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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Procedure: the combination group

• Registration Number: NCT01731847
• Lead Sponsor: Kaohsiung Veterans General Hospital.

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2007-02
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2012-11
• Study First Submitted: 2012-11-13
• Study First Submitted QC: 2012-11-18
• Last Update Submitted: 2012-11-18
• Study First Posted: 2012-11-22
• Last Update Posted: 2012-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The combination group	the combination group	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.

Primary Outcome Measures

Name	Time	Method
Functional Oral Intake Scale (FOIS)	at 6-month follow-up	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

Secondary Outcome Measures

Name	Time	Method
The degree of dysphagia	at 6-month follow-up	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
swallowing VAS	at 6-month follow-up	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).

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan