StrokeNCT07735702
ZEPU-AI5 Strength Training Study (ZEPUAI5RCT)
A study testing Robotic lower-limb gait training (ZEPU-AI5) and Standard-of-care rehabilitation (conventional physiotherapy) in people with Stroke and Incomplete Spinal Cord Injury, run by Bangladesh Medical University at 1 site in Bangladesh.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Stroke, Incomplete Spinal Cord Injury, Gait Impairment Following Orthopedic Surgery
- What is being tested?
- Robotic lower-limb gait training (ZEPU-AI5) and Standard-of-care rehabilitation (conventional physiotherapy)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteBangladesh
- Study dates
- 14 May 2026to 12 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
- Uncontrolled cardiac arrhythmia, pacemaker incompatibility, or any implanted electronic device incompatible with the robot's sensors
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Feasibility and Efficacy of ZEPU AI5 Lower Limb Muscle Strength Training and Evaluation Robot
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?
Read more
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
Read the detailed description
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.
- Being tested
- Robotic lower-limb gait training (ZEPU-AI5), Standard-of-care rehabilitation (conventional physiotherapy)
- Keywords
- Robotic Rehabilitation, Neurorehabilitation, Muscle Strength
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic lower-limb gait training (ZEPU-AI5)Device
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 (conventional physiotherapy)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm (Robotic-Augmented Rehabilitation Group) | Experimental | 18 participants receiving standard-of-care rehabilitation combined with ZEPU-AI5 assisted gait training Receives: Device: Robotic lower-limb gait training (ZEPU-AI5); Behavioral: Standard-of-care rehabilitation (conventional physiotherapy) |
| Control Arm (Usual Care Group) | Active comparator | 18 participants receiving standard-of-care rehabilitation alone (including IRR and exercise) Receives: Behavioral: Standard-of-care rehabilitation (conventional physiotherapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline (T=0) through 12-week intervention and follow-up (T=12 weeks)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and every 2 weeks up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start14 May 2026
- Primary completion12 Sep 2026
- Study completion12 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangladesh Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Md. Abdus Shakoor, Ph.D., Bangladesh Medical University
- Investigators
- Md. Abdus A Shakoor, Ph.D., Principal investigator, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735702
- Sponsor's protocol ID
- PR-1428
- Status last verified
- Sep 2026
- First submitted
- 26 Jul 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Feasibility and Efficacy of ZEPU AI5 Lower Limb Muscle Strength Training and Evaluation Robot
- ClinicalTrials.gov ID
- NCT07735702
- Acronym / sponsor ID
- PR-1428
- Keywords
- Robotic Rehabilitation, Neurorehabilitation, Muscle Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Bangladesh Medical UniversityUniversity, hospital or other
- Study start
- 14 May 2026 (actual)
- Primary completion
- 12 Sep 2026 (actual)
- Study completion
- 12 Sep 2026 (actual)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm (Robotic-Augmented Rehabilitation Group) | Experimental | Device: Robotic lower-limb gait training (ZEPU-AI5), Behavioral: Standard-of-care rehabilitation (conventional physiotherapy)18 participants receiving standard-of-care rehabilitation combined with ZEPU-AI5 assisted gait training |
| Control Arm (Usual Care Group) | Active comparator | Behavioral: Standard-of-care rehabilitation (conventional physiotherapy)18 participants receiving standard-of-care rehabilitation alone (including IRR and exercise) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
- Uncontrolled cardiac arrhythmia, pacemaker incompatibility, or any implanted electronic device incompatible with the robot's sensors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic lower-limb gait training (ZEPU-AI5)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 | Device | Intervention Arm (Robotic-Augmented Rehabilitation Group) |
| Standard-of-care rehabilitation (conventional physiotherapy)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. | Behavioural | Control Arm (Usual Care Group), Intervention Arm (Robotic-Augmented Rehabilitation Group) |
Primary outcome
Incidence of Device-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From baseline (T=0) through 12-week intervention and follow-up (T=12 weeks)
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.
7 secondary outcomes
Change in Walking Distance (6-Minute Walk Test)
Time frame: Baseline and every 2 weeks up to Week 12
Change in Lower-Limb Muscle Strength (MRC Scale)
Time frame: Baseline and every 2 weeks up to Week 12
Change in Functional Ambulation Category (FAC) Score
Time frame: Baseline and every 2 weeks up to Week 12
Change in Balance (Berg Balance Scale-Short Form)
Time frame: Baseline and every 2 weeks up to Week 12
Change in Functional Mobility (Timed Up and Go Test)
Time frame: Baseline and every 2 weeks up to Week 12
Change in Lower-Limb Spasticity (Modified Ashworth Scale)
Time frame: Baseline and every 2 weeks up to Week 12
Change in Health-Related Quality of Life (EuroQol Questionnaire)
Time frame: Baseline and every 2 weeks up to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Md. Abdus A Shakoor, Ph.D. principal investigator
Bangladesh Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic lower-limb gait training (ZEPU-AI5) and Standard-of-care rehabilitation (conventional physiotherapy) in people with Stroke and Incomplete Spinal Cord Injury, run by Bangladesh Medical University at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Device-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From baseline (T=0) through 12-week intervention and follow-up (T=12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.