Stroke Clinical Trials

Introduction: Stroke is a leading cause of long-term disability worldwide. Persistent lower-extremity motor and somatosensory impairments after stroke commonly limit walking and balance despite rehabilitation. Virtual reality (VR)-integrated robotic rehabilitation may support structured, goal-directed ankle-foot practice; however, there is limited evidence for ankle-foot-focused sensorimotor protocols. In particular, approaches that combine robot-assisted motor training with a plantar tactile localization task and VR-supported joint position sense (JPS) training to target plantar sensory and proprioceptive function are scarce. Therefore, this study aims to evaluate the effectiveness of a structured, VR-integrated, robot-assisted ankle-foot sensorimotor rehabilitation protocol in individuals with chronic stroke and to examine its effects on clinical and sensorimotor outcomes. Methods and analysis: This is an assessor-blinded, two-arm, parallel-group randomized controlled trial. Thirty individuals with chronic stroke will be randomized 1:1 to the Robot-assisted Training Group (RTG) or the Manual Training Group (MTG). All participants will receive conventional rehabilitation; in addition, RTG will receive a structured robot-assisted ankle-foot training program integrated with virtual reality and assist-as-needed control, whereas MTG will receive the same structured ankle-foot training protocol delivered manually by a physiotherapist. Interventions will be delivered three times per week for 6 weeks (18 sessions), and total session duration will be time-matched between groups (50-60 min per session). The primary outcome will be the change in walking speed, derived from the 10-Meter Walk Test, from baseline to 6 weeks. Secondary outcomes will include 2-Minute Walk Test distance, ankle range of motion, joint position sense, plantar tactile sensation, muscle tone, motor performance, static and dynamic balance, and stroke-specific quality of life.