NCT01731847

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Feb 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 22, 2012

Completed
Last Updated

November 22, 2012

Status Verified

November 1, 2012

Enrollment Period

1 year

First QC Date

November 13, 2012

Last Update Submit

November 18, 2012

Conditions

Stroke

Keywords

dysphagia,endoscopy, electrical stimulation,stroke

Outcome Measures

Primary Outcomes (1)

  • 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

    at 6-month follow-up

Secondary Outcomes (2)

  • The degree of dysphagia

    at 6-month follow-up

  • swallowing VAS

    at 6-month follow-up

Other Outcomes (2)

  • global satisfaction to the combination therapy

    at 6-month follow-up

  • The occurrence of adverse events or pneumonia

    at 6-month follow-up

Study Arms (1)

The combination group

EXPERIMENTAL

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

Interventions

the combination groupPROCEDURE

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.

The combination group

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

Location

Related Publications (8)

  • 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: 10971024BACKGROUND

  • 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: 7944924BACKGROUND

  • 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: 11309186BACKGROUND

  • 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: 18437464BACKGROUND

  • 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: 9779682BACKGROUND

  • 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: 16084801BACKGROUND

  • 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: 17305276BACKGROUND

  • 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.

    PMID: 23584790DERIVED

MeSH Terms

Conditions

StrokeDeglutition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,Department of Physical Medicine and Rehabilitation, Kaohsiung Veterans General Hospital, Taiwan

Study Record Dates

First Submitted

November 13, 2012

First Posted

November 22, 2012

Study Start

February 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

November 22, 2012

Record last verified: 2012-11

Locations

TW(1)