An interventional study of ZEPU-2000A and ZEPU-2000D in Stroke, Incomplete Spinal Cord Injury (SCI) and Traumatic Brain 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 18–70
Bangladesh Medical University · Sites in Bangladesh
Ages 18–60
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 clinical trial is to learn whether the ZEPU-2000A, ZEPU-2000D and ZEPU-2000E robotic rehabilitation trainers help people with weakness or movement problems in their arms and legs. These devices are used to guide repeated arm and leg movements as part of rehabilitation therapy. The study will also look at whether the devices are safe to use.
The main questions it aims to answer are:
Is training with the ZEPU-2000 devices safe, and how well do patients tolerate and stick with the training sessions? Does adding robotic training to usual rehabilitation improve muscle strength, joint movement, balance, walking, and daily function more than usual rehabilitation alone?
Researchers will compare a group receiving robotic-assisted rehabilitation plus usual care to a group receiving usual rehabilitation care alone, to see whether the robotic devices provide added benefit.
Participants will:
Be adults aged 18-60 with arm and/or leg movement problems caused by stroke, incomplete spinal cord injury, traumatic brain injury, or an orthopedic condition Attend training sessions 3 times a week for 12 weeks (about 36 sessions total), each lasting approximately 45 minutes Undergo assessments of strength, movement, balance, and daily function at the start of the study and every 2 weeks throughout the 12-week period Be monitored for any side effects or safety concerns, such as skin irritation, falls, or discomfort, at every session
This is a pilot randomized controlled trial evaluating the feasibility, safety, and preliminary efficacy of three robotic upper and lower limb rehabilitation trainer systems - ZEPU-2000A (upper limb trainer), ZEPU-2000D (lower limb gait and mobility trainer), and ZEPU-2000E (multifunctional upper and lower limb trainer) - when added to conventional rehabilitation, compared with conventional rehabilitation alone, in adults with upper and/or lower limb motor dysfunction.
Rationale: Upper- and lower-limb motor dysfunction following stroke, incomplete spinal cord injury, traumatic brain injury, and orthopedic conditions is a major cause of long-term disability. Motor recovery is closely linked to repetitive, task-specific, goal-oriented movement practice, but conventional therapist-led rehabilitation is often limited by therapist availability, fatigue, and variability in delivery. Electromechanical and robotic trainer systems can deliver standardized, repetitive, programmable movement training with objective performance monitoring across passive, active-assisted, and active-resisted modes. While robotic rehabilitation has shown benefit in high-income settings, evidence on feasibility, safety, and effectiveness in low- and middle-income countries remains limited. This study will generate local evidence to support the integration of the ZEPU-2000 series into rehabilitation services at Bangladesh Medical University (BMU) and to inform the design of a future adequately powered trial.
Setting: Robotic Rehabilitation Centre, Department of Physical Medicine and Rehabilitation, Bangladesh Medical University, Dhaka, Bangladesh. Devices are provided and supported by the manufacturer (Shandong ZEPU Medical Technology Co. Ltd) through an approved distributor. Sessions are conducted under the supervision of physiatrists and physiotherapists.
Design: Thirty-six participants will be enrolled for each robotic system and randomized 1:1 into two arms:
Intervention arm (Robotic-Augmented Rehabilitation Group): standard-of-care rehabilitation plus robotic-assisted therapy using the ZEPU-2000A, ZEPU-2000D, or ZEPU-2000E systems.
Control arm (Usual Care Group): standard-of-care rehabilitation alone (individualized rehabilitation and exercise), without robotic training.
All participants undergo baseline assessment at week 0, with outcome assessments repeated at two-week intervals across the 12-week intervention period and during follow-up.
Population: Adults aged 18-60 years with upper-limb motor dysfunction (with or without lower-limb involvement) due to stroke (2-24 months post-onset), incomplete spinal cord injury (ASIA Impairment Scale C or D, neurological level C5 or below), traumatic brain injury with persistent upper-limb limitation, or orthopedic/post-surgical conditions of the shoulder, elbow, wrist, or hand with functional impairment lasting more than 3 months. Participants must be medically stable, able to provide informed consent, and have body size/anthropometry compatible with the devices. Exclusions include complete spinal cord injury, severe cognitive impairment (MMSE \< 24), severe upper-limb spasticity (Modified Ashworth Scale > 3), unstable fractures or severe fixed joint contractures, uncontrolled cardiac arrhythmia or incompatible implanted electronic devices, and pregnancy.
