An interventional study of ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot and Conventional Rehabilitation in Stroke, Spinal Cord Injuries and Gait Disorders, sponsored by Bangladesh Medical University. Recruiting at 1 site in Bangladesh. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Bangladesh Medical University · Not applicable, Interventional, and Treatment
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.
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 32 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Bangladesh Medical University is the lead sponsor of 43 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot-assisted rehabilitation in addition to conventional rehabilitation according to the study protocol.
Device: ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot · Other: Conventional Rehabilitation
Participants will receive conventional rehabilitation according to institutional standard care without ZEPU-AI3 robotic training.
Other: Conventional Rehabilitation
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.
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.
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.
Time frame: 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.
Time frame: Baseline through Week 12
Change in 6-Minute Walk Test Distance
Change in walking endurance assessed using the 6-Minute Walk Test (6MWT)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: Baseline and Week 12
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Sep 2026, 2 months after the start.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 2 months is below that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
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Bangladesh Medical University