ZEPU-AI1 Gait Robot Training Study (ZEPUAI1RCT)

Walking problems caused by stroke, spinal cord injury, or orthopedic surgery are common and can seriously limit a person's independence. Robotic-assisted gait training devices, which use a computer-controlled system to help patients practice standing and walking, have shown promise in improving strength, balance, and walking ability in other countries. However, this type of technology has not yet been carefully studied in Bangladesh. This study will test a robotic gait training and evaluation device called ZEPU-AI1 in adults aged 19 to 60 years who have difficulty walking due to stroke, incomplete spinal cord injury, or gait problems following surgery. The main goals are to find out whether using this robotic device alongside standard physical therapy is feasible (practical to carry out) and safe, and to explore whether it helps improve walking speed, balance, muscle strength, and daily function compared with standard physical therapy alone. Thirty-two participants will take part. Half will receive robot-assisted gait training three times a week for 12 weeks in addition to usual rehabilitation therapy, while the other half will receive usual rehabilitation therapy alone. Participants will be assessed regularly using standard walking, balance, and strength tests over the 12-week period. The results of this study will help doctors and researchers understand whether this robotic technology can be safely and effectively introduced into rehabilitation care in Bangladesh.

Inclusion Criteria: * 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 \>3 months post-surgery * Age \>18 and ≤60 years * Able to provide informed consent and understand instructions * Weight ≤100 kg and height within device adjustable range (per manufacturer specification) * Medically stable and cleared by physician for exoskeleton use (no active infection, uncontrolled cardiac/respiratory disease, severe osteoporosis, uncontrolled epilepsy, or untreated DVT) Exclusion Criteria: * Complete spinal cord injury with inability to bear any weight * Severe cognitive impairment (e.g., MMSE \3) in lower limbs * Unstable fractures, severe hip/knee contractures (\>30° fixed flexion), or severe osteoarthritis requiring imminent surgery * Uncontrolled cardiac arrhythmia, pacemaker incompatibility, or implanted electronic device incompatible with robot sensors * Pregnancy