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

  • STATUS
    Recruiting
  • participants needed
    60
  • sponsor
    Seoul National University Bundang Hospital
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Updated on 16 February 2024
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stroke
conventional treatment
hemiplegia
chronic stroke
upper limb

Summary

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.

Details
Condition Hemiplegia, Cerebrovascular accident
Age 18years - 85years
Treatment BMI-assisted motor imagery OT, Motor imagery OT
Clinical Study IdentifierNCT04290377
SponsorSeoul National University Bundang Hospital
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Subcortical stroke with hemiplegia
st 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
Clear my responses
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