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NCT Number: NCT07459725

Comparison of EEG-Timed vs. Repetitive Robot Therapy for Chronic Stroke

This clinical trial compares two types of robotic hand rehabilitation-brain wave (EEG)-timed therapy versus simple repetitive therapy-to see which is more effective for recovering hand function in patients with chronic stroke. Participants will be randomly assigned to either group and will attend sessions using a wearable robotic hand device while wearing an EEG cap. In the EEG-timed group, the robot assists hand movements when participants successfully imagine moving and create specific brain signals, whereas in the repetitive group, the robot moves the hand automatically at set intervals. Both groups will receive a matched dose of robotic training to ensure a fair comparison of how the brain and hand function respond to the therapy.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with stroke.
  • Adults aged 19 to 85 years old at the time of screening.

Exclusion criteria

  • Patients with severe, uncontrolled medical conditions.
  • Patients with uncontrolled hypertension, diabetes mellitus, or renal disease.
  • Patients with severe cognitive impairment that prevents them from following instructions for motor tasks (Mini-Mental State Examination [MMSE] score of 15 or below).

Note: Patients with an MMSE score of 15 or below may still be included if the Principal Investigator (or a delegated physician) determines that they have the capacity to perform the tasks and provide informed consent.

Treatment and study plan

EEG-Timed Robot Operation

Device

A wearable hand robot that activates in real-time when the patient successfully generates a specific brain signal (ERD) during movement observation and motor imagery.

Repetitive Robotic System

Device

A wearable robotic hand that provides repetitive hand opening and closing movements at fixed intervals, without requiring EEG signal triggering.

Primary outcomes

  1. Change in Event-Related Desynchronization (ERD) During Motor Tasks

    Time frame: Baseline, Week 2, Week 4, and Week 6

    Event-Related Desynchronization (ERD) is continuously measured using multi-channel EEG over the sensorimotor cortex while participants perform action observation and motor imagery (AO+MI) tasks. ERD represents the decrease in EEG power in specific frequency bands (e.g., mu or beta rhythms), which reflects the level of cortical activation. A greater magnitude of ERD indicates stronger and more active neurophysiological engagement of the motor cortex.

Secondary outcomes

  1. Change in Upper Extremity Motor Function Assessed by the Fugl-Meyer Assessment (FMA-UE)

    Time frame: Baseline, Week 2, Week 4, and Week 6

    The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) is a stroke-specific, performance-based index designed to assess motor impairment. It evaluates movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. The total FMA-UE score ranges from 0 to 66. Higher scores indicate better motor function and less impairment.

  2. Change in Upper Extremity Motor Performance Assessed by the Action Research Arm Test (ARAT)

    Time frame: Baseline, Week 2, Week 4, and Week 6

    The Action Research Arm Test (ARAT) is an observational, performance-based measure used to assess upper extremity function, specifically focusing on grasping, gripping, pinching, and gross movement. The total score ranges from 0 to 57. Higher scores indicate better arm and hand motor performance and greater upper limb dexterity.

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Exploratory Comparison of Movement Observation/Imagery-Timed Robot Activation and Repetitive Robot Activation on Training Effects and Neurophysiological Responses in Chronic Stroke Patients

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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