Feasibility, Safety and Efficacy of ZEPU AI1 Gait Training and Evaluation System Robot in Patients With Lower Limb Motor Weakness
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 and Serious Adverse Events
研究概览
简要总结
Walking problems caused by stroke, spinal cord injury, or orthopedic surgery are common and can seriously limit a person's independence. Robotic-assisted gait training devices, which use a computer-controlled system to help patients practice standing and walking, have shown promise in improving strength, balance, and walking ability in other countries. However, this type of technology has not yet been carefully studied in Bangladesh.
This study will test a robotic gait training and evaluation device called ZEPU-AI1 in adults aged 19 to 60 years who have difficulty walking due to stroke, incomplete spinal cord injury, or gait problems following surgery. The main goals are to find out whether using this robotic device alongside standard physical therapy is feasible (practical to carry out) and safe, and to explore whether it helps improve walking speed, balance, muscle strength, and daily function compared with standard physical therapy alone.
Thirty-two participants will take part. Half will receive robot-assisted gait training three times a week for 12 weeks in addition to usual rehabilitation therapy, while the other half will receive usual rehabilitation therapy alone. Participants will be assessed regularly using standard walking, balance, and strength tests over the 12-week period.
The results of this study will help doctors and researchers understand whether this robotic technology can be safely and effectively introduced into rehabilitation care in Bangladesh.
详细描述
This is a single-site, pilot, randomized controlled trial evaluating the feasibility, safety, and preliminary efficacy of the ZEPU-AI1 Gait Training and Evaluation System, a computer-controlled robotic rehabilitation device, in adults with lower-limb motor dysfunction. The trial will be conducted at the Robotic Rehabilitation Centre, Department of Physical Medicine and Rehabilitation, Bangladesh Medical University (BMU), Dhaka, Bangladesh.
Thirty-two participants aged 19-60 years with lower-limb motor dysfunction secondary to stroke (2-24 months post-onset), incomplete spinal cord injury (ASIA C or D, neurological level T12 or below), or persistent gait impairment following orthopedic surgery (>3 months post-surgery) will be enrolled after screening against detailed inclusion/exclusion criteria (including device-specific anthropometric limits, medical stability, and absence of severe spasticity, unstable fractures, or cardiac contraindications). Participants will be randomized into two parallel arms:
Intervention Arm (n=16): ZEPU-AI1 robot-assisted gait training combined with standard-of-care rehabilitation.
Control Arm (n=16): Standard-of-care rehabilitation alone.
The ZEPU-AI1 is a bilateral robotic exoskeleton system integrating a gait control unit (programmable hip range 30°-50°, knee range 50°-80°), a dynamic body-weight support mechanism (0-80 kg unloading), a motorized treadmill (0.1-3.5 km/h), and dedicated software providing real-time gait monitoring, spasticity detection, and automatic safety shutoff. Intervention-arm participants will undergo supervised training three times weekly for 12 weeks (36 sessions total), each session approximately 45 minutes, comprising warm-up, device donning, structured standing/gait training (sit-to-stand, in-place stepping, overground walking, turning), and cool-down, with progressive adjustment of speed, body-weight support, and duration based on tolerance.
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 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 >3 months post-surgery
- •Age >18 and ≤60 years
- •Able to provide informed consent and understand instructions
- •Weight ≤100 kg and height within device adjustable range (per manufacturer specification)
- •Medically stable and cleared by physician for exoskeleton use (no active infection, uncontrolled cardiac/respiratory disease, severe osteoporosis, uncontrolled epilepsy, or untreated DVT)
排除标准
- •Complete spinal cord injury with inability to bear any weight
- •Severe cognitive impairment (e.g., MMSE <24) preventing safe participation
- •Severe spasticity (Modified Ashworth Scale >3) in lower limbs
- •Unstable fractures, severe hip/knee contractures (>30° fixed flexion), or severe osteoarthritis requiring imminent surgery
- •Uncontrolled cardiac arrhythmia, pacemaker incompatibility, or implanted electronic device incompatible with robot sensors
- •Pregnancy
研究组 & 干预措施
Robotic-Augmented Rehabilitation Group
Participants (n=16) will receive robot-assisted gait training using the ZEPU-AI1 Gait Training and Evaluation System in addition to standard-of-care rehabilitation. Training will be delivered 3 times per week for 12 weeks (36 sessions total), each session approximately 45 minutes, including warm-up, device donning, structured standing and gait training (sit-to-stand, in-place stepping, overground walking, turning), and cool-down. Body-weight support, walking speed, and session duration will be progressively adjusted based on participant tolerance and performance. Sessions will be supervised by trained physiatrists and physiotherapists at the Robotic Rehabilitation Centre, BMU. Standard-of-care rehabilitation (individualized rehabilitation and exercise) will continue in parallel.
干预措施: ZEPU-AI1 Gait Training and Evaluation System (Device)
Robotic-Augmented Rehabilitation Group
Participants (n=16) will receive robot-assisted gait training using the ZEPU-AI1 Gait Training and Evaluation System in addition to standard-of-care rehabilitation. Training will be delivered 3 times per week for 12 weeks (36 sessions total), each session approximately 45 minutes, including warm-up, device donning, structured standing and gait training (sit-to-stand, in-place stepping, overground walking, turning), and cool-down. Body-weight support, walking speed, and session duration will be progressively adjusted based on participant tolerance and performance. Sessions will be supervised by trained physiatrists and physiotherapists at the Robotic Rehabilitation Centre, BMU. Standard-of-care rehabilitation (individualized rehabilitation and exercise) will continue in parallel.
干预措施: Standard-of-Care Rehabilitation (Individualized Rehabilitation and Exercise) (Behavioral)
Usual Care (Control) Group
Participants (n=16) will receive standard-of-care rehabilitation alone, without robotic-assisted gait training. This includes individualized rehabilitation and exercise (IRR) as per institutional protocol at the Department of Physical Medicine and Rehabilitation, BMU, matched in overall therapeutic content to the conventional-therapy component received by the intervention group.
干预措施: Standard-of-Care Rehabilitation (Individualized Rehabilitation and Exercise) (Behavioral)
结局指标
主要结局
Incidence of Device-Related Adverse Events and Serious Adverse Events
时间窗: Baseline (T=0) through 12-week intervention period and follow-up, assessed every 2 weeks
Number and proportion of participants experiencing device-related adverse events (AEs) and serious adverse events (SAEs), including falls, skin breakdown/pressure sores, joint pain/injury, cardiovascular events, and fracture, during the intervention and follow-up period.
次要结局
- Change in Six-Minute Walk Distance (6MWD)(Baseline (T=0), every 2 weeks through 12 weeks)
- Change in Timed Up and Go (TUG) Test(Baseline (T=0), every 2 weeks through 12 weeks)
- Change in Medical Research Council (MRC) Muscle Strength Scale(Baseline (T=0), every 2 weeks through 12 weeks)
- Change in Functional Ambulation Category (FAC) Score(Baseline (T=0), every 2 weeks through 12 weeks)
- Change in Berg Balance Scale Score(Baseline (T=0), every 2 weeks through 12 weeks)
- Change in Modified Ashworth Scale (MAS) for Lower-Limb Muscles(Baseline (T=0), every 2 weeks through 12 weeks)
- Change in Quality of Life (EuroQol Questionnaire, Bengali Version)(Baseline (T=0), every 2 weeks through 12 weeks)
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