- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01731847
Combined NMES,FEES and Traditional Swallowing Rehabilitation in the Treatment of Stroke-related Dysphagia
November 18, 2012 updated by: Shu-Fen Sun, Kaohsiung Veterans General Hospital.
Combined Neuromuscular Electrical Stimulation (NMES) With Fiberoptic Endoscopic Evaluation of Swallowing (FEES) and Traditional Swallowing Rehabilitation in the Treatment of Stroke-related Dysphagia
The investigators aimed to evaluate effects of combined NMES, FEES and traditional swallowing rehabilitation in stroke patients with moderate-to-severe dysphagia.
Study Overview
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 Type
Interventional
Enrollment (Actual)
32
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
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Kaohsiung, Taiwan, 813
- Kaohsiung Veterans General Hospital
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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
20 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Oral Intake Scale (FOIS)
Time Frame: at 6-month follow-up
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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
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at 6-month follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The degree of dysphagia
Time Frame: at 6-month follow-up
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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
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at 6-month follow-up
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swallowing VAS
Time Frame: at 6-month follow-up
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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).
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at 6-month follow-up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
global satisfaction to the combination therapy
Time Frame: at 6-month follow-up
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Patients were asked to rate the level of global satisfaction to the combination therapy.
The rating was based on a 7-point categorical scale weighted from completely satisfied, satisfied, somewhat satisfied, no change, somewhat unsatisfied, unsatisfied to completely unsatisfied.
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at 6-month follow-up
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The occurrence of adverse events or pneumonia
Time Frame: at 6-month follow-up
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The occurrence of adverse events or pneumonia was recorded during the study period.
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at 6-month follow-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Shu-Fen Sun, MD, Department of Physical Medicine and Rehabilitation, Kaohsiung Veterans General Hospital, Taiwan; National Yang-Ming University School of Medicine, Taiwan
- Principal Investigator: Chien-Wei Hsu, MD, National Yang-Ming University School of Medicine, Taiwan; Department of Internal Medicine; Kaohsiung Veterans General Hospital, Taiwan
- Principal Investigator: Huey-Shyan Lin, PHD, School of Nursing, Fooyin University, Taiwan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Crary MA, Mann GD, Groher ME. Initial psychometric assessment of a functional oral intake scale for dysphagia in stroke patients. Arch Phys Med Rehabil. 2005 Aug;86(8):1516-20. doi: 10.1016/j.apmr.2004.11.049.
- Shaw GY, Sechtem PR, Searl J, Keller K, Rawi TA, Dowdy E. Transcutaneous neuromuscular electrical stimulation (VitalStim) curative therapy for severe dysphagia: myth or reality? Ann Otol Rhinol Laryngol. 2007 Jan;116(1):36-44. doi: 10.1177/000348940711600107.
- Langmore SE, Miller RM. Behavioral treatment for adults with oropharyngeal dysphagia. Arch Phys Med Rehabil. 1994 Oct;75(10):1154-60. doi: 10.1016/0003-9993(94)90094-9.
- Mann G, Hankey GJ, Cameron D. Swallowing disorders following acute stroke: prevalence and diagnostic accuracy. Cerebrovasc Dis. 2000 Sep-Oct;10(5):380-6. doi: 10.1159/000016094.
- Freed ML, Freed L, Chatburn RL, Christian M. Electrical stimulation for swallowing disorders caused by stroke. Respir Care. 2001 May;46(5):466-74.
- Bulow M, Speyer R, Baijens L, Woisard V, Ekberg O. Neuromuscular electrical stimulation (NMES) in stroke patients with oral and pharyngeal dysfunction. Dysphagia. 2008 Sep;23(3):302-9. doi: 10.1007/s00455-007-9145-9. Epub 2008 Apr 25.
- Leder SB. Serial fiberoptic endoscopic swallowing evaluations in the management of patients with dysphagia. Arch Phys Med Rehabil. 1998 Oct;79(10):1264-9. doi: 10.1016/s0003-9993(98)90273-8.
- Sun SF, Hsu CW, Lin HS, Sun HP, Chang PH, Hsieh WL, Wang JL. Combined neuromuscular electrical stimulation (NMES) with fiberoptic endoscopic evaluation of swallowing (FEES) and traditional swallowing rehabilitation in the treatment of stroke-related dysphagia. Dysphagia. 2013 Dec;28(4):557-66. doi: 10.1007/s00455-013-9466-9. Epub 2013 Apr 13.
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
February 1, 2007
Primary Completion (Actual)
February 1, 2008
Study Completion (Actual)
February 1, 2008
Study Registration Dates
First Submitted
November 13, 2012
First Submitted That Met QC Criteria
November 18, 2012
First Posted (Estimate)
November 22, 2012
Study Record Updates
Last Update Posted (Estimate)
November 22, 2012
Last Update Submitted That Met QC Criteria
November 18, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VGHKS96-079
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.
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