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ZEPU-AI Series Limb Feedback Robot Training Study (ZEPUAISRCT)

Sponsor: Bangladesh Medical University • ClinicalTrials.gov ID: NCT07749625

Registry updated: 2026-09-11

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Description

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

Interventions

ZEPU-AI2 (Device)
Upper 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 (Device)
Multi-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 (Device)
Multi-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 (Device)
Motor-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 (Behavioral)
Conventional 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.

Eligibility criteria

Inclusion Criteria: * 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 * Medically stable and cleared by a physician for robotic rehabilitation, with no active infection, uncontrolled cardiac or respiratory disease, severe osteoporosis, uncontrolled epilepsy, or untreated deep vein thrombosis Exclusion Criteria: * 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 * Uncontrolled cardiac arrhythmia, presence of a pacemaker, or other implanted electronic medical devices incompatible with robotic sensors * Pregnancy

Conditions

Stroke Spinal Cord Injuries Brain Injuries, Traumatic Movement Disorder, Upper Extremity Movement Disorder, Lower Extremity

Locations

Bangladesh Medical University — Dhaka, Bangladesh

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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