ZEPU-AI5 Strength Training Study (ZEPUAI5RCT)

Официальное название

Safety, Feasibility and Efficacy of ZEPU AI5 Lower Limb Muscle Strength Training and Evaluation Robot

Обзор

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

Подробное описание

Walking impairment due to neurological and orthopedic conditions significantly limits independence and functional mobility, making lower-limb strength training a key focus of rehabilitation. Robotic-assisted rehabilitation systems have shown promising results in improving strength and functional outcomes in high-income countries; however, their feasibility, safety, and efficacy remain underexplored in low- and middle-income settings. In Bangladesh, the ZEPU-AI5 lower-limb strength training and evaluation robot is a novel technology that has not yet been systematically evaluated in this population.

The ZEPU-AI5 is a computer-controlled electromechanical rehabilitation device consisting of a rigid main frame, a motor-driven walking training table, bilateral robotic mechanical legs aligned with the patient's hip and knee joints, adjustable foot pedals, thigh and calf fixation straps, and a body-weight support suspension system. The walking platform supports up to 135 kg, with continuously adjustable body-weight unloading from 0-80 kg, allowing progressive loading according to patient tolerance and recovery stage. Prior to training, individualized calibration is performed by measuring thigh and calf lengths to align the robotic joints with the participant's anatomical hip and knee axes, with bilateral symmetry adjustment available when needed.

The system provides programmable control over hip joint angles (30°-50°) and knee joint angles (50°-80°) in 1° increments, with gait offset parameters adjustable by ±10 units to allow individualized correction of abnormal gait patterns. Walking speed is adjustable from 0.1 to 3.5 km/h, allowing graded progression from slow assisted stepping to higher-speed gait training.

At study entry, participants will undergo a face-to-face interview to gather clinical and sociodemographic data using a semi-structured, pre-tested questionnaire. Weight and height will be measured to calculate Body Mass Index (BMI). All participants will be allocated a study ID, and assessments will be conducted at the Robotic Rehabilitation Center, Department of Physical Medicine and Rehabilitation, Bangladesh Medical University.

Вмешательства

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

Первичные конечные точки

• Incidence of Device-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: From baseline (T=0) through 12-week intervention and follow-up (T=12 weeks)]

Вторичные конечные точки (7)

• Change in Walking Distance (6-Minute Walk Test) [Срок оценки: Baseline and every 2 weeks up to Week 12]
• Change in Lower-Limb Muscle Strength (MRC Scale) [Срок оценки: Baseline and every 2 weeks up to Week 12]
• Change in Functional Ambulation Category (FAC) Score [Срок оценки: Baseline and every 2 weeks up to Week 12]
• Change in Balance (Berg Balance Scale-Short Form) [Срок оценки: Baseline and every 2 weeks up to Week 12]
• Change in Functional Mobility (Timed Up and Go Test) [Срок оценки: Baseline and every 2 weeks up to Week 12]
• Change in Lower-Limb Spasticity (Modified Ashworth Scale) [Срок оценки: Baseline and every 2 weeks up to Week 12]
• Change in Health-Related Quality of Life (EuroQol Questionnaire) [Срок оценки: Baseline and every 2 weeks up to Week 12]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Bangladesh · 1 центр

• Bangladesh Medical University — Dhaka

Идентификаторы

NCT: NCT07735702 · PR-1428

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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