ZEPU-SGI1PLUS Hand Training Study (ZEPUSGI1RCT)

NCT07739264 | Not Yet Recruiting DMC

• 1 other identifier: PR-1434
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Upper Limb Motor Dysfunction; Stroke; Incomplete Spinal Cord Injury; Traumatic Brain Injury; Upper Limb Orthopedic Trauma

Keywords

Robotic Rehabilitation; ZEPU-SG1PLUS; Hand Function Training; Neurorehabilitation; Musculoskeletal Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline (Week 0) through end of 12-week intervention and follow-up

• 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.

  12 weeks

Secondary Outcomes (4)

• Muscle Strength

  Baseline and every 2 weeks through 12 weeks

• Grip Strength

  Baseline and every 2 weeks through 12 weeks

• Upper-Limb Spasticity

  Baseline and every 2 weeks through 12 weeks

• Health-Related Quality of Life

  Baseline and every 2 weeks up to 12 weeks

Study Arms (2)

Robotic-Augmented Rehabilitation Group

EXPERIMENTAL

Participants receive standard-of-care rehabilitation combined with robotic-assisted hand training using the ZEPU-SG1PLUS Hand Functional Comprehensive Training System, 3 sessions per week for 12 weeks (approximately 30-45 minutes per session).

Device: ZEPU-SG1PLUS Hand Functional Comprehensive Training System; Other: Standard-of-Care Rehabilitation

Standard Care (Control) Group

ACTIVE COMPARATOR

Participants receive standard-of-care rehabilitation alone, including conventional exercise and wax bath therapy, without the addition of robotic-assisted hand training.

Other: Standard-of-Care Rehabilitation

Interventions

ZEPU-SG1PLUS Hand Functional Comprehensive Training System DEVICE

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.

Robotic-Augmented Rehabilitation Group

Standard-of-Care Rehabilitation OTHER

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.

Robotic-Augmented Rehabilitation Group; Standard Care (Control) Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bangladesh Medical University: lead

Study Sites (1)

Bangladesh Medical University

Dhaka, 1000, Bangladesh

Location

MeSH Terms

Conditions

Stroke; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Md. Abdus Shakoor, Ph.D.

  Bangladesh Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Md. Abdus Shakoor, Ph.D.

CONTACT

+8801819410080; shakoorma@bmu.ac.bd

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman & Professor, Department of Physical Medicine & Rehabilitation and Focal Person, Robotic Rehabilitation Centre, Bangladesh Medical University

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 31, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)