ZEPU-AI1 Gait Robot Training Study (ZEPUAI1RCT)

Overview

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.

This is a single-site, pilot, randomized controlled trial evaluating the feasibility, safety, and preliminary efficacy of the ZEPU-AI1 Gait Training and Evaluation System, a computer-controlled robotic rehabilitation device, in adults with lower-limb motor dysfunction. The trial will be conducted at the Robotic Rehabilitation Centre, Department of Physical Medicine and Rehabilitation, Bangladesh Medical University (BMU), Dhaka, Bangladesh. Thirty-two participants aged 19-60 years with lower-limb motor dysfunction secondary to stroke (2-24 months post-onset), incomplete spinal cord injury (ASIA C or D, neurological level T12 or below), or persistent gait impairment following orthopedic surgery (\>3 months post-surgery) will be enrolled after screening against detailed inclusion/exclusion criteria (including device-specific anthropometric limits, medical stability, and absence of severe spasticity, unstable fractures, or cardiac contraindications). Participants will be randomized into two parallel arms: Intervention Arm (n=16): ZEPU-AI1 robot-assisted gait training combined with standard-of-care rehabilitation. Control Arm (n=16): Standard-of-care rehabilitation alone. The ZEPU-AI1 is a bilateral robotic exoskeleton system integrating a gait control unit (programmable hip range 30°-50°, knee range 50°-80°), a dynamic body-weight support mechanism (0-80 kg unloading), a motorized treadmill (0.1-3.5 km/h), and dedicated software providing real-time gait monitoring, spasticity detection, and automatic safety shutoff. Intervention-arm participants will undergo supervised training three times weekly for 12 weeks (36 sessions total), each session approximately 45 minutes, comprising warm-up, device donning, structured standing/gait training (sit-to-stand, in-place stepping, overground walking, turning), and cool-down, with progressive adjustment of speed, body-weight support, and duration based on tolerance. Primary outcomes are feasibility (recruitment, session adherence, device set-up/donning time, therapist competency time) and safety (incidence of device-related adverse events and serious adverse events, tolerability, dropout rate), assessed continuously throughout the intervention and at two-week intervals. Secondary outcomes assess efficacy using standardized, validated instruments administered at baseline and two-week intervals over the 12-week period: 6-Minute Walk Test, Medical Research Council (MRC) Muscle Strength Scale, Functional Ambulation Category (FAC), Berg Balance Scale, Timed Up and Go (TUG) test, Modified Ashworth Scale (MAS), and a validated Bengali version of the EuroQol quality-of-life questionnaire. Usability and acceptability will be assessed via the Post-Study System Usability Questionnaire (PSSUQ) at study completion. Data will be collected on standardized case report forms and entered into a password-protected, anonymized electronic database, with independent verification and monthly adverse-event review by a safety monitor not involved in training delivery. Analysis will follow an intention-to-treat approach (with a secondary per-protocol analysis), using descriptive statistics for safety/feasibility outcomes and paired/unpaired t-tests or Wilcoxon signed-rank tests (as appropriate for data distribution) to compare baseline versus follow-up efficacy outcomes, with statistical significance set at p\<0.05 (two-tailed). This pilot study is intended to generate foundational safety, feasibility, and effect-size data to inform the design of a future, adequately powered randomized controlled trial and to guide responsible implementation of robotic gait rehabilitation technology within the Bangladeshi healthcare context.