StrokeZEPUAI3RCTNCT07705906
ZEPU-AI3 Lower Limb Feedback Robot Training Study
A study testing ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot and Conventional Rehabilitation in people with Stroke and Spinal Cord Injuries, run by Bangladesh Medical University at 1 site in Bangladesh.
Trial summary
Lower limb motor dysfunction resulting from stroke, spinal cord injury, or other neurological disorders substantially limits mobility, independence, and quality of life. Robotic rehabilitation has emerged as a promising approach to provide intensive, repetitive, task-oriented training. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke, Spinal Cord Injuries, Gait Disorders
- What is being tested?
- ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot and Conventional Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Jul 2026to 15 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Lower-limb motor dysfunction from one of the following: (a) stroke (onset 2-24 months), (b) incomplete spinal-cord injury (neurological level T12 and below, ASIA C or D), (c) orthopedic surgery (e.g., knee/hip replacement) with persistent gait impairment > 3month post-surgery. Stroke onset between 2-24 months ensures inclusion of individuals in the subacute to chronic phase, where gait recovery is still achievable and measurable. Incomplete SCI targets individuals with partial motor preservation, who are capable of engaging in active gait training with robotic assistance.
- Age >18 and ≤ 60 years. This age limit is chosen because individuals with this age range generally have better cardiopulmonary reserve and musculoskeletal tolerance, allowing safer participation in intensive robotic-assisted training with reduced risk of adverse events. Excluding younger patients minimizes heterogeneity related to growth, neurodevelopmental factors and congenital disorders, which may influence gait mechanics and response to robotic therapy. Excluding older adults (>60 years) helps reduce confounding from age-related degenerative changes that may affect gait outcomes and safety.
- Able to provide informed consent and understand instructions which ensures participants can actively engage in therapy, follow safety instructions and report adverse events.
- Weight ≤ 100 kg (as per device spec) and height within device adjustable range (manufacturer spec). Exceeding weight or height limits may compromise mechanical support, safety, and accurate gait training.
- Medically stable and cleared by physician for exoskeleton use (no active infection, uncontrolled cardiac/respiratory disease, severe osteoporosis, uncontrolled epilepsy, untreated DVT) through pre-screening with necessary investigations.
Who cannot join
- • Complete spinal cord injury with inability to bear any weight as it requires the patient to actively support some body weight or participate in stepping movements.
- Severe cognitive impairment (e.g., MMSE < 24) preventing safe participation.
- Severe spasticity (Modified Ashworth Scale > 3) in lower limbs. High muscle tone or rigidity increases risk of joint strain, skin injury and falls during robotic-assisted training.
- Unstable fractures, severe hip/knee contractures (> 30° fixed flexion), severe osteoarthritis requiring imminent surgery. They can pose high risk for injury during weight-bearing or gait cycles.
- Uncontrolled cardiac arrhythmia, pacemaker incompatibility or implanted electronic device incompatible with robot sensors. Individuals with these conditions may face elevated risk of adverse cardiac events or device malfunction.
- Pregnancy as safety data for robotic exoskeleton use in pregnant individuals are lacking.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site, 1 recruiting
- Recruiting
Bangladesh Medical University
Dhaka, Dhaka Division, 1000
Md. Abdus Shakoor, Ph.D., +8801819410080, shakoorma@bmu.ac.bd
About this study
Official title: Safety, Efficacy and Feasibility of ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot
Lower limb motor dysfunction resulting from stroke, spinal cord injury, or other neurological disorders substantially limits mobility, independence, and quality of life. Robotic rehabilitation has emerged as a promising approach to provide intensive, repetitive, task-oriented training. The ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot is designed to deliver interactive lower limb training while providing real-time performance feedback. This pilot randomized controlled trial aims to evaluate the safety, efficacy, and feasibility of ZEPU-AI3-assisted rehabilitation combined with conventional rehabilitation compared with conventional rehabilitation alone in patients with lower limb motor dysfunction. The primary outcomes include safety, feasibility, and changes in lower limb motor function, gait performance, and functional mobility. The findings will provide preliminary evidence to support future large-scale clinical trials and the implementation of robotic rehabilitation in clinical practice.
