NMES Plus Conventional Therapy for Stroke Dysphagia

NCT07415785 | Completed

• 1 other identifier: IRB2023055
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia; Stroke

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (1)

• 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.

Study Arms (2)

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.

Other: traditional dysphagia therapy

neuromuscular electrical stimulation combined with traditional dysphagia therapy

EXPERIMENTAL

Other: neuromuscular electrical stimulation

Interventions

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.

neuromuscular electrical stimulation combined with traditional dysphagia therapy

traditional dysphagia therapy OTHER

traditional dysphagia therapy

Sham neuromuscular electrical stimulation combined with traditional dysphagia therapy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chiayi Christian Hospital: lead

Study Sites (1)

Chiayi Christian Hospital

Chiayi City, Taiwan

Location

MeSH Terms

Conditions

Deglutition Disorders; Stroke

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 17, 2026
• Study Start: September 25, 2023
• Primary Completion: July 29, 2025
• Study Completion: July 29, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)