Assessment of Sensorized Insoles in Balance and Gait in Individuals With Parkinson's Disease.

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.

MITEx: A Portable Hand Exoskeleton for Assessment and Treatment in Neurological Rehabilitation.

This work describes the design and preliminary characterization of a novel portable hand exoskeleton for poststroke rehabilitation. The platform actively mobilizes the index-metacarpophalangeal (I-MCP) joint, and it additionally offers individual rigid support to distal degrees of freedom (DoFs) of the index and thumb. The test-bench characterization proves the capability of the device to render torques at the I-MCP level with high fidelity within frequencies of interest for the application (up to 3 Hz). The introduction of a feed-forward friction compensation at the actuator level lowers the output mechanical stiffness by 32%, contributing to a highly transparent behavior; moreover, the functionality of the platform in rendering different interaction strategies (patient/robot-in-charge) is tested with three healthy subjects, showing the potential of the device to provide assistance as needed.

Robotic Rehabilitation and Multimodal Instrumented Assessment of Post-stroke Elbow Motor Functions-A Randomized Controlled Trial Protocol.

Background: The reliable assessment, attribution, and alleviation of upper-limb joint stiffness are essential clinical objectives in the early rehabilitation from stroke and other neurological disorders, to prevent the progression of neuromuscular pathology and enable proactive physiotherapy toward functional recovery. However, the current clinical evaluation and treatment of this stiffness (and underlying muscle spasticity) are severely limited by their dependence on subjective evaluation and manual limb mobilization, thus rendering the evaluation imprecise and the treatment insufficiently tailored to the specific pathologies and residual capabilities of individual patients. Methods: To address these needs, the proposed clinical trial will employ the NEUROExos Elbow Module (NEEM), an active robotic exoskeleton, for the passive mobilization and active training of elbow flexion and extension in 60 sub-acute and chronic stroke patients with motor impairments (hemiparesis and/or spasticity) of the right arm. The study protocol is a randomized controlled trial consisting of a 4-week functional rehabilitation program, with both clinical and robotically instrumented assessments to be conducted at baseline and post-treatment. The primary outcome measures will be a set of standard clinical scales for upper limb spasticity and motor function assessment, including the Modified Ashworth Scale and Fugl-Meyer Index, to confirm the safety and evaluate the efficacy of robotic rehabilitation in reducing elbow stiffness and improving function. Secondary outcomes will include biomechanical, muscular activity, and motor performance parameters extracted from instrumented assessments using the NEEM along with synchronous EMG recordings. Conclusions: This randomized controlled trial aims to validate an innovative instrumented methodology for clinical spasticity assessment and functional rehabilitation, relying on the precision and accuracy of an elbow exoskeleton combined with EMG recordings and the expertise of a physiotherapist, thus complementing and maximizing the benefits of both practices. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT04484571.

Technologically-advanced assessment of upper-limb spasticity: a pilot study.

BACKGROUND: Spasticity is a muscle disorder associated with upper motor neuron syndrome occurring in neurological disorders, such as stroke, multiple sclerosis, spinal cord injury and others. It influences the patient's rehabilitation, interfering with function, limiting independence, causing pain and producing secondary impairments, such as contractures or other complications. Due to the heterogeneity of clinical signs of spasticity, there is no agreement on the most appropriate assessment and measurement modality for the evaluation of treatment outcomes. AIM: The aim of this article is to propose the use of new robotic devices for upper-limb spasticity assessment and describe the most relevant measures of spasticity which could be automatically assessed by using a technologically advanced device. DESIGN: Observational pilot study. SETTING: The treatment was provided in a Rehabilitation Centre where the device was located and the subjects were treated in an outpatients setting. POPULATION: Five post-stroke patients, age range 19-79 years (mean age 61, standard deviation [SD]±25) in their chronic phase. METHODS: A new robotic device able to automatically assess upper-limb spasticity during passive and active mobilization has been developed. The elbow spasticity of five post stroke patients has been assessed by using the new device and by means of the Modified Ashworth Scale (MAS). After the first assessment, subjects were treated with botulin toxin injections, and then underwent 10 sessions of robotic treatments. After the treatment, subjects spasticity was assessed by using the robotic device and the MAS Score. RESULTS: In four out of five patients, the botulin toxin injection and robotic treatment resulted in the improvement of the MAS Score; in three patients the robotic measures were able to detect the MAS changes. In one subject botulin toxin was not effective and the robotic device was able to detect the lack of effectiveness. CONCLUSIONS: By using the robotic device some spasticity parameters can be continuously recorded during the rehabilitation treatment in order to objectively measure the effectiveness of the interventions provided. CLINICAL REHABILITATION IMPACT: The standardized evaluation parameters recorded using robotic devices may provide several advantages: 1) the measures for spasticity assessment can be monitored during every rehabilitation session (even during each movement); 2) these measurements are able to highlight even small changes; 3) the recovery plateau can be detected early thus avoiding further rehabilitation sessions; and 4) these measurements can reduce the assessment bias in multicenter studies.