Read the detailed description
Background:
Lower limb motor dysfunction is a major cause of disability following neurological and musculoskeletal disorders. Conventional rehabilitation improves function but is often limited by therapist workload and the difficulty of delivering high-intensity, repetitive, task-specific training. Robotic rehabilitation systems have the potential to overcome these limitations by providing standardized, intensive, and feedback-guided exercise.
Objective:
To evaluate the safety, efficacy, and feasibility of the ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot in patients with lower limb motor dysfunction.
Study Design:
This is a prospective, single-center, pilot randomized controlled trial conducted at the Department of Physical Medicine and Rehabilitation, Bangladesh Medical University. Eligible participants will be randomly allocated in a 1:1 ratio to receive either ZEPU-AI3-assisted rehabilitation plus conventional rehabilitation or conventional rehabilitation alone.
Intervention:
Participants in the intervention group will receive robot-assisted lower limb feedback training using the ZEPU-AI3 device in addition to conventional rehabilitation. The control group will receive conventional rehabilitation according to institutional standards. The intervention duration, frequency, and intensity will follow the approved study protocol.
Outcome Measures:
Primary and secondary outcomes include safety, feasibility, lower limb motor recovery, gait performance, balance, functional mobility, and adverse events. Participants will be assessed at baseline and after completion of the intervention.
Significance:
This pilot study will generate preliminary evidence regarding the clinical utility, safety, and feasibility of the ZEPU-AI3 robotic rehabilitation system and will inform the design of future multicenter randomized controlled trials.
- Conditions
- Stroke, Spinal Cord Injuries, Gait Disorders
- Being tested
- ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot, Conventional Rehabilitation
- Keywords
- Robotic Rehabilitation, Neurorehabilitation, Feedback Training
- Medical subject headings
- Stroke, Spinal Cord Injuries, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZEPU-AI3 Lower Limb Feedback Training and Evaluation RobotDevice
Participants assigned to the experimental arm will receive rehabilitation using the ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot in addition to conventional rehabilitation. Robot-assisted training will be delivered according to the approved study protocol, including supervised lower-limb feedback training sessions combined with standard rehabilitation care.
Conventional RehabilitationOther
Participants assigned to the control arm will receive conventional rehabilitation according to the standard clinical practice of the Department of Physical Medicine and Rehabilitation, Bangladesh Medical University. Conventional rehabilitation may include therapeutic exercises, gait training, balance training, strengthening exercises, and other standard rehabilitation interventions as indicated.
| Study group | Role | What they receive |
|---|---|---|
| ZEPU-AI3 + Conventional Rehabilitation | Experimental | Participants will receive ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot-assisted rehabilitation in addition to conventional rehabilitation according to the study protocol. Receives: Device: ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot; Other: Conventional Rehabilitation |
| Conventional Rehabilitation | Active comparator | Participants will receive conventional rehabilitation according to institutional standard care without ZEPU-AI3 robotic training. Receives: Other: Conventional Rehabilitation |
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)
Incidence of device-related adverse events (AEs) and serious adverse events (SAEs) occurring during the 12-week intervention, including falls, skin breakdown or pressure sores, joint pain or injury, cardiovascular events, fractures, and device malfunction.
Measured: Baseline through Week 12
Device Tolerability
Device tolerability assessed by the proportion of planned treatment sessions completed, participant adherence, study withdrawals, and reasons for withdrawal during the 12-week intervention.
Measured: Baseline through Week 12
Secondary outcomes (7)
Change in 6-Minute Walk Test Distance
Change in walking endurance assessed using the 6-Minute Walk Test (6MWT)
Measured: Baseline and Week 12
Change in Lower-Limb Muscle Strength on the Medical Research Council (MRC) Muscle Strength Scale
Lower-limb muscle strength graded using the Medical Research Council (MRC) Muscle Strength Scale, ranging from 0 (no visible muscle contraction) to 5 (normal power against full resistance). A higher score indicates better outcome (greater muscle strength).
Measured: Baseline and Week 12
Change in Ambulatory Function on the Functional Ambulation Category (FAC)
Level of walking independence graded on the Functional Ambulation Category, ranging from 0 (non-functional ambulation, unable to walk) to 5 (independent ambulation on any surface). A higher score indicates better outcome (greater independence in walking).
