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
Age ≥ 18 and ≤ 60 years.
Lower-limb motor dysfunction from one of the following: (a) stroke (onset 2-24 months), (b) incomplete spinal-cord injury (neurological level T12 and below, ASIA C or D), (c) orthopedic surgery (e.g., knee/hip replacement) with persistent gait impairment > 3months post-surgery.
Able to provide informed consent and understand instructions.
Weight ≤ 100 kg (as per device spec) and height within device adjustable range (manufacturer spec).
Complete spinal cord injury with inability to bear any weight.
Severe cognitive impairment (e.g., MMSE < 24) preventing safe participation.
Severe spasticity (Modified Ashworth Scale > 3) in lower limbs.
Unstable fractures, severe hip/knee contractures (> 30° fixed flexion), severe osteoarthritis requiring imminent surgery.
Parallel
ZEPU-AI9 Lower Limb Exoskeleton Gait Training
DeviceA 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.
Standard-of-Care Rehabilitation
BehavioralInstitutional 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.
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.
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.
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.
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).
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.
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