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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Hemiparesis; Chronic Stroke
• Intervention / Treatment: Device: EEG-Timed Robot Operation; Device: Repetitive Robotic System

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EEG-Timed Robot Therapy	Device: EEG-Timed Robot Operation; 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.
Active Comparator: Repetitive Robot Therapy	Device: Repetitive Robotic System; A wearable robotic hand that provides repetitive hand opening and closing movements at fixed intervals, without requiring EEG signal triggering.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Event-Related Desynchronization (ERD) During Motor Tasks	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.	Baseline, Week 2, Week 4, and Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Upper Extremity Motor Function Assessed by the Fugl-Meyer Assessment (FMA-UE)	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.	Baseline, Week 2, Week 4, and Week 6
Change in Upper Extremity Motor Performance Assessed by the Action Research Arm Test (ARAT)	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.	Baseline, Week 2, Week 4, and Week 6

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 16, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Stroke; Paresis
• Other Study ID Numbers: B-2601-1020-302

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No