Neural interfacing architecture enables enhanced motor control and residual limb functionality postamputation.

Despite advancements in prosthetic technologies, patients with amputation today suffer great diminution in mobility and quality of life. We have developed a modified below-knee amputation (BKA) procedure that incorporates agonist-antagonist myoneural interfaces (AMIs), which surgically preserve and couple agonist-antagonist muscle pairs for the subtalar and ankle joints. AMIs are designed to restore physiological neuromuscular dynamics, enable bidirectional neural signaling, and offer greater neuroprosthetic controllability compared to traditional amputation techniques. In this prospective, nonrandomized, unmasked study design, 15 subjects with AMI below-knee amputation (AB) were matched with 7 subjects who underwent a traditional below-knee amputation (TB). AB subjects demonstrated significantly greater control of their residual limb musculature, production of more differentiable efferent control signals, and greater precision of movement compared to TB subjects (P < 0.008). This may be due to the presence of greater proprioceptive inputs facilitated by the significantly higher fascicle strains resulting from coordinated muscle excursion in AB subjects (P < 0.05). AB subjects reported significantly greater phantom range of motion postamputation (AB: 12.47 ± 2.41, TB: 10.14 ± 1.45 degrees) when compared to TB subjects (P < 0.05). Furthermore, AB subjects also reported less pain (12.25 ± 5.37) than TB subjects (17.29 ± 10.22) and a significant reduction when compared to their preoperative baseline (P < 0.05). Compared with traditional amputation, the construction of AMIs during amputation confers the benefits of enhanced physiological neuromuscular dynamics, proprioception, and phantom limb perception. Subjects' activation of the AMIs produces more differentiable electromyography (EMG) for myoelectric prosthesis control and demonstrates more positive clinical outcomes.

3D Ultrasound Shear Wave Elastography for Musculoskeletal Tissue Assessment Under Compressive Load: A Feasibility Study.

Given its real-time capability to quantify mechanical tissue properties, ultrasound shear wave elastography holds significant promise in clinical musculoskeletal imaging. However, existing shear wave elastography methods fall short in enabling full-limb analysis of 3D anatomical structures under diverse loading conditions, and may introduce measurement bias due to sonographer-applied force on the transducer. These limitations pose numerous challenges, particularly for 3D computational biomechanical tissue modeling in areas like prosthetic socket design. In this feasibility study, a clinical linear ultrasound transducer system with integrated shear wave elastography capabilities was utilized to scan both a calibrated phantom and human limbs in a water tank imaging setup. By conducting 2D and 3D scans under varying compressive loads, this study demonstrates the feasibility of volumetric ultrasound shear wave elastography of human limbs. Our preliminary results showcase a potential method for evaluating 3D spatially varying tissue properties, offering future extensions to computational biomechanical modeling of tissue for various clinical scenarios.

ARACAM: A RGB-D Multi-View Photogrammetry System for Lower Limb 3D Reconstruction Applications.

In the world, there is a growing need for lower limb prostheses due to a rising number of amputations caused primarily, by diabetic foot. Researchers enable functional and comfortable prostheses through prosthetic design by integrating new technologies applied to the traditional handcrafted method for prosthesis fabrication that is still current. That is why computer vision shows to be a promising tool for the integration of 3D reconstruction that may be useful for prosthetic design. This work has the objective to design, prototype, and test a functional system to scan plaster cast molds, which may serve as a platform for future technologies for lower limb reconstruction applications. The image capture system comprises 5 stereoscopic color and depth cameras, each with 4 DOF mountings on an enveloping frame, as well as algorithms for calibration, segmentation, registration, and surface reconstruction. The segmentation metrics of dice coefficient and Hausdorff distance (HD) show strong visual similarity with an average similarity of 87% and average error of 6.40 mm, respectively. Moving forward, the system was tested on a known 3D printed model obtained from a computer tomography scan to which comparison results via HD show an average error of ≤1.93 mm thereby making the system competitive against the systems reviewed from the state-of-the-art.

Reinventing Extremity Amputation in the Era of Functional Limb Restoration.

