Upper Extremity Rehabilitation Training Using Brain-Machine Interface Biofeedback in Stroke Patients With Hemiplegia

NCT04290377 | Terminated

• 1 other identifier: B-1908-559-301
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the efficacy of upper extremity rehabilitation using a Brain-Machine Interface (BMI) in individuals with hemiplegia due to stroke. The main questions it aims to answer are:

• Can BMI-assisted occupational therapy improve the Fugl Meyer Assessment-Upper Limb (FMA-UL) score in chronic stroke participants?
• How does the effectiveness of BMI-assisted occupational therapy compare to conventional occupational therapy alone? Participants will: Undergo 5 sessions of BMI-assisted occupational therapy in phase 1. Be randomly allocated to either a control group (receiving conventional occupational therapy) or an experimental group (receiving BMI-assisted OT plus conventional OT) in phase 2. Researchers will compare the control group (OT plus OT) and the experimental group (BMI-assisted OT plus OT) to see if there is a significant difference in the change of FMA-UL score between the two groups.

Conditions

Stroke; Hemiplegia

Keywords

Neural plasticity; Brain Machine Interface; Functional near-infrared spectroscopy; Stroke; Upper extremity; Function; Recovery

Outcome Measures

Primary Outcomes (1)

• Change of Fugl Meyer Assessment-Upper Limb (FMA-UL) Score

  Impairment measurement

  Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 month of T2 (T3).

Secondary Outcomes (9)

• Change of Finger Tapping Test Score (taps/minute)

  Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 months of T2 (T3).

• Change of Finger Extension (Metarcapophalangeal [MCP] joint) Range of Motion (degree)

  Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 month of T2 (T3).

• Change of Hand grasp power (lb)

  Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 month of T2 (T3).

• Change of Brunnstrom Stage

  Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 month of T2 (T3).

• Change of muscle strength (Medical Research Council)-Upper extremity

  Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 month of T2 (T3).

Study Arms (2)

Conventional OT + Motor Imagery OT

ACTIVE COMPARATOR

Conventional OT (30 minutes/day) plus Motor Imagery OT (30 minutes/day) for 10 days.

Other: Motor imagery OT

Conventional OT + BMI-assisted Motor Imagery OT

EXPERIMENTAL

Conventional OT (30 minutes/day) plus BMI-assisted motor imagery OT (30 minutes/day) for 10 days.

Device: BMI-assisted motor imagery OT

Interventions

BMI-assisted motor imagery OT DEVICE

As the goal of the intervention is to promote finger extension in participants who are unable to extend his/her finger due to stroke, the pneumatic glove provides extension assist when appropriate brain activity is present. The brain activity is obtained by Functional Near-Infrared Spectroscopy (fNIRS). Hypothetically, this will repeatedly induce brain activation that is related to finger extension.

Conventional OT + BMI-assisted Motor Imagery OT

Motor imagery OT OTHER

In Motor imagery OT, Subjects try to extend their fingers (imagine) without BMI assistance. All other setting is equal to BMI-assisted motor imagery OT.

Conventional OT + Motor Imagery OT

Eligibility Criteria

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

You may qualify if:

• Subcortical stroke with hemiplegia
• st stroke
• Time since onset is less than 3 months
• Brunnstrom stage 2,3

You may not qualify if:

• Recurred stroke
• MMSE score below 10
• Delirium
• Unstable medical condition
• Pregnancy
• Cannot sustain sitting position for 30 minutes
• Pain that limits upper extremity exercise

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

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

Study Officials

• Nam-Jong Paik, MD, PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Impossible to mask participants and care providers due to using a device that is so obvious.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Phase1 (chronic stroke): with-in group (one group) multiple measurements Phase2 (subacute stroke): Randomized controlled study. Control (OT plus OT) vs Experimental (OT plus BMI-assisted OT)

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 28, 2020
• Study Start: February 25, 2020
• Primary Completion: September 13, 2022
• Study Completion: September 13, 2022
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)