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ZEPU-AI1 Gait Robot Training Study (ZEPUAI1RCT)
Sponsor: Bangladesh Medical University
Summary
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. Fifty-one participants took part (32 were originally planned; more were enrolled because additional eligible patients were available). Twenty-five received robot-assisted gait training three times a week for 12 weeks in addition to usual rehabilitation therapy, while 26 received usual rehabilitation therapy alone. Participants were 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.
Official title: Feasibility, Safety and Efficacy of ZEPU AI1 Gait Training and Evaluation System Robot in Patients With Lower Limb Motor Weakness
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
51
Start Date
2026-05-14
Completion Date
2026-10-07
Last Updated
2026-11-02
Healthy Volunteers
No
Interventions
ZEPU-AI1 Gait Training and Evaluation System
Participants received robot-assisted gait training using the ZEPU-AI1 Gait Training and Evaluation System, a robotic device providing body-weight-supported, guided gait training. Training was delivered 3 times per week for 12 weeks (36 sessions total), approximately 45 minutes per session, including warm-up, device donning, structured standing and gait training (sit-to-stand, in-place stepping, overground walking, turning), and cool-down. Body-weight support, walking speed, and session duration were progressively adjusted based on participant tolerance and performance.
Standard-of-Care Rehabilitation (Individualized Rehabilitation and Exercise)
Participants received individualized rehabilitation and exercise (IRR) as per institutional protocol at the Department of Physical Medicine and Rehabilitation, BMU. This standard-of-care rehabilitation program was tailored to each participant's functional status and needs, and was matched in overall therapeutic content and intensity across both study groups. It was delivered without any robotic-assisted device and represents the conventional-therapy component of care for individuals undergoing gait and mobility rehabilitation.
Locations (1)
Bangladesh Medical University
Dhaka, Bangladesh