ZEPU-SGI1PLUS Hand Training Study (ZEPUSGI1RCT)

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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

Key Dates

First listed

Jul 31, 2026

Start date

Jul 31, 2026

Status verified

Jul 2026

Primary completion

Sep 30, 2026

Completion

Nov 30, 2026

Study Design

Enrollment

36 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Robotic-Augmented Rehabilitation Group
  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).
• Active Comparator: Standard Care (Control) Group
  Participants receive standard-of-care rehabilitation alone, including conventional exercise and wax bath therapy, without the addition of robotic-assisted hand training.

Primary Outcome Measure

Incidence of Device-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline (Week 0) through end of 12-week intervention and follow-up ]

Central Contacts

• Md. Abdus Shakoor, Ph.D.
  +8801819410080
  [email protected]

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