Safety, Efficacy and Feasibility of ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Incidence of Device-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
Lower limb motor dysfunction resulting from stroke, spinal cord injury, or other neurological disorders substantially limits mobility, independence, and quality of life. Robotic rehabilitation has emerged as a promising approach to provide intensive, repetitive, task-oriented training. The ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot is designed to deliver interactive lower limb training while providing real-time performance feedback. This pilot randomized controlled trial aims to evaluate the safety, efficacy, and feasibility of ZEPU-AI3-assisted rehabilitation combined with conventional rehabilitation compared with conventional rehabilitation alone in patients with lower limb motor dysfunction. The primary outcomes include safety, feasibility, and changes in lower limb motor function, gait performance, and functional mobility. The findings will provide preliminary evidence to support future large-scale clinical trials and the implementation of robotic rehabilitation in clinical practice.
详细描述
Background:
Lower limb motor dysfunction is a major cause of disability following neurological and musculoskeletal disorders. Conventional rehabilitation improves function but is often limited by therapist workload and the difficulty of delivering high-intensity, repetitive, task-specific training. Robotic rehabilitation systems have the potential to overcome these limitations by providing standardized, intensive, and feedback-guided exercise.
Objective:
To evaluate the safety, efficacy, and feasibility of the ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot in patients with lower limb motor dysfunction.
Study Design:
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Lower-limb motor dysfunction from one of the following: (a) stroke (onset 2-24 months), (b) incomplete spinal-cord injury (neurological level T12 and below, ASIA C or D), (c) orthopedic surgery (e.g., knee/hip replacement) with persistent gait impairment > 3month post-surgery. Stroke onset between 2-24 months ensures inclusion of individuals in the subacute to chronic phase, where gait recovery is still achievable and measurable. Incomplete SCI targets individuals with partial motor preservation, who are capable of engaging in active gait training with robotic assistance.
- •Age >18 and ≤ 60 years. This age limit is chosen because individuals with this age range generally have better cardiopulmonary reserve and musculoskeletal tolerance, allowing safer participation in intensive robotic-assisted training with reduced risk of adverse events. Excluding younger patients minimizes heterogeneity related to growth, neurodevelopmental factors and congenital disorders, which may influence gait mechanics and response to robotic therapy. Excluding older adults (>60 years) helps reduce confounding from age-related degenerative changes that may affect gait outcomes and safety.
- •Able to provide informed consent and understand instructions which ensures participants can actively engage in therapy, follow safety instructions and report adverse events.
- •Weight ≤ 100 kg (as per device spec) and height within device adjustable range (manufacturer spec). Exceeding weight or height limits may compromise mechanical support, safety, and accurate gait training.
- •Medically stable and cleared by physician for exoskeleton use (no active infection, uncontrolled cardiac/respiratory disease, severe osteoporosis, uncontrolled epilepsy, untreated DVT) through pre-screening with necessary investigations.
排除标准
- •• Complete spinal cord injury with inability to bear any weight as it requires the patient to actively support some body weight or participate in stepping movements.
- •Severe cognitive impairment (e.g., MMSE < 24) preventing safe participation.
- •Severe spasticity (Modified Ashworth Scale > 3) in lower limbs. High muscle tone or rigidity increases risk of joint strain, skin injury and falls during robotic-assisted training.
- •Unstable fractures, severe hip/knee contractures (> 30° fixed flexion), severe osteoarthritis requiring imminent surgery. They can pose high risk for injury during weight-bearing or gait cycles.
- •Uncontrolled cardiac arrhythmia, pacemaker incompatibility or implanted electronic device incompatible with robot sensors. Individuals with these conditions may face elevated risk of adverse cardiac events or device malfunction.
- •Pregnancy as safety data for robotic exoskeleton use in pregnant individuals are lacking.
研究组 & 干预措施
ZEPU-AI3 + Conventional Rehabilitation
Participants will receive ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot-assisted rehabilitation in addition to conventional rehabilitation according to the study protocol.
干预措施: ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot (Device)
ZEPU-AI3 + Conventional Rehabilitation
Participants will receive ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot-assisted rehabilitation in addition to conventional rehabilitation according to the study protocol.
干预措施: Conventional Rehabilitation (Other)
Conventional Rehabilitation
Participants will receive conventional rehabilitation according to institutional standard care without ZEPU-AI3 robotic training.
干预措施: Conventional Rehabilitation (Other)
结局指标
主要结局
Incidence of Device-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Baseline through Week 12
Incidence of device-related adverse events (AEs) and serious adverse events (SAEs) occurring during the 12-week intervention, including falls, skin breakdown or pressure sores, joint pain or injury, cardiovascular events, fractures, and device malfunction.
Device Tolerability
时间窗: Baseline through Week 12
Device tolerability assessed by the proportion of planned treatment sessions completed, participant adherence, study withdrawals, and reasons for withdrawal during the 12-week intervention.
次要结局
- Change in 6-Minute Walk Test Distance(Baseline and Week 12)
- Change in Medical Research Council (MRC) Muscle Strength Scale Score(Baseline and Week 12)
- Change in Functional Ambulation Category (FAC) Score(Baseline and Week 12)
- Change in Berg Balance Scale Score(Baseline and Week 12)
- Change in Timed Up and Go (TUG) Test(Baseline and Week 12)
- Change in Modified Ashworth Scale (MAS) Score(Baseline and Week 12)
- Change in EuroQol Quality of Life Score(Baseline and Week 12)
- Change in Lower-Limb Muscle Strength on the Medical Research Council (MRC) Muscle Strength Scale(Baseline and Week 12)
- Change in Ambulatory Function on the Functional Ambulation Category (FAC)(Baseline and Week 12)
- Change in Balance on the Berg Balance Scale-Short Form (BBS-SF)(Baseline and Week 12)
- Change in Lower-Limb Spasticity on the Modified Ashworth Scale (MAS)(Baseline and Week 12)
- Change in Health-Related Quality of Life on the EuroQol 5-Dimension (EQ-5D) Questionnaire, Validated Bengali Version(Baseline and Week 12)
研究者
Md. Abdus Shakoor, Ph.D.
Chairman & Professor, Department of Physical Medicine & Rehabilitation, Bangladesh Medical University
Bangladesh Medical University