Measured: Baseline and Week 12
Change in Balance on the Berg Balance Scale-Short Form (BBS-SF)
Balance and postural control assessed using the Berg Balance Scale-Short Form, a 7-item version of the original Berg Balance Scale, each item scored 0 to 4, for a total range of 0 (severely impaired balance) to 28 (excellent balance). A higher score indicates better outcome (better balance).
Measured: Baseline and Week 12
Change in Timed Up and Go (TUG) Test
Change in functional mobility assessed using the Timed Up and Go (TUG) test
Measured: Baseline and Week 12
Change in Lower-Limb Spasticity on the Modified Ashworth Scale (MAS)
Muscle tone and spasticity of the lower limbs graded on the Modified Ashworth Scale, ranging from 0 (no increase in muscle tone) to 4 (limb rigid in flexion or extension), with an intermediate grade of 1+. A lower score indicates better outcome (less spasticity).
Measured: Baseline and Week 12
Change in Health-Related Quality of Life on the EuroQol 5-Dimension (EQ-5D) Questionnaire, Validated Bengali Version
Health-related quality of life assessed using the EuroQol 5-Dimension (EQ-5D) questionnaire (validated Bengali version), comprising a descriptive index score and a visual analogue scale (EQ-VAS) ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). A higher score indicates better outcome (better quality of life).
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Jul 2026
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
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
- None (open label)
- Enrolment
- 32 participants (estimated)
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 Shakoor, Ph.D., Principal investigator, Department of Physical Medicine & Rehabilitation, Bangladesh Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705906
- Sponsor's protocol ID
- PR-1429
- Acronym
- ZEPUAI3RCT
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 11 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Efficacy and Feasibility of ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot
- ClinicalTrials.gov ID
- NCT07705906
- Acronym / sponsor ID
- ZEPUAI3RCT / PR-1429
- Conditions
- Stroke, Spinal Cord Injuries, Gait Disorders
- Keywords
- Robotic Rehabilitation, Neurorehabilitation, Feedback Training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Bangladesh Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 15 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.
Lower limb motor dysfunction resulting from stroke, spinal cord injury, or other neurological disorders substantially limits mobility, independence, and quality of life. Robotic rehabilitation has emerged as a promising approach to provide intensive, repetitive, task-oriented training. The ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot is designed to deliver interactive lower limb training while providing real-time performance feedback. This pilot randomized controlled trial aims to evaluate the safety, efficacy, and feasibility of ZEPU-AI3-assisted rehabilitation combined with conventional rehabilitation compared with conventional rehabilitation alone in patients with lower limb motor dysfunction. The primary outcomes include safety, feasibility, and changes in lower limb motor function, gait performance, and functional mobility. The findings will provide preliminary evidence to support future large-scale clinical trials and the implementation of robotic rehabilitation in clinical practice.
Detailed description
Background:
Lower limb motor dysfunction is a major cause of disability following neurological and musculoskeletal disorders. Conventional rehabilitation improves function but is often limited by therapist workload and the difficulty of delivering high-intensity, repetitive, task-specific training. Robotic rehabilitation systems have the potential to overcome these limitations by providing standardized, intensive, and feedback-guided exercise.
Objective:
To evaluate the safety, efficacy, and feasibility of the ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot in patients with lower limb motor dysfunction.
Study Design:
This is a prospective, single-center, pilot randomized controlled trial conducted at the Department of Physical Medicine and Rehabilitation, Bangladesh Medical University. Eligible participants will be randomly allocated in a 1:1 ratio to receive either ZEPU-AI3-assisted rehabilitation plus conventional rehabilitation or conventional rehabilitation alone.
Intervention:
Participants in the intervention group will receive robot-assisted lower limb feedback training using the ZEPU-AI3 device in addition to conventional rehabilitation. The control group will receive conventional rehabilitation according to institutional standards. The intervention duration, frequency, and intensity will follow the approved study protocol.
Outcome Measures:
Primary and secondary outcomes include safety, feasibility, lower limb motor recovery, gait performance, balance, functional mobility, and adverse events. Participants will be assessed at baseline and after completion of the intervention.
