Effectiveness of Robot-Assisted Structured Foot-Ankle Sensorimotor Training in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Walking Speed (10-Meter Walk Test)
研究概览
简要总结
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.
详细描述
Power analysis using G-Power version 3.1 yielded 90% power, a d=1.135 effect size, and a total sample size of n=30, with each group consisting of 15 observations. Participants will be randomly assigned to either the Robotic-Assisted Foot-Ankle Training Protocol (REG) or the Conventional Foot-Ankle Training Protocol (CEG). One group will receive training with the robotic foot-ankle platform, while the other group will receive conventional training (manual training with a physiotherapist). Exercise programs will last 6 weeks, 3 days a week, for 40-45 minutes. Progression will be provided using the AAN control paradigm on the robot, and by the physiotherapist in the conventional training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
This study will be single-blind. Outcome assessments will be performed by an experienced physiotherapist blinded to group allocation. Due to the nature of the interventions, participants and treating physiotherapists cannot be blinded.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria are as follows:
- •Age 40-65 years,
- •Able to understand and follow study instructions,
- •Able to communicate coherently and oriented in time and place,
- •Provided written informed consent,
- •Stroke ≥6 months prior to enrollment (chronic stroke),
- •Ankle plantarflexor spasticity ≤2 on the Modified Ashworth Scale,
- •Ankle dorsiflexor strength ≥ grade 2 on the Medical Research Council (MRC) scale,
- •Passive ankle dorsiflexion to neutral (90°; 0°) without a plantarflexion contracture,
- •Moderate or mild lower-extremity impairment based on the Fugl-Meyer Assessment-Lower Extremity (FMA-LE) score (21-27 moderate; 28-34 mild/good),
- •Able to sit for at least 1 hour,
- •Able to walk at least 10 meters with or without an assistive device,
- •Completed all conventional lower-extremity physical therapy and rehabilitation programs.
排除标准
- •are as follows:
- •Cognitive impairment (Mini-Mental State Test score ≤ 24),
- •Conditions affecting walking or balance (e.g., orthopedic complications, lower extremity amputation, osteoporosis),
- •Insufficient visual acuity to view a screen (e.g., diplopia),
- •Severe visual deficits (e.g., hemianopia) or vestibular disorders34,
- •Sensory deficits such as hemisensory neglect,
- •Acute musculoskeletal or cardiovascular disorders,
- •Intrathecal baclofen pump use or botulinum toxin injections within the past 5 months,
- •Fixed or painful contracture of the paretic ankle,
- •Uncontrolled systemic diseases (e.g., diabetes, hypertension, debilitating or immunosuppressive diseases),
- •history of a non-stroke neurological disease/disorder that may impair comprehension of instructions,
- •Concurrent participation in other lower-extremity physical therapy, robotic rehabilitation, or neurological exercise programs.
研究组 & 干预措施
Robot-assisted training group (RTG)
Robot-assisted ankle-foot sensorimotor training will consist of plantar vibrotactile sensory training, passive ROM training, VR-based joint position sense training, active ROM training using an assist-as-needed paradigm, and a final sensory training phase. Training will be delivered three times per week for six weeks, with progression individualized according to participant performance, ROM capacity, and safety limits. Difficulty will be increased by modifying sensory task complexity, repetitions, target positions, movement speed, and robotic assistance parameters.
干预措施: Robot-Assisted Foot-Ankle Training (Other)
Manual Training Group (MTG)
Participants in the manual training group will receive a structured ankle-foot sensorimotor training program delivered by a physiotherapist. The intervention will include plantar sensory training, passive ROM training, joint position sense training, active ROM training, and a final sensory training phase. Training will be provided three times per week for six weeks, with progression individualized according to participant performance, ROM capacity, and safety limits. Progression will be achieved by modifying sensory task difficulty, repetitions, target positions, movement speed, and exercise volume throughout the intervention period.
干预措施: Conventional Foot-Ankle Training (Other)
结局指标
主要结局
Walking Speed (10-Meter Walk Test)
时间窗: From baseline to the end of the 6-week intervention
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.
次要结局
- Static Balance Assessment (The Single-Leg Stance Test)(From baseline to the end of the 6-week intervention)
- Assessment of Joint Position Sense(From baseline to the end of the 6-week intervention)
- Dynamic Balance Assessment 2 (The Mini Balance Evaluation Systems Test)(From baseline to the end of the 6-week intervention)
- Assessment of Satisfaction Level Related to the Robot (Quest Scale-Lıkert Scale-4's)(From baseline to the end of the 6-week intervention)
- Quality of Life Assessment (The Stroke-Specific Quality of Life Scale)(From baseline to the end of the 6-week intervention)
- Tactile Perception Level (The Semmes-Weinstein Monofilament Test)(From baseline to the end of the 6-week intervention)
- Walking Capacity(From baseline to the end of the 6-week intervention)
- Motor Performance (The Fugl-Meyer Assessment for the Lower Extremity)(From baseline to the end of the 6-week intervention)
- Dynamic Balance Assessment 1 (TUG)(From baseline to the end of the 6-week intervention)
- Modified Ashworth Scale (Tonus Assessment)(From enrollment to the end of treatment at 6 week intervention)
- Assessment of Joint Range of Motion (Electrogoniometer)(From baseline to the end of the 6-week intervention)
研究者
Esra TEKECİ
Principal Investigator
Medipol University