An interventional study of ZEPU-AI2 and ZEPU-AI4 in Stroke, Spinal Cord Injuries and Brain Injuries, Traumatic, sponsored by Bangladesh Medical University. Recruiting at 1 site in Bangladesh. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Bangladesh Medical University · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn whether robotic rehabilitation devices (ZEPU-AI2, AI4, AI6 Plus, and AI7A) are feasible, safe, and effective for adults with upper or lower limb motor problems. These problems can result from stroke, incomplete spinal cord injury, traumatic brain injury, or orthopedic surgery. The main questions it aims to answer are:
Is robotic rehabilitation training safe and practical to deliver alongside conventional therapy? Does adding robotic-assisted therapy improve motor function, balance, gait, and independence in daily activities compared to conventional rehabilitation alone? What side effects or device-related problems, if any, occur during robotic training?
The Investigators will compare a robotic-augmented rehabilitation group to a control group receiving conventional rehabilitation alone, to see if adding robotic therapy leads to better recovery.
Participants will:
Receive robotic-assisted therapy sessions three times a week for 12 weeks, each lasting about 45 minutes (robotic group), or continue with conventional rehabilitation alone (control group) Undergo assessments of movement, balance, walking ability, and daily function before and after the study period Be monitored for any side effects or complications related to the device or training
Upper- and lower-limb motor dysfunction due to stroke, incomplete spinal cord injury, traumatic brain injury, and orthopedic conditions represents a major cause of long-term disability, with limited access to intensive, high-repetition rehabilitation in resource-constrained settings such as Bangladesh. Conventional physiotherapy, while effective, is often constrained by therapist workload, time limitations, and difficulty consistently delivering the volume of task-specific repetition believed necessary to drive neuroplastic recovery. Robotic rehabilitation systems offer programmable, high-repetition, objectively monitored movement training that can supplement conventional therapy, but evidence supporting their feasibility, safety, and effectiveness remains largely derived from high-income settings, with limited data from low- and middle-income countries.
This prospective, parallel-group, two-arm pilot randomized controlled trial will be conducted at the Robotic Rehabilitation Centre, Department of Physical Medicine and Rehabilitation, Bangladesh Medical University (BMU). It will evaluate four robotic rehabilitation platforms manufactured by Shandong ZEPU Medical Technology Co., Ltd: the ZEPU-AI2 (upper-extremity feedback training and evaluation system), ZEPU-AI4 (multi-joint isokinetic training and evaluation system for upper and lower limb joints), ZEPU-AI6 Plus (three-dimensional robotic upper-limb active/passive training system), and ZEPU-AI7A (upper and lower limb active/passive rehabilitation system using motor-driven circular motion). Each device supports active, passive, and active-assisted training modes with adjustable resistance, range of motion, and assistance level, along with integrated safety features such as emergency stop mechanisms, motion limits, and, in some systems, spasm-detection and protection functions.
A total of 36 participants will be randomly allocated in a 1:1 ratio to a robotic-augmented rehabilitation arm (standard-of-care rehabilitation plus supervised robotic-assisted therapy) or a usual-care control arm (standard-of-care rehabilitation alone). The intervention phase will run for 12 weeks, with robotic sessions delivered three times weekly (approximately 45 minutes per session, including donning/doffing and warm-up/cool-down), followed by a period of follow-up. Sessions will be supervised throughout by trained physiatrists and physiotherapists, with structured pre-session screening (vital signs, skin integrity, pain), safety harnessing during initial sessions as needed, and post-session skin and fatigue checks. Training parameters will be progressively adjusted on an individualized basis according to participant tolerance and performance.
Assessments will be performed at baseline and at two-week intervals throughout the intervention and follow-up periods, using a battery of validated motor, strength, balance, gait, spasticity, pain, and functional-independence measures, together with device-recorded performance metrics (e.g., repetitions, torque, range of motion, training duration). Safety will be monitored through structured adverse event and serious adverse event reporting, with oversight from a Data Safety Monitoring Committee and a manufacturer-linked reporting pathway; predefined pause rules apply if more than two device-attributable serious adverse events occur. Feasibility and usability will be assessed through recruitment and screening metrics, session adherence and dropout rates, staff training/setup time, and a participant usability questionnaire administered at study completion.
Statistical analysis will use an intention-to-treat approach as primary, with a per-protocol analysis as secondary. Continuous efficacy variables will be summarized as mean ± SD (or median/IQR where non-normally distributed) at each time point, with paired and unpaired comparisons as appropriate; a two-tailed p-value \< 0.05 will be considered statistically significant.
This pilot study is intended to generate local, context-specific evidence on the feasibility, safety, and preliminary therapeutic potential of multi-platform robotic rehabilitation in Bangladesh, to inform the design of a future, adequately powered, large-scale randomized controlled trial and to support clinical and policy decision-making around robotic rehabilitation services.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 36 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.
