Clinical Research Directory
Browse clinical research sites, groups, and studies.
ZEPU-SGI1PLUS Hand Training Study (ZEPUSGI1RCT)
Sponsor: Bangladesh Medical University
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
Official title: Feasibility, Safety and Efficacy of ZEPU-SGI1PLUS Hand Functional Comprehensive Training Systems in Patients With Upper Limb Motor Dysfunction
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2026-07
Completion Date
2026-11
Last Updated
2026-07-31
Healthy Volunteers
No
Conditions
Interventions
ZEPU-SG1PLUS Hand Functional Comprehensive Training System
A non-powered, mechanically assisted robotic training device for the hand and upper limb, incorporating twelve dedicated training modules (e.g., thumb-to-palm motion, wrist flexion-extension, forearm rotation, finger flexion/extension, pinching, grip rotation) with an adjustable counterweight resistance system (500g-3000g). Administered 3 sessions/week for 12 weeks (30-45 minutes/session) in addition to standard-of-care rehabilitation.
Standard-of-Care Rehabilitation
Standard rehabilitation program including conventional therapeutic exercise and wax bath therapy, delivered per institutional protocol at the Department of Physical Medicine and Rehabilitation, BMU, without the addition of robotic-assisted training.
Locations (1)
Bangladesh Medical University
Dhaka, Bangladesh