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ZEPU-AI5 Strength Training Study (ZEPUAI5RCT)

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Minor Trial completed Show 6 more changesShow less
    • Final enrollment: 51 participants (planned 36)
    • Study completion date changed from estimate of Nov 2026 to Sep 12, 2026
    • Start date moved earlier from Jul 1, 2026 to May 14, 2026
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 1 of 7 entries
    • Site details revised
  2. Notable Recruitment opened
    • Start date changed from estimate of Jul 2026 to Jul 1, 2026
    • Site details revised
    v3
  3. Minor Secondary endpoints: details revised at 4 of 7 entriesv2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
(from sponsor)
Stroke, Incomplete Spinal Cord Injury, Gait Impairment Following Orthopedic Surgery
Related terms Stroke
Enrollment 51 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov