Clinical trials

Multicenter Prospective Controlled Randomized Trial, open-label, in patients with atherosclerotic cardiovascular disease (ASCVD) (acute coronary syndrome or chronic coronary syndrome and ischemic heart failure) and an approved indication for cardiac rehabilitation (CR). Patients completing phase II CR will be randomized 1:1 to usual Phase-III care (standard care) versus standard care plus the Digitally-Enhanced Extended PrEvention \& Rehabilitation (DEEPER) package (intervention). Primary outcome is 6-month change in composite Life's Crucial 9 (LC9) (LE8 + PHQ-9).

This two-arm, parallel-group randomized clinical trial investigates the effectiveness of an additional telerehabilitation program compared with standard care in patients with Post-Intensive Care Syndrome (PICS). The post-rehabilitation phase is crucial for consolidating recovery and ensuring continuity of care, with telerehabilitation offering a promising tool to enhance long-term adherence and outcomes. The primary objective is to evaluate whether a structured, multidisciplinary remote rehabilitation program can reduce the risk of rehospitalization and mortality while improving clinical, functional, and psychosocial recovery. Approximately 326 patients aged 30-75 years will be enrolled after inpatient rehabilitation and randomly assigned to either a four-month structured telerehabilitation program or standard post-discharge follow-up. All participants will undergo assessments at 4 and 12 months to monitor physical, cognitive, psychological, and metabolic recovery, with the ultimate aim of promoting a more complete and sustained rehabilitation after critical illness.

The aim of the SCORES Haptic Glove Study is to assess the technical features, safety, and reliability of a sensor-equipped glove designed to evaluate tactile perception. This will help guide further technical and functional improvements to finalize the device. The secondary goal is to validate a new tactile sensitivity index based on data collected using the glove. This will be done in a randomized controlled multicenter study (ClinicalTrials.gov ID NCT06109324) aimed to compare the effectiveness of robotic upper limb rehabilitation to conventional treatment in improving cognitive and sensory deficits, as well as evaluating the impact of these deficits on motor recovery.

The goal of this clinical trial is to learn if the use of a digital cognitive rehabilitation system named RICORDO, that is flexible and capable of adapting the rehabilitation pathway according to the needs and capacity of the patients will prove effective for subjects with Subjective Memory Complaint or with Mild Cognitive Impairment or with Mild Dementia. The main questions it aims to answer are: Will the RICORDO rehabilitation treatment, lead to an improvement in the global cognitive level? Will the RICORDO rehabilitation treatment lead to improved activation of participants in managing their own health and healthcare? Researchers will compare the multidomain cognitive rehabilitation strategy of RICORDO digital solution, with a standard paper pencil rehabilitation care (usual care). Participants will undergo a comprehensive neuropsychological evaluation immediately before, immediately after and six months after the completion of the rehabilitation program. Both interventions, the experimental and the usual care, will last 5 weeks, with 3 weekly sessions of 45 minutes each and can be done autonomously by the patient at home.

The goal of this clinical trial is to assess the usability and feasibility of a robotic and virtual reality-based system called NeglectARm 3D for the three-dimensional assessment of unilateral spatial neglect (USN) in patients with brain injury due to ischemic or hemorrhagic stroke. The main questions it aims to answer are: * Is the NeglectARm 3D system usable and feasible for patients with USN? * Do the robotic measurements show preliminary reliability and validity compared with conventional clinical neglect assessments (e.g., BIT, CBS)? Participants will: * Perform two assessment sessions, three weeks apart (T0 and T1); * Interact with the NeglectARm 3D system using a robotic end-effector and a VR headset to reach sequentially presented targets in a 3D virtual space; * Receive robotic assistance if targets are not reached, allowing the system to record trajectories, spatial positions, and assistance applied; * Complete standard clinical neglect tests to enable comparison between robotic and conventional measures. This study aims to develop a repeatable, standardized, and objective tool for the assessment of USN in patients with brain injury, potentially improving evaluation of depth perception and spatial attention deficits.

This study aims to evaluate the effectiveness of physiotherapy treatment combined with functional electrical stimulation (FES) in a small group of patients with severe acquired brain injury (SABI) of vascular origin and with a clinical and instrumental diagnosis of "Intensive Care Unit-Acquired Weakness" (ICU-AW). Functional electrical stimulation is a technology that uses electrical impulses, generated by an external device, to reactivate the neuromuscular system through electrodes applied to the skin. In functional electrical stimulation, this process is integrated into physiotherapy sessions, with the active involvement of the patient, through the performance of exercises with the assistance and supervision of the physiotherapist. The rationale behind this is to stimulate neuroplasticity processes by facilitating movement through the application of electrical stimuli and the active participation of the patient in performing a motor task, in an attempt to promote improvement in an impaired function. In particular, the objectives that will be pursued are: improvement of lower limb neuromyopathy assessed clinically using the Medical Research Council (MRC) scale, the Fugl-Meyer scale for lower limbs, the Short Physical Performance Battery (SPPB) scale, the assessment of active and passive Range Of Motion (ROM) of the main joints of the lower limb (hip, knee, ankle) and measured instrumentally by neurophysiological examination and ultrasound examination. After randomization, patients in the control arm will be treated with physiotherapy and speech therapy sessions as per the conventional protocol, and an additional 15 physiotherapy sessions lasting 60 minutes over a period of 5 weeks. Alternatively, patients in the experimental group will receive, in addition to conventional rehabilitation treatment, a treatment consisting of 15 physiotherapy sessions combined with FES lasting 60 minutes over a period of 5 weeks. At the end of the treatment period, baseline characteristics and clinical and instrumental outcome variables will be compared between the two groups using the chi-square test for dichotomous and categorical variables and the t-test for independent samples or the Mann-Whitney U test for continuous variables, depending on whether or not they are normally distributed. In all analyses, a p-value \<0.05 will be considered significant.

The goal of this clinical trial is to validate an artificial intelligence-based decision support system (AI-DSS) for robotic rehabilitation in participants with stroke. The study aims to answer the following questions: * Can the AI-DSS support therapists in setting therapy parameters and adapting personalized robotic rehabilitation programs effectively? * Can AI-supported robotic rehabilitation improve upper limb function, activities of daily living (ADL), cognitive function, and quality of life compared with standard therapist-guided robotic rehabilitation? Researchers will compare two groups: * Robotic rehabilitation supported by the AI-DSS (CO-AIDER); * Robotic rehabilitation with parameters set by therapists (control group). Participants will: * Receive robotic rehabilitation for the upper limb, either guided by the AI-DSS or by therapists; * Be monitored throughout the program, with therapy parameters adjusted according to their progress; * Complete assessments to evaluate changes in upper limb function, activities of daily living, cognitive function, and quality of life. The study will also evaluate the usability and acceptability of the AI-supported robotic system as perceived by participants and clinical staff, and will include a cost-effectiveness analysis of the two interventions.

The goal of this clinical trial is to validate the use of innovative tele-rehabilitation (TR) models in terms of efficiency and effectiveness in a pilot cohort of subjects with central and peripheral chemotherapy-induced neurotoxicity. Participants will be randomized (with an allocation ratio of 1:1) into the experimental group (TRUST\_ME - 15 sessions of motor and cognitive activities delivered at home through a TR approach using the Maia platform) and Treatment as Usual (15 sessions of multimedia content of educational/rehabilitation activities delivered via telemedicine platfom). It expected that the TR system to be considered acceptable in terms of efficiency (usability and acceptability of the technologies) and clinically effective, with positive impacts on both quality of life and central and peripheral functioning in these patients.

This study evaluates the impact of assistive technologies designed to improve the independence and safety of adults with disabilities living in shared residential environments. The project is called SALSA, which stands for "Sensorisation, Automation for Freedom, Security and Autonomy." It is being conducted in Milan, Italy, by a collaboration between Cascina Biblioteca Società Cooperativa Sociale, Fondazione Don Carlo Gnocchi ONLUS, and Informatici Senza Frontiere APS. The goal of the study is to determine how well specific technologies-such as smart lighting systems and wearable monitoring devices-support residents' autonomy and daily functioning, while also reducing the workload for professional caregivers. These technologies are installed in apartments where people with mental, social, and/or physical disabilities live together with some support. A total of 55 adults over the age of 18, all residents of Cascina Biblioteca's shared flats, will be enrolled. Technologies will be set up prior to the beginning of the trial. Data will be collected in three phases: before using the technologies (T0), after 30 days (T1), and after 60 days (T2). The evaluation includes personalized goals, physical environment metrics (like temperature, air quality, door use, and night movements), and ease of use of the systems by staff. The study uses Goal Attainment Scaling (GAS) to track whether residents achieve their individual or group goals, and the System Usability Scale (SUS) to assess how user-friendly the technologies are from the caregivers' perspective. All data will be collected through structured webforms to reduce the chance of missing information and increase consistency. The study team will use both descriptive and inferential statistical methods to assess results over time. A total of 55 adults over the age of 18, all residents of Cascina Biblioteca's shared flats, will be enrolled. Technologies will be set up prior to the beginning of the trial. Data will be collected in three phases: before using the technologies (T0), after 30 days (T1), and after 60 days (T2). The evaluation includes personalized goals, physical environment metrics (like temperature, air quality, door use, and night movements), and ease of use of the systems by staff. The study uses Goal Attainment Scaling (GAS) to track whether residents achieve their individual or group goals, and the System Usability Scale (SUS) to assess how user-friendly the technologies are from the caregivers' perspective. All data will be collected through structured webforms to reduce the chance of missing information and increase consistency. The study team will use both descriptive and inferential statistical methods to assess results over time. This research aims to provide practical insights into how technology can support adults with disabilities in more independent, safer living situations. It may also inform broader applications of these systems in similar care contexts. The protocol was approved by an Ethics Committee (CET 130/24; FDG 28\_17/12/2024) and is in the data collection phase as of early 2025.

The study aims to improve the quality of prosthetic intervention and verify the adequacy of assistive devices, and measurement outcomes. Fifty patients in need of prosthetic interventions for Augmentative Alternative Communication, computer accessibility, and environmental control will be recruited within the DAT Unit of the Fondazione Don Carlo Gnocchi "IRCCS S.Maria Nascente" in Milan. At baseline (T0) a physician and a psychologist will perform a clinical evaluation and the AT outcome assessment. The participants will be contacted for the follow-up phase (T1) 3 to 6 months after having received the assistive solution. At T1 clinicians will readminister the AT outcome assessment. In order to make the assessment accessible to all participants, these tests and questionnaires will be administered on Windows PCs, using Grid3 software, or on a specifically created accessible web page.

In this pilot observational study the primary outcome is to assess, in a Respiratory Rehabilitation Unit, if there is an association between sarcopenia, assessed by handgrip strenght and BIA, and a delayed decannulation time in patients who underwent tracheostomy. Secondary outcomes are to assess if there is an association between an increased malnutrition risk (assessed by MUST), a poor nutritional status (assessed by GLIM criteria) and a delayed decannulation time and the gut microbiota composition.

