Costa Masnaga

Researchers are investigating neural biomarkers to monitor and improve the recovery of walking and movement in people who have had a stroke. The study aims to explore these biomarkers both in everyday natural settings and during enhanced treatment using a robotic device. The goal is to see if these biomarkers can help predict how well patients will recover and to optimize personalized rehabilitation strategies for better outcomes. Participants will receive treatment using an overground wearable robotic device designed to assist walking. Motor and cognitive evaluations will be conducted before treatment, after 12 sessions, and at a one-month follow-up. Data collection during the first and last treatment sessions will include brain and muscle activity measurements using EEG and EMG, as well as ground reaction forces to assess progress. During the study, participants will be assessed through motor outcome measures from the start of the study until the end of treatment and follow-up. Researchers will monitor brain and muscle activity, movement patterns, and other biomarkers related to walking ability. The total study period includes treatment sessions and a follow-up phase to track recovery over time and evaluate the effectiveness of the robotic gait therapy.

Researchers are conducting a multicenter prospective observational cohort study in the Lombardy region to better understand the clinical, neuropsychological, and biological characteristics of adults attending Brain Health Services (BHS). The study focuses on adults with subjective cognitive decline (SCD), functional cognitive disorder (FCD), or those who are "well worried" without objective cognitive impairment. It aims to explore differences in Alzheimer's disease (AD) plasma biomarkers, factors predicting biomarker positivity, the psychological impact of biomarker result disclosure, and how biomarkers relate to cognitive decline over up to 5 years of follow-up. Participants will undergo standard clinical evaluations at their local BHS and provide blood samples for plasma biomarker analysis, including markers such as p-tau217, GFAP, NfL, and ApoE. They will also complete neuropsychological testing, cognitive screenings, and questionnaires assessing psychological impact before and after learning their biomarker results. Additional procedures like MRI, lumbar puncture, or polysomnography may be done if clinically needed. The study plans to enroll approximately 1000 participants and follow them annually for 5 years, with a total study duration of 7 years. During the study, participants will be regularly assessed through clinical and cognitive evaluations, blood biomarker testing, and psychological questionnaires. Researchers will measure clinical, neuropsychological, and biological patterns linked to AD plasma biomarker positivity at the baseline visit. The study will monitor how biomarker status relates to the development of mild cognitive impairment or dementia and track changes in biomarkers over time to support early detection and preventive strategies within Brain Health Services.

Researchers are studying post-stroke gait rehabilitation to see if training with the SHAJA unilateral hip exoskeleton improves walking speed and endurance compared to conventional gait training. The trial aims to assess the safety and reliability of the SHAJA device while evaluating its short-term effects on walking ability in adults who have had a stroke at least three months ago. Participants will receive six sessions of either SHAJA-assisted overground walking or conventional gait training without the device, each lasting 30 to 40 minutes. They will undergo five assessment sessions to compare changes in walking velocity, endurance, and device-related safety issues. The study measures outcomes from before training to about three months after, including walking tests at self-selected and fast speeds. During the study, participants will be closely monitored for any device malfunctions or adverse events. Walking performance will be evaluated using timed tests over 10 meters and longer walk tests. Researchers will track changes in walking speed and endurance from before training through a follow-up about 14 weeks later, ensuring safety and effectiveness throughout the trial period.

Researchers are evaluating the effectiveness of the Gloreha Sinfonia robotic exoskeleton for upper limb rehabilitation in adults who have upper limb weakness following a recent stroke. This international multicenter randomized controlled trial compares robotic-assisted therapy combined with conventional therapy to conventional therapy alone. The main goal is to see if robotic therapy improves voluntary motor control and coordination better than conventional therapy, using the Fugl-Meyer Assessment for the upper limb as the primary measure. The study also looks at muscle strength, range of motion, eye-hand coordination, manual dexterity, functional independence, patient satisfaction, and any adverse events. Participants will be randomly assigned to one of two groups. The Experimental Group receives 90 minutes per day of upper limb therapy, including 30 minutes with the robotic device and the rest conventional physical and occupational therapy, progressing through passive to active mobilization over five weeks. The Control Group receives 90 minutes per day of conventional physical and occupational therapy tailored to their clinical needs. Both groups follow individualized rehabilitation programs. The study includes a baseline evaluation, treatment period, post-treatment evaluation, and a 3-month follow-up. Throughout the study, clinical assessments occur at baseline, after treatment, and at 3 months follow-up, with some follow-ups done remotely. Researchers measure motor function using standardized scales and track changes in strength, coordination, dexterity, and independence in daily living. Patient data are securely collected and analyzed to compare outcomes between groups. The total study duration is about 36 months, including recruitment, treatment, and follow-up phases.