Montescano

Chronic Obstructive Pulmonary Disease (COPD) causes exercise intolerance and significant disability due to symptoms like breathlessness and fatigue, which impair daily activities. Pulmonary rehabilitation (PR), especially exercise-based, is key in managing COPD by improving exercise tolerance, reducing symptoms, and enhancing quality of life. This study aims to compare whether combined arm and leg training is more effective than standard lower limb training alone in improving activity of daily living (ADL) performance as measured by the GLITTRE test. Participants will be randomly assigned to one of two rehabilitation programs lasting 14 daily sessions of 90 minutes each. The lower limbs (LL) group will perform 60 minutes of stationary cycling for legs and 30 minutes of strengthening exercises. The lower plus upper limbs (L+UL) group will do 30 minutes of leg cycling, 30 minutes of arm-ergometer training, and 30 minutes of strengthening exercises for both upper and lower limbs. All sessions will be supervised by a physiotherapist, and training intensity will be progressively adjusted based on individual effort. During the study, researchers will collect clinical and lung function data at baseline and assess quality of life and functional ability before and after the program. The primary measure is the change in time to complete the GLITTRE test up to 16 days after randomization. Secondary outcomes include effort tolerance of upper and lower limbs and energy cost of walking. Safety, symptoms, and disability will also be monitored throughout the rehabilitation period.

Researchers are evaluating the effects of adding a therapeutic dose of oxygen during exercise on patients with chronic respiratory failure or exertional hypoxemia caused by chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD). This multicenter crossover trial aims to assess exercise performance, gas exchange, heart rate, symptom perception, and the ease of performing exercise in patients hospitalized in specialized pulmonary rehabilitation centers. The study also seeks to understand differences in responses among different disease groups and to improve oxygen therapy prescriptions during exertion. Participants will perform two 6-minute walk tests under different oxygen conditions in random order: one using their usual oxygen flow prescribed at rest or room air for those with exertional hypoxemia, and the other with supplemental oxygen set at double the resting flow rate or 2 liters per minute for those with exertional hypoxemia. The tests will be done at least 3 hours apart and within 24 hours. Oxygen is delivered through nasal cannula, and patients will carry oxygen in a stroller or similar device during the walks. The study includes three groups based on diagnosis and oxygen needs: COPD with exertional hypoxemia, COPD with chronic respiratory failure, and ILD with chronic respiratory failure. During the study, researchers will measure walking distance, oxygen saturation, heart rate, blood pressure, and symptom scales before, during, and after each walk. Participants will also complete a questionnaire about the ease of performance. The main outcome is the change in distance walked with supplemental oxygen compared to usual oxygen. Data analysis will explore clinical factors related to oxygen response, aiming to identify which patients benefit most and to inform better oxygen therapy dosing during exercise. The study plans to enroll 114 patients and follow strict statistical methods for comparison.

Researchers are studying the effects of trans-auricular vagus nerve stimulation (tVNS) on recovery of movement in patients who have had a stroke within the past 6 months and are in the subacute phase. The study compares traditional physical therapy and technological rehabilitation using the Khymeia robotic system, each combined with either active tVNS or sham (placebo) tVNS. The aim is to see if tVNS can enhance brain plasticity and speed up motor recovery in the upper limbs after stroke with minimal side effects. Participants will receive daily treatments for 60 minutes, five days a week, over a period of four weeks. Active tVNS is applied using the Parasym4 device on the left ear's tragus, delivering electrical stimulation at specific settings. Sham tVNS uses the same device but places electrodes on a non-vagal area of the ear to simulate treatment without actual nerve stimulation. Rehabilitation will involve either the Khymeia robotic device for upper limb therapy or traditional physical therapy methods. During the study, researchers will assess motor recovery of the upper limb using the Fugl-Meyer Assessment at the start and four weeks after treatment. Secondary assessments include clinical, cognitive, psychological, neurophysiological, and cardiovascular measures. Safety and any side effects, such as mild skin irritation, will be monitored. Participants will be involved in intensive rehabilitation sessions at specialized centers, with careful tracking of treatment effects and recovery progress.

