NCT07739264 ZEPU-SGI1PLUS Hand Training Study (ZEPUSGI1RCT)
| NCT ID | NCT07739264 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bangladesh Medical University |
| Condition | Upper Limb Motor Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2026-07-01 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * Presence of upper-limb motor dysfunction, with or without concurrent lower-limb impairment, due to one of the following conditions: (a) stroke, with onset between 2 and 24 months prior to enrollment; (b) incomplete spinal cord injury (neurological level C5 and below), classified as ASIA Impairment Scale C or D; (c) traumatic brain injury with persistent upper-limb functional limitation; or (d) orthopedic or post-surgical conditions involving the shoulder, elbow, wrist, or hand with persistent functional impairment for \> 3 months * Age between 18 and 60 years, inclusive * Ability to understand study procedures and follow instructions, and to provide written informed consent (or assent with guardian consent where applicable) * Body weight and limb anthropometry compatible with the ZEPU-SG1PLUS Hand Functional Comprehensive Training System per manufacturer specifications * Medically stable and cleared by a physician for robotic rehabilitation, with no active infection, uncontrolled cardiac or respiratory disease, severe osteoporosis, uncontrolled epilepsy, or untreated deep vein thrombosis Exclusion Criteria: * Complete spinal cord injury or profound motor paralysis preventing safe interaction with robotic devices * Severe cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score \< 24, that would compromise safe participation * Severe spasticity of the upper limb, defined as a Modified Ashworth Scale score \> 3 * Unstable fractures, severe fixed joint contractures of the shoulder, elbow, wrist, or hand (e.g., \> 30°), or severe pain limiting safe robotic training * Uncontrolled cardiac arrhythmia, presence of a pacemaker, or other implanted electronic medical device incompatible with robotic sensors * Pregnancy
Contact & Investigator
Md. Abdus Shakoor, Ph.D.
PRINCIPAL INVESTIGATOR
Bangladesh Medical University
Frequently Asked Questions
Who can join the NCT07739264 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Upper Limb Motor Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07739264 currently recruiting?
Yes, NCT07739264 is actively recruiting participants. Contact the research team at shakoorma@bmu.ac.bd for enrollment information.
Where is the NCT07739264 trial being conducted?
This trial is being conducted at Dhaka, Bangladesh.
Who is sponsoring the NCT07739264 clinical trial?
NCT07739264 is sponsored by Bangladesh Medical University. The principal investigator is Md. Abdus Shakoor, Ph.D. at Bangladesh Medical University. The trial plans to enroll 36 participants.