An interventional study of Robotic lower-limb gait training (ZEPU-AI5) and Standard-of-care rehabilitation (conventional physiotherapy) in Stroke, Incomplete Spinal Cord Injury and Gait Impairment Following Orthopedic Surgery, sponsored by Bangladesh Medical University. Completed at 1 site in Bangladesh. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Bangladesh Medical University · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if robot-assisted lower-limb strength and gait training can improve safety, feasibility, and functional recovery in adults aged 18-60 years with lower-limb motor dysfunction due to stroke, incomplete spinal cord injury, or persistent gait impairment following orthopedic surgery. The main questions it aims to answer are:
Is robot-assisted training using the ZEPU-AI5 device safe and well-tolerated, with an acceptable rate of device-related adverse events? Does adding ZEPU-AI5-assisted training to standard-of-care rehabilitation improve functional outcomes (such as walking distance, muscle strength, balance, and mobility) compared to standard-of-care rehabilitation alone?
Researchers will compare an intervention group receiving standard-of-care rehabilitation combined with ZEPU-AI5-assisted training to a control group receiving standard-of-care rehabilitation alone, to see if the addition of robotic training leads to greater improvements in safety, functional recovery, and quality of life.
Participants will:
Undergo a baseline assessment before starting the study Receive either robot-assisted training plus standard-of-care rehabilitation, or standard-of-care rehabilitation alone, three times per week for 12 weeks Complete follow-up assessments every two weeks to evaluate safety, functional outcomes, and durability of any benefits
Walking impairment due to neurological and orthopedic conditions significantly limits independence and functional mobility, making lower-limb strength training a key focus of rehabilitation. Robotic-assisted rehabilitation systems have shown promising results in improving strength and functional outcomes in high-income countries; however, their feasibility, safety, and efficacy remain underexplored in low- and middle-income settings. In Bangladesh, the ZEPU-AI5 lower-limb strength training and evaluation robot is a novel technology that has not yet been systematically evaluated in this population.
The ZEPU-AI5 is a computer-controlled electromechanical rehabilitation device consisting of a rigid main frame, a motor-driven walking training table, bilateral robotic mechanical legs aligned with the patient's hip and knee joints, adjustable foot pedals, thigh and calf fixation straps, and a body-weight support suspension system. The walking platform supports up to 135 kg, with continuously adjustable body-weight unloading from 0-80 kg, allowing progressive loading according to patient tolerance and recovery stage. Prior to training, individualized calibration is performed by measuring thigh and calf lengths to align the robotic joints with the participant's anatomical hip and knee axes, with bilateral symmetry adjustment available when needed.
The system provides programmable control over hip joint angles (30°-50°) and knee joint angles (50°-80°) in 1° increments, with gait offset parameters adjustable by ±10 units to allow individualized correction of abnormal gait patterns. Walking speed is adjustable from 0.1 to 3.5 km/h, allowing graded progression from slow assisted stepping to higher-speed gait training.
At study entry, participants will undergo a face-to-face interview to gather clinical and sociodemographic data using a semi-structured, pre-tested questionnaire. Weight and height will be measured to calculate Body Mass Index (BMI). All participants will be allocated a study ID, and assessments will be conducted at the Robotic Rehabilitation Center, Department of Physical Medicine and Rehabilitation, Bangladesh Medical University.
7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's enrollment of 51 is close to the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →Bangladesh Medical University is the lead sponsor of 40 studies on the registry; 26 are open to participants now.
