An interventional study of ZEPU-AI1 Gait Training and Evaluation System and Standard-of-Care Rehabilitation (Individualized Rehabilitation and Exercise) in Stroke, Spinal Cord Injuries (SCI) and Gait Disorders, Neurologic, sponsored by Bangladesh Medical University. Completed at 1 site in Bangladesh. Open to participants aged 19 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Bangladesh Medical University · Not applicable, Interventional, and Treatment
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Among 14 studies in Stroke with a site in Bangladesh — 8 open to participants now, 9 under way, none of them phase 3. Stroke · Bangladesh.
Among the 14 studies in Stroke with a site in Bangladesh, this one is the 6th largest by enrollment, is one of 8 that started in 2026, is one of 12 with no phase, and was the 9th registered.
8,268 studies on the registry are indexed under Stroke; 2,062 are open to participants now.
Browse Stroke studies →8 of the 14 studies in Stroke with a site in Bangladesh are open now. Recruiting first, the newest first:
Bangladesh Medical University · Sites in Bangladesh
Ages 18–60
Bangladesh Medical University · Sites in Bangladesh
Ages 18–60
Bangladesh Medical University · Sites in Bangladesh
Ages 18–60
Bangladesh Medical University · Sites in Bangladesh
Ages 18–70
Bangladesh Medical University · Sites in Bangladesh
Ages 18–60
A study can be open while its sites in Bangladesh have not opened yet or have stopped. Only those recruiting at a site in Bangladesh →
Of the 1,418 Stroke studies recruiting now, 696 (49%) set no upper age limit and 282 (20%) stop at 75 or younger; 77 take children under 18; 196 take healthy volunteers.
This study: 19 Years to 60 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
14 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 8 started in 2026.
This study's enrollment of 51 is close to the median of 49 across 6,036 interventional studies indexed under Stroke.
Median enrollment 44 across the 14 interventional studies. Of the 5 that completed or were terminated, 1 (20%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 14 has an industry lead sponsor. The 7 most frequent:
Bangladesh Medical University is the lead sponsor of 44 studies on the registry; 26 are open to participants now.
Bangladesh Medical University has 7 studies filed under Stroke — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 14 studies in Stroke with a site in Bangladesh, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study tested a robotic gait training and evaluation device called ZEPU-AI1 in adults aged 19 to 60 years who had difficulty walking due to stroke, incomplete spinal cord injury, or gait problems following surgery. The main goals were to find out whether using this device alongside standard physical therapy was feasible and safe, and to explore whether it improved walking distance, ambulation, balance, and lower-limb strength compared with standard physical therapy alone.
This is a single-site, pilot, randomized controlled trial evaluating the feasibility, safety, and preliminary efficacy of the ZEPU-AI1 Gait Training and Evaluation System, a computer-controlled robotic rehabilitation device, in adults with lower-limb motor dysfunction. The trial will be conducted at the Robotic Rehabilitation Centre, Department of Physical Medicine and Rehabilitation, Bangladesh Medical University (BMU), Dhaka, Bangladesh.
Fifty-one participants aged 19-60 years (planned enrolment 36; enrolment exceeded the target because additional eligible participants were available) with lower-limb motor dysfunction secondary to stroke (2-24 months post-onset), incomplete spinal cord injury (ASIA C or D, neurological level T12 or below), or persistent gait impairment following orthopedic surgery (>3 months post-surgery) were enrolled after screening against detailed inclusion/exclusion criteria (including device-specific anthropometric limits, medical stability, and absence of severe spasticity, unstable fractures, or cardiac contraindications). Participants were randomized into two parallel arms:
Intervention Arm (n=25): ZEPU-AI1 robot-assisted gait training combined with standard-of-care rehabilitation.
Control Arm (n=26): Standard-of-care rehabilitation alone.
The ZEPU-AI1 is a bilateral robotic exoskeleton system integrating a gait control unit (programmable hip range 30°-50°, knee range 50°-80°), a dynamic body-weight support mechanism (0-80 kg unloading), a motorized treadmill (0.1-3.5 km/h), and dedicated software providing real-time gait monitoring, spasticity detection, and automatic safety shutoff. Intervention-arm participants will undergo supervised training three times weekly for 12 weeks (36 sessions total), each session approximately 45 minutes, comprising warm-up, device donning, structured standing/gait training (sit-to-stand, in-place stepping, overground walking, turning), and cool-down, with progressive adjustment of speed, body-weight support, and duration based on tolerance.
Primary outcomes are feasibility (recruitment, session adherence, device set-up/donning time, therapist competency time) and safety (incidence of device-related adverse events and serious adverse events, tolerability, dropout rate), assessed continuously throughout the intervention and at two-week intervals.
Secondary outcomes assess efficacy using standardized, validated instruments administered at baseline and two-week intervals over the 12-week period: 6-Minute Walk Test, Medical Research Council (MRC) Muscle Strength Scale, Functional Ambulation Category (FAC), Berg Balance Scale, Timed Up and Go (TUG) test, Modified Ashworth Scale (MAS), and a validated Bengali version of the EuroQol quality-of-life questionnaire. Usability and acceptability will be assessed via the Post-Study System Usability Questionnaire (PSSUQ) at study completion.
