ZEPU-SG1PLUS Hand Training with Robotic Rehab for Arm Problems

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot randomized trial compares robotic-assisted hand training using the ZEPU-SG1PLUS alongside standard rehabilitation to standard rehabilitation alone in adults with upper-limb motor dysfunction from stroke, incomplete spinal cord injury, traumatic brain injury, or orthopedic conditions. The study aims to assess safety, feasibility, and preliminary effectiveness on strength, range of motion, and functional ability. It also evaluates how well the robotic training can be integrated into routine rehabilitation services at a Bangladeshi university hospital. The ZEPU-SG1PLUS is a mechanically assisted, non-powered training device used on a stable framework to deliver repetitive hand movements with supervision and feedback. Data from this LMIC-setting will inform the design of a larger, adequately powered trial if results are favorable.

Why it matters

Who can join: the full rules

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

Where it's running

• Bangladesh Medical University
  Dhaka, Bangladesh Recruiting

Study contacts

• Principal investigator: Md. Abdus Shakoor, Ph.D. — Bangladesh Medical University
• Study coordinator: Md. Abdus Shakoor, Ph.D.
• Email: shakoorma@bmu.ac.bd
• Phone: +8801819410080

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.