ZEPU AI9 Exoskeleton Rehabilitation Robot

Summary

The goal of this clinical trial is to learn whether the ZEPU AI9 lower limb exoskeleton robot is feasible, safe, and effective for people with walking difficulty caused by stroke, incomplete spinal cord injury, or orthopedic surgery. The main questions it aims to answer are:

Is exoskeleton-assisted gait training well tolerated, and how often do device-related problems (such as falls, pain, or skin injury) occur? Does adding exoskeleton training to usual rehabilitation improve walking distance, walking speed, balance, muscle strength, and joint movement compared with usual rehabilitation alone? Is it practical to add this robotic training into the rehabilitation program at Bangladesh Medical University?

Researchers will compare a group receiving exoskeleton-assisted gait training plus standard rehabilitation to a group receiving standard rehabilitation alone, to see whether the exoskeleton adds benefit.

Participants will:

Be randomly assigned to either the exoskeleton group or the standard-care group If assigned to the exoskeleton group, attend 45-minute training sessions 3 times a week for 12 weeks, supervised by physical therapists with safety harness support Both groups will continue their usual rehabilitation therapy throughout the study Undergo walking, balance, strength, and quality-of-life assessments at the start of the study and every 2 weeks for 12 weeks Be monitored for any side effects or safety concerns during and after each session

Conditions

• Stroke
• Gait Disorders, Neurologic
• Spinal Cord Injuries, Incomplete
• Postoperative Complication

Interventions

DEVICE

ZEPU-AI9 Lower Limb Exoskeleton Gait Training

A powered, dual-leg lower-limb exoskeleton (Shandong Zepu Medical Technology Co., Ltd.) that generates repeated physiological gait cycles via motorized hip and knee joints, supporting standing, sitting, stepping-in-place, and over-ground walking. Adjustable thigh/calf length, height, waist width, joint angles, step length, and training duration accommodate individual anthropometrics. Participants will use the device 3 times per week for 12 weeks (45-minute sessions), supervised by trained physiatrists/physiotherapists, with an overhead safety harness. Training parameters are progressively adjusted based on performance. Safety features include emergency stop, automated spasm protection, mechanical joint limits, overload detection, and anti-tilt protection. Used in addition to standard-of-care rehabilitation.

BEHAVIORAL

Standard-of-Care Rehabilitation

Institutional standard rehabilitation therapy delivered by physiotherapists, comprising balance training, lower-limb strengthening exercises, stretching, and gait retraining, per Department of Physical Medicine and Rehabilitation protocol at Bangladesh Medical University. Received by all participants throughout the 12-week study period, either alone (Usual Care Group) or in combination with ZEPU-AI9 exoskeleton-assisted gait training (Robotic-Augmented Rehabilitation Group).

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