Clinical Trial

ZEPU-AI5 Strength Training Study (ZEPUAI5RCT)

Not Yet Recruiting
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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
Trial Details
NCT Number NCT07735702
Lead Sponsor Bangladesh Medical University
Conditions Stroke, Incomplete Spinal Cord Injury, Gait Impairment Following Orthopedic Surgery
Enrollment 36 participants
Start Date 2026-07
Primary Completion 2026-09 (estimated)
Study Completion 2026-11 (estimated)
Updated on ClinicalTrials.gov 2026-07-31