ZEPU-2000 Limb Rehabilitation Trainer Study (ZEPU2000RCT)

Summary

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

Conditions

• Stroke
• Incomplete Spinal Cord Injury (SCI)
• Traumatic Brain Injury
• Upper Extremity Motor Dysfunction
• Lower Extremity Motor Dysfunction

Interventions

DEVICE

ZEPU-2000A

An 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.

DEVICE

ZEPU-2000D

A 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.

DEVICE

ZEPU-2000E

A 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.

BEHAVIORAL

Standard Rehabilitation Care

Individualized 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.

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

2026-10-31

Completion

2026-12-31

Countries

• Bangladesh

Study Locations