Lazne Belohrad

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.