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ZEPU AI9 Exoskeleton Rehabilitation Robot

RecruitingNAAges 18 Years - 60 YearsAllBangladesh Medical University
NCT07750808 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn whether the ZEPU AI9 lower limb exoskeleton robot is feasible, safe, and effective for people with walking difficulty caused by stroke, incomplete spinal cord injury, or orthopedic surgery. The main questions it aims to answer are: Is exoskeleton-assisted gait training well tolerated, and how often do device-related problems (such as falls, pain, or skin injury) occur? Does adding exoskeleton training to usual rehabilitation improve walking distance, walking speed, balance, muscle strength, and joint movement compared with usual rehabilitation alone? Is it practical to add this robotic training into the rehabilitation program at Bangladesh Medical University? Researchers will compare a group receiving exoskeleton-assisted gait training plus standard rehabilitation to a group receiving standard rehabilitation alone, to see whether the exoskele

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 and ≤ 60 years. * 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 \> 3months post-surgery. * Able to provide informed consent and understand instructions. * Weight ≤ 100 kg (as per device spec) and height within device adjustable range (manufacturer spec). * Medically stable and cleared by physician for exoskeleton use (no active infection, uncontrolled cardiac/respiratory disease, severe osteoporosis, uncontrolled epilepsy, untreated DVT) with necessary investigations. 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), severe osteoarthritis requiring imminent surgery. * Uncontrolled cardiac arrhythmia, pacemaker incompatibility, or implanted electronic device incompatible with robot sensors. * Pregnancy.
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What it tests

  • ZEPU-AI9 Lower Limb Exoskeleton Gait Training
  • Standard-of-Care Rehabilitation
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Where

1 site
Bangladesh Medical University
Dhaka, Bangladesh
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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