NCT07735702Completed
ZEPU-AI5 Strength Training Study (ZEPUAI5RCT)
Safety, Feasibility and Efficacy of ZEPU AI5 Lower Limb Muscle Strength Training and Evaluation Robot
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 51 (actual)
- First submitted
- 26 Jul 2026
- Start date
- 14 May 2026
- Primary completion date
- 12 Sept 2026
- Lead sponsor
- Bangladesh Medical University
- Diseases
- Stroke
- NCT number
- NCT07735702
What you commit to
- Study type: Interventional
- Participants enrolled: 51
- From 14 May 2026 to the primary completion date, 12 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 (greater than 30 degrees fixed flexion), or severe osteoarthritis requiring imminent surgery
Other illness
- Severe cognitive impairment (Mini-Mental State Examination score less than 24) preventing safe participation
- Uncontrolled cardiac arrhythmia, pacemaker incompatibility, or any implanted electronic device incompatible with the robot's sensors
Other
- Complete spinal cord injury with inability to bear any weight
- Severe spasticity of the lower limbs (Modified Ashworth Scale greater than 3)
- Pregnancy
Who the study is looking for
- 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
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.