Dysphagia, Stroke
Conditions
Brief summary
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.
Interventions
OTHERneuromuscular electrical stimulation
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.
OTHERtraditional dysphagia therapy
traditional dysphagia therapy
Sponsors
Chiayi Christian Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Acute or subacute stroke; 2. Presence of dysphagia; 3. Receiving tube feeding; 4. Age between 20 and 80 years; 5. Able to understand and follow simple instructions with prompts, and able to respond to questions either verbally or through gestures.
Exclusion criteria
1. Pre-existing dysphagia prior to the current stroke; 2. Other neurological diseases (e.g., dementia); 3. Unstable cardiopulmonary function; 4. Severe psychiatric disorders; 5. Head and neck cancer, history of surgical tissue removal, or radiation therapy; 6. Prior participation in swallowing training before this study; 7. Presence of implanted electronic devices (e.g., pacemakers, cochlear implants); 8. Impaired consciousness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Oral Intake | 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 was assessed using the Functional Oral Intake Scale (FOIS), an ordinal scale that reflects the functional level of oral intake in patients with dysphagia. |
| Swallowing function assessment | 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 was assessed using the self-administered Eating Assessment Tool (EAT-10, Chinese version). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Swallowing quality of life | 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. | 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. |
Countries
Taiwan
Outcome results
None listed