NCT07735676Completed
ZEPU-AI1 Gait Robot Training Study (ZEPUAI1RCT)
Feasibility, Safety and Efficacy of ZEPU AI1 Gait Training and Evaluation System Robot in Patients With Lower Limb Motor Weakness
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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. Fifty-one participants took part (32 were originally planned; more were enrolled because additional eligible patients were available). Twenty-five received robot-assisted gait training three times a week for 12 weeks in addition to usual rehabilitation therapy, while 26 received usual rehabilitation therapy alone. Participants were 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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 51 (actual)
- First submitted
- 26 Jul 2026
- Start date
- 14 May 2026
- Primary completion date
- 15 Sept 2026
- Lead sponsor
- Bangladesh Medical University
- Diseases
- Stroke
- NCT number
- NCT07735676
What you commit to
- Study type: Interventional
- Participants enrolled: 51
- From 14 May 2026 to the primary completion date, 15 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unstable fractures, severe hip/knee contractures (\>30° fixed flexion), or severe osteoarthritis requiring imminent surgery
Other illness
- Severe cognitive impairment (e.g., MMSE \<24) preventing safe participation
- Uncontrolled cardiac arrhythmia, pacemaker incompatibility, or implanted electronic device incompatible with robot sensors
Other
- Complete spinal cord injury with inability to bear any weight
- Severe spasticity (Modified Ashworth Scale \>3) in lower limbs
- Pregnancy
Who the study is looking for
- 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)
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bangladesh Medical University Coordinator of this site? Confirm its status | Dhaka | Bangladesh | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.