Effectiveness of Robot-Assisted Structured Foot-Ankle Sensorimotor Training in Stroke Patients

Medipol University30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Interventions

Robot-Assisted Foot-Ankle TrainingOTHER

Stage 1: Vibration Training Applied for Proper Stepping on the Sole of the Foot and Proper Pressure Distribution: The first step of the training will be constant vibration, and the second step will be sensory localization training with vibration. Stage 2: Passive Joint Range of Motion Training with Virtual Reality: The platform will move the ankle passively (passive stretching). Stage 3: Joint Position Sense Training: The platform will bring the patient's ankle to a certain dorsiflexion position, the patient will be asked to feel and be aware of this angle, then the patient will be asked to return to the neutral position and perform ankle dorsiflexion at the angle that the platform initially brought. Stage 4: Active Joint Range of Motion Training with Virtual Reality: Along with active dorsiflexion, when necessary, assistance will be provided with the Assistance as Needed (AAN) control paradigm, a feature of the robotic device. Stage 5: It is the same as Stage 1

Conventional Foot-Ankle TrainingOTHER

Stage 1: Sensory Training to the Sole of the Foot: In the first step of the training, the physiotherapist will manually apply constant pressure with a blunt object, and in the second step, sensory localization training with a blunt object will be performed. Stage 2: Passive Joint Range of Motion Training: The ankle will be manually moved passively (passive stretching) by the physiotherapist. Stage 3: Joint Position Sense Training: The physiotherapist will bring the patient's ankle to a certain dorsiflexion position, the patient will be asked to feel and be aware of this angle, then the patient will be asked to return to the neutral position and perform ankle dorsiflexion at the angle that the physiotherapist initially brought. Stage 4: Active Joint Range of Motion Training: This stage will be performed with manual assistance provided by the physiotherapist when necessary, along with active dorsiflexion. Stage 5: It is the same as Stage 1

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 Years

Medical Language ↔ Plain English

The inclusion criteria are as follows: 1. Age 40-65 years, 2. Able to understand and follow study instructions, 3. Able to communicate coherently and oriented in time and place, 4. Provided written informed consent, 5. Stroke ≥6 months prior to enrollment (chronic stroke), 6. Ankle plantarflexor spasticity ≤2 on the Modified Ashworth Scale, 7. Ankle dorsiflexor strength ≥ grade 2 on the Medical Research Council (MRC) scale, 8. Passive ankle dorsiflexion to neutral (90°; 0°) without a plantarflexion contracture, 9. Moderate or mild lower-extremity impairment based on the Fugl-Meyer Assessment-Lower Extremity (FMA-LE) score (21-27 moderate; 28-34 mild/good), 10. Able to sit for at least 1 hour, 11. Able to walk at least 10 meters with or without an assistive device, 12. Completed all conventional lower-extremity physical therapy and rehabilitation programs. The exclusion criteria are as follows: 1. Cognitive impairment (Mini-Mental State Test score ≤ 24), 2. Conditions affecting walking or balance (e.g., orthopedic complications, lower extremity amputation, osteoporosis), 3. Insufficient visual acuity to view a screen (e.g., diplopia), 4. Severe visual deficits (e.g., hemianopia) or vestibular disorders34, 5. Sensory deficits such as hemisensory neglect, 6. Acute musculoskeletal or cardiovascular disorders, 7. Intrathecal baclofen pump use or botulinum toxin injections within the past 5 months, 8. Fixed or painful contracture of the paretic ankle, 9. Uncontrolled systemic diseases (e.g., diabetes, hypertension, debilitating or immunosuppressive diseases), 10. history of a non-stroke neurological disease/disorder that may impair comprehension of instructions, 11. Concurrent participation in other lower-extremity physical therapy, robotic rehabilitation, or neurological exercise programs.

Outcomes

Primary Outcomes

Walking Speed (10-Meter Walk Test)

Walking speed will be assessed using the 10-Meter Walk Test (10MWT). The test will be performed on a 14-m flat, unobstructed walkway including 2-m acceleration and 2-m deceleration distances. Time (s) will be recorded between 2 and 12 m using a stopwatch (dynamic start method), and walking speed (m/s) will be calculated as 10 m divided by the recorded time. Participants may use their customary walking aids. The test will be performed three times, and the mean walking speed will be used for analysis.