Researchers are evaluating whether a high-tech rehabilitation approach is more effective than traditional rehabilitation in improving balance and motor function for adults with acute neuromuscular diseases such as Guillain-Barré Syndrome, Critical Illness Myopathy, and Critical Illness Polyneuromyopathy. This study focuses on patients within 15 to 30 days of disease onset and aims to improve outcomes like balance control, fatigue, muscle strength, cognitive engagement, and quality of life. The study is designed as a randomized, controlled trial comparing advanced technology-based rehabilitation to standard care. The high-tech rehabilitation includes the use of a Robotic Verticalization System to help regain upright posture and mobility, Virtual Reality for engaging cognitive and motor exercises, Stabilometric Platforms for balance training, and a Treadmill System for aerobic exercise with gait analysis and feedback. The control group receives traditional rehabilitation treatment. The treatment period lasts 60 days. Participants will be assessed for changes in balance using the Berg Balance Scale at the end of treatment. Throughout the study, researchers will monitor motor function, fatigue levels, muscle strength, and overall quality of life. Safety and adherence will be tracked, and participants will undergo regular evaluations to measure the effectiveness of the rehabilitation methods over the 60-day treatment period.

Researchers are investigating whether advanced rehabilitation methods using robotic and technological devices are as effective as traditional rehabilitation in reducing fatigue among adults with chronic neuromuscular diseases such as Amyotrophic Lateral Sclerosis, Chronic Inflammatory Demyelinating Polyneuropathy, and Charcot-Marie-Tooth Disease. This study aims to evaluate if high-tech interventions can improve balance, motor function, fatigue, muscle loss, cognitive engagement, and quality of life better or as well as conventional treatments. The study compares two groups: one receiving high-tech rehabilitation including virtual reality for cognitive and motor exercises, stabilometric platforms for balance and posture training, and treadmill systems for aerobic exercise with gait analysis; and a control group receiving traditional rehabilitation treatments. This randomized, pragmatic trial tests the non-inferiority of the high-tech approach compared to standard methods. Participants will be assessed multiple times over 60 days to monitor changes in fatigue using the Fatigue Severity Scale, as well as improvements in balance and other motor functions. Researchers will perform evaluations at baseline and at several points during the study to gather data on treatment effects. Safety and adherence to the protocol will be monitored throughout the trial period.

Subjective cognitive decline (SCD) is a condition where individuals notice cognitive problems without these being detected through standard diagnostic or neuropsychological tests. It can negatively affect patients' frailty and quality of life and may lead to more serious cognitive impairments. This research aims to evaluate a new screening tool called MASCoD (Multidimensional Assessment of Subjective Cognitive Decline) to see if it can detect and monitor SCD and predict the risk of developing severe cognitive decline over time. Participants will first undergo a thorough evaluation including neuropsychological tests and brain imaging (18F-FDG-PET). After this initial assessment (T0), they will be randomly assigned to either an experimental group receiving cognitive training through technological devices (Neurotablet) or a wait-list control group. The cognitive training involves supervised sessions lasting about 30 minutes five days a week for 8 weeks, plus weekly hour-long face-to-face sessions. The control group will receive no treatment during this period but will have assessments. All participants will be re-evaluated at 6 months to 1 year (T1) using MASCoD and neuropsychological tests to assess changes. Researchers will analyze MASCoD's validity by comparing its results to brain imaging and neuropsychological evaluations, and assess its usefulness in monitoring cognitive changes and treatment effects. The study includes ongoing monitoring of cognitive status to help identify patients who might benefit most from cognitive training.

This research focuses on elderly individuals aged 65 to 80 with early neurocognitive impairment caused by vascular disease or multiple causes. The study aims to evaluate the effectiveness of different rehabilitation programs in improving cognitive functions in patients who have cognitive impairment alongside other health conditions. The trial recognizes the importance of early diagnosis, effective treatment, and patient-centered care for dementia related to cerebrovascular diseases. It also notes that while physical exercise benefits health and cognition, the benefits of cognitive rehabilitation remain uncertain and need further study. Combining motor and cognitive training with new technology may better support cognitive function than single interventions alone. Participants are randomly assigned to one of three rehabilitation groups: motor rehabilitation alone, motor rehabilitation combined with paper-based cognitive exercises, or motor rehabilitation combined with digital cognitive exercises using a tablet. Motor training includes walking, balance, postural control, proprioception, joint mobilization, and muscle strengthening, followed by muscle relaxation. Cognitive exercises target attention, memory, executive function, visuospatial skills, and orientation, delivered either on paper or digitally. Each session lasts about 90 minutes, with 45 minutes of motor training and 45 minutes of cognitive training where applicable. During the study, cognitive performance is assessed before, immediately after the 8-week intervention, and again 3 months later. Researchers also evaluate motor skills, mood, anxiety, quality of life, treatment adherence, communication in care, caregiver burden, and the usability of digital devices. These comprehensive assessments help understand how the different rehabilitation approaches affect multiple aspects of health and cognitive function in this patient population.

