NCT07750808Recruiting
ZEPU AI9 Exoskeleton Rehabilitation Robot
Feasibility, Safety and Efficacy of ZEPU AI9 Lower Limb Exoskeleton Rehabilitation Robot in Patients With 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 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 exoskeleton adds benefit. Participants will: Be randomly assigned to either the exoskeleton group or the standard-care group If assigned to the exoskeleton group, attend 45-minute training sessions 3 times a week for 12 weeks, supervised by physical therapists with safety harness support Both groups will continue their usual rehabilitation therapy throughout the study Undergo walking, balance, strength, and quality-of-life assessments at the start of the study and every 2 weeks for 12 weeks Be monitored for any side effects or safety concerns during and after each session
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 2 Aug 2026
- Start date
- 1 Aug 2026
- Primary completion date
- Oct 2026
- Lead sponsor
- Bangladesh Medical University
- Diseases
- Stroke
- NCT number
- NCT07750808
What you commit to
- Study type: Interventional
- Planned participants: 36
- From 1 Aug 2026 to the primary completion date, Oct 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.
Prior treatment
- Unstable fractures, severe hip/knee contractures (\> 30° fixed flexion), severe osteoarthritis requiring imminent surgery.
Other illness
- Severe cognitive impairment (e.g., MMSE \< 24) preventing safe participation.
- Uncontrolled cardiac arrhythmia, pacemaker incompatibility, or implanted electronic device incompatible with robot sensors.
Other
- Complete spinal cord injury with inability to bear any weight.
- Severe spasticity (Modified Ashworth Scale \> 3) in lower limbs.
- Pregnancy.
Who the study is looking for
- 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.
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.