ZEPU-AI5 Strength Training Study (ZEPUAI5RCT)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorBangladesh Medical University

About this trial

The goal of this clinical trial is to learn if robot-assisted lower-limb strength and gait training can improve safety, feasibility, and functional recovery in adults aged 18-60 years with lower-limb motor dysfunction due to stroke, incomplete spinal cord injury, or persistent gait impairment following orthopedic surgery. The main questions it aims to answer are:

Is robot-assisted training using the ZEPU-AI5 device safe and well-tolerated, with an acceptable rate of device-related adverse events? Does adding ZEPU-AI5-assisted training to standard-of-care rehabilitation improve functional outcomes (such as walking distance, muscle strength, balance, and mobility) compared to standard-of-care rehabilitation alone?

Researchers will compare an intervention group receiving standard-of-care rehabilitation combined with ZEPU-AI5-assisted training to a control group receiving standard-of-care rehabilitation alone, to see if the addition of robotic training leads to greater improvements in safety, functional recovery, and quality of life.

Participants will:

Undergo a baseline assessment before starting the study Receive either robot-assisted training plus standard-of-care rehabilitation, or standard-of-care rehabilitation alone, three times per week for 12 weeks Complete follow-up assessments every two weeks to evaluate safety, functional outcomes, and durability of any benefits

Eligibility criteria

Qualifiers

Lower-limb motor dysfunction due to one of the following: (a) stroke (onset 2-24 months), (b) incomplete spinal cord injury (neurological level T12 or below, ASIA Impairment Scale C or D), or (c) orthopedic surgery (e.g., knee/hip replacement) with persistent gait impairment more than 3 months post-surgery

Age greater than 18 years and up to 60 years

Medically stable and able to provide informed consent

Able to meet device anthropometric criteria for use of the ZEPU-AI5 system

Disqualifiers

Complete spinal cord injury with inability to bear any weight

Severe cognitive impairment (Mini-Mental State Examination score less than 24) preventing safe participation

Severe spasticity of the lower limbs (Modified Ashworth Scale greater than 3)

Unstable fractures, severe hip/knee contractures (greater than 30 degrees fixed flexion), or severe osteoarthritis requiring imminent surgery

Trial design

Treatments tested in this trial

  • Robotic lower-limb gait training (ZEPU-AI5)
  • Standard-of-care rehabilitation (conventional physiotherapy)

Treatment groups

36 Participants
are divided into 2 treatment groups

Sponsors and collaborators