Stroke
Conditions
Interventions
Speaking Valve Group:Conventional Rehabilitation + Speaking Valve Training
Closed-Loop Regulation Group:Conventional Rehabilitation + Speaking Valve Training + Central Activation by tDCS - Peripheral Muscle Activation by NMES
Sponsors
Hebei General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1 Patients with a first-time diagnosis of acute or subacute stroke, confirmed by computed tomography (CT) or magnetic resonance imaging (MRI). 2 Aged between 18 and 80 years. 3 Patients with a clear medical history of tracheostomy, who are in a stable postoperative condition. 4 Presence of moderate to severe dysphagia confirmed by Fiberoptic Endoscopic Evaluation of Swallowing (FEES) or Videofluoroscopic Swallowing Study (VFSS). 5 Conscious and able to cooperate (GCS>=9). 6 Tolerates speaking valve training for at least 5 minutes without significant respiratory distress, as assessed by a bedside evaluation. 7 Provides signed informed consent by the subject or their legally authorized representative.
Exclusion criteria
Exclusion criteria: 1 Presence of severe cognitive impairment or coma. 2 Active respiratory instability, defined as a respiratory rate>30 breaths per minute, oxygen saturation (SpO2)<92% despite supplemental oxygen, or current requirement for mechanical ventilation. 3 History of recent aspiration pneumonia. 4 Significant structural abnormalities of the larynx. 5 Presence of a cardiac pacemaker or a known history of epilepsy. 6 Pre-existing severe psychiatric disorder. 7 Concurrent participation in any other clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fiberoptic Endoscopic Evaluation of Swallowing (FEES);Maximal expiratory pressure,(MEP);Maximal inspiratory pressure(MIP);Videofluoroscopic Swallow Study(VFSS);Penetration Aspiration Scale(PAS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional Oral Intake Scale(FOIS);Semiquantitative cough strength score(SCSS);Maximum Phonation Time,(MPT);Mann assessment of swallowing ability(MASA);Wallowing Quality-of-Life Questionnaire()SWAL-QOL);Maximum Decibel(dB); | — |
Countries
China
Contacts
Public ContactWang Yanan
Hebei General Hospital
Outcome results
None listed