Study of Bilateral Robot-Assisted Therapy for Upper Limb Motor Recovery in Adults With Subacute Stroke Compared to Conventional Rehabilitation

What this Trial Is About

Researchers are evaluating the effects of a robotic rehabilitation treatment called Bilateral Robot-Assisted Therapy BRAT on upper limb motor recovery in people who have had a stroke in the subacute phase. This study compares BRAT combined with standard rehabilitation to conventional arm rehabilitation without robotic assistance. The main goal is to determine if BRAT improves motor function better than traditional therapy, measured by the Fugl-Meyer Assessment for the upper limb. Secondary goals include assessing quality of life and identifying which patients benefit most from BRAT based on age, time since stroke, and severity of motor deficit. Participants will be randomly assigned to either the experimental group EG or the control group CG. The EG will receive standard rehabilitation plus daily 45-minute sessions of BRAT using the Arm Light Exoskeleton Hybrid Alex RS robotic system, completing about 16 treatment sessions over four weeks. The CG will also receive standard rehabilitation plus 45 minutes of conventional upper limb exercises with a therapist, without any robotic devices, for a similar number of sessions and duration. Both groups will receive personalized therapy based on their clinical needs. During the study, participants will be assessed at the start baseline, after treatment completion, and again three months later via telephone follow-up. Evaluations include clinical exams, rating scales like the Fugl-Meyer Assessment, and instrumental measures such as EEG and muscle activity recordings. The study aims to measure motor recovery, muscle activation, cognitive effects, and improvements in daily activities. Safety and satisfaction will also be monitored throughout the 24-month study period.

Bilateral Robot-assisted Upper Extremity Rehabilitation on Motor Recovery in People With Subacute Stroke