Transfemoral amputation is a debilitating condition that leads to long-term mobility restriction and secondary disorders that negatively affect the quality of life of millions of individuals ...worldwide. Currently available prostheses are not able to restore energetically efficient and functional gait, thus, recently, the alternative strategy to inject energy at the residual hip has been proposed to compensate for the lack of energy of the missing leg. Here, we show that a portable and powered hip exoskeleton assisting both the residual and intact limb induced a reduction of walking energy expenditure in four individuals with above-knee amputation. The reduction of the energy expenditure, quantified using the Physiological Cost Index, was in the range -10, -17% for all study participants compared to walking without assistance, and between -2, -24% in three out of four study participants compared to walking without the device. Additionally, all study participants were able to walk comfortably and confidently with the hip exoskeleton overground at both their self-selected comfortable and fast speed without any observable alterations in gait stability. The study findings confirm that injecting energy at the hip level is a promising approach for individuals with above-knee amputation. By reducing the energy expenditure of walking and facilitating gait, a hip exoskeleton may extend mobility and improve locomotor training of individuals with above-knee amputation, with several positive implications for their quality of life.
The effectiveness of haptic feedback devices highly depends on the perception of tactile stimuli, which differs across body parts and can be affected by movement. In this study, a novel wearable ...sensory feedback apparatus made of a pair of pressure-sensitive insoles and a belt equipped with vibrotactile units is presented; the device provides time-discrete vibrations around the waist, synchronized with biomechanically-relevant gait events during walking. Experiments with fifteen healthy volunteers were carried out to investigate users' tactile perception on the waist. Stimuli of different intensities were provided at twelve locations, each time synchronously with one pre-defined gait event (i.e. heel strike, flat foot or toe off), following a pseudo-random stimulation sequence. Reaction time, detection rate and localization accuracy were analyzed as functions of the stimulation level and site and the effect of gait events on perception was investigated. Results revealed that above-threshold stimuli (i.e. vibrations characterized by acceleration amplitudes of 1.92g and 2.13g and frequencies of 100 Hz and 150 Hz, respectively) can be effectively perceived in all the sites and successfully localized when the intertactor spacing is set to 10 cm. Moreover, it was found that perception of time-discrete vibrations was not affected by phase-related gating mechanisms, suggesting that the waist could be considered as a preferred body region for delivering haptic feedback during walking.
Current state-of-the-art locomotion mode classifiers for controlling robotic lower-limb prostheses rely on multiple sensors to achieve high accuracy, prediction performance, and robustness to both ...speed changes and subject-specific gait patterns. However, multiple sensors placed on different body parts usually entail discomfort and poor usability for the user. This paper presents an intention detection method that relies on the features extracted from an inertial measurement unit worn on the thigh and an online phase estimator. The algorithm classifies the locomotion mode of the upcoming stride among the three modes of ground-level walking, stair ascent, and stair descent. A two-stage classification process first distinguishes between transient and steady-state strides and then classifies the locomotion mode of the impending stride based on directed acyclic graphs of binary classifiers. The classification is performed at 75% or 85% of the previous stride phase, respectively for steady-state and transient strides. Data were gathered from 10 healthy subjects and processed offline. Feature design and selection were based on the data of all subjects, while the classification performance was assessed by leave-one-subject-out cross-validation. Results presented a median recognition accuracy of 98.7% for steady-state strides and 95.6% for transitions, suggesting that the method was inherently robust to variations in gait cadence, since all of the features were phase-based and not dependent on fixed time intervals. These results inform the design of control strategies for active transfemoral prostheses able to predict the user's locomotion intention during the next stride, using minimum sensors.
As a consequence of limb loss, trans-femoral amputees exert 60% additional knee extension torque and 50% more plantar flexion torque in the healthy limb compared to non-amputees. In this paper, we ...developed an active knee-ankle-foot orthosis (KAFO) designed to assist the healthy leg of trans-femoral amputees in activities of daily living, such as walking, ascending/descending stairs, and transitioning from sit-to-stand with adequate range of motion, speed, and peak torque. Our KAFO was designed to exceed the performance of similar assistive devices reported in literature in terms of: 1) portability; 2) power; 3) compliance; and 4) versatility. It is based on one-degree-of-freedom active series-elastic actuators in both the knee and ankle, with an additional passive degree of freedom at the ankle level to allow natural inversion/eversion. The knee module consists of a worm-gear surrounded by two pre-compressed springs. The ankle actuator relies on a mechanically adjustable compliance system combined with a 4-bar linkage transmission. The actuators were designed to optimize the torque output at the joints while fulfilling low-power requirements. This novel KAFO is controlled with a three-layer structure. The optimized low level, based on a closed-loop torque controller, has adequate performances for the targeted application. The device is also shown to fulfill the three pre-defined functional requirements for all locomotion modes.