BACKGROUND: Recent progress in biomechatronics and vascularized composite allotransplantation have occurred in the absence of congruent advancements in the surgical approaches generally utilized for limb amputation. Consideration of these advances, as well as of both novel and time-honored reconstructive surgical techniques, argues for a fundamental reframing of the way in which amputation procedures should be performed. METHODS: We review sentinel developments in external prosthetic limb technology and limb transplantation, in addition to standard and emerging reconstructive surgical techniques relevant to limb modification, and then propose a new paradigm for limb amputation. RESULTS: An approach to limb amputation based on the availability of native tissues is proposed, with the intent of maximizing limb function, limiting neuropathic pain, restoring limb perception/proprioception and mitigating limb atrophy. CONCLUSIONS: We propose a reinvention of the manner in which limb amputations are performed, framed in the context of time-tested reconstructive techniques, as well as novel, state-of-the-art surgical procedures. Implementation of the proposed techniques in the acute setting has the potential to elevate advanced limb replacement strategies to a clinical solution that perhaps exceeds what is possible through traditional surgical approaches to limb salvage. We therefore argue that amputation, performed with the intent of optimizing the residuum for interaction with either a bionic or a transplanted limb, should be viewed not as a surgical failure, but as an alternative form of limb reconstruction.

Restoration of bilateral motor coordination from preserved agonist-antagonist coupling in amputation musculature.

BACKGROUND: Neuroprosthetic devices controlled by persons with standard limb amputation often lack the dexterity of the physiological limb due to limitations of both the user's ability to output accurate control signals and the control system's ability to formulate dynamic trajectories from those signals. To restore full limb functionality to persons with amputation, it is necessary to first deduce and quantify the motor performance of the missing limbs, then meet these performance requirements through direct, volitional control of neuroprosthetic devices. METHODS: We develop a neuromuscular modeling and optimization paradigm for the agonist-antagonist myoneural interface, a novel tissue architecture and neural interface for the control of myoelectric prostheses, that enables it to generate virtual joint trajectories coordinated with an intact biological joint at full physiologically-relevant movement bandwidth. In this investigation, a baseline of performance is first established in a population of non-amputee control subjects ([Formula: see text]). Then, a neuromuscular modeling and optimization technique is advanced that allows unilateral AMI amputation subjects ([Formula: see text]) and standard amputation subjects ([Formula: see text]) to generate virtual subtalar prosthetic joint kinematics using measured surface electromyography (sEMG) signals generated by musculature within the affected leg residuum. RESULTS: Using their optimized neuromuscular subtalar models under blindfolded conditions with only proprioceptive feedback, AMI amputation subjects demonstrate bilateral subtalar coordination accuracy not significantly different from that of the non-amputee control group (Kolmogorov-Smirnov test, [Formula: see text]) while standard amputation subjects demonstrate significantly poorer performance (Kolmogorov-Smirnov test, [Formula: see text]). CONCLUSIONS: These results suggest that the absence of an intact biological joint does not necessarily remove the ability to produce neurophysical signals with sufficient information to reconstruct physiological movements. Further, the seamless manner in which virtual and intact biological joints are shown to coordinate reinforces the theory that desired movement trajectories are mentally formulated in an abstract task space which does not depend on physical limb configurations.

Goats decrease hindlimb stiffness when walking over compliant surfaces.

Leg stiffness, commonly estimated as the 'compression' of a defined leg element in response to a load, has long been used to characterize terrestrial locomotion. This study investigated how goats adjust the stiffness of their hindlimbs to accommodate surfaces of different stiffness. Goats provide a compelling animal model for studying leg stiffness modulation, because they skillfully ambulate over a range of substrates that vary in compliance. To investigate the adjustments that goats make when walking over such substrates, ground reaction forces and three-dimensional trajectories of hindlimb markers were recorded as goats walked on rigid, rubber and foam surfaces. Net joint moments, power and work at the hip, knee, ankle and metatarsophalangeal joints were estimated throughout stance via inverse dynamics. Hindlimb stiffness was estimated from plots of total leg force versus total leg length, and individual joint stiffness was estimated from plots of joint moment versus joint angle. Our results support the hypothesis that goats modulate hindlimb stiffness in response to surface stiffness; specifically, hindlimb stiffness decreased on the more compliant surfaces (P<0.002). Estimates of joint stiffness identified hip and ankle muscles as the primary drivers of these adjustments. When humans run on compliant surfaces, they generally increase leg stiffness to preserve their center-of-mass mechanics. We did not estimate center-of-mass mechanics in this study; nevertheless, our estimates of hindlimb stiffness suggest that goats exhibit a different behavior. This study offers new insight into mechanisms that allow quadrupeds to modulate their gait mechanics when walking on surfaces of variable compliance.

