ZEPU AI9 lower-limb exoskeleton gait training for walking difficulties

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial compares exoskeleton-assisted gait training plus standard rehabilitation to standard rehabilitation alone in adults with walking impairments due to stroke, incomplete spinal cord injury, or orthopedic surgery. It aims to assess safety (e.g., device-related adverse events), tolerability, and functional outcomes such as walking distance, speed, balance, and leg strength. The ZEPU-AI9 is a dual-leg, motorized exoskeleton that guides hip and knee movements and supports safe over-ground and in-clinic training, with built-in safety features and a supervised harness. Participants will be randomized to the exoskeleton group or usual care, and the program will be tailored to each person's size and abilities. The study addresses implementation in a low-to-middle-income country setting by evaluating practicality within Bangladeshi rehabilitation services.

Why it matters

Who can join: the full rules

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.

Where it's running

• Bangladesh Medical University
  Dhaka, Bangladesh Recruiting

Study contacts

• Principal investigator: Md. Abdus Shakoor, Ph.D. — Bangladesh Medical University
• Study coordinator: Md. Abdus Shakoor, Ph.D.
• Email: shakoorma@bmu.ac.bd
• Phone: +8801819410080

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.