Individuals with Parkinson's disease (PD) are characterized by gait and balance disorders limiting their independence and quality of life. Home-based rehabilitation programs, combined with drug ...therapy, demonstrated to be beneficial in the daily-life activities of PD subjects. Sensorized shoes can extract balance- and gait-related data in home-based scenarios and allow clinicians to monitor subjects' activities. In this study, we verified the capability of a pair of sensorized shoes (including pressure-sensitive insoles and one inertial measurement unit) in assessing ground-level walking and body weight shift exercises. The shoes can potentially be combined with a sensory biofeedback module that provides vibrotactile cues to individuals. Sensorized shoes have been assessed in terms of the capability of detecting relevant gait events (heel strike, flat foot, toe off), estimating spatiotemporal parameters of gait (stance, swing, and double support duration, stride length), estimating gait variables (vertical ground-reaction force, vGRF; coordinate of the center of pressure along the longitudinal axes of the feet, yCoP; and the dorsiflexion angle of the feet, Pitch angle). The assessment compared the outcomes with those extracted from the gold standard equipment, namely force platforms and a motion capture system. Results of this comparison with 9 PD subjects showed an overall median absolute error lower than 0.03 s in detecting the foot-contact, foot-off, and heel-off gait events while performing ground-level walking and lower than 0.15 s in body weight shift exercises. The computation of spatiotemporal parameters of gait showed median errors of 1.62 % of the stance phase duration and 0.002 m of the step length. Regarding the estimation of vGRF, yCoP, and Pitch angle, the median across-subjects Pearson correlation coefficient was 0.90, 0.94, and 0.91, respectively. These results confirm the suitability of the sensorized shoes for quantifying biomechanical features during body weight shift and gait exercises of PD and pave the way to exploit the biofeedback modules of the bidirectional interface in future studies.
This work presents a new shoulder-elbow exoskeleton (NESM) for upper-limb neurological rehabilitation. The system has four active degrees of freedom, namely shoulder adduction/abduction, ...flexion/extension and intra/extra rotation and elbow flexion/extension, together with eight additional passive degrees of freedom for the alignment of the motor axes to the human joint axes, regardless the user's specific anthropometry sizes. All the four active joints employ series elastic actuators: such compliant architecture makes the device both controllable in position mode and in torque mode. In order to realize a safe human-machine interface in the rehabilitation treatment, an algorithm for detecting spastic user contractions, or equivalently collisions with external objects, based on the torque measured in real-time by the device, has been preliminary tested.
We present an automated segmentation method based on the analysis of plantar pressure signals recorded from two synchronized wireless foot insoles. Given the strict limits on computational power and ...power consumption typical of wearable electronic components, our aim is to investigate the capability of a Hidden Markov Model machine-learning method, to detect gait phases with different levels of complexity in the processing of the wearable pressure sensors signals. Therefore three different datasets are developed: raw voltage values, calibrated sensor signals and a calibrated estimation of total ground reaction force and position of the plantar center of pressure. The method is tested on a pool of 5 healthy subjects, through a leave-one-out cross validation. The results show high classification performances achieved using estimated biomechanical variables, being on average the 96%. Calibrated signals and raw voltage values show higher delays and dispersions in phase transition detection, suggesting a lower reliability for online applications.
The kinins (primarily bradykinin, BK) represent the mediators responsible for local increase of vascular permeability in hereditary angioedema (HAE), HAE I-II associated with alterations of the ...SERPING1 gene and HAE with normal C1-Inhibitor function (HAE-nC1INH). Besides C1-Inhibitor function and concentration, no biological assay of kinin metabolism is actually available to help physicians for the diagnosis of angioedema (AE). We describe enzymatic tests on the plasma for diagnosis of BK-dependent AE.
The plasma amidase assays are performed using the Pro-Phe-Arg-p-nitroanilide peptide substrate to evaluate the spontaneous amidase activity and the proenzyme activation. We analyzed data of 872 patients presenting with BK-dependent AE or BK-unrelated diseases, compared to 303 controls. Anti-high MW kininogen (HK) immunoblot was achieved to confirm HK cleavage in exemplary samples. Reproducibility, repeatability, limit of blank, limit of detection, precision, linearity and receiver operating characteristics (ROC) were used to calculate the diagnostic performance of the assays.
Spontaneous amidase activity was significantly increased in all BK-dependent AE, associated with the acute phase of disease in HAE-nC1INH, but preserved in BK-unrelated disorders. The increase of the amidase activity was associated to HK proteolysis, indicating its relevance to identify kininogenase activity. The oestrogens, known for precipitating AE episodes, were found as triggers of enzymatic activity. Calculations from ROC curves gave the optimum diagnostic cut-off for women (9.3 nmol⋅min(-1)⋅mL(-1), area under curve AUC 92.1%, sensitivity 80.0%, and specificity 90.1%) and for men (6.6 nmol·min(-1)⋅mL(-1), AUC 91.0%, sensitivity 87.0% and specificity 81.2%).
The amidase assay represents a diagnostic tool to help physicians in the decision to distinguish between BK-related and -unrelated AE.