Biomechanical walking mechanisms underlying the metabolic reduction caused by an autonomous exoskeleton.

BACKGROUND: Ankle exoskeletons can now reduce the metabolic cost of walking in humans without leg disability, but the biomechanical mechanisms that underlie this augmentation are not fully understood. In this study, we analyze the energetics and lower limb mechanics of human study participants walking with and without an active autonomous ankle exoskeleton previously shown to reduce the metabolic cost of walking. METHODS: We measured the metabolic, kinetic and kinematic effects of wearing a battery powered bilateral ankle exoskeleton. Six participants walked on a level treadmill at 1.4 m/s under three conditions: exoskeleton not worn, exoskeleton worn in a powered-on state, and exoskeleton worn in a powered-off state. Metabolic rates were measured with a portable pulmonary gas exchange unit, body marker positions with a motion capture system, and ground reaction forces with a force-plate instrumented treadmill. Inverse dynamics were then used to estimate ankle, knee and hip torques and mechanical powers. RESULTS: The active ankle exoskeleton provided a mean positive power of 0.105 ± 0.008 W/kg per leg during the push-off region of stance phase. The net metabolic cost of walking with the active exoskeleton (3.28 ± 0.10 W/kg) was an 11 ± 4 % (p = 0.019) reduction compared to the cost of walking without the exoskeleton (3.71 ± 0.14 W/kg). Wearing the ankle exoskeleton significantly reduced the mean positive power of the ankle joint by 0.033 ± 0.006 W/kg (p = 0.007), the knee joint by 0.042 ± 0.015 W/kg (p = 0.020), and the hip joint by 0.034 ± 0.009 W/kg (p = 0.006). CONCLUSIONS: This study shows that the ankle exoskeleton does not exclusively reduce positive mechanical power at the ankle joint, but also mitigates positive power at the knee and hip. Furthermore, the active ankle exoskeleton did not simply replace biological ankle function in walking, but rather augmented the total (biological + exoskeletal) ankle moment and power. This study underscores the need for comprehensive models of human-exoskeleton interaction and global optimization methods for the discovery of new control strategies that optimize the physiological impact of leg exoskeletons.

Impact on gait biomechanics of using an active variable impedance prosthetic knee.

BACKGROUND: An above knee amputation can have a significant impact on gait, with substantial deviations in inter-leg symmetry, step length, hip exertion and upper body involvement even when using a current clinical standard of care prosthesis. These differences can produce gait that is less efficient and less comfortable, resulting in slower and shorter distance walking, particularly with long term use. METHODS: A robotic variable impedance prosthetic knee (VI Knee) was tested with five individuals (N = 5) with unilateral amputation above the knee at fixed speeds both above and below their normal walking speed. Subject gait was measured as they walked along an instrumented walkway via optical motion capture and force plates in the floor. Each subject's gait while using the VI Knee was compared to that while using their standard of care knee (OttoBock C-Leg). RESULTS: Significant differences (p < 0.05) in walking between the standard of care and variable impedance devices were seen in step length and hip range of motion symmetries, hip extension moment, knee power and torso lean angle. While using the VI Knee, several subjects demonstrated statistically significant improvements in gait, particularly in increased hip range of motion symmetry between affected and intact sides, greater prosthesis knee power and in reducing upper body involvement in the walking task by decreasing forward and affected side lean and reducing the pelvis-torso twist coupling. These changes to torso posture during gait also resulted in increased terminal stance hip flexion moment across subjects. Detriments to gait were also observed in that some subjects exhibited decreased step length symmetry while using the VI Knee compared to the C-Leg. CONCLUSIONS: The knee tested represents the potential to improve gait biomechanics and reduce upper body involvement in persons with above knee amputation compared to current standard of care devices. While using the VI Knee, subjects demonstrated statistically significant improvements in several aspects of gait though some were worsened while using the device. It is possible that these negative effects may be mitigated through longer term training and experience with the VI Knee. Given the demonstrated benefits and the potential to reduce or eliminate detriments through training, using a powered device like the VI Knee, particularly over an extended period of time, may help to improve walking performance and comfort.

