An interventional study of ZEPU-SG1PLUS Hand Functional Comprehensive Training System and Standard-of-Care Rehabilitation in Upper Limb Motor Dysfunction, Stroke and Incomplete Spinal Cord Injury, 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
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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 8th largest by planned enrollment, is one of 8 that started in 2026, is one of 12 with no phase, and was the 11th 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
Hiroshima University · Sites in Bangladesh
Ages 18+
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: 18 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 planned enrollment of 36 is below 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.
The goal of this pilot randomized controlled trial is to learn whether the ZEPU-SG1PLUS Hand Functional Comprehensive Training System - a robotic device used alongside standard rehabilitation - is safe, feasible, and helpful for people with upper limb (arm/hand) motor problems caused by stroke, incomplete spinal cord injury, traumatic brain injury, or orthopedic conditions.
The main questions it aims to answer are:
Is robotic-assisted hand training well tolerated by patients, and can it be safely added to standard rehabilitation, with acceptable rates of device-related side effects? Does adding robotic hand training to standard rehabilitation improve arm and hand strength, range of motion, and functional ability compared with standard rehabilitation alone? Is it practical to fit this type of robotic training into everyday rehabilitation services at Bangladesh Medical University?
Researchers will compare a robotic-augmented rehabilitation group to a standard-care (control) group to see whether adding robotic hand training works better than usual rehabilitation alone.
Participants will:
Be randomly assigned to one of two groups: one receiving standard rehabilitation plus robotic hand training with the ZEPU-SG1PLUS device, and one receiving standard rehabilitation alone If assigned to the robotic training group, attend three training sessions per week for 12 weeks, each lasting about 30-45 minutes, at the Robotic Rehabilitation Centre, BMU Undergo assessments at the start of the study and at two-week intervals during the 12-week program and follow-up period, including tests of muscle strength, joint movement, hand function, and daily activity ability Be monitored throughout for any side effects or safety concerns related to the training
Upper limb motor dysfunction following stroke, incomplete spinal cord injury, traumatic brain injury, and orthopedic conditions is a major contributor to long-term disability. Conventional rehabilitation, while foundational, is often limited in the intensity, repetition, and task specificity needed to optimally drive neuroplasticity-dependent motor recovery. Electromechanical and robotic rehabilitation systems have emerged as adjuncts capable of delivering standardized, repetitive, programmable movement training with real-time feedback and objective performance monitoring, and evidence from high-income settings suggests such systems can improve motor function and functional outcomes when combined with conventional therapy. However, data on the feasibility, safety, and effectiveness of these technologies in low- and middle-income country (LMIC) settings, including Bangladesh, remain limited.
Bangladesh Medical University (BMU) has recently introduced the ZEPU-SG1PLUS Hand Functional Comprehensive Training System at its Robotic Rehabilitation Centre. Before this technology is integrated more broadly into clinical practice, this pilot study will generate foundational local evidence on its feasibility, safety, and preliminary efficacy, and will inform the design and sample-size estimation of a future adequately powered randomized controlled trial.
Device: The ZEPU-SG1PLUS is a non-powered, mechanically assisted training system built around a stable steel-frame table integrated with twelve dedicated training modules targeting distinct hand and upper-limb movement patterns, including thumb-to-palm motion, wrist flexion-extension, forearm rotation, finger flexion/extension, pinching, side pinching, spherical grip rotation, ulnar/radial deviation, horizontal stretching, and hand lifting. Resistance is provided by an adjustable counterweight system (four independent columns, 250 g increments, 500 g-3000 g range), allowing progressive, individualized resistance training. A tablet-based interactive software interface supports user identification, session setup, timing control, and recording of training activity, with session duration configurable from 1-99 minutes.
Design: This is a pilot randomized controlled trial conducted at the Robotic Rehabilitation Centre, Department of Physical Medicine and Rehabilitation, BMU. Eligible participants (adults with upper-limb motor dysfunction due to stroke, incomplete spinal cord injury, traumatic brain injury, or orthopaedic/post-surgical conditions) will be randomly allocated 1:1 to an Intervention Arm (standard-of-care rehabilitation plus ZEPU-SG1PLUS training) or a Control Arm (standard-of-care rehabilitation alone). Robotic sessions will be delivered 3 times weekly for 12 weeks (30-45 minutes per session), under supervision of physiatrists and physiotherapists, with training parameters progressively adjusted based on individual performance and tolerance. Assessments occur at baseline and at two-week intervals through the intervention and follow-up periods.
