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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shu-Fen Sun, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier:
NCT01731847
First received: November 13, 2012
Last updated: November 18, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention
Stroke
Procedure: the combination group

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Kaohsiung Veterans General Hospital.:

Primary Outcome Measures:
  • Functional Oral Intake Scale (FOIS) [ Time Frame: at 6-month follow-up ] [ Designated as safety issue: No ]
    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 [ Time Frame: at 6-month follow-up ] [ Designated as safety issue: No ]
    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 [ Time Frame: at 6-month follow-up ] [ Designated as safety issue: No ]
    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).


Other Outcome Measures:
  • global satisfaction to the combination therapy [ Time Frame: at 6-month follow-up ] [ Designated as safety issue: No ]
    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.

  • The occurrence of adverse events or pneumonia [ Time Frame: at 6-month follow-up ] [ Designated as safety issue: Yes ]
    The occurrence of adverse events or pneumonia was recorded during the study period.


Enrollment: 32
Study Start Date: February 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: 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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01731847

Locations
Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 813
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shu-Fen Sun, MD,Department of Physical Medicine and Rehabilitation, Kaohsiung Veterans General Hospital, Taiwan, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT01731847     History of Changes
Other Study ID Numbers: VGHKS96-079
Study First Received: November 13, 2012
Last Updated: November 18, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Kaohsiung Veterans General Hospital.:
dysphagia,endoscopy, electrical stimulation,stroke

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014