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ZEPU-AI1 Gait Robot Training Study (ZEPUAI1RCT)

NCT07735676 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-07-31

No results posted yet for this study

Summary

Walking problems caused by stroke, spinal cord injury, or orthopedic surgery are common and can seriously limit a person's independence. Robotic-assisted gait training devices, which use a computer-controlled system to help patients practice standing and walking, have shown promise in improving strength, balance, and walking ability in other countries. However, this type of technology has not yet been carefully studied in Bangladesh.

This study will test a robotic gait training and evaluation device called ZEPU-AI1 in adults aged 19 to 60 years who have difficulty walking due to stroke, incomplete spinal cord injury, or gait problems following surgery. The main goals are to find out whether using this robotic device alongside standard physical therapy is feasible (practical to carry out) and safe, and to explore whether it helps improve walking speed, balance, muscle strength, and daily function compared with standard physical therapy alone.

Thirty-two participants will take part. Half will receive robot-assisted gait training three times a week for 12 weeks in addition to usual rehabilitation therapy, while the other half will receive usual rehabilitation therapy alone. Participants will be assessed regularly using standard walking, balance, and strength tests over the 12-week period.

The results of this study will help doctors and researchers understand whether this robotic technology can be safely and effectively introduced into rehabilitation care in Bangladesh.

Conditions

  • Stroke
  • Spinal Cord Injuries (SCI)
  • Gait Disorders, Neurologic

Interventions

DEVICE

ZEPU-AI1 Gait Training and Evaluation System

Participants will receive robot-assisted gait training using the ZEPU-AI1 Gait Training and Evaluation System, a robotic device providing body-weight-supported, guided gait training. Training will be delivered 3 times per week for 12 weeks (36 sessions total), approximately 45 minutes per session, including warm-up, device donning, structured standing and gait training (sit-to-stand, in-place stepping, overground walking, turning), and cool-down. Body-weight support, walking speed, and session duration will be progressively adjusted based on participant tolerance and performance

BEHAVIORAL

Standard-of-Care Rehabilitation (Individualized Rehabilitation and Exercise)

Participants will receive individualized rehabilitation and exercise (IRR) as per institutional protocol at the Department of Physical Medicine and Rehabilitation, BMU. This standard-of-care rehabilitation program is tailored to each participant's functional status and needs, and is matched in overall therapeutic content and intensity across both study groups. It is delivered without any robotic-assisted device and represents the conventional-therapy component of care for individuals undergoing gait and mobility rehabilitation.

Sponsors & Collaborators

  • Bangladesh Medical University

    lead OTHER

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
2026-07-31
Primary Completion
2026-09-30
Completion
2026-11-30

Countries

  • Bangladesh

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07735676 on ClinicalTrials.gov