NMES Plus Conventional Therapy for Stroke Dysphagia

February 10, 2026 updated by: Chiayi Christian Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Chiayi City, Taiwan
        • Chiayi Christian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sham neuromuscular electrical stimulation combined with traditional dysphagia therapy
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.
Other: traditional dysphagia therapy
traditional dysphagia therapy
Experimental: neuromuscular electrical stimulation combined with traditional dysphagia therapy
Other: neuromuscular 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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).
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiayi Christian Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2023

Primary Completion (Actual)

July 29, 2025

Study Completion (Actual)

July 29, 2025

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

February 10, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB2023055

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on traditional dysphagia therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe