A Study on the Effectiveness of Upper Extremity Rehabilitation Training Using Brain-Machine Interface Biofeedback in Stroke Patients With Hemiplegia
A Study on the Effectiveness of Upper Extremity Rehabilitation Training Using Brain-Machine Interface Biofeedback in Stroke Patients With Hemiplegia
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:
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.
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.
Inclusion Criteria:
Exclusion Criteria: