Back to resultsCombined NMES,FEES and Traditional Swallowing Rehabilitation in the Treatment of Stroke-related Dysphagia
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
the combination group
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring dysphagia,endoscopy, electrical stimulation,stroke
Eligibility Criteria
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
Sites / Locations
- Kaohsiung Veterans General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
The combination group
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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).
Full Information
NCT ID
NCT01731847
First Posted
November 13, 2012
Last Updated
November 18, 2012
Sponsor
Kaohsiung Veterans General Hospital.
1. Study Identification
Unique Protocol Identification Number
NCT01731847
Brief Title
Combined NMES,FEES and Traditional Swallowing Rehabilitation in the Treatment of Stroke-related Dysphagia
Official Title
Combined Neuromuscular Electrical Stimulation (NMES) With Fiberoptic Endoscopic Evaluation of Swallowing (FEES) and Traditional Swallowing Rehabilitation in the Treatment of Stroke-related Dysphagia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Veterans General Hospital.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
dysphagia,endoscopy, electrical stimulation,stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The combination group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
the combination group
Intervention Description
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 Measure Information:
Title
Functional Oral Intake Scale (FOIS)
Description
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 Outcome Measure Information:
Title
The degree of dysphagia
Description
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
Title
swallowing VAS
Description
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
Other Pre-specified Outcome Measures:
Title
global satisfaction to the combination therapy
Description
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.
Time Frame
at 6-month follow-up
Title
The occurrence of adverse events or pneumonia
Description
The occurrence of adverse events or pneumonia was recorded during the study period.
Time Frame
at 6-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shu-Fen Sun, MD
Organizational Affiliation
Department of Physical Medicine and Rehabilitation, Kaohsiung Veterans General Hospital, Taiwan; National Yang-Ming University School of Medicine, Taiwan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chien-Wei Hsu, MD
Organizational Affiliation
National Yang-Ming University School of Medicine, Taiwan; Department of Internal Medicine; Kaohsiung Veterans General Hospital, Taiwan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Huey-Shyan Lin, PHD
Organizational Affiliation
School of Nursing, Fooyin University, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
10971024
Citation
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.
Results Reference
background
PubMed Identifier
7944924
Citation
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.
Results Reference
background
PubMed Identifier
11309186
Citation
Freed ML, Freed L, Chatburn RL, Christian M. Electrical stimulation for swallowing disorders caused by stroke. Respir Care. 2001 May;46(5):466-74.
Results Reference
background
PubMed Identifier
18437464
Citation
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.
Results Reference
background
PubMed Identifier
9779682
Citation
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.
Results Reference
background
PubMed Identifier
16084801
Citation
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.
Results Reference
background
PubMed Identifier
17305276
Citation
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.
Results Reference
background
PubMed Identifier
23584790
Citation
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.
Results Reference
derived
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Combined NMES,FEES and Traditional Swallowing Rehabilitation in the Treatment of Stroke-related Dysphagia
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