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.