ZEPU-AI3 Lower Limb Feedback Robot Training Study

Sponsor
Bangladesh Medical University
Study ID
NCT07705906
Status
Not Yet Recruiting

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Conditions

  • Gait Disorders
  • Spinal Cord Injuries
  • Stroke

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot — DEVICE
    Participants assigned to the experimental arm will receive rehabilitation using the ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot in addition to conventional rehabilitation. Robot-assisted training will be delivered according to the approved study protocol, including supervised lower-limb feedback training sessions combined with standard rehabilitation care.
  • Conventional Rehabilitation — OTHER
    Participants assigned to the control arm will receive conventional rehabilitation according to the standard clinical practice of the Department of Physical Medicine and Rehabilitation, Bangladesh Medical University. Conventional rehabilitation may include therapeutic exercises, gait training, balance training, strengthening exercises, and other standard rehabilitation interventions as indicated.

Study Details

Lower limb motor dysfunction resulting from stroke, spinal cord injury, or other neurological disorders substantially limits mobility, independence, and quality of life. Robotic rehabilitation has emerged as a promising approach to provide intensive, repetitive, task-oriented training. The ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot is designed to deliver interactive lower limb training while providing real-time performance feedback. This pilot randomized controlled trial aims to evaluate the safety, efficacy, and feasibility of ZEPU-AI3-assisted rehabilitation combined with conventional rehabilitation compared with conventional rehabilitation alone in patients with lower limb motor dysfunction. The primary outcomes include safety, feasibility, and changes in lower limb motor function, gait performance, and functional mobility. The findings will provide preliminary evidence to support future large-scale clinical trials and the implementation of robotic rehabilitation in clinical practice.

Key Dates

First listed
Jul 15, 2026
Start date
Jul 15, 2026
Status verified
Jul 2026
Primary completion
Sep 15, 2026
Completion
Nov 15, 2026

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ZEPU-AI3 + Conventional Rehabilitation
    Participants will receive ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot-assisted rehabilitation in addition to conventional rehabilitation according to the study protocol.
  • Active Comparator: Conventional Rehabilitation
    Participants will receive conventional rehabilitation according to institutional standard care without ZEPU-AI3 robotic training.

Primary Outcome Measure

Incidence of Device-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline through Week 12 ]

Central Contacts

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