Exoskeleton Robot Walking Training for People With Walking Difficulty After Stroke or Spinal Injury
Tests a wearable leg exoskeleton robot for walking training in people with walking difficulty.
Plain-language title generated from the registry record
Registry title: ZEPU AI9 Exoskeleton Rehabilitation Robot
Key facts
- Where
- Dhaka, BangladeshSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT07750808, who can take part
Where in Bangladesh
- Bangladesh Medical UniversityDhaka, BangladeshTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bangladesh Medical University
- Trial code
- NCT07750808
- Record updated
- 11 September 2026
- Original description
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:Read full original descriptionShow less
Feasibility, Safety and Efficacy of ZEPU AI9 Lower Limb Exoskeleton Rehabilitation Robot in Patients With Lower Limb Motor Dysfunction
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
Inclusion: 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: Unstable fractures, severe hip/knee contractures (> 30° fixed flexion), severe osteoarthritis requiring imminent surgery; Severe cognitive impairment (e.g., MMSE < 24) preventing safe participation; Uncontrolled cardiac arrhythmia, pacemaker incompatibility, or implanted electronic device incompatible with robot sensors; Complete spinal cord injury with inability to bear any weight; Severe spasticity (Modified Ashworth Scale > 3) in lower limbs; Pregnancy.