None listed
Conditions
Interventions
Medical Device : The investigational intervention is a home-use transcranial photobiomodulation (t-PBM) medical device intended for stroke rehabilitation. The device delivers near-infrared laser light
however, the device will emit only 1/50 of the energy delivered by the active treatment device.
All participants will perform the intervention in a home setting, and study procedures—including duratio
Sponsors
Y&J Bio Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women aged 19 to 90 years 2. Individuals diagnosed with first-ever cerebral infarction or intracerebral hemorrhage 3. Individuals with an Fugl Meyer Assessment-Upper Extremity score of 58 or lower 4. Individuals who are fluent in Korean and have no impairment in reading, writing, or auditory comprehension 5. Individuals who have agreed to participate for the entire duration of the clinical trial
Exclusion criteria
Exclusion criteria: 1. Individuals with visual impairments 2. Individuals exhibiting signs of unilateral neglect 3. Individuals whose upper limb dysfunction may be caused by joint contracture or stiffness due to infection or trauma 4. Individuals with intracranial metallic objects (e.g., brain stimulators, neurostimulators, aneurysm clips, cochlear implants) 5. Individuals with uncontrolled cardiac, renal, or hepatic disease 6. Individuals deemed unsuitable for participation in the clinical trial by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fugl-Meyer Upper Extremity Assessment;Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Action Research Arm Test;National Institutes of Health Stroke Scale;Modified Barthel Index | — |
Countries
Korea, Republic of
Contacts
Public ContactHyelim Chun
St. Peter's Hospital
Outcome results
None listed