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

NCT04290377 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-07-03

No results posted yet for this study

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

Interventions

DEVICE

BMI-assisted motor imagery OT

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.

OTHER

Motor imagery OT

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.

Sponsors & Collaborators

  • Seoul National University Bundang Hospital

    lead OTHER

Principal Investigators

  • Nam-Jong Paik, MD, PhD · Seoul National University Bundang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-25
Primary Completion
2022-09-13
Completion
2022-09-13

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04290377 on ClinicalTrials.gov