Combined NMES,FEES and Traditional Swallowing Rehabilitation in the Treatment of Stroke-related Dysphagia

Kaohsiung Veterans General Hospital.32 enrolled

Overview

The investigators aimed to evaluate effects of combined NMES, FEES and traditional swallowing rehabilitation in stroke patients with moderate-to-severe dysphagia.

Neuromuscular electrical stimulation (NMES)and Fiberoptic endoscopic evaluation of swallowing (FEES) are both promising approaches to enhance swallowing recovery for dysphagic patients. However, there is no literature on the effectiveness of combined application of these modalities in the treatment of patients with poststroke dysphagia. The purpose of this study was to prospectively investigate whether combined NMES, FEES and traditional swallowing rehabilitation can improve swallowing functions in patients with moderate-to-severe dysphagia after stroke.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stroke

Interventions

the combination groupPROCEDURE

Patients received 12 sessions of NMES for 1 hour /day, 5 days/week within a period of 2-3 weeks. FEES was done before and after NMES for evaluation and guiding therapy. All patients subsequently received 12 sessions of traditional swallowing rehabilitation (50 minutes/day, 3 days/week) for 4 weeks.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age between 20-85 years old * first-time stroke confirmed by computed tomography or magnetic resonance image * dysphagia \> 3 weeks, with preservation of the swallowing reflex * currently on a restricted diet, with a Functional Oral Intake Scale (FOIS) score of 5 or less * Mini-Mental State Examination (MMSE)\> 21 * no obvious mental depression, receptive aphasia or cognitive impairment Exclusion Criteria: * progressive cerebrovascular disease or other neurologic diseases * unstable cardiopulmonary status, serious psychologic disorder or epilepsy; * tumors, extensive surgery or radiotherapy of the head and neck region * cardiac pacemakers * swallowing therapy within 2 months before participation

Locations (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Outcomes

Primary Outcomes

Functional Oral Intake Scale (FOIS)

The FOIS is a 7-point ordinal scale reflecting the dietary intake of patients with dysphagia. It has adequate reliability and validity and has been used extensively in clinical studies of dysphagia to measure functional oral intake

Time frame: at 6-month follow-up

Secondary Outcomes

The degree of dysphagia

The degree of dysphagia was classified from grade 1 to 4 after detailed clinical swallowing evaluation including cranial nerve assessment, observations of swallowing and related movements and swallowing trials using various volumes and consistencies of food

Time frame: at 6-month follow-up

swallowing VAS

Each patient completed a perceptual evaluation of his swallowing ability using a 10-cm visual analog scale (VAS). It was rated by answering a single question: ''How do you qualify your swallowing ability?'' Scores can vary from 0 (no difficulty at all) to 10 (unable to swallow).

Time frame: at 6-month follow-up

Data from ClinicalTrials.gov

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