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Exclusion Criteria:
18 participants receiving standard-of-care rehabilitation combined with ZEPU-AI5 assisted gait training
Device: Robotic lower-limb gait training (ZEPU-AI5) · Behavioral: Standard-of-care rehabilitation (conventional physiotherapy)
18 participants receiving standard-of-care rehabilitation alone (including IRR and exercise)
Behavioral: Standard-of-care rehabilitation (conventional physiotherapy)
The ZEPU-AI5 Lower Limb Strength Training and Evaluation Robot (Shandong ZEPU Medical Technology Co. Ltd.) is a computer-controlled electromechanical rehabilitation device that delivers task-specific, repetitive lower-limb gait training. It consists of a motorized walking platform, bilateral robotic mechanical legs aligned to the patient's hip and knee joints, adjustable body-weight support (0-80 kg unloading, up to 135 kg capacity), and an overhead safety harness. Hip joint range is adjustable 30-50° and knee joint range 50-80°, with walking speed adjustable from 0.1-3.5 km/h. Training modes include standing, sitting, stepping-in-place, and over-ground walking. Participants in the intervention arm will receive robot-assisted gait training 3 sessions/week for 12 weeks (45 minutes/session, \~36 sessions total), supervised by trained physiotherapists, in addition to standard-of-care rehabilitation. Real-time feedback on joint angles, torque, and gait parameters is provided, with built-in
Standard-of-care rehabilitation consisting of conventional physiotherapy, including individualized rehabilitation regimen (IRR) and exercise therapy, delivered by trained physiotherapists at the Department of Physical Medicine and Rehabilitation, Bangladesh Medical University. This includes balance training, lower-limb strengthening exercises, stretching, and gait retraining, following standard institutional rehabilitation protocols. Participants in the control arm receive this standard therapy alone, without robotic-assisted gait training, over the same 12-week study period, with outcome assessments conducted at baseline and two-week intervals.
Incidence of Device-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number and proportion of participants experiencing device-related adverse events, including falls, skin breakdown/pressure sores, joint pain/injury, cardiovascular events, fracture, and device malfunction, recorded through continuous monitoring during each robotic training session and reviewed monthly by an independent safety monitor.
Time frame: From baseline (T=0) through 12-week intervention and follow-up (T=12 weeks)
Change in Walking Distance (6-Minute Walk Test)
Distance walked in 6 minutes, measured using the standardized 6-Minute Walk Test to assess functional exercise capacity and gait endurance, compared between the ZEPU-AI5 intervention group and control group.
Time frame: Baseline and every 2 weeks up to Week 12
Change in Lower-Limb Muscle Strength (MRC Scale)
Lower-limb muscle strength assessed using the Medical Research Council (MRC) Muscle Strength Scale (0-5 grading), compared between the ZEPU-AI5 intervention group and control group.
Time frame: Baseline and every 2 weeks up to Week 12
Change in Functional Ambulation Category (FAC) Score
Level of ambulatory function and physical assistance required for walking, assessed using the Functional Ambulation Category, a clinician-rated ordinal scale ranging from 0 (non-functional ambulation, unable to walk) to 5 (independent ambulation on any surface), with higher scores indicating better ambulatory function, compared between the ZEPU-AI5 intervention group and control group.
Time frame: Baseline and every 2 weeks up to Week 12
Change in Balance (Berg Balance Scale-Short Form)
Balance and postural control assessed using the Berg Balance Scale-Short Form (BBS-SF), a clinician-administered scale ranging from 0 to 28, with higher scores indicating better balance, compared between the ZEPU-AI5 intervention group and control group.
Time frame: Baseline and every 2 weeks up to Week 12
Change in Functional Mobility (Timed Up and Go Test)
Functional mobility and fall risk assessed using the Timed Up and Go (TUG) test, measuring time taken to rise from a chair, walk a short distance, turn, and sit back down, compared between groups.
Time frame: Baseline and every 2 weeks up to Week 12
Change in Lower-Limb Spasticity (Modified Ashworth Scale)
Muscle tone and spasticity of the lower limbs assessed using the Modified Ashworth Scale (MAS), a clinician-rated measure of resistance to passive muscle stretch, scored from 0 (no increase in muscle tone) to 4 (limb rigid in flexion or extension), with higher scores indicating greater spasticity (worse outcome), compared between the ZEPU-AI5 intervention group and control group.
Time frame: Baseline and every 2 weeks up to Week 12
Change in Health-Related Quality of Life (EuroQol Questionnaire)
Health-related quality of life assessed using the EuroQol 5-Dimension (EQ-5D) questionnaire, validated Bengali version, a self-rated measure with a descriptive system score and index value where higher scores/values indicate better health-related quality of life, compared between the ZEPU-AI5 intervention group and control group.
Time frame: Baseline and every 2 weeks up to Week 12
Plan to share: No
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Bangladesh Medical University