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
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
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
Parallel
ZEPU-SG1PLUS Hand Functional Comprehensive Training System
DeviceA 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
Other interventionStandard 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.
Incidence of Device-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number and proportion of participants experiencing device-related AEs or SAEs, including falls, skin breakdown/pressure sores, joint pain or injury, cardiovascular events, fracture, or device malfunction.
Device Tolerability (Session Completion Rate)
Number of robotic training sessions completed relative to sessions planned; number of participant drop-outs and reasons for drop-out.
Muscle Strength
Assessed using Manual Muscle Testing (MMT).
Grip Strength
Assessed using a hand-held dynamometer.
Upper-Limb Spasticity
Assessed using the Modified Ashworth Scale (MAS), a clinician-rated measure of resistance to passive muscle stretch, scored from 0 (no increase in muscle tone) to 4 (limb rigid in flexion or extension), with higher scores indicating greater spasticity (worse outcome).
Health-Related Quality of Life
Health-related quality of life assessed using the EQ Visual Analogue Scale (EQ-VAS), a self-rated measure of current health status on a vertical scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating better health-related quality of life.
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