Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07739264 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

ZEPU-SGI1PLUS Hand Training Study (ZEPUSGI1RCT)

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened
    • Start date changed from estimate of Jul 2026 to Jul 1, 2026
    • Site details revised
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this pilot randomized controlled trial is to learn whether the ZEPU-SG1PLUS Hand Functional Comprehensive Training System - a robotic device used alongside standard rehabilitation - is safe, feasible, and helpful for people with upper limb (arm/hand) motor problems caused by stroke, incomplete spinal cord injury, traumatic brain injury, or orthopedic conditions. The main questions it aims to answer are: Is robotic-assisted hand training well tolerated by patients, and can it be safely added to standard rehabilitation, with acceptable rates of device-related side effects? Does adding robotic hand training to standard rehabilitation improve arm and hand strength, range of motion, and functional ability compared with standard rehabilitation alone? Is it practical to fit this type of robotic training into everyday rehabilitation services at Bangladesh Medical University? Researchers will compare a robotic-augmented rehabilitation group to a standard-care (control) group to see whether adding robotic hand training works better than usual rehabilitation alone. Participants will: Be randomly assigned to one of two groups: one receiving standard rehabilitation plus robotic hand training with the ZEPU-SG1PLUS device, and one receiving standard rehabilitation alone If assigned to the robotic training group, attend three training sessions per week for 12 weeks, each lasting about 30-45 minutes, at the Robotic Rehabilitation Centre, BMU Undergo assessments at the start of the study and at two-week intervals during the 12-week program and follow-up period, including tests of muscle strength, joint movement, hand function, and daily activity ability Be monitored throughout for any side effects or safety concerns related to the training
Trial Details
NCT Number NCT07739264
Lead Sponsor Bangladesh Medical University
Conditions
(from sponsor)
Upper Limb Motor Dysfunction, Stroke, Incomplete Spinal Cord Injury, Traumatic Brain Injury, Upper Limb Orthopedic Trauma
Related terms Brain Injuries, Traumatic, Stroke
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov