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

Seoul National University

Status: Terminated

Conditions: Stroke; Hemiplegia

Treatments: Device: BMI-assisted motor imagery OT; Other: Motor imagery OT

Study type: Interventional

Funder types: Other

Identifiers

NCT04290377

B-1908-559-301

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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7 participants in 2 patient groups

Conventional OT + Motor Imagery OT

Active Comparator group

Description:

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

Treatment:

Other: Motor imagery OT

Conventional OT + BMI-assisted Motor Imagery OT

Experimental group

Description:

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

Treatment:

Device: BMI-assisted motor imagery OT