Functional Gastrointestinal Disorders (FGIDs) are conditions characterized by chronic gastrointestinal symptoms without evidence of pathology. These disorders are believed to result from alterations in gut-brain communication. The most common subtypes are Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD), often accompanied by chronic pain, anxiety, and depression. The role of stress in the manifestation of FGIDs is notable, with stress-related distress affecting the nerve pathways that connect gut and brain. Recent interest has focused on the use of Heart Rate Biofeedback (HRV). High levels of stress are associated with reduced HRV, which is common in patients with FGID. HRV biofeedback has been shown to be effective in improving parasympathetic tone and reducing sympathetic tone. The present study aims to evaluate the effectiveness of this approach in reducing stress and symptoms associated with FGIDs in college students. The project involves online screening to recruit participants, who will then be randomized to receive either the true HRV biofeedback treatment or a placebo condition. Pre- and post-treatment assessments include psychological questionnaires, physiological recordings, and a three-month follow-up. The treatment is expected to improve HRV, thereby reducing anxiety and gastrointestinal symptoms.

Objective: This observational, cross-sectional pilot study aims to assess "Brain Fog" (cognitive symptoms impacting memory, attention, and concentration) in severe Obstructive Sleep Apnea (OSA) patients. It compares two groups: those on CPAP treatment for at least 3 months and those not yet treated. Procedures: Severe OSA patients (AHI \> 30) will complete a 30-minute questionnaire at the Sleep Center Clinic, covering sociodemographic information, OSA diagnosis, and treatment details. Assessment scales will measure daytime sleepiness, sleep quality, and psychophysical fatigue. Participants: 80 Sleep Center outpatients, evenly divided by age and gender: 40 with severe OSA on CPAP for at least 3 months. 40 with severe OSA not yet on CPAP. Duration: Approximately 12 months.

The goal of this interventional study is to test whether combining transcranial magnetic stimulation (TMS) with functional electrical stimulation (FES) can improve hand and upper limb function in adults with Multiple Sclerosis (MS). The clinical trial aims to determine the following points: 1. Whether TMS combined with FES produces greater effects compared to FES alone. 2. Changes in brain and muscle activity related to hand function after treatment. 3. Specific clinical or neurophysiological factors that predict who will benefit most from the intervention. Researchers will compare the TMS-FES group (receiving brain magnetic stimulation and muscle electrostimulation) with the FES group (receiving only muscle electrostimulation) to assess whether TMS provides additional benefits in improving upper limb function Participants will: * Be assigned to a group (TMS-FES group or FES group) * Attend 15 sessions (45 minutes each, 3 times per week for 5 weeks) of task-based hand and arm exercises, during which FES, or TMS and FES, will be administered to the participant. * Undergo assessments before, after, and 3 months after training to measure hand function, brain and muscle responses, fatigue, and daily activity performance.

Early diagnosis of Neurodegenerative diseases (NDDs) and accurate patient profiling are key goals needed to tailor prompt personalized therapeutic strategies that can significantly impact disease progression and patients' quality of life. The project will validate a novel, cost-effective and quick biophotonic-based method for early and differential diagnosis of NDDs (Parkinson's disease, atypical parkinsonisms, Alzheimer's disease) and for routine clinical monitoring of NDD progression (longitudinal study). Raman spectroscopy (RS) will be applied to biochemically profile saliva and salivaderived Extracellular Vesicles (sEVs) and to identify a spectroscopic biomarker for NDDs. Optimized protocols for RS will be used to concomitantly evaluate saliva and sEVs from people with NDDs and to detect salivary changes in the biochemical profile, with special focus on EV-associated components. The accuracy of the method in discriminating NDDs at different disease stages and during disease progression will be verified. A nanotechnology-based biomolecular characterization of saliva and sEV will clarify the involvement of specific pathological molecules in NDDs progression.

The goal of the pragmatic study is to evaluate the effectiveness of a home-based telerehabilitation protocol for patients with post-stroke disabilities, compared to a home-based educational program. The main question it aims to answer is: Is home-based neuromotor and cognitive rehabilitation using digital tools more effective than a traditional educational program for improving static and dynamic balance in patients with subacute and chronic stroke? Researchers will compare the outcome (Berg Balance Scale) measured at baseline with the outcome after treatment to test its effectiveness.

The aim of this study is to investigate the predictive value of various biopsychosocial variables on the outcomes of subjects with chronic spinal pain undergoing public health rehabilitation pathways. Secondly, the study aims to assess the reliability of certain questionnaires, classified as Patient-Reported Outcome Measures (PROMs), which are frequently used in the evaluation of spinal pain but whose metric properties have not yet been established. These objectives will be pursued through two comprehensive assessment sessions (before and after rehabilitation), a re-test session immediately before rehabilitation (to evaluate the reliability of the questionnaires in stable subjects), and two follow-up assessments at 3 and 6 months after discharge.

The goal of this pilot clinical trial is to develop an integrated motor and cognitive rehabilitation program and evaluate the usability and acceptability of a new virtual reality scenario designed for the MOTORE device. This study will focus on the rehabilitation of the upper limbs in post-stroke patients with plegia and left-sided hemi-inattention. The main questions it aims to answer are: * The evaluation of the usability and acceptability of the newly developed scenario * The evaluation of the effects of the new scenario on patients' hemi-inattention * The evaluation of changes in upper limb functional parameters Participants will undergo a total of 13 rehabilitation sessions, each lasting 45 minutes, using the new scenario, including an initial and final assessment.

The aim of the study is to perform a cultural validation of the Italian translation of the Fugl-Meyer Assessment scale for the upper and the lower limb on a group of post-stroke patients admitted to the neurological department at The Don Carlo Foundation. The purpose is to validate the Italian translation of the Fugl-Meyer Assessment scale in order to allow immediate clinical use.

This study will be conducted at a single research center, the main objective of the study will be to evaluate the efficacy, safety, and accuracy of a medical device that has not yet been commercialized; therefore, it is still under development or testing and is not yet available for private use and is not for profit (nonprofit). Fifty participants will be recruited from subjects afferent to the outpatient and inpatient neuro-motor rehabilitation clinics of IRCCS Fondazione Don Carlo Gnocchi in Florence, Italy, and afferent to the outpatient and inpatient rehabilitation clinics of Elias University Emergency Hospital in Bucharest, Romania. In detail, it is deemed necessary to collect clinical and instrumental data. The study will be conducted by an interdisciplinary team composed of healthcare professionals and engineers afferent to the Department of Industrial Engineering. Should you decide to participate in the study, a visit to verify the inclusion and exclusion criteria will be primarily conducted. Once the admission criteria have been verified, participants will undergo a series of assessments. The first, involves the administration of some specific sections of the Fugl-Meyer scale (FMA), focusing on the upper extremities. Specifically, the following will be examined: section A for general upper limb function, section B assessing wrist mobility, and finally section D for limb coordination and speed. During this phase, both upper limbs will be assessed, in addition, the first examiner will carefully place sensors on the participants and assign scores to the tests performed, according to the criteria established by the FMA scale. Next, a second assessment (T1) will be conducted, in which a second examiner will be responsible for placing the sensors and recording data only on the most affected side. At a third time, called "T2" and again with at least 15 minutes interval from T1, the first examiner will repeat the same assessments performed in "T1." While performing these assessments, a RealSense camera will be used.

The rehabilitation outcome and recovery, in people after stroke or with vascular severe brain injury(vSBI), are difficult to predict. Moreover, the clinical management of patients during hospitalization is problematic due to complex clinical conditions and complications, e.g. healthcare-associated infections(HAIs). Today we still lack early objective biomarkers that could predict the patient's trajectory at admission. Extracellular vesicles are nanoparticles naturally released by cells in physiological and pathological conditions. As important actors of cellular communication between different organs and body districts, EVs are currently under investigation as an informative tool able to reflect the clinical conditions of patients. Using an optimized Surface Plasmon Resonance imaging (SPRi) based biosensor, our main objective is to assess the predictive capacity of biomarkers associated to blood-derived extracellular vesicles for anticipating patients' recovery after stroke and vSBI. If successful, the project will 1) demonstrate the ability of the SPRi biosensor to reveal differences in the relative amount of specific cell-derived EV subpopulations and their molecular cargo during disease progression and rehabilitation-induced recovery, 2) verify the impact of HAI on patients' response, 3) perform a patient's stratification to personalize the rehabilitation protocol.

