Clinical trial NCT01731847: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: dysphagia,endoscopy, electrical stimulation,stroke
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2012-11-22
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Functional Oral Intake Scale (FOIS)
timeFrame: at 6-month follow-up
Secondary outcomes:
measure: The degree of dysphagia
timeFrame: at 6-month follow-up
measure: swallowing VAS
timeFrame: at 6-month follow-up
Other outcomes:
measure: global satisfaction to the combination therapy
timeFrame: at 6-month follow-up
measure: The occurrence of adverse events or pneumonia
timeFrame: at 6-month follow-up
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, Kaohsiung Veterans General Hospital, Taiwan; National Yang-Ming University School of Medicine, Taiwan
name: Shu-Fen Sun, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Yang-Ming University School of Medicine, Taiwan; Department of Internal Medicine; Kaohsiung Veterans General Hospital, Taiwan
name: Chien-Wei Hsu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Nursing, Fooyin University, Taiwan
name: Huey-Shyan Lin, PHD
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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: 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: 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: 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: 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: 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.