Physical human-robot interaction of an active pelvis orthosis: toward ergonomic assessment of wearable robots.

BACKGROUND: In human-centered robotics, exoskeletons are becoming relevant for addressing needs in the healthcare and industrial domains. Owing to their close interaction with the user, the safety and ergonomics of these systems are critical design features that require systematic evaluation methodologies. Proper transfer of mechanical power requires optimal tuning of the kinematic coupling between the robotic and anatomical joint rotation axes. We present the methods and results of an experimental evaluation of the physical interaction with an active pelvis orthosis (APO). This device was designed to effectively assist in hip flexion-extension during locomotion with a minimum impact on the physiological human kinematics, owing to a set of passive degrees of freedom for self-alignment of the human and robotic hip flexion-extension axes. METHODS: Five healthy volunteers walked on a treadmill at different speeds without and with the APO under different levels of assistance. The user-APO physical interaction was evaluated in terms of: (i) the deviation of human lower-limb joint kinematics when wearing the APO with respect to the physiological behavior (i.e., without the APO); (ii) relative displacements between the APO orthotic shells and the corresponding body segments; and (iii) the discrepancy between the kinematics of the APO and the wearer's hip joints. RESULTS: The results show: (i) negligible interference of the APO in human kinematics under all the experimented conditions; (ii) small (i.e., < 1 cm) relative displacements between the APO cuffs and the corresponding body segments (called stability); and (iii) significant increment in the human-robot kinematics discrepancy at the hip flexion-extension joint associated with speed and assistance level increase. CONCLUSIONS: APO mechanics and actuation have negligible interference in human locomotion. Human kinematics was not affected by the APO under all tested conditions. In addition, under all tested conditions, there was no relevant relative displacement between the orthotic cuffs and the corresponding anatomical segments. Hence, the physical human-robot coupling is reliable. These facts prove that the adopted mechanical design of passive degrees of freedom allows an effective human-robot kinematic coupling. We believe that this analysis may be useful for the definition of evaluation metrics for the ergonomics assessment of wearable robots.

Effects of lower limb length and body proportions on the energy cost of overground walking in older persons.

BACKGROUND: Although walking has been extensively investigated in its biomechanical and physiological aspects, little is known on whether lower limb length and body proportions affect the energy cost of overground walking in older persons. METHODS: We enrolled 50 men and 12 women aged 65 years and over, mean 69.1 ± SD 5.4, who at the end of their cardiac rehabilitation program performed the six-minute walk test while wearing a portable device for direct calorimetry and who walked a distance comparable to that of nondisabled community-dwelling older persons. RESULTS: In the multivariable regression model (F = 12.75, P < 0.001, adjusted R(2) = 0.278) the energy cost of overground walking, expressed as the net energy expenditure, in kg(-1) sec(-1), needed to provide own body mass with 1 joule kinetic energy, was inversely related to lower limb length and directly related to lower limb length to height ratio (ß ± SE(ß) = -3.72 × 10(-3) ± 0.74 × 10(-3), P < 0.001, and 6.61 × 10(-3) ± 2.14 × 10(-3), P = 0.003, resp.). Ancillary analyses also showed that, altogether, 1 cm increase in lower limb length reduced the energy cost of overground walking by 2.57% (95%CI 2.35-2.79). CONCLUSIONS: Lower limb length and body proportions actually affect the energy cost of overground walking in older persons.

Why effectiveness of robot-mediated neurorehabilitation does not necessarily influence its adoption.

This paper discusses the reasons why evidence of clinical effectiveness is not enough to facilitate adequate adoption of robotic technologies for upper-limb neurorehabilitation. The paper also provides a short review of the state of the art technologies. In particular, the paper highlights the barriers to the adoption of these technologies by the markets in which they are, or should be, deployed. On the other hand, the paper explores how low rates of adoption may depend on communication biases between the producers of the technologies and potential adopters. Finally, it is shown that, although technology-efficacy issues are usually well-documented, barriers to adoption also originate from the lack of solid evidence of the economic implications of the new technologies.