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NCT Number: NCT07415785

NMES Plus Conventional Therapy for Stroke Dysphagia

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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Key information

Conditions

Dysphagia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Stroke Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chiayi Christian Hospital

Chiayi City, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute or subacute stroke;
  • Presence of dysphagia;
  • Receiving tube feeding;
  • Age between 20 and 80 years;
  • Able to understand and follow simple instructions with prompts, and able to respond to questions either verbally or through gestures.

Exclusion criteria

  • Pre-existing dysphagia prior to the current stroke;
  • Other neurological diseases (e.g., dementia);
  • Unstable cardiopulmonary function;
  • Severe psychiatric disorders;
  • Head and neck cancer, history of surgical tissue removal, or radiation therapy;
  • Prior participation in swallowing training before this study;
  • Presence of implanted electronic devices (e.g., pacemakers, cochlear implants);
  • Impaired consciousness.

Treatment and study plan

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.

traditional dysphagia therapy

Other

traditional dysphagia therapy

Primary outcomes

  1. Functional Oral Intake

    Time frame: 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.

  2. Swallowing function assessment

    Time frame: 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 outcomes

  1. Swallowing quality of life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chiayi Christian Hospital

Other

Registry information

Official study title

Efficacy of Neuromuscular Electrical Stimulation Plus Conventional Dysphagia Therapy in Acute and Subacute Stroke Patients: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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