Autonomous exoskeleton reduces metabolic cost of human walking.

BACKGROUND: Passive exoskeletons that assist with human locomotion are often lightweight and compact, but are unable to provide net mechanical power to the exoskeletal wearer. In contrast, powered exoskeletons often provide biologically appropriate levels of mechanical power, but the size and mass of their actuator/power source designs often lead to heavy and unwieldy devices. In this study, we extend the design and evaluation of a lightweight and powerful autonomous exoskeleton evaluated for loaded walking in (J Neuroeng Rehab 11:80, 2014) to the case of unloaded walking conditions. FINDINGS: The metabolic energy consumption of seven study participants (85 ± 12 kg body mass) was measured while walking on a level treadmill at 1.4 m/s. Testing conditions included not wearing the exoskeleton and wearing the exoskeleton, in both powered and unpowered modes. When averaged across the gait cycle, the autonomous exoskeleton applied a mean positive mechanical power of 26 ± 1 W (13 W per ankle) with 2.12 kg of added exoskeletal foot-shank mass (1.06 kg per leg). Use of the leg exoskeleton significantly reduced the metabolic cost of walking by 35 ± 13 W, which was an improvement of 10 ± 3% (p = 0.023) relative to the control condition of not wearing the exoskeleton. CONCLUSIONS: The results of this study highlight the advantages of developing lightweight and powerful exoskeletons that can comfortably assist the body during walking.

Autonomous exoskeleton reduces metabolic cost of human walking during load carriage.

BACKGROUND: Many soldiers are expected to carry heavy loads over extended distances, often resulting in physical and mental fatigue. In this study, the design and testing of an autonomous leg exoskeleton is presented. The aim of the device is to reduce the energetic cost of loaded walking. In addition, we present the Augmentation Factor, a general framework of exoskeletal performance that unifies our results with the varying abilities of previously developed exoskeletons. METHODS: We developed an autonomous battery powered exoskeleton that is capable of providing substantial levels of positive mechanical power to the ankle during the push-off region of stance phase. We measured the metabolic energy consumption of seven subjects walking on a level treadmill at 1.5 m/s, while wearing a 23 kg vest. RESULTS: During the push-off portion of the stance phase, the exoskeleton applied positive mechanical power with an average across the gait cycle equal to 23 ± 2 W (11.5 W per ankle). Use of the autonomous leg exoskeleton significantly reduced the metabolic cost of walking by 36 ± 12 W, which was an improvement of 8 ± 3% (p = 0.025) relative to the control condition of not wearing the exoskeleton. CONCLUSIONS: In the design of leg exoskeletons, the results of this study highlight the importance of minimizing exoskeletal power dissipation and added limb mass, while providing substantial positive power during the walking gait cycle.

Non-pyrogenicity and biocompatibility of parylene-coated magnetic bead implants.

Clinical grade magnetic bead implants have important applications in interfacing with the human body, providing contactless mechanical attachment or wireless communication through human tissue. We recently developed a new strategy, magnetomicrometry, that uses magnetic bead implants as passive communication devices to wirelessly sense muscle tissue lengths. We manufactured clinical-grade magnetic bead implants and verified their biocompatibility via intramuscular implantation, cytotoxicity, sensitization, and intracutaneous irritation testing. In this work, we test the pyrogenicity of the magnetic bead implants via a lagomorph model, and we test the biocompatibility of the magnetic bead implants via a full chemical characterization and toxicological risk assessment. Further, we test the cleaning, sterilization, and dry time of the devices that are used to deploy these magnetic bead implants. We find that the magnetic bead implants are non-pyrogenic and biocompatible, with the insertion device determined to be safe to clean, sterilize, and dry in a healthcare setting. These results provide confidence for the safe use of these magnetic bead implants in humans.