Significance:
This pilot study will generate preliminary evidence regarding the clinical utility, safety, and feasibility of the ZEPU-AI3 robotic rehabilitation system and will inform the design of future multicenter randomized controlled trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZEPU-AI3 + Conventional Rehabilitation | Experimental | Device: ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot, Other: Conventional RehabilitationParticipants will receive ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot-assisted rehabilitation in addition to conventional rehabilitation according to the study protocol. |
| Conventional Rehabilitation | Active comparator | Other: Conventional RehabilitationParticipants will receive conventional rehabilitation according to institutional standard care without ZEPU-AI3 robotic training. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Lower-limb motor dysfunction from one of the following: (a) stroke (onset 2-24 months), (b) incomplete spinal-cord injury (neurological level T12 and below, ASIA C or D), (c) orthopedic surgery (e.g., knee/hip replacement) with persistent gait impairment > 3month post-surgery. Stroke onset between 2-24 months ensures inclusion of individuals in the subacute to chronic phase, where gait recovery is still achievable and measurable. Incomplete SCI targets individuals with partial motor preservation, who are capable of engaging in active gait training with robotic assistance.
Key exclusion criteria (6 listed)
- • Complete spinal cord injury with inability to bear any weight as it requires the patient to actively support some body weight or participate in stepping movements.
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 |
|---|---|---|
| ZEPU-AI3 Lower Limb Feedback Training and Evaluation RobotParticipants assigned to the experimental arm will receive rehabilitation using the ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot in addition to conventional rehabilitation. Robot-assisted training will be delivered according to the approved study protocol, including supervised lower-limb feedback training sessions combined with standard rehabilitation care. | Device | ZEPU-AI3 + Conventional Rehabilitation |
| Conventional RehabilitationParticipants assigned to the control arm will receive conventional rehabilitation according to the standard clinical practice of the Department of Physical Medicine and Rehabilitation, Bangladesh Medical University. Conventional rehabilitation may include therapeutic exercises, gait training, balance training, strengthening exercises, and other standard rehabilitation interventions as indicated. | Other | Conventional Rehabilitation, ZEPU-AI3 + Conventional Rehabilitation |
Primary outcome
Incidence of Device-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline through Week 12
Incidence of device-related adverse events (AEs) and serious adverse events (SAEs) occurring during the 12-week intervention, including falls, skin breakdown or pressure sores, joint pain or injury, cardiovascular events, fractures, and device malfunction.
Device Tolerability
Time frame: Baseline through Week 12
Device tolerability assessed by the proportion of planned treatment sessions completed, participant adherence, study withdrawals, and reasons for withdrawal during the 12-week intervention.
7 secondary outcomes
Change in 6-Minute Walk Test Distance
Time frame: Baseline and Week 12
Change in Lower-Limb Muscle Strength on the Medical Research Council (MRC) Muscle Strength Scale
Time frame: Baseline and Week 12
Change in Ambulatory Function on the Functional Ambulation Category (FAC)
Time frame: Baseline and Week 12
Change in Balance on the Berg Balance Scale-Short Form (BBS-SF)
Time frame: Baseline and Week 12
Change in Timed Up and Go (TUG) Test
Time frame: Baseline and Week 12
Change in Lower-Limb Spasticity on the Modified Ashworth Scale (MAS)
Time frame: Baseline and Week 12
Change in Health-Related Quality of Life on the EuroQol 5-Dimension (EQ-5D) Questionnaire, Validated Bengali Version
Time frame: Baseline and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 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.
Md. Abdus Shakoor, Ph.D. principal investigator
Department of Physical Medicine & Rehabilitation, Bangladesh Medical University, Dhaka, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot and Conventional Rehabilitation in people with Stroke and Spinal Cord Injuries, 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 5 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: looking for participants now, as of the sponsor's last update on 11 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Md. Abdus Shakoor, Ph.D. (+8801819410080, shakoorma@bmu.ac.bd), or a site near the patient. 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: Baseline through Week 12). The study lists 2 primary outcomes in all. 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 11 Sep 2026.