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Aim: The aim of this study is to investigate the effect of neuromuscular electrical stimulation (NMES) combined with traditional dysphagia therapy (TDT) in acute/subacute stroke patients with dysphagia.
Methods: We design a randomized controlled trial to conduct this study. A total of 100 participants with stroke-induced dysphagia are included and randomly assigned to two groups: NMES+TDT and sham NMES+TDT. Participants receive a two-week training protocol, 5 times a week, with each session lasting 30 minutes. Clinical outcomes are recorded at baseline and at 1-, 2-, and 4-week follow-up visits. These outcomes include the Function Oral Intake Scale (FOIS), Eating Assessment Tool (EAT-10), and Swallowing-Related Quality of Life (Taiwan version).
Expected results: We hope that the effectiveness of NMES in treating stroke-induced dysphagia can be clarified. This information can be provided when treating patients with stroke-induced dysphagia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham neuromuscular electrical stimulation combined with traditional dysphagia therapy | Experimental | Traditional dysphagia therapy combined with sham neuromuscular electrical stimulation electrical, in which stimulation intensity was set at the minimum level (1 mA), with a frequency of 80 Hz and a pulse duration of 700 μs. |
|
| neuromuscular electrical stimulation combined with traditional dysphagia therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neuromuscular electrical stimulation | Other | This intervention is distinguished from other clinical interventions by the combination of neuromuscular electrical stimulation (NMES) with conventional dysphagia therapy in acute and subacute stroke patients. Unlike studies that employ either NMES or traditional therapy alone, this protocol integrates both approaches to potentially enhance swallowing function through simultaneous neuromuscular activation and task-specific swallowing exercises. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Oral Intake | Swallowing function was assessed using the Functional Oral Intake Scale (FOIS), an ordinal scale that reflects the functional level of oral intake in patients with dysphagia. | The time frame included four assessment points: at baseline, after 1 week of treatment, after 2 weeks of treatment, and at a 2-week follow-up. |
| Swallowing function assessment | Swallowing function was assessed using the self-administered Eating Assessment Tool (EAT-10, Chinese version). | The time frame included four assessment points: at baseline, after 1 week of treatment, after 2 weeks of treatment, and at a 2-week follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Swallowing quality of life | This questionnaire is designed to investigate the impact of dysphagia caused by various conditions on quality of life and is applicable to all populations with swallowing difficulties. The Swallowing Quality of Life Questionnaire (SWAL-QOL) consists of 44 items across 11 domains, including: burden, eating duration, eating desire, symptom frequency, food selection, communication, fear, mental health, social functioning, fatigue, and sleep. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiayi Christian Hospital | Chiayi City | Taiwan |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| traditional dysphagia therapy | Other | traditional dysphagia therapy |
|
| The time frame included four assessment points: at baseline, after 1 week of treatment, after 2 weeks of treatment, and at a 2-week follow-up. |
| D010038 | Otorhinolaryngologic Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |