"Progettazione e Sviluppo di un sistema endoscopico per il monitoraggio nel decorso post-operatorio"

La maggior parte dei Dispositivi Medicali(DM) ha come utilizzatori finali il medico e i pazienti. Le indicazioni dei medici e degli operatori dell’ambiente ospedaliero sono alla base del processo di progettazione e sviluppo di un qualsiasi dispositivo medicale. In quanto sono loro, riscontrando problemi ogni giorno, ad avere le idee da cui possono nascere potenziali dispositivi utili. I campi di applicazione sono vari e spaziano dall’ambito diagnostico all’ambito della terapia e della riabilitazione. Questo progetto nasce dall’idea di Microtech s.r.l di creare un dispositivo medico per la diagnosi nel decorso post-operatorio in seguito ad interventi chirurgici, denominato LapDrain. Questo DM è particolarmente indicato in seguito a resezioni di stomaco, intestino e retto; anastomosi e suture a rischio. La progettazione di LapDrain può essere riassunta dalle seguenti fasi,tutte elaborate in questo progetto: 1.Analisi del contesto medico. 2.Stato dell’arte nel campo di applicazione. 3.Ricerca Brevettuale. 4.Analisi delle potenziali configurazioni e progettazione CAD. 5.Analisi e ricerca materiali. 6.Realizzazione prototipi. 7.Valutazioni sui sistemi di visione. 8.Scelta della configurazione finale. 9.Realizzazione del dispositivo. 10.Prove di resistenza meccanica. 11.Test in vivo. 12.Studio e stesura del fascicolo tecnico

User-centered design and development of TWIN-Acta: A novel control suite of the TWIN lower limb exoskeleton for the rehabilitation of persons post-stroke

Introduction: Difficulties faced while walking are common symptoms after stroke, significantly reducing the quality of life. Walking recovery is therefore one of the main priorities of rehabilitation. Wearable powered exoskeletons have been developed to provide lower limb assistance and enable training for persons with gait impairments by using typical physiological movement patterns. Exoskeletons were originally designed for individuals without any walking capacities, such as subjects with complete spinal cord injuries. Recent systematic reviews suggested that lower limb exoskeletons could be valid tools to restore independent walking in subjects with residual motor function, such as persons post-stroke. To ensure that devices meet end-user needs, it is important to understand and incorporate their perspectives. However, only a limited number of studies have followed such an approach in the post-stroke population. Methods: The aim of the study was to identify the end-users needs and to develop a user-centered-based control system for the TWIN lower limb exoskeleton to provide post-stroke rehabilitation. We thus describe the development and validation, by clinical experts, of TWIN-Acta: a novel control suite for TWIN, specifically designed for persons post-stroke. We detailed the conceived control strategy and developmental phases, and reported evaluation sessions performed on healthy clinical experts and people post-stroke to evaluate TWIN-Acta usability, acceptability, and barriers to usage. At each developmental stage, the clinical experts received a one-day training on the TWIN exoskeleton equipped with the TWIN-Acta control suite. Data on usability, acceptability, and limitations to system usage were collected through questionnaires and semi-structured interviews. Results: The system received overall good usability and acceptability ratings and resulted in a well-conceived and safe approach. All experts gave excellent ratings regarding the possibility of modulating the assistance provided by the exoskeleton during the movement execution and concluded that the TWIN-Acta would be useful in gait rehabilitation for persons post-stroke. The main limit was the low level of system learnability, attributable to the short-time of usage. This issue can be minimized with prolonged training and must be taken into consideration when planning rehabilitation. Discussion: This study showed the potential of the novel control suite TWIN-Acta for gait rehabilitation and efficacy studies are the next step in its evaluation process

Screening of postpartum diabetes in women with gestational diabetes: high-risk subgroups and areas for improvements-the strong observational study

AIMS: To assess the proportion of women with gestational diabetes (GDM) by performing postpartum Oral Glucose Tolerance Test (OGTT) and to identify GDM phenotypes at high-risk of postpartum dysglycemia (PPD).METHODS: Observational, retrospective, multicenter study involving consecutive GDM women. Recursive partitioning (RECPAM) analysis was used to identify distinct and homogeneous subgroups of women at different PPD risk.RESULTS: From a sample of 2,736 women, OGTT was performed in 941 (34.4%) women, of whom 217 (23.0%) developed PPD. Insulin-treated women having family history of diabetes represented the subgroup with the highest PPD risk (OR 5.57, 95% CI 3.60-8.63) compared to the reference class (women on diet with pre-pregnancy BMI<=28.1kg/m2). Insulin-treated women without family diabetes history and women on diet with pre-pregnancy BMI>28.1kg/m2 showed a two-fold PPD risk. Previous GDM and socioeconomic status represent additional predictors. Fasting more than post-prandial glycemia plays a predictive role, with values of 81-87mg/dl (4.5-4.8mmol/l) (lower than the current diagnostic GDM threshold) being associated with PPD risk.CONCLUSIONS: Increasing compliance to postpartum OGTT to prevent/delay PPD is a priority. Easily available characteristics identify subgroups of women more likely to benefit from preventive strategies. Fasting BG values during pregnancy lower than those usually considered deserve attention

Insights into emotions, learning and motor function in Parkinson’s disease to improve the multidisciplinary approach of the treatment

Quantitative methods are nowadays available to assess human balance by measuring movements of the body Center of Pressure (CoP) and Center of Mass (CoM) in static (i.e. posturography) or dynamic condition (i.e. walking). The CoP displacements are commonly recorded using force platforms, as CoP is the point of application of the resultant of ground reaction forces, while the CoM is usually extrapolated from the 3D coordinates of the body anatomical landmarks related to the kinematics through biomechanical models. The availability of such methods has improved over the years the knowledge of the physiological movement and of its alterations in pathological conditions in people with neurological diseases, such as Parkinson’s disease (PD). The strength of instrumented measurements lays in their ability to detect slight differences in movement patterns and motor control, not clinically detectable by a human observation, between PD patients at the early stage of the disease and healthy subjects, as well as in the possibility to capture the changes induced by rehabilitation. In addition, the usefulness of these measurements became fundamental for the management of individual patients, in particular for tailoring the therapeutic interventions on balance deficits in PD patients. Recent narrative reviews highlighted that a multidisciplinary approach, which include pharmacological, surgical, and non-pharmacological treatments (i.e., physiotherapy, occupational-therapy, and cognitive-emotional interventions), is essential for a positive effect on PD persons, especially when Freezing of Gait (FOG) symptoms occur. In light of the above consideration, this thesis has been divided into two main lines of research, that are: 1) the investigation of the effects of the emotional sphere on visual-spatial learning and gait initiation in persons with PD, with and without FOG symptoms, to advance the knowledge on PD pathophysiology and to provide useful data for a tailored therapeutic approach (Chapter 2 and 3); 2) the assessment of quantitative measures of movement, related to static and dynamic balance, during gait initiation and walking in persons with PD, using both wearable systems and optoelectronic instrumentation (Chapter 4 and 5). This thesis have the objective of adding a piece of knowledge about the neurophysiological basis of usual and complex gait in healthy subjects and in people with PD by means of movement analysis methodologies. Overall, our results highlighted some relevant findings regarding: (i) the protective strategy adopted by subjects with PD to manage their dynamic balance deficit; (ii) the development of home-based rehabilitation protocol based on a single wearable