<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01731847</url>
  </required_header>
  <id_info>
    <org_study_id>VGHKS96-079</org_study_id>
    <nct_id>NCT01731847</nct_id>
  </id_info>
  <brief_title>Combined NMES,FEES and Traditional Swallowing Rehabilitation in the Treatment of Stroke-related Dysphagia</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaohsiung Veterans General Hospital.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaohsiung Veterans General Hospital.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators aimed to evaluate effects of combined NMES, FEES and traditional swallowing&#xD;
      rehabilitation in stroke patients with moderate-to-severe dysphagia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Neuromuscular electrical stimulation (NMES)and Fiberoptic endoscopic evaluation of swallowing&#xD;
      (FEES) are both promising approaches to enhance swallowing recovery for dysphagic patients.&#xD;
      However, there is no literature on the effectiveness of combined application of these&#xD;
      modalities in the treatment of patients with poststroke dysphagia. The purpose of this study&#xD;
      was to prospectively investigate whether combined NMES, FEES and traditional swallowing&#xD;
      rehabilitation can improve swallowing functions in patients with moderate-to-severe dysphagia&#xD;
      after stroke.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2007</start_date>
  <completion_date type="Actual">February 2008</completion_date>
  <primary_completion_date type="Actual">February 2008</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functional Oral Intake Scale (FOIS)</measure>
    <time_frame>at 6-month follow-up</time_frame>
    <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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The degree of dysphagia</measure>
    <time_frame>at 6-month follow-up</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>swallowing VAS</measure>
    <time_frame>at 6-month follow-up</time_frame>
    <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).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>global satisfaction to the combination therapy</measure>
    <time_frame>at 6-month follow-up</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>The occurrence of adverse events or pneumonia</measure>
    <time_frame>at 6-month follow-up</time_frame>
    <description>The occurrence of adverse events or pneumonia was recorded during the study period.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>The combination group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>the combination group</intervention_name>
    <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.</description>
    <arm_group_label>The combination group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 20-85 years old&#xD;
&#xD;
          -  first-time stroke confirmed by computed tomography or magnetic resonance image&#xD;
&#xD;
          -  dysphagia &gt; 3 weeks, with preservation of the swallowing reflex&#xD;
&#xD;
          -  currently on a restricted diet, with a Functional Oral Intake Scale (FOIS) score of 5&#xD;
             or less&#xD;
&#xD;
          -  Mini-Mental State Examination (MMSE)&gt; 21&#xD;
&#xD;
          -  no obvious mental depression, receptive aphasia or cognitive impairment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  progressive cerebrovascular disease or other neurologic diseases&#xD;
&#xD;
          -  unstable cardiopulmonary status, serious psychologic disorder or epilepsy;&#xD;
&#xD;
          -  tumors, extensive surgery or radiotherapy of the head and neck region&#xD;
&#xD;
          -  cardiac pacemakers&#xD;
&#xD;
          -  swallowing therapy within 2 months before participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shu-Fen Sun, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Physical Medicine and Rehabilitation, Kaohsiung Veterans General Hospital, Taiwan; National Yang-Ming University School of Medicine, Taiwan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chien-Wei Hsu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Yang-Ming University School of Medicine, Taiwan; Department of Internal Medicine; Kaohsiung Veterans General Hospital, Taiwan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Huey-Shyan Lin, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>School of Nursing, Fooyin University, Taiwan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaohsiung Veterans General Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>813</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>10971024</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>7944924</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>11309186</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>18437464</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>9779682</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>16084801</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>17305276</PMID>
  </reference>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>November 18, 2012</last_update_submitted>
  <last_update_submitted_qc>November 18, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 22, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kaohsiung Veterans General Hospital.</investigator_affiliation>
    <investigator_full_name>Shu-Fen Sun</investigator_full_name>
    <investigator_title>MD,Department of Physical Medicine and Rehabilitation, Kaohsiung Veterans General Hospital, Taiwan</investigator_title>
  </responsible_party>
  <keyword>dysphagia,endoscopy, electrical stimulation,stroke</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deglutition Disorders</mesh_term>
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01731847
org study id: VGHKS96-079
nct id: NCT01731847
lead sponsor: 
has dmc: No
The investigators aimed to evaluate effects of combined NMES, FEES and traditional swallowing
      rehabilitation in stroke patients with moderate-to-severe dysphagia.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Functional Oral Intake Scale (FOIS)
time frame: at 6-month follow-up
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
measure: The degree of dysphagia
time frame: at 6-month follow-up
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
measure: swallowing VAS
time frame: at 6-month follow-up
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).
measure: global satisfaction to the combination therapy
time frame: at 6-month follow-up
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.
measure: The occurrence of adverse events or pneumonia
time frame: at 6-month follow-up
description: The occurrence of adverse events or pneumonia was recorded during the study period.
arm group label: The combination group
arm group type: Experimental
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: the combination group
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.
arm group label: The combination group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 85 Years
healthy volunteers: No
last name: Shu-Fen Sun, MD
role: Principal Investigator
affiliation: Department of Physical Medicine and Rehabilitation, Kaohsiung Veterans General Hospital, Taiwan; National Yang-Ming University School of Medicine, Taiwan
last name: Chien-Wei Hsu, MD
role: Principal Investigator
affiliation: National Yang-Ming University School of Medicine, Taiwan; Department of Internal Medicine; Kaohsiung Veterans General Hospital, Taiwan
last name: Huey-Shyan Lin, PHD
role: Principal Investigator
affiliation: School of Nursing, Fooyin University, Taiwan
facility: 
country: Taiwan
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.
PMID: 10971024
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.
PMID: 7944924
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.
PMID: 11309186
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.
PMID: 18437464
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.
PMID: 9779682
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.
PMID: 16084801
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.
PMID: 17305276
responsible party type: Principal Investigator
investigator affiliation: Kaohsiung Veterans General Hospital.
investigator full name: Shu-Fen Sun
investigator title: MD,Department of Physical Medicine and Rehabilitation, Kaohsiung Veterans General Hospital, Taiwan
mesh term: Deglutition Disorders
mesh term: Stroke