NCT07749625Recruiting
ZEPU-AI Series Limb Feedback Robot Training Study (ZEPUAISRCT)
Feasibility, Safety and Efficacy of ZEPU-AI2, AI4, AI6 Plus and AI7A Robotic Rehabilitation Systems in Patients With Upper and Lower Limb Motor Dysfunction
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
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 recovery. Participants will: Receive robotic-assisted therapy sessions three times a week for 12 weeks, each lasting about 45 minutes (robotic group), or continue with conventional rehabilitation alone (control group) Undergo assessments of movement, balance, walking ability, and daily function before and after the study period Be monitored for any side effects or complications related to the device or training
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 28 Jul 2026
- Start date
- 1 Aug 2026
- Primary completion date
- Sept 2026
- Lead sponsor
- Bangladesh Medical University
- Diseases
- Stroke
- NCT number
- NCT07749625
What you commit to
- Study type: Interventional
- Planned participants: 36
- From 1 Aug 2026 to the primary completion date, 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.
Other illness
- Severe cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score \< 24, that would compromise safe participation
- Uncontrolled cardiac arrhythmia, presence of a pacemaker, or other implanted electronic medical devices incompatible with robotic sensors
Other
- Complete spinal cord injury or profound motor paralysis preventing safe interaction with robotic devices
- 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., \> 30°), or severe pain limiting safe robotic training
- Pregnancy
Who the study is looking for
- 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
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 | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.