sensor to improve the anticipatory postural adjustments in subjects with PD; (iii) the effects of music evoked-emotions on visual-spatial learning in elderly and in subjects with PD; (iv) the correlates of emotions aroused by the common real-life sounds with the FOG symptom experienced in subjects PD. Although physiotherapy is considered an essential intervention to improve independence and quality of life of PD patients, the development of innovative, multi-domains, and personalized treatment, to support patients along the course of the disease is still needed. Nowadays, the availability of cost-effective technologies, able to detect movements in ecological settings (e.g. home, outdoor activities), allow researchers to deeply investigate motor and cognitive disturbances induced by PD. Humans are emotional beings. We have the ability to accept and give love, feel anger and fear, experience shame, guilt, and humiliation, transform with joy, pride, and elation, and so much more. Our ability to be emotional sets us apart from other living beings in the world. And it’s our emotional responses to stimuli in our world that can either bring out the best or the worst from us. The results reported in this project (Section 2 and 3) suggest that emotions play an important role in motor and cognitive ability in healthy subjects and in subjects with PD. In the more advanced stages of the disease more severe symptoms appear such as FOG, which is a very disabling episodic symptom. For this reason, a part of this thesis has been focused on trying to understand what the triggering factors of FOG may be. Based on the study of APAs, which are fundamental movements for dynamic balance and for the integrity of walking, it emerged that the unpleasant emotions can be among the triggering factors of the FOG symptom in subjects with PD. We compared behavioral data from a cohort of PD participants with or without the FOG symptom during gait initiation, to investigate which among the most realistic circumstances involving emotional factors may influence gait patterns. The main finding of our study was that the influence of auditory emotional stimuli on automatic movement during gait initiation is different in subjects with and without FOG. In particular, the negative-oriented auditory stimuli (i.e., unpleasant stimuli) reduced the APA generation in PD patients with FOG, while positive-oriented ones (i.e., pleasant stimuli) facilitate the APA displacement. In addition, we found that this emotion-evoked behavior was mainly associated with non-motor domain factors, such as depression, confirming the role of non-motor symptoms in the developing of the FOG. The results of cross sectional studies conducted in this project (Section 4 and Section 5) highlighted the possible lines of development on rehabilitation protocols to improve the dynamic balance in subjects with PD and increase their effects with testing protocols applicable in a home-based setting. The training as constant as possible could prolong the maintenance of the beneficial effects after the end of therapy. The availability of easy-to-administer tests for the evaluation of balance control and motor skills makes a realistic scenario the one in which similar solutions will be soon adopted in the tele-monitoring of community-dwelling healthy elderly and neurological patients, offering the possibility of an early diagnosis and fast intervention. The possibility to learn new motor strategies in a familiar domestic environment could be of high value for the patient, since it could enable the possibility to directly improve activities that are really conducted in that setting on a daily basis, thus assisting the final users in preserving their lifestyle, autonomy and health. Our results support previous finding, suggesting that emotional management (also known as emotion-focused therapy), which assumes that lacking emotional awareness or avoiding unpleasant emotions can cause harm, might be an adjunctive therapeutic intervention to improve gait and balance performance in PD patients and in particular in those who experience FOG. Future studies should investigate whether adding emotion-focused training to physiotherapy might reduce the effects of FOG in individuals with Parkinson's disease

