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โ† Trials
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ZEPU-AI Series Limb Feedback Robot Training Study (ZEPUAISRCT)

RecruitingNAAges 18 Years - 60 YearsAllBangladesh Medical University
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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 robotic rehabilitation devices (ZEPU-AI2, AI4, AI6 Plus, and AI7A) are feasible, safe, and effective for adults with upper or lower limb motor problems. These problems can result from stroke, incomplete spinal cord injury, traumatic brain injury, or orthopedic surgery. The main questions it aims to answer are: Is robotic rehabilitation training safe and practical to deliver alongside conventional therapy? Does adding robotic-assisted therapy improve motor function, balance, gait, and independence in daily activities compared to conventional rehabilitation alone? What side effects or device-related problems, if any, occur during robotic training? The Investigators will compare a robotic-augmented rehabilitation group to a control group receiving conventional rehabilitation alone, to see if adding robotic therapy leads to better recover

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Presence of upper-limb motor dysfunction, with or without concurrent lower-limb impairment, due to one of the following conditions: (a) Stroke, with onset between 2 and 24 months prior to enrollment; (b) Incomplete spinal cord injury (ASIA Scale B, C, or D); (c) Traumatic brain injury; or (d) Orthopedic disorders affecting upper and/or lower limb motor function * Age between 18 and 60 years * Ability to understand study procedures and follow instructions, and to provide written informed consent (or assent with guardian consent where applicable) * Body weight and limb anthropometry compatible with ZEPU-AI2, AI4, AI6 Plus, and AI7A systems, as per manufacturer specifications * Medically stable and cleared by a physician for robotic rehabilitation, with no active infection, uncontrolled cardiac or respiratory disease, severe osteoporosis, uncontrolled epilepsy, or untreated deep vein thrombosis Exclusion Criteria: * Complete spinal cord injury or profound motor paralysis preventing safe interaction with robotic devices * Severe cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score \< 24, that would compromise safe participation * Severe spasticity of the upper limb, defined as a Modified Ashworth Scale score \> 3 * Unstable fractures, severe fixed joint contractures of the shoulder, elbow, wrist, or hand (e.g., \> 30ยฐ), or severe pain limiting safe robotic training * Uncontrolled cardiac arrhythmia, presence of a pacemaker, or other implanted electronic medical devices incompatible with robotic sensors * Pregnancy
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What it tests

  • ZEPU-AI2
  • ZEPU-AI4
  • ZEPU-AI6 Plus
  • ZEPU-AI7A
  • Standard-of-Care Physiotherapy
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Where

1 site
Bangladesh Medical University
Dhaka, Bangladesh
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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