Variable-stiffness prosthesis improves biomechanics of walking across speeds compared to a passive device.

Ankle push-off power plays an important role in healthy walking, contributing to center-of-mass acceleration, swing leg dynamics, and accounting for 45% of total leg power. The majority of existing passive energy storage and return prostheses for people with below-knee (transtibial) amputation are stiffer than the biological ankle, particularly at slower walking speeds. Additionally, passive devices provide insufficient levels of energy return and push-off power, negatively impacting biomechanics of gait. Here, we present a clinical study evaluating the kinematics and kinetics of walking with a microprocessor-controlled, variable-stiffness ankle-foot prosthesis (945 g) compared to a standard low-mass passive prosthesis (Ottobock Taleo, 463 g) with 7 study participants having unilateral transtibial amputation. By modulating prosthesis stiffness under computer control across walking speeds, we demonstrate that there exists a stiffness that increases prosthetic-side energy return, peak power, and center-of-mass push-off work, and decreases contralateral limb peak ground reaction force compared to the standard passive prosthesis across all evaluated walking speeds. We demonstrate a significant increase in center-of-mass push-off work of 26.1%, 26.2%, 29.6% and 29.9% at 0.75 m/s, 1.0 m/s, 1.25 m/s, and 1.5 m/s, respectively, and a significant decrease in contralateral limb ground reaction force of 3.1%, 3.9%, and 3.2% at 1.0 m/s, 1.25 m/s, and 1.5 m/s, respectively. This study demonstrates the potential for a quasi-passive microprocessor-controlled variable-stiffness prosthesis to increase push-off power and energy return during gait at a range of walking speeds compared to a passive device of a fixed stiffness.

Resting state neurophysiology of agonist-antagonist myoneural interface in persons with transtibial amputation.

The agonist-antagonist myoneural interface (AMI) is an amputation surgery that preserves sensorimotor signaling mechanisms of the central-peripheral nervous systems. Our first neuroimaging study investigating AMI subjects conducted by Srinivasan et al. (2020) focused on task-based neural signatures, and showed evidence of proprioceptive feedback to the central nervous system. The study of resting state neural activity helps non-invasively characterize the neural patterns that prime task response. In this study on resting state functional magnetic resonance imaging in AMI subjects, we compared functional connectivity in patients with transtibial AMI (n = 12) and traditional (n = 7) amputations (TA). To test our hypothesis that we would find significant neurophysiological differences between AMI and TA subjects, we performed a whole-brain exploratory analysis to identify a seed region; namely, we conducted ANOVA, followed by t-test statistics to locate a seed in the salience network. Then, we implemented a seed-based connectivity analysis to gather cluster-level inferences contrasting our subject groups. We show evidence supporting our hypothesis that the AMI surgery induces functional network reorganization resulting in a neural configuration that significantly differs from the neural configuration after TA surgery. AMI subjects show significantly less coupling with regions functionally dedicated to selecting where to focus attention when it comes to salient stimuli. Our findings provide researchers and clinicians with a critical mechanistic understanding of the effect of AMI amputation on brain networks at rest, which has promising implications for improved neurorehabilitation and prosthetic control.

Continuous neural control of a bionic limb restores biomimetic gait after amputation.

For centuries scientists and technologists have sought artificial leg replacements that fully capture the versatility of their intact biological counterparts. However, biological gait requires coordinated volitional and reflexive motor control by complex afferent and efferent neural interplay, making its neuroprosthetic emulation challenging after limb amputation. Here we hypothesize that continuous neural control of a bionic limb can restore biomimetic gait after below-knee amputation when residual muscle afferents are augmented. To test this hypothesis, we present a neuroprosthetic interface consisting of surgically connected, agonist-antagonist muscles including muscle-sensing electrodes. In a cohort of seven leg amputees, the interface is shown to augment residual muscle afferents by 18% of biologically intact values. Compared with a matched amputee cohort without the afferent augmentation, the maximum neuroprosthetic walking speed is increased by 41%, enabling equivalent peak speeds to persons without leg amputation. Further, this level of afferent augmentation enables biomimetic adaptation to various walking speeds and real-world environments, including slopes, stairs and obstructed pathways. Our results suggest that even a small augmentation of residual muscle afferents restores biomimetic gait under continuous neuromodulation in individuals with leg amputation.

