None listed
Conditions
Interventions
Medical Device : Intervention Group: Participants will continue their usual rehabilitation treatment and receive upper-limb rehabilitation training using the smart board together with transcutaneous v
Sponsors
National Rehabilitation Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with hemiplegia and upper-limb dysfunction within 6 months after stroke onset 2. Adults aged 19 years or older and younger than 85 years 3. Individuals who voluntarily provide written informed consent to participate in the study 4. Individuals with sufficient cognitive ability to understand and follow the investigator’s instructions, defined as a K-MMSE score of 21 or higher 5. Individuals with a Medical Research Council grade of 2 or higher in the shoulder flexor and adductor muscles 6. Individuals with a Modified Ashworth Scale score of 1+ or lower for spasticity of the shoulder extensor and abductor muscles
Exclusion criteria
Exclusion criteria: 1. Individuals currently receiving upper-limb rehabilitation treatment using transcutaneous vagus nerve stimulation (tVNS) 2. Individuals with neurological disorders other than stroke, such as Parkinson’s disease, multiple sclerosis, motor neuron disease, or peripheral neuropathy 3. Individuals with pre-existing pain, muscle atrophy, or other conditions that could interfere with upper-limb rehabilitation before stroke onset 4. Individuals with severe upper-limb spasticity, defined as a Modified Ashworth Scale score of 3 or higher 5. Individuals with a skin disorder or open wound on the upper limb 6. Individuals with implanted medical devices, such as a cardiac pacemaker, implanted insulin pump, or metallic implant 7. Individuals using life-supporting electronic medical devices, such as a cardiopulmonary support system 8. Individuals unable to participate because of musculoskeletal pain, defined as a Numeric Rating Scale score greater than 6 9. Pregnant women 10. Individuals with upper-limb amputation, fracture, soft-tissue disease, or injury 11. Individuals unable to maintain a seated position for at least 30 minutes 12. Individuals with severe visual impairment that prevents recognition of the smart-board display 13. Individuals with uncontrolled hypertension, unstable angina, recent myocardial infarction, or a history of seizures 14. Individuals with a psychiatric disorder that may interfere with study participation 15. Individuals otherwise considered unsuitable for participation by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the total score of the Fugl-Meyer Assessment of Upper Extremity (FMA-UE) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the total score and performance time of the Action Research Arm Test (ARAT);Change in Medical Research Council (MRC) muscle strength grades of the shoulder and elbow flexors and extensors;Change in active range of motion of the shoulder and elbow joints;Change in the Modified Ashworth Scale (MAS) score of the elbow flexors;Change in the total score of the Confidence in Arm and Hand Movement (CAHM) scale;Change in the Stroke Impact Scale (SIS) 3.0 score;Change in the total score of the Geriatric Depression Scale (GDS);Change in the total score of the Stroke Rehabilitation Motivation Scale (SRMS);Change in the total score of the Korean version of the Modified Barthel Index (K-MBI);Usability of the intervention assessed using the System Usability Scale (SUS);Occurrence and type of intervention-related adverse events assessed through participant interviews | — |
Countries
Korea, Republic of
Contacts
Public ContactKimyung Kim
National Rehabilitation Center
Outcome results
None listed