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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01731847 |
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Date of registration:
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13/11/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Combined NMES,FEES and Traditional Swallowing Rehabilitation in the Treatment of Stroke-related Dysphagia
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Scientific title:
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Combined Neuromuscular Electrical Stimulation (NMES) With Fiberoptic Endoscopic Evaluation of Swallowing (FEES) and Traditional Swallowing Rehabilitation in the Treatment of Stroke-related Dysphagia |
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Date of first enrolment:
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February 2007 |
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Target sample size:
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32 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01731847 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Chien-Wei Hsu, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Yang-Ming University School of Medicine, Taiwan; Department of Internal Medicine; Kaohsiung Veterans General Hospital, Taiwan |
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Name:
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Shu-Fen Sun, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Physical Medicine and Rehabilitation, Kaohsiung Veterans General Hospital, Taiwan; National Yang-Ming University School of Medicine, Taiwan |
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Name:
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Huey-Shyan Lin, PHD |
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Address:
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Telephone:
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Email:
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Affiliation:
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School of Nursing, Fooyin University, Taiwan |
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Key inclusion & exclusion criteria
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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
Age minimum:
20 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Stroke
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Intervention(s)
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Procedure: the combination group
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Primary Outcome(s)
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Functional Oral Intake Scale (FOIS)
[Time Frame: at 6-month follow-up]
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Secondary Outcome(s)
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swallowing VAS
[Time Frame: at 6-month follow-up]
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The degree of dysphagia
[Time Frame: at 6-month follow-up]
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Secondary ID(s)
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VGHKS96-079
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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