)) while walking were calculated under five conditions: 1) naïve, 2A) after scale training (apply 20%BW to cane while standing, using a beam scale), 2B) scale recall (attempt to load the cane to 20%BW), 3A) after haptic training (vibrotactile biofeedback delivered when target cane load achieved), and 3B) haptic recall (attempt to load the cane to 20%BW with vibrotactile biofeedback delivered). Compared to the naïve condition all interventions significantly increased cane loading and reduced PKAM and KAAI. No differences between haptic recall and scale recall condition were observed. The haptic biofeedback cane was shown to be an effective and simple way to increase cane loading and reduced knee loading. Haptic biofeedback and scale training were equally effective at producing immediate short-term improvements in cane loading and knee loading. Future studies should examine the long-term effects of scale training and canes with haptic biofeedback on knee joint health, pain, and osteoarthritis disease progression.

Proloquo2Go Enhances Classroom Performance in Children With Autism Spectrum Disorder.

Independent participation in academic settings is decreased for children who have limited speech and are diagnosed with autism spectrum disorder (ASD). The use of technology with children with ASD changes behavior, assists with making choices, and increases communication; however, no studies evaluated its impact on performance or required support in classroom activities. The objective of this study was to determine whether an iPad with Proloquo2Go would increase independent activity/task performance and reduce required support for children with ASD, during classroom activities compared with no and other forms of technology (i.e., picture exchange communication system [PECS], SMARTBoard). The study compared the use of Proloquo2Go on the iPad to alternative technologies for performance in classroom activities in four children diagnosed with ASD. Using Proloquo2Go to respond to academic opportunities, children required less support than when using no technology, and equal support to when using a PECS or SMARTBoard. Proloquo2Go on the iPad can enhance academic occupational performance in adding voice output and a variety of response choices.

Factors leading to obstacle contact during adaptive locomotion.

During everyday life, healthy adults occasionally trip over an obstacle that they knew was there. These 'spontaneous' trips can provide insight into the circumstances leading to trips and falls. The goal of this study was to describe the errors in foot placement and/or foot elevation that resulted in a spontaneous contact with a fixed, visible obstacle in young, healthy adults. Fifteen subjects stepped over an obstacle (height set to 25 % leg length) placed in the middle of an 8 m walkway, up to 300 times. Three subjects never contacted the obstacle and 12 subjects contacted the obstacle 1-4 times, totaling 24 contacts in 3,843 trials (0.6 %). Most of the contacts (92 %) were with the trail limb. Minimum foot clearance of the trail limb (trail MFC) decreased linearly (average slope of -1 mm/trial) with repeated trials. The majority of subjects (70 %) continued the linear decrease of trail MFC until they contacted the obstacle. The remaining contacts resulted from an apparent misjudgment of foot placement and/or foot elevation. Following contact, trail MFC increased 75 % in the subsequent trials and remained elevated at least up to 30 trials post-contact, but the trajectory of the unperturbed lead limb did not change, further supporting the idea of independent control for the lead and trail limbs during obstacle crossing. Possible causes of the progressive decrease in trail MFC until obstacle contact are considered.

Interpolation techniques to reduce error in measurement of toe clearance during obstacle avoidance.

Foot and toe clearance (TC) are used regularly to describe locomotor control for both clinical and basic research. However, accuracy of TC during obstacle crossing can be compromised by typical sample frequencies, which do not capture the frame when the foot is over the obstacle due to high limb velocities. The purpose of this study was to decrease the error of TC measures by increasing the spatial resolution of the toe trajectory with interpolation. Five young subjects stepped over an obstacle in the middle of an 8 m walkway. Position data were captured at 600 Hz as a gold standard signal (GS-600-Hz). The GS-600-Hz signal was downsampled to 60 Hz (DS-60-Hz). The DS-60-Hz was then interpolated by either upsampling or an algorithm. Error was calculated as the absolute difference in TC between GS-600-Hz and each of the remaining signals, for both the leading limb and the trailing limb. All interpolation methods reduced the TC error to a similar extent. Interpolation reduced the median error of trail TC from 5.4 to 1.1 mm; the maximum error was reduced from 23.4 to 4.2 mm (16.6-3.8%). The median lead TC error improved from 1.6 to 0.5 mm, and the maximum error improved from 9.1 to 1.8 mm (5.3-0.9%). Therefore, interpolating a 60 Hz signal is a valid technique to decrease the error of TC during obstacle crossing.