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=18 per device cohort) receive standard-of-care physiotherapy plus robotic-assisted rehabilitation using the ZEPU-AI2, AI4, AI6 Plus, or AI7A system, 3 sessions/week (\~45 min each) for 12 weeks (36 sessions total), including warm-up, device donning, structured training (upper/lower limb, gait, or isokinetic depending on device), and cool-down, delivered under supervision of trained physiotherapists.
Device: ZEPU-AI2 · Device: ZEPU-AI4 · Device: ZEPU-AI6 Plus · Device: ZEPU-AI7A · Behavioral: Standard-of-Care Physiotherapy
Participants (n=18 per device cohort) receive standard-of-care rehabilitation alone (balance training, lower-limb strengthening, stretching, and gait retraining as per institutional protocol) without the addition of robotic-assisted therapy.
Behavioral: Standard-of-Care Physiotherapy
Upper Extremity Feedback Training and Evaluation System Intervention Description: Robotic upper-extremity feedback training and evaluation device enabling active, passive, and active-assisted movement training with real-time feedback for patients with upper-limb motor dysfunction, used 3 sessions/week for 12 weeks in addition to standard physiotherapy.
Multi-Joint Isokinetic Training and Evaluation System Intervention Description: Robotic multi-joint isokinetic training and evaluation device supporting controlled, resistance-based rehabilitation and objective strength assessment of upper- and lower-limb joints, used 3 sessions/week for 12 weeks in addition to standard physiotherapy.
Multi-axis robotic arm device that simulates physiological upper-limb movement patterns for three-dimensional active and passive training, used 3 sessions/week for 12 weeks in addition to standard physiotherapy.
Motor-driven robotic device providing active and passive rehabilitation of the upper and lower limbs, separately or simultaneously, via circular motion training, used 3 sessions/week for 12 weeks in addition to standard physiotherapy.
Conventional physiotherapy comprising balance training, lower-limb strengthening, stretching, and gait retraining delivered per institutional protocol; provided alone in the control arm and alongside robotic training in the intervention arm.
Incidence of Device-Related Adverse Events and Serious Adverse Events
Number of participants experiencing device-related adverse events (AEs) and serious adverse events (SAEs), including falls, skin breakdown/pressure sores, joint pain/injury, cardiovascular events, fracture, and device malfunction.
Time frame: Baseline (T0) to 12 weeks, assessed at 2-week intervals
Device Tolerability
Number of training sessions completed relative to sessions planned, and number of participant drop-outs with reasons for discontinuation.
Time frame: Baseline (T0) to 12 weeks, assessed at 2-week intervals
Change in Walking Distance on 6-Minute Walk Test
Distance walked (in meters) in 6 minutes, used to assess functional exercise capacity and gait endurance.
Time frame: Baseline (T0) to 12 weeks, assessed at 2-week intervals
Change in Muscle Strength on MRC Scale
Muscle strength of affected upper and/or lower limb muscle groups graded using the Medical Research Council (MRC) Muscle Strength Scale (0-5).
Time frame: Baseline (T0) to 12 weeks, assessed at 2-week intervals
Change in Functional Ambulation Category (FAC) Score
Level of walking independence assessed using the Functional Ambulation Category, scored 0 (non-ambulatory) to 5 (independent on all surfaces).
Time frame: Baseline (T0) to 12 weeks, assessed at 2-week intervals
Change in Balance on Berg Balance Scale-Short Form (BBS-SF)
Balance performance assessed using the Berg Balance Scale-Short Form (BBS-SF), a validated 7-item reduced version of the original 14-item Berg Balance Scale. Scores range from 0 to 28, with higher scores indicating better balance performance.
Time frame: Baseline (T0) to 12 weeks, assessed at 2-week intervals
Change in Spasticity on Modified Ashworth Scale (MAS)
Muscle spasticity of the affected limb(s) graded using the Modified Ashworth Scale (0 to 4).
Time frame: Baseline (T0) to 12 weeks, assessed at 2-week intervals
Change in Pain on Visual Analogue Scale (VAS)
Self-reported pain intensity rated on a 0-10 cm Visual Analogue Scale.
Time frame: Baseline (T0) to 12 weeks, assessed at 2-week intervals
Change in Functional Independence Measure (FIM) Score
Level of independence in activities of daily living assessed using the Functional Independence Measure (FIM), an 18-item scale covering motor and cognitive domains. Total scores range from 18 to 126, with higher scores indicating greater functional independence.
Time frame: Baseline (T0) to 12 weeks, assessed at 2-week intervals
Change in Grip Strength
Hand grip strength of the affected upper limb measured in kilograms using a hand dynamometer.
Time frame: Baseline (T0) to 12 weeks, assessed at 2-week intervals
Change in Upper Limb Function on Action Research Arm Test (ARAT)
Upper limb motor function assessed using the Action Research Arm Test, covering grasp, grip, pinch, and gross movement subscales.
Time frame: Baseline (T0) to 12 weeks, assessed at 2-week intervals
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Started Aug 2026 (actual). Primary completion is estimated for Sep 2026, 1 month 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 1 month 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.
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Bangladesh Medical University