Effectiveness of a Structured Robot-Assisted Ankle-Foot Sensorimotor Training Program Versus Manual Training in Chronic Stroke: Protocol for an Assessor-Blinded, Parallel-Group Randomized Controlled Trial.

Abstract

Background: 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, evidence for ankle-foot-focused sensorimotor protocols remains limited. In particular, approaches that combine robot-assisted motor training with plantar tactile localization and VR-supported joint position sense training to target plantar sensory and proprioceptive function are scarce.

Objective: This study aims to evaluate the effectiveness of a structured, VR-integrated, robot-assisted ankle-foot sensorimotor rehabilitation protocol compared with a content-matched manual training protocol in individuals with chronic stroke and to examine its effects on clinical and sensorimotor outcomes.

Methods: This is an assessor-blinded, 2-arm, parallel-group randomized controlled trial. Thirty individuals with chronic stroke will be randomized 1:1 to the robot-assisted training group or the manual training group. All participants will receive conventional rehabilitation. In addition, the robot-assisted training group will receive a structured robot-assisted ankle-foot training program integrated with VR and assist-as-needed control, whereas the manual training group will receive the same structured ankle-foot training protocol delivered manually by a physiotherapist. Interventions will be delivered 3 times per week for 6 weeks, for a total of 18 sessions. Total session duration will be time matched between groups at 50 to 60 minutes per session. The primary outcome will be the change in 10-meter walk test-derived walking speed from baseline to 6 weeks. The 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.

Results: This study is funded by the Scientific and Technological Research Council of Turkey (TÜBİTAK) under the 1002-A Rapid Support Program (grant 225S390). Recruitment began in March 2026 and is planned to continue until May 2027. As of March 25, 2026, four participants have been enrolled and are currently receiving the assigned intervention. Data analysis will begin once all enrolled participants have completed post-intervention assessments.

Conclusions: This trial will provide evidence on whether a structured robot-assisted ankle-foot sensorimotor training program offers additional benefit compared with a content-matched manual training protocol in individuals with chronic stroke. The findings may contribute to the development of standardized, individualized, and sensorimotor-oriented rehabilitation protocols for improving walking and balance after stroke.