A compact solution for vibrotactile proprioceptive feedback of wrist rotation and hand aperture.

BACKGROUND: Closing the control loop between users and their prostheses by providing artificial sensory feedback is a fundamental step toward the full restoration of lost sensory-motor functions. METHODS: We propose a novel approach to provide artificial proprioceptive feedback about two degrees of freedom using a single array of 8 vibration motors (compact solution). The performance afforded by the novel method during an online closed-loop control task was compared to that achieved using the conventional approach, in which the same information was conveyed using two arrays of 8 and 4 vibromotors (one array per degree of freedom), respectively. The new method employed Gaussian interpolation to modulate the intensity profile across a single array of vibration motors (compact feedback) to convey wrist rotation and hand aperture by adjusting the mean and standard deviation of the Gaussian, respectively. Ten able-bodied participants and four transradial amputees performed a target achievement control test by utilizing pattern recognition with compact and conventional vibrotactile feedback to control the Hannes prosthetic hand (test conditions). A second group of ten able-bodied participants performed the same experiment in control conditions with visual and auditory feedback as well as no-feedback. RESULTS: Conventional and compact approaches resulted in similar positioning accuracy, time and path efficiency, and total trial time. The comparison with control condition revealed that vibrational feedback was intuitive and useful, but also underlined the power of incidental feedback sources. Notably, amputee participants achieved similar performance to that of able-bodied participants. CONCLUSIONS: The study therefore shows that the novel feedback strategy conveys useful information about prosthesis movements while reducing the number of motors without compromising performance. This is an important step toward the full integration of such an interface into a prosthesis socket for clinical use.

Organ Neuroprosthetics: Connecting Transplanted and Artificial Organs with the Nervous System.

Implantable neural interfaces with the central and peripheral nervous systems are currently used to restore sensory, motor, and cognitive functions in disabled people with very promising results. They have also been used to modulate autonomic activities to treat diseases such as diabetes or hypertension. Here, this study proposes to extend the use of these technologies to (re-)establish the connection between new (transplanted or artificial) organs and the nervous system in order to increase the long-term efficacy and the effective biointegration of these solutions. In this perspective paper, some clinically relevant applications of this approach are briefly described. Then, the choices that neural engineers must implement about the type, implantation location, and closed-loop control algorithms to successfully realize this approach are highlighted. It is believed that these new "organ neuroprostheses" are going to become more and more valuable and very effective solutions in the years to come.

Reliable in vitro method for the evaluation of the primary stability and load transfer of transfemoral prostheses for osseointegrated implantation.

Osseointegrated transfemoral prostheses experience aseptic complications with an incidence between 3% and 30%. The main aseptic risks are implant loosening, adverse bone remodeling, and post-operative periprosthetic fractures. Implant loosening can either be due to a lack of initial (primary) stability of the implant, which hinders bone ingrowth and therefore prevents secondary stability, or, in the long-term, to the progressive resorption of the periprosthetic bone. Post-operative periprosthetic fractures are most often caused by stress concentrations. A method to simultaneously evaluate the primary stability and the load transfer is currently missing. Furthermore, the measurement errors are seldom reported in the literature. In this study a method to reliably quantify the bone implant interaction of osseointegrated transfemoral prostheses in terms of primary stability and load transfer was developed, and its precision was quantified. Micromotions between the prosthesis and the host bone and the strains on the cortical bone were measured on five human cadaveric femurs with a typical commercial osseointegrated implant. To detect the primary stability of the implant and the load transfer, cyclic loads were applied, simulating the peak load during gait. Digital Image Correlation was used to measure displacements and bone strains simultaneously throughout the test. Permanent migrations and inducible micromotions were measured (three translations and three rotations), while, on the same specimen, the full-field strain distribution on the bone surface was measured. The repeatability tests showed that the devised method had an intra-specimen variability smaller than 6 µm for the translation, 0.02 degrees for the rotations, and smaller than 60 microstrain for the strain distribution. The inter-specimen variability was larger than the intra-specimen variability due to the natural differences between femurs. Altogether, the measurement uncertainties (intrinsic measurement errors, intra-specimen repeatability and inter-specimen variability) were smaller than critical levels of biomarkers for adverse remodelling and aseptic loosening, thus allowing to discriminate between stable and unstable implants, and to detect critical strain magnitudes in the host bone. In conclusion, this work showed that it is possible to measure the primary stability and the load transfer of an osseointegrated transfemoral prosthesis in a reliable way using a combination of mechanical testing and DIC.

A Sensory Feedback Neural Stimulator Prototype for Both Implantable and Wearable Applications.

The restoration of sensory feedback is one of the current challenges in the field of prosthetics. This work, following the analysis of the various types of sensory feedback, aims to present a prototype device that could be used both for implantable applications to perform PNS and for wearable applications, performing TENS, to restore sensory feedback. The two systems are composed of three electronic boards that are presented in detail, as well as the bench tests carried out. To the authors' best knowledge, this work presents the first device that can be used in a dual scenario for restoring sensory feedback. Both the implantable and wearable versions respected the expected values regarding the stimulation parameters. In its implantable version, the proposed system allows simultaneous and independent stimulation of 30 channels. Furthermore, the capacity of the wearable version to elicit somatic sensations was evaluated on healthy participants demonstrating performance comparable with commercial solutions.

A retrospective multidimensional comparison of microprocessor and mechanical knee users: Analysis of quality of life and satisfaction with the prosthesis.