Pathology registers are scientific research tools for the development of epidemiological and clinical studies and health planning, which allows access to useful elements for planning adequate health services. The Registry collects demographic, clinical and functional data of stroke patients and arises from the need to order and update this information for epidemiological and research purposes, for a better knowledge of this pathology from a rehabilitation point of view and to accelerate the development of new treatments.

The overall objective of the study is to identify prognostic predictors of cerebrovascular disease during various stages of the cerebrovascular disease itself, namely: hospitalization at the acute care facility, residential hospitalization at neurorehabilitation facilities, outpatient follow-up visits, and day hospital admissions at the various facilities. The aim is to obtain data on those factors that can influence the prognosis, thus the clinical outcome, of patients with cerebrovascular disease. Cerebrovascular diseases are defined by the World Health Organization (WHO) as "all those disorders in which there is an area of the brain transiently or permanently affected by ischemia or bleeding or in which one or more cerebral blood vessels are primarily affected in a pathological process, or a combination of the two conditions mentioned above." These diseases include a wide range of conditions, of which ischemic stroke and cerebral hemorrhage are the most common. Given the high overall frequency of these diseases and, consequently, the high social and economic cost of them on the population, it is essential to recognize as soon as possible those factors capable of predicting the time course of patients affected, as you are, by these diseases, also with a view to identifying strategies to improve the prognosis of patients for whom an unfavorable outcome is predicted. In addition, given the high prevalence of cerebrovascular disease, it is necessary that an extremely large patient population be enrolled, and thus an enormous amount of data be collected, in order for meaningful results to be obtained. The primary objective of this study is, in fact, to collect a large amount of clinical data, i.e., to establish a national data registry, obtained from the records of patients with cerebrovascular diseases that began after January 1, 2016, in order to be able to identify and define the subtypes of each cerebrovascular disease associated with poor prognosis. The secondary objectives are to identify clinical, neurophysiological, radiological, and biomarker data that are able to predict the clinical course of cerebrovascular disease over time and to identify prognostic scores obtained from the combination of the variables first indicated. With this study, we also aim to identify those clinical, radiological, and neurophysiological data that are able to help the clinician in the early differential diagnosis of these diseases and that are able to predict the occurrence of spontaneous or procedure-related complications and the successful outcome of treatment. Finally, we aim to identify those clinical, radiological, and neurophysiological variables that are able to predict a good outcome of rehabilitation performed as a result of the onset of cerebrovascular disease.

The aim of Re-Walk-Easy is to evaluate the effects of rehabilitation based on electrical stimulation on the motor performance of critically ill patients. The study will also investigate the pathophysiology of the two forms-the myopathic-predominant and the polyneuropathic-predominant variants-by examining the longitudinal progression of CIP and CIM and determining which form benefits more from electrical stimulation as a rehabilitative approach.

The goal of the FIT4TeleNEURO pragmatic trial is to verify, in real-life care contexts, the superiority in terms of the effectiveness of early rehabilitation intervention with Telerehabilitation (TR) protocols (TR single Approach, task-oriented - TRsA; TR combined approach, task-oriented and impairment-oriented - TRcA) compared to conventional management (Educational treatment, ET). The main questions it aims to answer are: * Are Telerehabilitation protocols more effective than educational treatment? * Is the TRcA treatment more effective than the TRsA? The study investigates the effects of rehabilitation treatment by comparing the two target cases (Multiple Sclerosis - MS and Parkinson's Diseases - PD). Participants will be subjective to: * 3 time-point of assessment (baseline, post-treatment and follow up) with motor, cognitive and quality-of-life measures * A 5-weeks rehabilitation treatment (4 times/week)