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

NCT07459725 | Not Yet Recruiting

• 1 other identifier: B-2601-1020-302
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Stroke; Chronic Stroke; Hemiparesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  Baseline, Week 2, Week 4, and Week 6

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

  Baseline, Week 2, Week 4, and Week 6

Study Arms (2)

EEG-Timed Robot Therapy

EXPERIMENTAL

Device: EEG-Timed Robot Operation

Repetitive Robot Therapy

ACTIVE COMPARATOR

Device: Repetitive Robotic System

Interventions

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.

EEG-Timed Robot Therapy

Repetitive Robotic System DEVICE

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

Repetitive Robot Therapy

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 10, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 10, 2026

Record last verified: 2026-02