The goal of this clinical trial is to learn whether robotic rehabilitation devices (ZEPU-AI2, AI4, AI6 Plus, and AI7A) are feasible, safe, and effective for adults with upper or lower limb motor problems. These problems can result from stroke, incomplete spinal cord injury, traumatic brain injury, or orthopedic surgery. The main questions it aims to answer are:
Is robotic rehabilitation training safe and practical to deliver alongside conventional therapy? Does adding robotic-assisted therapy improve motor function, balance, gait, and independence in daily activities compared to conventional rehabilitation alone? What side effects or device-related problems, if any, occur during robotic training?
The Investigators will compare a robotic-augmented rehabilitation group to a control group receiving conventional rehabilitation alone, to see if adding robotic therapy leads to better recovery.
Participants will:
Receive robotic-assisted therapy sessions three times a week for 12 weeks, each lasting about 45 minutes (robotic group), or continue with conventional rehabilitation alone (control group) Undergo assessments of movement, balance, walking ability, and daily function before and after the study period Be monitored for any side effects or complications related to the device or training
Presence of upper-limb motor dysfunction, with or without concurrent lower-limb impairment, due to one of the following conditions: (a) Stroke, with onset between 2 and 24 months prior to enrollment; (b) Incomplete spinal cord injury (ASIA Scale B, C, or D); (c) Traumatic brain injury; or (d) Orthopedic disorders affecting upper and/or lower limb motor function
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-AI2, AI4, AI6 Plus, and AI7A systems, as 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 < 24, that would compromise safe participation
Severe spasticity of the upper limb, defined as a Modified Ashworth Scale score > 3
Unstable fractures, severe fixed joint contractures of the shoulder, elbow, wrist, or hand (e.g., > 30°), or severe pain limiting safe robotic training
Parallel
ZEPU-AI2
DeviceUpper Extremity Feedback Training and Evaluation System Intervention Description: Robotic upper-extremity feedback training and evaluation device enabling active, passive, and active-assisted movement training with real-time feedback for patients with upper-limb motor dysfunction, used 3 sessions/week for 12 weeks in addition to standard physiotherapy.
ZEPU-AI4
DeviceMulti-Joint Isokinetic Training and Evaluation System Intervention Description: Robotic multi-joint isokinetic training and evaluation device supporting controlled, resistance-based rehabilitation and objective strength assessment of upper- and lower-limb joints, used 3 sessions/week for 12 weeks in addition to standard physiotherapy.
ZEPU-AI6 Plus
DeviceMulti-axis robotic arm device that simulates physiological upper-limb movement patterns for three-dimensional active and passive training, used 3 sessions/week for 12 weeks in addition to standard physiotherapy.
ZEPU-AI7A
DeviceMotor-driven robotic device providing active and passive rehabilitation of the upper and lower limbs, separately or simultaneously, via circular motion training, used 3 sessions/week for 12 weeks in addition to standard physiotherapy.
Standard-of-Care Physiotherapy
BehavioralConventional physiotherapy comprising balance training, lower-limb strengthening, stretching, and gait retraining delivered per institutional protocol; provided alone in the control arm and alongside robotic training in the intervention arm.
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/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 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 Muscle Strength on MRC Scale
Muscle strength of affected upper and/or lower limb muscle groups graded using the Medical Research Council (MRC) Muscle Strength Scale (0-5).
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 Balance on Berg Balance Scale-Short Form (BBS-SF)
Balance performance assessed using the Berg Balance Scale-Short Form (BBS-SF), a validated 7-item reduced version of the original 14-item Berg Balance Scale. Scores range from 0 to 28, with higher scores indicating better balance performance.
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