ZEPU-AI5 Strength Training Study (ZEPUAI5RCT)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorBangladesh Medical University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Lower-limb motor dysfunction due to one of the following: (a) stroke (onset 2-24 months), (b) incomplete spinal cord injury (neurological level T12 or below, ASIA Impairment Scale C or D), or (c) orthopedic surgery (e.g., knee/hip replacement) with persistent gait impairment more than 3 months post-surgery
Age greater than 18 years and up to 60 years
Medically stable and able to provide informed consent
Able to meet device anthropometric criteria for use of the ZEPU-AI5 system
Disqualifiers
Complete spinal cord injury with inability to bear any weight
Severe cognitive impairment (Mini-Mental State Examination score less than 24) preventing safe participation
Severe spasticity of the lower limbs (Modified Ashworth Scale greater than 3)
Unstable fractures, severe hip/knee contractures (greater than 30 degrees fixed flexion), or severe osteoarthritis requiring imminent surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Robotic lower-limb gait training (ZEPU-AI5)
DeviceThe 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 (conventional physiotherapy)
BehavioralStandard-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.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Intervention Arm (Robotic-Augmented Rehabilitation Group)Experimental treatment 2 interventions
Group B: Control Arm (Usual Care Group)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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 122
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 123
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 124
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 12Sponsors and contacts
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Source ClinicalTrials.gov
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