ZEPU-AI1 Gait Robot Training Study (ZEPUAI1RCT) (NCT07735676) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
ZEPU-AI1 Gait Robot Training Study (ZEPUAI1RCT)
Bangladesh32 participantsStarted 2026-07
Plain-language summary
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.
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 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)
Exclusion Criteria:
* 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
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 focused on measuring device-related adverse events as its primary outcome — what does that tell us about how much is already known about the safety of this gait robot, and what risks should I be aware of before considering it?
2The trial hasn't started recruiting yet — given where I am in my recovery from stroke or spinal cord injury right now, would it make more sense to pursue established rehabilitation options first rather than waiting for this study to open?
3Since this study is listed as Phase NA, which often applies to device trials, how does that affect what we can expect to learn about whether the robot actually improves my walking compared to standard physiotherapy?
4What kinds of gait or neurological impairments is this robot designed to address, and based on my specific condition, does my doctor think I'd be a realistic candidate to discuss once enrollment opens?
5If I were eventually to participate in a trial like this, what would the training schedule and clinic visits likely look like, and is that realistic given my current situation and support at home?
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 and Serious Adverse Events
Timeframe: Baseline (T=0) through 12-week intervention period and follow-up, assessed every 2 weeks