None listed
Conditions
Interventions
Medical Device : The intervention in this study is transcutaneous neuromuscular electrical stimulation (NMES) for the treatment of dysphagia, delivered using the VitalStim® device. Surface electrodes
the sham stimulation consists of low-level sensory stimulation for the initial 3 minutes followed by no current, resulting in a total of 600 minutes of active NMES. Both groups receive conventional sw
Sponsors
Pusan National University Yangsan Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients admitted to or transferred to a university hospital stroke center within 7 days of stroke onset 2) Adults aged 19 years or older 3) Patients with a confirmed diagnosis of stroke by a neurologist or neurosurgeon based on imaging studies such as CT or MRI 4) Patients admitted to or transferred to the Department of Rehabilitation Medicine within 1 month of stroke onset 5) Patients with a Functional Oral Intake Scale (FOIS) score = 5 at the time of admission or transfer to the Department of Rehabilitation Medicine 6) Patients who provide informed consent to participate in a 4-week intensive rehabilitation program
Exclusion criteria
Exclusion criteria: 1) Patients admitted more than 8 days after the onset of stroke symptoms 2) Transient ischemic attack (TIA) 3) History of prior stroke with clear clinical symptoms 4) Progressive or unstable stroke 5) Patients with pre-existing and active major neurological disease 6) Pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease or dementia 7) Patients with advanced liver, kidney, cardiac, or pulmonary disease 8) Patients with a terminal medical condition with an expected survival of less than 1 year 9) Patients with contraindications to electrical stimulation of the neck muscles (e.g., implanted electronic devices, active skin lesions on the neck, pregnancy, etc.) 10) Patients with a history of surgical or radiation treatment for head and neck diseases, such as head and neck cancer 11) Patients currently undergoing treatment for pneumonia 12) Patients who refuse to participate in the study 13) Patients deemed unsuitable for participation in this clinical trial by the investigator 14) Patients currently participating in another clinical study 15) Pregnant women or women of childbearing potential (including those who are breastfeeding)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Videofluoroscopic Dysphagia Scale(VDS) ;Penetration-Aspiration Scale(PAS);American Speech-Language-Hearing Association-National Outcome Measurement System (ASHA-NOMS);The swallowing quality of life questionnaire(SWAL-QOL);Height/Weight/BMI;Mini Nutritional Assessment (MNA);Presence of pneumonia during initial hospitalization;Presence or absence of pneumonia during the intervention period;FOIS (Functional Oral Intake Scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| Korean version of the National Institutes of Health Stroke Scale (K-NIHSS);Fugl-Meyer Assessment (FMA);Functional Ambulation Category (FAC);modified Rankin Scale (mRS);Korean modified Barthel Index (K-MBI);Functional independence measure (FIM);Korean-Geriatric depression scale (K-GDS);EuroQo5-Dimensions (EQ-5D) | — |
Countries
Korea, Republic of
Contacts
Public ContactSIHYUN Lee
Pusan National University Yangsan Hospital
Outcome results
None listed