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

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

Recruiting
18-85 years
All
Phase N/A

Overview

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.

Eligibility

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

Study details
    Hemiplegia
    Cerebrovascular accident

NCT04290377

Seoul National University Bundang Hospital

16 February 2024

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