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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-25

Study Completion Date

2022-09-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Quantified Analysis of Neuronal Recovery Using Myelin Imaging After Robot Assisted Upper Arm Training in Subacute Stroke Patients

NCT04651322

Stroke

UNKNOWN NA

Effectiveness of Intelligent Rehabilitation Robot Training System Combined With Repetitive Facilitative Exercise on Upper Limb Motor Function After Stroke: a Randomized Control Trial.

NCT06435624

Stroke

COMPLETED NA

Effects of Upper Limb Motor and Robotic Training Over Neuroplasticity and Function Capacity

NCT02700061

Stroke

UNKNOWN PHASE2

Effect of Brain-Computer Interfaced-Assisted Motor Imagery for Gait Retraining in Stroke Patients

NCT02507895

Stroke

COMPLETED NA

Usability and Effectiveness of a Novel Bilateral Upper Limb Training Device for Stroke Patients With Hemiparesis: A Preliminary Study

NCT06956677

The Effectiveness of Novel Rehabilitation Device on Upper Limb Impairment Among Patients With Stroke

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a study to evaluate the efficacy of upper extremity rehabilitation using Brain-Machine Interface (BMI) on individuals with hemiplegia due to stroke. BMI is a device that can record and analyze human brain signals (in this study Functional near-infrared spectroscopy was used) and also provide live feedback (by pneumatic glove movement) to the individual wearing it. This device hypothetically enables more accurate training by reinforcing the correctly activated brain signal repeatedly then conventional therapy.

In phase 1 study investigators will evaluate the feasibility of BMI on chronic stroke participants. 5 sessions of BMI-assisted occupational therapy (OT) will be performed and the Fugl Meyer Assessment-Upper Limb (FMA-UL) score change between the pre-treatment and post-treatment will be analyzed by paired t-test.

In phase 2 study, a randomized controlled study will be performed by randomly allocating participants to either control (OT plus OT) or experimental group (BMI-assisted OT plus OT) and the difference of FMA-UL score change between the two groups will be analyzed by Student's t-test.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Hemiplegia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Impossible to mask participants and care providers due to using a device that is so obvious.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Conventional OT + Motor Imagery OT

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

Group Type ACTIVE_COMPARATOR

Motor imagery OT

Intervention Type 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 + BMI-assisted Motor Imagery OT

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

Group Type EXPERIMENTAL

BMI-assisted motor imagery OT

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subcortical stroke with hemiplegia
* 1st stroke
* Time since onset is less than 3 months
* Brunnstrom stage 2,3

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No