Assessment methods: Muscle strength is assessed by Manual Muscle Testing, grip strength by dynamometer, spasticity by the Modified Ashworth Scale, and general health status by the EQ-VAS. Device-recorded training parameters (e.g., repetitions, resistance level, session duration) are captured as objective indicators of rehabilitation progress. Feasibility and usability are evaluated through screening/enrollment flow, session adherence and dropout tracking, therapist training and device set-up time, level of assistance required for donning/doffing, and a Post-Study System Usability Questionnaire administered at study completion.
Safety monitoring: Pre-session screening of vital signs and skin integrity, use of a safety harness/tracking system during initial sessions, continuous therapist supervision, post-session skin and fatigue checks, and an emergency-stop mechanism on the device are built into the protocol. All adverse events and serious adverse events are recorded and reported to the safety monitor and the BMU Institutional Review Board.
Statistical analysis: Descriptive statistics will summarize safety outcomes (AEs/SAEs, adherence, dropouts). Continuous efficacy variables will be summarized as mean ± SD (or median/IQR for non-normal data) at each time point, with paired/unpaired t-tests or Wilcoxon signed-rank tests used to compare baseline versus follow-up findings as appropriate. The primary analysis will follow an intention-to-treat approach including all randomized participants, with a secondary per-protocol analysis restricted to those completing the intervention per protocol; missing follow-up data will be handled using group-wise mean substitution. A two-tailed p-value \< 0.05 will be considered statistically significant. Analyses will be performed using SPSS.
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 receive standard-of-care rehabilitation combined with robotic-assisted hand training using the ZEPU-SG1PLUS Hand Functional Comprehensive Training System, 3 sessions per week for 12 weeks (approximately 30-45 minutes per session).
Device: ZEPU-SG1PLUS Hand Functional Comprehensive Training System · Other: Standard-of-Care Rehabilitation
Participants receive standard-of-care rehabilitation alone, including conventional exercise and wax bath therapy, without the addition of robotic-assisted hand training.
Other: Standard-of-Care Rehabilitation
A non-powered, mechanically assisted robotic training device for the hand and upper limb, incorporating twelve dedicated training modules (e.g., thumb-to-palm motion, wrist flexion-extension, forearm rotation, finger flexion/extension, pinching, grip rotation) with an adjustable counterweight resistance system (500g-3000g). Administered 3 sessions/week for 12 weeks (30-45 minutes/session) in addition to standard-of-care rehabilitation.
Standard rehabilitation program including conventional therapeutic exercise and wax bath therapy, delivered per institutional protocol at the Department of Physical Medicine and Rehabilitation, BMU, without the addition of robotic-assisted training.
Incidence of Device-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number and proportion of participants experiencing device-related AEs or SAEs, including falls, skin breakdown/pressure sores, joint pain or injury, cardiovascular events, fracture, or device malfunction.
Time frame: Baseline (Week 0) through end of 12-week intervention and follow-up
Device Tolerability (Session Completion Rate)
Number of robotic training sessions completed relative to sessions planned; number of participant drop-outs and reasons for drop-out.
Time frame: 12 weeks
Muscle Strength
Assessed using Manual Muscle Testing (MMT).
Time frame: Baseline and every 2 weeks through 12 weeks
Grip Strength
Assessed using a hand-held dynamometer.
Time frame: Baseline and every 2 weeks through 12 weeks
Upper-Limb Spasticity
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).
Time frame: Baseline and every 2 weeks through 12 weeks
Health-Related Quality of Life
Health-related quality of life assessed using the EQ Visual Analogue Scale (EQ-VAS), a self-rated measure of current health status on a vertical scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating better health-related quality of life.
Time frame: Baseline and every 2 weeks up to 12 weeks
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 3,117 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 planned 2 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.
How these figures are worked out, and which studies are left out of them.
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Bangladesh Medical University