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

Summary

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

Conditions

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

Interventions

DEVICE

ZEPU-AI2

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.

DEVICE

ZEPU-AI4

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.

DEVICE

ZEPU-AI6 Plus

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.

DEVICE

ZEPU-AI7A

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.

BEHAVIORAL

Standard-of-Care Physiotherapy

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.

Sponsors & Collaborators

• Bangladesh Medical University

  lead OTHER

Principal Investigators

• Md. Abdus Shakoor, Ph.D. · Bangladesh Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-31

Primary Completion

2026-09-30

Completion

2026-11-30

Countries

• Bangladesh

Study Locations