Association of 7-Day Profiles of Motor Activity in Marital Dyads with One Component Affected by Parkinson’s Disease

(1) Background: A noticeable association between the motor activity (MA) profiles of persons living together has been found in previous studies. Social actigraphy methods have shown that this association, in marital dyads composed of healthy individuals, is greater than that of a single person compared to itself. This study aims at verifying the association of MA profiles in dyads where one component is affected by Parkinson’s disease (PD). (2) Methods: Using a wearable sensor-based social actigraphy approach, we continuously monitored, for 7 days, the activities of 27 marital dyads including one component with PD. (3) Results: The association of motor activity profiles within a marital dyad (cross-correlation coefficient 0.344) is comparable to the association of any participant with themselves (0.325). However, when considering the disease severity quantified by the UPDRS III score, it turns out that the less severe the symptoms, the more associated are the MA profiles. (4) Conclusions: Our findings suggest that PD treatment could be improved by leveraging the MA of the healthy spouse, thus promoting lifestyles also beneficial for the component affected by PD. The actigraphy approach provided valuable information on habitual functions and motor fluctuations, and could be useful in investigating the response to treatment

Association of 7-Day Profiles of Motor Activity in Marital Dyads with One Component Affected by Parkinson’s Disease

(1) Background: A noticeable association between the motor activity (MA) profiles of persons living together has been found in previous studies. Social actigraphy methods have shown that this association, in marital dyads composed of healthy individuals, is greater than that of a single person compared to itself. This study aims at verifying the association of MA profiles in dyads where one component is affected by Parkinson’s disease (PD). (2) Methods: Using a wearable sensor-based social actigraphy approach, we continuously monitored, for 7 days, the activities of 27 marital dyads including one component with PD. (3) Results: The association of motor activity profiles within a marital dyad (cross-correlation coefficient 0.344) is comparable to the association of any participant with themselves (0.325). However, when considering the disease severity quantified by the UPDRS III score, it turns out that the less severe the symptoms, the more associated are the MA profiles. (4) Conclusions: Our findings suggest that PD treatment could be improved by leveraging the MA of the healthy spouse, thus promoting lifestyles also beneficial for the component affected by PD. The actigraphy approach provided valuable information on habitual functions and motor fluctuations, and could be useful in investigating the response to treatment

Indagini sulla sopravvivenza ad essiccamento e stress termico e sulla ripresa della vita attiva in tardigradi colonizzanti ambienti a variabilit\ue0 stocastica

La possibilit\ue0 di attuare la criptobiosi consente ai tardigradi di colonizzare ambienti estremi (deserti, montagne elevate, o regioni polari) preclusi alla maggior parte degli altri organismi e, nelle zone temperate, di vivere in habitat particolari caratterizzati dall\u2019alternanza stocastica di periodi di siccit\ue0 e pioggia, o di congelamento e scongelamento. Studi sulla criptobiosi nei tardigradi sono stati rivolti ad individuare le molecole bioprotettrici, soprattutto il trealosio, prodotte quando gli animali entrano in questo stato. Nostre indagini, basate sull\u2019interazione tra osservazione in natura e sperimentazione in laboratorio, hanno riguardato l\u2019effettiva capacit\ue0 di sopravvivenza dei tardigradi in anidrobiosi e i relativi aspetti microevolutivi. Esse hanno portato all\u2019individuazione di differenze nel tasso di sopravvivenza, sia tra specie, che tra popolazioni della stessa specie provenienti da aree geografiche diverse. Abbiamo ora inteso considerare gli effetti combinati di stress da essiccamento e da calore. Sono stati pertanto condotti alcuni esperimenti utilizzando Macrobiotus richtersi, eutardigrado facilmente reperibile nella lettiera di bosco sottoposta a ripetuti e imprevedibili eventi di disidratazione e reidratazione (oltre che a congelamento e scongelamento). Esemplari lasciati seccare all\u2019interno di un campione di lettiera di bosco raccolto in natura e quindi ulteriormente stressati mantenendoli a 37\ub0C per 21 giorni, non evidenziano diminuzioni significative della sopravvivenza dopo la reidratazione. Tuttavia, il tempo necessario per riprendere la vita attiva da parte di questi animali non resta uguale, ma aumenta in relazione diretta al tempo trascorso a 37\ub0C. Diversamente, esemplari seccati in un campione di lettiera di bosco e stressati a 37\ub0C per 21 giorni, ma mantenuti a diversi livelli di umidit\ue0 relativa dell\u2019aria (RH, 80%, 25%, circa 0%), mostrano, dopo reidratazione, una sopravvivenza inversamente proporzionale al valore di RH. Inoltre, il tempo necessario per la ripresa della vita attiva \ue8 direttamente proporzionale al valore di RH a cui gli animali stessi sono stati esposti. Un risultato simile (ma con sopravvivenza complessivamente minore) \ue8 emerso da animali essiccati sperimentalmente su carta a condizioni controllate e quindi sottoposti a 21 giorni di stress termico, sempre a 37\ub0C. Alcuni autori sostengono che la criptobiosi, o almeno l\u2019anidrobiosi, comporti un danno del DNA e quindi che la ripresa della vita attiva sia accompagnata da fenomeni riparativi del DNA stesso. Questo si accorderebbe con il maggior tempo necessario agli animali sottoposti a forti livelli di stress per riprendersi. Tuttavia, nostre indagini sul DNA estratto da esemplari di M. richtersi essiccati su carta e stressati a 37\ub0C non hanno verificato la presenza di rotture dell\u2019acido nucleico, indicando che la causa del ritardo nella ripresa della vita attiva deve essere ricercata in altri tipi di molecole

