An interventional study of ZEPU-AI9 Lower Limb Exoskeleton Gait Training and Standard-of-Care Rehabilitation in Stroke, Gait Disorders, Neurologic and Spinal Cord Injuries, Incomplete, 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 the ZEPU AI9 lower limb exoskeleton robot is feasible, safe, and effective for people with walking difficulty caused by stroke, incomplete spinal cord injury, or orthopedic surgery. The main questions it aims to answer are:
Is exoskeleton-assisted gait training well tolerated, and how often do device-related problems (such as falls, pain, or skin injury) occur? Does adding exoskeleton training to usual rehabilitation improve walking distance, walking speed, balance, muscle strength, and joint movement compared with usual rehabilitation alone? Is it practical to add this robotic training into the rehabilitation program at Bangladesh Medical University?
Researchers will compare a group receiving exoskeleton-assisted gait training plus standard rehabilitation to a group receiving standard rehabilitation alone, to see whether the exoskeleton adds benefit.
Participants will:
Be randomly assigned to either the exoskeleton group or the standard-care group If assigned to the exoskeleton group, attend 45-minute training sessions 3 times a week for 12 weeks, supervised by physical therapists with safety harness support Both groups will continue their usual rehabilitation therapy throughout the study Undergo walking, balance, strength, and quality-of-life assessments at the start of the study and every 2 weeks for 12 weeks Be monitored for any side effects or safety concerns during and after each session
Lower-limb motor dysfunction following stroke, incomplete spinal cord injury, and orthopedic surgery is a major contributor to disability in low- and middle-income countries, where access to intensive, repetitive gait training is often limited by shortages of rehabilitation professionals and structured multidisciplinary programs. Robotic-assisted gait training has emerged as a way to deliver consistent, task-specific, and intensity-controlled practice that is difficult to achieve with therapist-delivered conventional therapy alone, by enabling programmable gait cycles with controlled step length, cadence, symmetry, and body-weight support.
The ZEPU-AI9 is a dual-leg, passive-training lower-limb exoskeleton (Shandong Zepu Medical Technology Co., Ltd.) that generates repeated physiological gait cycles through motorized hip and knee joints while maintaining ankle alignment within a controlled range. It supports standing, sitting, stepping-in-place, and over-ground walking modes via a touchscreen interface and handheld steering joystick, with adjustable thigh/calf length, height, waist width, joint movement angles, step length, and training duration to accommodate individual anthropometrics. Built-in safety features include an emergency stop, automated spasm protection, mechanical joint limits, overload detection, low-battery alarms, and anti-tilt protection, supplemented by an overhead fall-arrest harness during supervised sessions. Powered lower-extremity exoskeletons are classified as Class II medical devices by the U.S. FDA (product code PHL), reflecting both their therapeutic potential and the need for supervised clinical use and standardized protocols. No clinical data on the ZEPU-AI9 currently exist from Bangladesh, and its performance within a Bangladeshi rehabilitation setting has not been evaluated.
This single-site pilot randomized controlled trial will be conducted at the Robotic Rehabilitation Centre, Department of Physical Medicine and Rehabilitation, Bangladesh Medical University. Following screening and informed consent, eligible participants will be randomized to receive either ZEPU-AI9-assisted gait training in addition to standard-of-care rehabilitation, or standard-of-care rehabilitation alone, over a 12-week intervention period. Exoskeleton sessions will be conducted three times weekly (45 minutes each, comprising warm-up, device donning, structured gait training, and cool-down), supervised by physiatrists and physiotherapists trained in robotic rehabilitation, with training parameters progressively adjusted based on participant performance and tolerance. Pre- and post-session safety checks (vital signs, skin integrity, pain/fatigue via VAS) will be performed at every session, with device-related adverse events recorded in real time.
Standardized assessments (6-Minute Walk Test, Manual/MRC Muscle Strength Testing, Functional Ambulation Category, Berg Balance Scale, Timed Up and Go test, Modified Ashworth Scale, and a validated Bengali quality-of-life measure) will be administered at baseline and at two-week intervals through week 12, allowing paired comparison of pre- and post-intervention values. Feasibility will additionally be evaluated through recruitment and screening metrics, session adherence and dropout rates, therapist training time, device set-up and donning/doffing time, and a Post-Study System Usability Questionnaire administered at study completion.
