Safety, Feasibility and Efficacy of ZEPU AI5 Lower Limb Muscle Strength 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
- 36
- 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
The goal of this clinical trial is to learn if robot-assisted lower-limb strength and gait training can improve safety, feasibility, and functional recovery in adults aged 18-60 years with lower-limb motor dysfunction due to stroke, incomplete spinal cord injury, or persistent gait impairment following orthopedic surgery. The main questions it aims to answer are:
Is robot-assisted training using the ZEPU-AI5 device safe and well-tolerated, with an acceptable rate of device-related adverse events? Does adding ZEPU-AI5-assisted training to standard-of-care rehabilitation improve functional outcomes (such as walking distance, muscle strength, balance, and mobility) compared to standard-of-care rehabilitation alone?
Researchers will compare an intervention group receiving standard-of-care rehabilitation combined with ZEPU-AI5-assisted training to a control group receiving standard-of-care rehabilitation alone, to see if the addition of robotic training leads to greater improvements in safety, functional recovery, and quality of life.
Participants will:
Undergo a baseline assessment before starting the study Receive either robot-assisted training plus standard-of-care rehabilitation, or standard-of-care rehabilitation alone, three times per week for 12 weeks Complete follow-up assessments every two weeks to evaluate safety, functional outcomes, and durability of any benefits
详细描述
Walking impairment due to neurological and orthopedic conditions significantly limits independence and functional mobility, making lower-limb strength training a key focus of rehabilitation. Robotic-assisted rehabilitation systems have shown promising results in improving strength and functional outcomes in high-income countries; however, their feasibility, safety, and efficacy remain underexplored in low- and middle-income settings. In Bangladesh, the ZEPU-AI5 lower-limb strength training and evaluation robot is a novel technology that has not yet been systematically evaluated in this population.
The ZEPU-AI5 is a computer-controlled electromechanical rehabilitation device consisting of a rigid main frame, a motor-driven walking training table, bilateral robotic mechanical legs aligned with the patient's hip and knee joints, adjustable foot pedals, thigh and calf fixation straps, and a body-weight support suspension system. The walking platform supports up to 135 kg, with continuously adjustable body-weight unloading from 0-80 kg, allowing progressive loading according to patient tolerance and recovery stage. Prior to training, individualized calibration is performed by measuring thigh and calf lengths to align the robotic joints with the participant's anatomical hip and knee axes, with bilateral symmetry adjustment available when needed.
The system provides programmable control over hip joint angles (30°-50°) and knee joint angles (50°-80°) in 1° increments, with gait offset parameters adjustable by ±10 units to allow individualized correction of abnormal gait patterns. Walking speed is adjustable from 0.1 to 3.5 km/h, allowing graded progression from slow assisted stepping to higher-speed gait training.
At study entry, participants will undergo a face-to-face interview to gather clinical and sociodemographic data using a semi-structured, pre-tested questionnaire. Weight and height will be measured to calculate Body Mass Index (BMI). All participants will be allocated a study ID, and assessments will be conducted at the Robotic Rehabilitation Center, Department of Physical Medicine and Rehabilitation, Bangladesh Medical University.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lower-limb motor dysfunction due to one of the following: (a) stroke (onset 2-24 months), (b) incomplete spinal cord injury (neurological level T12 or below, ASIA Impairment Scale C or D), or (c) orthopedic surgery (e.g., knee/hip replacement) with persistent gait impairment more than 3 months post-surgery
- •Age greater than 18 years and up to 60 years
- •Medically stable and able to provide informed consent
- •Able to meet device anthropometric criteria for use of the ZEPU-AI5 system
排除标准
- •Complete spinal cord injury with inability to bear any weight
- •Severe cognitive impairment (Mini-Mental State Examination score less than 24) preventing safe participation
- •Severe spasticity of the lower limbs (Modified Ashworth Scale greater than 3)
- •Unstable fractures, severe hip/knee contractures (greater than 30 degrees fixed flexion), or severe osteoarthritis requiring imminent surgery
- •Uncontrolled cardiac arrhythmia, pacemaker incompatibility, or any implanted electronic device incompatible with the robot's sensors
- •Pregnancy
研究组 & 干预措施
Intervention Arm (Robotic-Augmented Rehabilitation Group)
18 participants receiving standard-of-care rehabilitation combined with ZEPU-AI5 assisted gait training
干预措施: Robotic lower-limb gait training (ZEPU-AI5) (Device)
Intervention Arm (Robotic-Augmented Rehabilitation Group)
18 participants receiving standard-of-care rehabilitation combined with ZEPU-AI5 assisted gait training
干预措施: Standard-of-care rehabilitation (conventional physiotherapy) (Behavioral)
Control Arm (Usual Care Group)
18 participants receiving standard-of-care rehabilitation alone (including IRR and exercise)
干预措施: Standard-of-care rehabilitation (conventional physiotherapy) (Behavioral)
结局指标
主要结局
Incidence of Device-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: From baseline (T=0) through 12-week intervention and follow-up (T=12 weeks)
Number and proportion of participants experiencing device-related adverse events, including falls, skin breakdown/pressure sores, joint pain/injury, cardiovascular events, fracture, and device malfunction, recorded through continuous monitoring during each robotic training session and reviewed monthly by an independent safety monitor.
次要结局
- Change in Walking Distance (6-Minute Walk Test)(Baseline and every 2 weeks up to Week 12)
- Change in Lower-Limb Muscle Strength (MRC Scale)(Baseline and every 2 weeks up to Week 12)
- Change in Functional Mobility (Timed Up and Go Test)(Baseline and every 2 weeks up to Week 12)
- Change in Functional Ambulation Category (FAC) Score(Baseline and every 2 weeks up to Week 12)
- Change in Balance (Berg Balance Scale-Short Form)(Baseline and every 2 weeks up to Week 12)
- Change in Lower-Limb Spasticity (Modified Ashworth Scale)(Baseline and every 2 weeks up to Week 12)
- Change in Health-Related Quality of Life (EuroQol Questionnaire)(Baseline and every 2 weeks up to Week 12)
研究者
Md. Abdus Shakoor, Ph.D.
Chairman & Professor, Department of Physical Medicine & Rehabilitation and Focal Person, Robotic Rehabilitation Centre, Bangladesh Medical University
Bangladesh Medical University