BACKGROUND: Despite the demonstrated greater efficacy of microprocessor knees (MPK) over mechanical knees (MK), the latter is still widely used by persons with transfemoral amputation. Besides motivations related to local insurance policies, quality of life (QoL) and satisfaction with the prosthesis play a key role in user preference. OBJECTIVE: The aim of this study is to compare QoL and satisfaction in a large sample of MPK and MK users and to assess how these outcomes are explained by clinical and demographic characteristics. STUDY DESIGN: Retrospective study. METHODS: The study was conducted on 75 MPK and 60 MK users. Quality of life was assessed using the EuroQoL Five Dimensions and the EuroQoL Visual Analog Scale questionnaires. Satisfaction was assessed with the Satisfaction with Prosthesis questionnaire. All 3 instruments were self-administered. Univariate and multivariate regression analyses were conducted thereafter. RESULTS: The difference in satisfaction between MPK and MK users was not statistically significant. Significant differences were observed instead for QoL. From the univariate regression analysis, 6 factors were significant predictors of QoL and satisfaction. On multivariate analysis, the number of significant factors was reduced to 3, namely knee type, age at the first prosthesis, and experience with prosthesis. Type of knee and age at the first prosthesis significantly predicted QoL scores, explaining 12% of EuroQoL Five Dimensions and 25% of EuroQoL Visual Analog Scale variances. Age at the first prosthesis and experience with prosthesis predicted Satisfaction with Prosthesis scores in the multivariate model, explaining 25% of the variance. CONCLUSIONS: MPK affects QoL but not satisfaction, which is positively driven by patients' experience with prosthesis and negatively affected by the age at the time of the first prosthesis.

A sensory-motor hand prosthesis with integrated thermal feedback.

BACKGROUND: Recently, we reported the presence of phantom thermal sensations in amputees: thermal stimulation of specific spots on the residual arm elicited thermal sensations in their missing hands. Here, we exploit phantom thermal sensations via a standalone system integrated into a robotic prosthetic hand to provide real-time and natural temperature feedback. METHODS: The subject (a male adult with unilateral transradial amputation) used the sensorized prosthesis to manipulate objects and distinguish their thermal properties. We tested his ability to discriminate between (1) hot, cold, and ambient temperature objects, (2) different materials (copper, glass, and plastic), and (3) artificial versus human hands. We also introduced the thermal box and block test (thermal BBT), a test to evaluate real-time temperature discrimination during standardized pick-and-place tasks. FINDINGS: The subject performed all three discrimination tasks above chance level with similar accuracies as with his intact hand. Additionally, in all 15 sessions of the thermal BBT, he correctly placed more than half of the samples. Finally, the phantom thermal sensation was stable during the 13 recording sessions spread over 400 days. CONCLUSION: Our study paves the way for more natural hand prostheses that restore the full palette of sensations. FUNDING: This work was funded by the Bertarelli Foundation (including the Catalyst program); the Swiss National Science Foundation through the National Centre of Competence in Research (NCCR) Robotics; the European Union's Horizon 2020 research and innovation program; the Horizon Europe Research & Innovation Program; the Ministry of University and Research (MUR), National Recovery and Resilience Plan (NRRP); and the Tuscany Health Ecosystem.

Improving Walking Energy Efficiency in Transtibial Amputees Through the Integration of a Low-Power Actuator in an ESAR Foot.

Reducing energy consumption during walking is a critical goal for transtibial amputees. The study presents the evaluation of a semi-active prosthesis with five transtibial amputees. The prosthesis has a low-power actuator integrated in parallel into an energy-storing-and-releasing foot. The actuator is controlled to compress the foot during the stance phase, supplementing the natural compression due to the user's dynamic interaction with the ground, particularly during the ankle dorsiflexion phase, and to release the energy stored in the foot during the push-off phase, to enhance propulsion. The control strategy is adaptive to the user's gait patterns and speed. The clinical protocol to evaluate the system included treadmill and overground walking tasks. The results showed that walking with the semi-active prosthesis reduced the Physiological Cost Index of transtibial amputees by up to 16% compared to walking using the subjects' proprietary prosthesis. No significant alterations were observed in the spatiotemporal gait parameters of the participants, indicating the module's compatibility with users' natural walking patterns. These findings highlight the potential of the mechatronic actuator in effectively reducing energy expenditure during walking for transtibial amputees. The proposed prosthesis may bring a positive impact on the quality of life, mobility, and functional performance of individuals with transtibial amputation.

A low-power ankle-foot prosthesis for push-off enhancement.

Passive ankle-foot prostheses are light-weighted and reliable, but they cannot generate net positive power, which is essential in restoring the natural gait pattern of amputees. Recent robotic prostheses addressed the problem by actively controlling the storage and release of energy generated during the stance phase through the mechanical deformation of elastic elements housed in the device. This study proposes an innovative low-power active prosthetic module that fits on off-the-shelf passive ankle-foot energy-storage-and-release (ESAR) prostheses. The module is placed parallel to the ESAR foot, actively augmenting the energy stored in the foot and controlling the energy return for an enhanced push-off. The parallel elastic actuation takes advantage of the amputee's natural loading action on the foot's elastic structure, retaining its deformation. The actuation unit is designed to additionally deform the foot and command the return of the total stored energy. The control strategy of the prosthesis adapts to changes in the user's cadence and loading conditions to return the energy at a desired stride phase. An early verification on two transtibial amputees during treadmill walking showed that the proposed mechanism could increase the subjects' dorsiflexion peak of 15.2% and 41.6% for subjects 1 and 2, respectively, and the cadence of about 2%. Moreover, an increase of 26% and 45% was observed in the energy return for subjects 1 and 2, respectively.