NMES Plus Conventional Therapy for Stroke Dysphagia

Chiayi Christian Hospital

Status: Completed

Conditions: Dysphagia; Stroke

Treatments: Other: traditional dysphagia therapy; Other: neuromuscular electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07415785

IRB2023055

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Sham neuromuscular electrical stimulation combined with traditional dysphagia therapy

Experimental group

Description:

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.

Treatment:

Other: traditional dysphagia therapy

neuromuscular electrical stimulation combined with traditional dysphagia therapy

Experimental group

Treatment:

Other: neuromuscular electrical stimulation