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
Presence of upper-limb motor dysfunction, with or without concurrent lower-limb impairment, due to one of the following: stroke with onset between 2 and 24 months prior to enrolment; incomplete spinal cord injury (neurological level C5 and below), classified as ASIA Impairment Scale C or D; traumatic brain injury with persistent upper-limb functional limitation; or orthopedic/post-surgical conditions involving the shoulder, elbow, wrist, or hand with persistent functional impairment for more than 3 months
Age between 18 and 60 years
Ability to understand study procedures and follow instructions, and to provide written informed consent (or assent with guardian consent where applicable)
Body weight and limb anthropometry compatible with ZEPU-2000A, ZEPU-2000D, and ZEPU-2000E systems, per manufacturer specifications
Complete spinal cord injury or profound motor paralysis preventing safe interaction with robotic devices
Severe cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score less than 24, that would compromise safe participation Severe spasticity of the upper limb, defined as a Modified Ashworth Scale score greater than 3
Unstable fractures, severe fixed joint contractures of the shoulder, elbow, wrist, or hand (e.g., greater than 30 degrees), or severe pain limiting safe robotic training
Uncontrolled cardiac arrhythmia, or presence of a pacemaker or other implanted electronic medical device incompatible with robotic sensors
Parallel
ZEPU-2000A
DeviceAn 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.
ZEPU-2000D
DeviceA 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.
ZEPU-2000E
DeviceA 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.
Standard Rehabilitation Care
BehavioralIndividualized 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.
Device Tolerability
Number of training sessions completed relative to sessions planned, and number of participant drop-outs with reasons for discontinuation.
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.
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.
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.
Change in Functional Independence
Functional independence assessed using the Functional Independence Measure (FIM).
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