ZEPU-AI5 Strength Training Study (ZEPUAI5RCT) (NCT07735702) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
ZEPU-AI5 Strength Training Study (ZEPUAI5RCT)
Bangladesh36 participantsStarted 2026-07
Plain-language summary
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
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is listed as 'not yet recruiting' — can you help me find out when it's expected to open and whether it would even be worth waiting for, given my current condition?
2The trial's main goal seems to be checking whether this AI-assisted strength training device causes any safety problems, not whether it improves outcomes — does that mean we don't yet have strong evidence it works, and how does that affect whether it might be right for me?
3Since this study covers three very different conditions — stroke, incomplete spinal cord injury, and gait impairment after orthopedic surgery — can you help me understand whether the device is being tested in a way that's actually relevant to my specific situation?
4Given that the primary focus is tracking device-related adverse events and serious adverse events, what kinds of risks or side effects should I be aware of before deciding whether to consider a trial like this?
5Would it make more sense for me to pursue established rehabilitation or physical therapy options first, or is there a reason you think participating in a safety-focused device study like this could be a reasonable path to explore at this stage?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Device-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: From baseline (T=0) through 12-week intervention and follow-up (T=12 weeks)