Constitutive parameter identification of transtibial residual limb soft tissue using ultrasound indentation and shear wave elastography.

Finite element analysis (FEA) can be used to evaluate applied interface pressures and internal tissue strains for computational prosthetic socket design. This type of framework requires realistic patient-specific limb geometry and constitutive properties. In recent studies, indentations and inverse FEA with MRI-derived 3D patient geometries were used for constitutive parameter identification. However, long computational times and use of specialized equipment presents challenges for clinical, deployment. In this study, we present a novel approach for constitutive parameter identification using a combination of FEA, ultrasound indentation, and shear wave elastography. Local shear modulus measurement using elastography during an ultrasound indentation experiment has particular significance for biomechanical modeling of the residual limb since there are known regional dependencies of soft tissue properties such as varying levels of scarring and atrophy. Beyond prosthesis design, this work has broader implications to the fields of muscle health and monitoring of disease progression.

Bionic ankle-foot prosthesis normalizes walking gait for persons with leg amputation.

Over time, leg prostheses have improved in design, but have been incapable of actively adapting to different walking velocities in a manner comparable to a biological limb. People with a leg amputation using such commercially available passive-elastic prostheses require significantly more metabolic energy to walk at the same velocities, prefer to walk slower and have abnormal biomechanics compared with non-amputees. A bionic prosthesis has been developed that emulates the function of a biological ankle during level-ground walking, specifically providing the net positive work required for a range of walking velocities. We compared metabolic energy costs, preferred velocities and biomechanical patterns of seven people with a unilateral transtibial amputation using the bionic prosthesis and using their own passive-elastic prosthesis to those of seven non-amputees during level-ground walking. Compared with using a passive-elastic prosthesis, using the bionic prosthesis decreased metabolic cost by 8 per cent, increased trailing prosthetic leg mechanical work by 57 per cent and decreased the leading biological leg mechanical work by 10 per cent, on average, across walking velocities of 0.75-1.75 m s(-1) and increased preferred walking velocity by 23 per cent. Using the bionic prosthesis resulted in metabolic energy costs, preferred walking velocities and biomechanical patterns that were not significantly different from people without an amputation.

Human leg model predicts ankle muscle-tendon morphology, state, roles and energetics in walking.

A common feature in biological neuromuscular systems is the redundancy in joint actuation. Understanding how these redundancies are resolved in typical joint movements has been a long-standing problem in biomechanics, neuroscience and prosthetics. Many empirical studies have uncovered neural, mechanical and energetic aspects of how humans resolve these degrees of freedom to actuate leg joints for common tasks like walking. However, a unifying theoretical framework that explains the many independent empirical observations and predicts individual muscle and tendon contributions to joint actuation is yet to be established. Here we develop a computational framework to address how the ankle joint actuation problem is resolved by the neuromuscular system in walking. Our framework is founded upon the proposal that a consideration of both neural control and leg muscle-tendon morphology is critical to obtain predictive, mechanistic insight into individual muscle and tendon contributions to joint actuation. We examine kinetic, kinematic and electromyographic data from healthy walking subjects to find that human leg muscle-tendon morphology and neural activations enable a metabolically optimal realization of biological ankle mechanics in walking. This optimal realization (a) corresponds to independent empirical observations of operation and performance of the soleus and gastrocnemius muscles, (b) gives rise to an efficient load-sharing amongst ankle muscle-tendon units and (c) causes soleus and gastrocnemius muscle fibers to take on distinct mechanical roles of force generation and power production at the end of stance phase in walking. The framework outlined here suggests that the dynamical interplay between leg structure and neural control may be key to the high walking economy of humans, and has implications as a means to obtain insight into empirically inaccessible features of individual muscle and tendons in biomechanical tasks.

Erratum: Publisher Correction: Agonist-antagonist muscle strain in the residual limb preserves motor control and perception after amputation.

[This corrects the article DOI: 10.1038/s43856-022-00162-z.].