Intervention: Robotic training sessions occur 3 times weekly for 12 weeks (approximately 36 sessions total), each lasting about 45 minutes inclusive of donning/doffing and warm-up/cool-down. A typical session includes a 5-minute warm-up, 10 minutes of device set-up, 25 minutes of structured training (e.g., sit-to-stand, standing, in-place and over-ground walking, turning, or upper-limb task-oriented movement depending on device), and a 5-minute cool-down. Training parameters (e.g., support level, range, speed) are progressively adjusted weekly by the supervising physiotherapist based on participant performance and safety. Standard physical therapy continues per institutional protocol in both arms. Pre-session checks include vital signs, skin integrity, and pain/discomfort screening; safety harnesses are used during early sessions until safe performance is demonstrated; a therapist is present throughout; and post-session checks include skin inspection, fatigue/pain rating (VAS), and review of device-logged training data.
Outcome Measures:
Primary (safety/feasibility): incidence of device-related adverse events (AEs) and serious adverse events (SAEs) - including falls, skin breakdown, joint pain/injury, cardiovascular events, fracture, or device malfunction - over the 12-week intervention and follow-up; device tolerability (sessions completed vs. planned, dropouts and reasons).
Secondary (efficacy): Medical Research Council (MRC) muscle strength grading, Modified Ashworth Scale (MAS) for spasticity, Functional Ambulation Category (FAC), Functional Independence Measure (FIM), Timed Up and Go (TUG), Action Research Arm Test (ARAT), and Barthel Index.
Feasibility/usability: screening and recruitment metrics, session adherence, time required for therapist competency training, device set-up time, assistance required for donning/doffing, and the Post-Study System Usability Questionnaire (PSSUQ) administered at week 16 to assess device comfort, perceived benefit, and willingness to continue.
Data Collection: Clinical and sociodemographic data are collected at enrolment via a semi-structured, pre-tested questionnaire. Height and weight are measured to calculate BMI. Assessments are repeated at baseline and two-week intervals for 12 weeks. Telephone and video calls supplement in-person visits to monitor compliance; robotic sessions are tracked via attendance sheets.
Statistical Analysis: Descriptive statistics will summarize safety outcomes (AE/SAE counts, adherence, dropouts). Continuous efficacy variables will be summarized as mean ± SD (or median/IQR if non-normally distributed) at each time point, with paired and unpaired t-tests or Wilcoxon signed-rank tests used to compare baseline versus follow-up findings, as appropriate. Both intention-to-treat (all 36 randomized participants, 18 per group) and per-protocol analyses (participants completing the intervention as specified) will be conducted. Missing follow-up data will be handled using group-wise mean substitution. Statistical significance will be set at p \< 0.05 (two-tailed), using SPSS.
Safety Monitoring: Identified risks include falls, joint stress or injury, skin breakdown from device straps, cardiovascular events, equipment malfunction, fatigue, muscle soreness, and spasticity exacerbation. Mitigation measures include safety harnesses, continuous physiotherapist/physician presence, pre-session vital sign screening, gradual progression of training intensity, skin inspections, an emergency stop mechanism, staff training on emergency procedures, and immediate AE reporting. SAEs will be reported to the BMU Institutional Review Board within 24 hours and to the manufacturer per their protocol. A Data Safety Monitoring Committee (including representatives from Neuromedicine, Physical Medicine and Rehabilitation, and Internal Medicine) will conduct monthly safety reviews, with a pre-specified pause rule if more than 2 device-attributable SAEs occur. Any study-related physical injury will be managed free of cost to the participant.
Ethics: The protocol and informed consent form have been reviewed and approved by the BMU Institutional Review Board (Memo No. BMU/2026/5035, dated 13-05-2026) prior to enrolment. Written informed consent will be obtained in Bengali (with an English version available), covering device use, potential risks and benefits, voluntary participation, and the right to withdraw at any time without affecting standard care. Participant confidentiality will be maintained, and the study will be registered on a public trial registry before first participant enrolment.
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 therapy using the ZEPU-2000A, ZEPU-2000D, or ZEPU-2000E upper and lower limb trainer systems. Robotic training is provided 3 times weekly for 12 weeks (approximately 36 sessions), each session lasting approximately 45 minutes and including warm-up, device set-up, structured passive/active-assisted/active training, and cool-down.
Device: ZEPU-2000A · Device: ZEPU-2000D · Device: ZEPU-2000E · Behavioral: Standard Rehabilitation Care
Participants receive standard-of-care rehabilitation alone, including individualized rehabilitation and exercise (e.g., strengthening, balance training, stretching, gait retraining), without robotic-assisted therapy.
Behavioral: Standard Rehabilitation Care
An electromechanical upper limb rehabilitation system providing passive, active-assisted, and active-resisted movement training across the shoulder, elbow, and wrist. Integrated sensors record range of motion, movement speed, and torque, with software-guided protocols and real-time feedback. Administered 3 times weekly for 12 weeks in addition to standard rehabilitation.
A lower limb robotic trainer with actuated joints at the hip, knee, and ankle supporting repetitive stepping and weight-bearing training that simulates gait kinematics. Provides passive to active-assisted progression with force sensors and visual biofeedback on step length, cadence, and symmetry. Administered 3 times weekly for 12 weeks in addition to standard rehabilitation.
A multifunctional robotic system combining upper and lower limb training on a single platform, supporting task-oriented movements such as reaching-to-grasp, stepping, and sit-to-stand. Intelligent control adjusts support level in real time based on performance. Administered 3 times weekly for 12 weeks in addition to standard rehabilitation.
Individualized conventional rehabilitation without robotic assistance, including therapist-led strengthening exercises, balance training, stretching, and gait retraining, delivered per institutional protocol throughout the 12-week study period.
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 or injury, cardiovascular events, fracture, and device malfunction.
Time frame: Baseline (T=0) up to 12 weeks, assessed every 2 weeks
Device Tolerability
Number of training sessions completed relative to sessions planned, and number of participant drop-outs with reasons for discontinuation.
Time frame: Baseline (T=0) up to 12 weeks, assessed every 2 weeks
Change in Muscle Strength
Muscle strength assessed using the unabbreviated Medical Research Council (MRC) Muscle Scale, ranging from 0 (no visible or palpable contraction) to 5 (normal strength), with higher scores indicating better muscle strength.
Time frame: Baseline (T=0) to 12 weeks, assessed every 2 weeks
Change in Muscle Spasticity
Muscle spasticity assessed using the unabbreviated Modified Ashworth Scale (MAS), ranging from 0 (no increase in muscle tone) to 4 (limb rigid in flexion or extension), with higher scores indicating worse (greater) spasticity.
Time frame: Baseline (T=0) to 12 weeks, assessed every 2 weeks
Change in Functional Ambulation
Walking ability assessed using the unabbreviated Functional Ambulation Category (FAC) scale, ranging from 0 (unable to walk or requires help from two or more persons) to 5 (able to walk independently on level and uneven ground, stairs, and slopes), with higher scores indicating better functional ambulation.
Time frame: Baseline (T=0) to 12 weeks, assessed every 2 weeks
Change in Functional Independence
Functional independence assessed using the Functional Independence Measure (FIM).
Time frame: Baseline (T=0) to 12 weeks, assessed every 2 weeks
Change in Functional Mobility
Functional mobility and fall risk assessed using the Timed Up and Go Test (TUG).
Time frame: Baseline (T=0) to 12 weeks, assessed every 2 weeks
Change in Upper Limb Motor Function
Upper limb motor function assessed using the Action Research Arm Test (ARAT).
Time frame: Baseline (T=0) to 12 weeks, assessed every 2 weeks
Change in Activities of Daily Living
Independence in activities of daily living assessed using the Barthel Index.
Time frame: Baseline (T=0) to 12 weeks, assessed every 2 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Oct 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