Data will be analyzed on an intention-to-treat basis (all randomized participants analyzed per original group assignment), with a secondary per-protocol analysis restricted to participants completing the intervention as specified. Continuous variables will be summarized as mean ± SD (or median/IQR where non-normally distributed) and compared using paired or unpaired t-tests, or Wilcoxon signed-rank tests as appropriate, with statistical significance set at p\<0.05. Findings from this pilot study are intended to generate feasibility indicators and preliminary effect-size estimates to inform the design of a future, adequately powered randomized controlled trial and to guide national implementation strategies for robotic rehabilitation in Bangladesh.
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.
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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 will receive ZEPU-AI9 exoskeleton-assisted gait training in addition to standard-of-care rehabilitation. Exoskeleton sessions will be conducted 3 times per week for 12 weeks (45 minutes/session, including donning, warm-up, structured gait training, and cool-down), supervised by trained physiatrists and physiotherapists with safety harness support. Training parameters will be progressively adjusted based on participant performance and tolerance. Standard rehabilitation (balance training, lower-limb strengthening, stretching, gait retraining) will continue in parallel per institutional protocol.
Device: ZEPU-AI9 Lower Limb Exoskeleton Gait Training · Behavioral: Standard-of-Care Rehabilitation
Participants will receive standard-of-care rehabilitation alone (balance training, lower-limb strengthening, stretching, gait retraining) per institutional protocol, without ZEPU-AI9 exoskeleton-assisted training, over the 12-week study period.
Behavioral: Standard-of-Care Rehabilitation
A powered, dual-leg lower-limb exoskeleton (Shandong Zepu Medical Technology Co., Ltd.) that generates repeated physiological gait cycles via motorized hip and knee joints, supporting standing, sitting, stepping-in-place, and over-ground walking. Adjustable thigh/calf length, height, waist width, joint angles, step length, and training duration accommodate individual anthropometrics. Participants will use the device 3 times per week for 12 weeks (45-minute sessions), supervised by trained physiatrists/physiotherapists, with an overhead safety harness. Training parameters are progressively adjusted based on performance. Safety features include emergency stop, automated spasm protection, mechanical joint limits, overload detection, and anti-tilt protection. Used in addition to standard-of-care rehabilitation.
Institutional standard rehabilitation therapy delivered by physiotherapists, comprising balance training, lower-limb strengthening exercises, stretching, and gait retraining, per Department of Physical Medicine and Rehabilitation protocol at Bangladesh Medical University. Received by all participants throughout the 12-week study period, either alone (Usual Care Group) or in combination with ZEPU-AI9 exoskeleton-assisted gait training (Robotic-Augmented Rehabilitation Group).
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 or injury, cardiovascular events, fracture, and device malfunction, during the 12-week intervention and follow-up period.
Time frame: Baseline (T0) to 12 weeks, assessed at 2-week intervals
Device Tolerability
Tolerability of ZEPU-AI9 exoskeleton training assessed as the number of sessions completed versus sessions planned, number of participant dropouts, and reasons for dropout, during the 12-week intervention period.
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 Lower-Limb Muscle Strength (MRC Scale)
Lower-limb muscle strength assessed using the Medical Research Council (MRC) Muscle Strength Scale, graded 0-5 for key muscle groups.
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 Berg Balance Scale (BBS) Score
Balance ability assessed using the Berg Balance Scale, a 14-item performance-based measure scored 0-56, with higher scores indicating better balance.
Time frame: Baseline (T0) to 12 weeks, assessed at 2-week intervals
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, used to assess functional mobility and fall risk.
Time frame: Baseline and every 2 weeks through 12 weeks
Change in Lower-Limb Spasticity (Modified Ashworth Scale)
Muscle tone and spasticity in the lower limbs assessed using the Modified Ashworth Scale (MAS), a 6-point ordinal scale (0 to 4, including 1+).
Time frame: Baseline and every 2 weeks through 12 weeks
Change in Quality of Life (EuroQol Questionnaire)
Health-related quality of life assessed using the EuroQol (EQ-5D) questionnaire, validated Bengali version, covering mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Time frame: Baseline and every 2 weeks through 12 weeks
Plan to share: No
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