Are Modular Activations Altered in Lower Limb Muscles of Persons with Multiple Sclerosis during Walking? Evidence from Muscle Synergies and Biomechanical Analysis

Background: Persons with Multiple Sclerosis frequently have gait deficits that lead to diminished activities of daily living. Identification of motoneuron activity patterns may elucidate new insight into impaired locomotor coordination and underlying neural systems. The aim of the present study was to investigate muscle synergies, identified by motor modules and their activation profiles, in persons with Multiple Sclerosis (PwMS) during walking compared to those of healthy subjects (HS), as well as, exploring relationship of muscle synergies with walking ability of PwMS. Methods: Seventeen PwMS walked at their natural speed while 12 HS walked at slower than their natural speeds in order to provide normative gait values at matched speeds (spatio-temporal, kinematic, and kinetic parameters and electromyography signals). Non-negative matrix factorization was used to identify muscle synergies from eight muscles. Pearson's correlation coefficient was used to evaluate the similarity of motor modules between PwMS and HS. To assess differences in module activations, each module's activation timing was integrated over 100% of gait cycle and the activation percentage was computed in six phases. Results: Fifty-nine% of PwMS and 58% of HS had 4 modules while the remaining of both populations had 3 modules. Module 2 (related to soleus, medial, and lateral gastrocnemius primarily involved in mid and terminal stance) and Module 3 (related to tibialis anterior and rectus femoris primarily involved in early stance, and early and late swing) were comparable across all subjects regardless of synergies number. PwMS had shorter stride length, longer double support phase and push off deficit with respect to HS (p < 0.05). The alterations of activation timing profiles of specific modules in PwMS were associated with their walking deficits (e.g., the reduction of Module 2 activation percentage index in terminal stance, PwMS 35.55 ± 13.23 vs. HS 50.51 ± 9.13% p < 0.05, and the push off deficit, PwMS 0.181 ± 0.136 vs. HS 0.291 ± 0.062 w/kg p < 0.05). Conclusion: During gait PwMS have synergies numbers similar to healthy persons. Their neurological deficit alters modular control through modifications of the timing activation profiles rather than module composition. These changes were associated with their main walking impairment, muscle weakness, and prolonged double support.Italy. Ministry of Healt

Surface-Electromyography-Based Co-Contraction Index for Monitoring Upper Limb Improvements in Post-Stroke Rehabilitation: A Pilot Randomized Controlled Trial Secondary Analysis

Persons post-stroke experience excessive muscle co-contraction, and consequently the arm functions are compromised during the activities of daily living. Therefore, identifying instrumental outcome measures able to detect the motor strategy adopted after a stroke is a primary clinical goal. Accordingly, this study aims at verifying whether the surface electromyography (sEMG)-based co-contraction index (CCI) could be a new clinically feasible approach for assessing and monitoring patients' motor performance. Thirty-four persons post-stroke underwent clinical assessment and upper extremity kinematic analysis, including sEMG recordings. The participants were randomized into two treatment groups (robot and usual care groups). Ten healthy subjects provided a normative reference (NR). Frost's CCI was used to quantify the muscle co-contraction of three different agonist/antagonist muscle pairs during an object-placing task. Persons post-stroke showed excessive muscle co-contraction (mean (95% CI): anterior/posterior deltoid CCI: 0.38 (0.34-0.41) p = 0.03; triceps/biceps CCI: 0.46 (0.41-0.50) p = 0.01) compared to NR (anterior/posterior deltoid CCI: 0.29 (0.21-0.36); triceps/biceps CCI: 0.34 (0.30-0.39)). After robot therapy, persons post-stroke exhibited a greater improvement (i.e., reduced CCI) in proximal motor control (anterior/posterior deltoid change score of CCI: -0.02 (-0.07-0.02) p = 0.05) compared to usual care therapy (0.04 (0.00-0.09)). Finally, the findings of the present study indicate that the sEMG-based CCI could be a valuable tool in clinical practice