ZEPU-AI5 Strength Training Study (ZEPUAI5RCT)

NCT07735702 | Not Yet Recruiting DMC

• 1 other identifier: PR-1428
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke; Incomplete Spinal Cord Injury; Gait Impairment Following Orthopedic Surgery

Keywords

Robotic Rehabilitation; Neurorehabilitation; Muscle Strength

Outcome Measures

Primary Outcomes (1)

• Incidence of Device-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Number and proportion of participants experiencing device-related adverse events, including falls, skin breakdown/pressure sores, joint pain/injury, cardiovascular events, fracture, and device malfunction, recorded through continuous monitoring during each robotic training session and reviewed monthly by an independent safety monitor.

  From baseline (T=0) through 12-week intervention and follow-up (T=12 weeks)

Secondary Outcomes (7)

• Change in Walking Distance (6-Minute Walk Test)

  Baseline and every 2 weeks up to Week 12

• Change in Lower-Limb Muscle Strength (MRC Scale)

  Baseline and every 2 weeks up to Week 12

• Change in Functional Ambulation Category (FAC) Score

  Baseline and every 2 weeks up to Week 12

• Change in Balance (Berg Balance Scale-Short Form)

  Baseline and every 2 weeks up to Week 12

• Change in Functional Mobility (Timed Up and Go Test)

  Baseline and every 2 weeks up to Week 12

Study Arms (2)

Intervention Arm (Robotic-Augmented Rehabilitation Group)

EXPERIMENTAL

18 participants receiving standard-of-care rehabilitation combined with ZEPU-AI5 assisted gait training

Device: Robotic lower-limb gait training (ZEPU-AI5); Behavioral: Standard-of-care rehabilitation (conventional physiotherapy)

Control Arm (Usual Care Group)

ACTIVE COMPARATOR

18 participants receiving standard-of-care rehabilitation alone (including IRR and exercise)

Behavioral: Standard-of-care rehabilitation (conventional physiotherapy)

Interventions

Robotic lower-limb gait training (ZEPU-AI5) DEVICE

The ZEPU-AI5 Lower Limb Strength Training and Evaluation Robot (Shandong ZEPU Medical Technology Co. Ltd.) is a computer-controlled electromechanical rehabilitation device that delivers task-specific, repetitive lower-limb gait training. It consists of a motorized walking platform, bilateral robotic mechanical legs aligned to the patient's hip and knee joints, adjustable body-weight support (0-80 kg unloading, up to 135 kg capacity), and an overhead safety harness. Hip joint range is adjustable 30-50° and knee joint range 50-80°, with walking speed adjustable from 0.1-3.5 km/h. Training modes include standing, sitting, stepping-in-place, and over-ground walking. Participants in the intervention arm will receive robot-assisted gait training 3 sessions/week for 12 weeks (45 minutes/session, \~36 sessions total), supervised by trained physiotherapists, in addition to standard-of-care rehabilitation. Real-time feedback on joint angles, torque, and gait parameters is provided, with built-in

Intervention Arm (Robotic-Augmented Rehabilitation Group)

Standard-of-care rehabilitation (conventional physiotherapy) BEHAVIORAL

Standard-of-care rehabilitation consisting of conventional physiotherapy, including individualized rehabilitation regimen (IRR) and exercise therapy, delivered by trained physiotherapists at the Department of Physical Medicine and Rehabilitation, Bangladesh Medical University. This includes balance training, lower-limb strengthening exercises, stretching, and gait retraining, following standard institutional rehabilitation protocols. Participants in the control arm receive this standard therapy alone, without robotic-assisted gait training, over the same 12-week study period, with outcome assessments conducted at baseline and two-week intervals.

Control Arm (Usual Care Group); Intervention Arm (Robotic-Augmented Rehabilitation Group)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Uncontrolled cardiac arrhythmia, pacemaker incompatibility, or any implanted electronic device incompatible with the robot's sensors
• Pregnancy

Sponsors & Collaborators

• Bangladesh Medical University: lead

Study Sites (1)

Bangladesh Medical University

Dhaka, 1000, Bangladesh

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Md. Abdus A Shakoor, Ph.D.

  Bangladesh Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Md. Abdus Shakoor, Ph.D.

CONTACT

+8801819410080; shakoorma@bmu.ac.bd

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman & Professor, Department of Physical Medicine & Rehabilitation and Focal Person, Robotic Rehabilitation Centre, Bangladesh Medical University

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: July 30, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)