Researchers are investigating the impact of different types of pain and autonomic symptoms in patients diagnosed with Parkinson's disease (PD) and multiple system atrophy (MSA). The study focuses on evaluating how prevalent pain and autonomic symptoms are in these conditions, and how they affect patients' quality of life. It also aims to assess the effect of rehabilitation on these symptoms by comparing patients with PD and MSA. This observational study is conducted at the Istituti Clinici Scientifici Maugeri Centers and includes both inpatients and outpatients. All participants will receive a neurological examination and undergo a personalized rehabilitation program designed to improve strength, coordination, balance, endurance, and daily living activities. Alongside rehabilitation, clinical scales will be used to assess disease stage, severity, motor and non-motor symptoms, cognitive function, depression, quality of life, autonomic dysfunction, and pain. The rehabilitation program allows evaluation over time to observe any significant changes in clinical parameters. Participants will be closely monitored before and after the rehabilitation program, with outcome measures including the prevalence and characterization of pain at recruitment and after about 30 days of rehabilitation. Researchers will collect data through clinical scales and neurological examinations to understand the impact of pain and autonomic symptoms on disability and quality of life. This comprehensive evaluation aims to guide clinicians in managing patient disability and refining rehabilitation strategies to improve patient outcomes.

Researchers are evaluating whether adding music to rehabilitation training can improve exercise tolerance in people with chronic obstructive pulmonary disease (COPD) and chronic respiratory failure (CRF). This study compares the effects of music-supported training versus usual rehabilitation without music, focusing on endurance, fatigue, and breathlessness. Music therapy is known to help in various medical settings by improving psychological and physical symptoms, and this trial aims to assess its impact specifically in COPD and CRF patients. Participants will be randomly assigned to one of two groups: a music-supported (MS) group and a control (C) group. The MS group will perform their usual training on a cycle ergometer while listening to music chosen from four styles (rock, modern, jazz, classical) with a steady rhythm matching the pedaling pace. The C group will perform supervised exercise sessions without music, with training intensity adjusted based on perceived effort. Both groups will complete 12 to 14 sessions over several weeks, each session lasting about 30 minutes plus warm-up and recovery. During the study, participants will undergo evaluations including lung function tests, a 6-minute walk test measuring fatigue and breathlessness, muscle strength assessments, blood gas analysis, and exercise capacity tests on a cycle ergometer. Heart rate, oxygen saturation, and perceived exertion will be monitored before and after each session. The main outcome is the change in effort tolerance measured by the 6-minute walk test over the program lasting up to 3 weeks. Researchers will also track reasons for withdrawal and analyze factors that predict improvement.

Researchers are evaluating the effectiveness of rehabilitation using Robot and Allied Digital Technologies (RADTs) compared to traditional rehabilitation in patients who have had a stroke within the past six months. This large multicenter randomized controlled trial aims to assess not only recovery of daily living activities but also upper and lower limb abilities, balance, cognitive skills, neurophysiological factors, and the economic sustainability of treatments. The study uses a pragmatic approach with blinded assessors across inpatient and outpatient settings. Participants are randomly assigned to two groups: one receives robotic rehabilitation with two physiotherapists supervising 4 to 6 patients in a gym equipped with advanced devices, while the other group receives traditional one-on-one physiotherapy. Both groups complete 25 sessions of 45 minutes each. Inpatients attend sessions 5 times a week for 5 weeks, and outpatients attend 3 times a week for about 8.3 weeks. Treatments focus on improving sensorimotor functions of upper and lower limbs, gait, balance, and cognitive abilities. During the study, participants' progress is assessed using the modified Barthel Index to measure changes in daily living activities. Researchers also evaluate other motor and cognitive outcomes, neuroplasticity, treatment acceptability, usability, and cost-effectiveness. Standardized procedures and data collection through the REDCap platform ensure consistency. The total study participation includes treatment sessions and follow-up assessments to monitor medium-term effects and safety.