About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- ZEPU-AI2
- ZEPU-AI4
- ZEPU-AI6 Plus
- ZEPU-AI7A
- Standard-of-Care Physiotherapy