Data will be collected on standardized case report forms and entered into a password-protected, anonymized electronic database, with independent verification and monthly adverse-event review by a safety monitor not involved in training delivery. Analysis will follow an intention-to-treat approach (with a secondary per-protocol analysis), using descriptive
The criteria were revised on the registry on Nov 9, 2026. See what changed
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.
Exclusion Criteria:
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 (n=25) received robot-assisted gait training using the ZEPU-AI1 Gait Training and Evaluation System in addition to standard-of-care rehabilitation. Training was delivered 3 times per week for 12 weeks (36 sessions total), each session approximately 45 minutes, including warm-up, device donning, structured standing and gait training (sit-to-stand, in-place stepping, overground walking, turning), and cool-down. Body-weight support, walking speed, and session duration were progressively adjusted based on participant tolerance and performance. Sessions were supervised by trained physiatrists and physiotherapists at the Robotic Rehabilitation Centre, BMU. Standard-of-care rehabilitation (individualized rehabilitation and exercise) continued in parallel.
Device: ZEPU-AI1 Gait Training and Evaluation System · Behavioral: Standard-of-Care Rehabilitation (Individualized Rehabilitation and Exercise)
Participants (n=26) received standard-of-care rehabilitation alone, without robotic-assisted gait training. This included an individualized rehabilitation regimen and exercise (IRR) as per institutional protocol at the Department of Physical Medicine and Rehabilitation, BMU, matched in overall therapeutic content to the conventional-therapy component received by the intervention group.
Behavioral: Standard-of-Care Rehabilitation (Individualized Rehabilitation and Exercise)
Participants received robot-assisted gait training using the ZEPU-AI1 Gait Training and Evaluation System, a robotic device providing body-weight-supported, guided gait training. Training was delivered 3 times per week for 12 weeks (36 sessions total), approximately 45 minutes per session, including warm-up, device donning, structured standing and gait training (sit-to-stand, in-place stepping, overground walking, turning), and cool-down. Body-weight support, walking speed, and session duration were progressively adjusted based on participant tolerance and performance.
Participants received individualized rehabilitation and exercise (IRR) as per institutional protocol at the Department of Physical Medicine and Rehabilitation, BMU. This standard-of-care rehabilitation program was tailored to each participant's functional status and needs, and was matched in overall therapeutic content and intensity across both study groups. It was delivered without any robotic-assisted device and represents the conventional-therapy component of care for individuals undergoing gait and mobility rehabilitation.
Incidence of Device-Related Adverse Events and Serious Adverse Events
Number and proportion of participants experiencing device-related adverse events (AEs) and serious adverse events (SAEs), including falls, skin breakdown/pressure sores, joint pain/injury, cardiovascular events, and fracture, during the intervention and follow-up period.
Time frame: Baseline (T=0) through 12-week intervention period and follow-up, assessed every 2 weeks
Change in Six-Minute Walk Distance (6MWD)
Distance (in meters) walked in six minutes, a standardized measure of walking capacity, endurance, and functional mobility.
Time frame: Baseline (T=0), every 2 weeks through 12 weeks
Change in Medical Research Council (MRC) Muscle Strength Scale
Manual muscle strength grading of lower-limb muscle groups using the Medical Research Council (MRC) Muscle Strength Scale, scored from 0 (no muscle contraction) to 5 (normal muscle strength), with higher scores indicating better muscle strength.
Time frame: Baseline (T=0), every 2 weeks through 12 weeks
Change in Functional Ambulation Category (FAC) Score
Level of physical assistance required for ambulation assessed using the Functional Ambulation Category, a 6-point 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.
Time frame: Baseline (T=0), every 2 weeks through 12 weeks
Change in Berg Balance Scale Score
Assessment of static and dynamic balance during functional tasks using the Berg Balance Scale, a clinician-administered scale ranging from 0 to 56, with higher scores indicating better balance.
Time frame: Baseline (T=0), every 2 weeks through 12 weeks
Change in Timed Up and Go (TUG) Test
Time (in seconds) taken to rise from a chair, walk 3 meters, turn, walk back, and sit down; a measure of functional mobility and fall risk.
Time frame: Baseline (T=0), every 2 weeks through 12 weeks
Change in Modified Ashworth Scale (MAS) for Lower-Limb Muscles
Clinical assessment of spasticity/muscle tone in the lower limbs using the Modified Ashworth Scale (MAS), scored from 0 (no increase in muscle tone) to 4 (limb rigid in flexion or extension), with higher scores indicating greater spasticity (worse outcome).
Time frame: Baseline (T=0), every 2 weeks through 12 weeks
Change in Quality of Life (EuroQol Questionnaire, Bengali Version)
Validated Bengali-language EuroQol (EQ-5D) questionnaire assessing health-related quality of life, a self-rated measure with a descriptive system score and index value where higher scores/values indicate better health-related quality of life.
Time frame: Baseline (T=0), every 2 weeks through 12 weeks
Plan to share: Yes
No publications or documents are linked to this record.
Ran from May 2026 to primary completion in Sep 2026, 4 months.
Of 3,117 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 4 months is below that.
Counting every sponsor, half of 3,261 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 16, 2026: start Jul 2026 → May 2026 and completion Nov 2026 → Oct 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Bangladesh Medical University