Functional Electrical Stimulation in Irradiated Nasopharyngeal Carcinoma (NPC)
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|ClinicalTrials.gov Identifier: NCT00815087|
Recruitment Status : Completed
First Posted : December 29, 2008
Results First Posted : March 26, 2014
Last Update Posted : March 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Dysphagia||Device: Functional electrical stimulation Behavioral: Exercise home program||Phase 2|
Nasopharyngeal carcinoma (NPC) patients usually underwent radiotherapy (RT) or chemoradiotherapy(CRT). There were some complications caused by RT, like dysphagia.
In recent studies, functional electrical stimulation (FES) was be used in neurologically dysphagia patients, and there were some positive effects with these studies. Hence, we decided applied FES to these NPC patients with dysphagia.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Functional Electrical Stimulation in Dysphagia of Nasopharyngeal Cancer Post Radiotherapy|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||October 2013|
Experimental: Functional Electrical Stimulation (FES)
Functional electrical stimulation: Experimental
Device: Functional electrical stimulation
15 sessions of VitalStim® therapy, 60 minutes per session
Other Name: VitalStim®
Active Comparator: Home Rehabilitation Program (HRP)
Exercise home program
Behavioral: Exercise home program
Daily exercise training
Other Name: Range of motion exercises, resistence exercises, etc...
- The Change From Baseline and Cut Point VFSS in Velocity of Displacement of Hyoid Bone at 1 to 3 Months [ Time Frame: Averaged 2 months ]A parameter of the VFSS assessment was velocity of displacement of hyoid bone on 5mL thin barium sulfate bolus, which was defined as the displacement divided by the duration. The outcome measure time frame was based on VFSS assessment with the range between one to three months due to subjects received 1 to 3 times per week. We will provide the mean time frame, which is 2 months.
- Questionnaire of Life Quality [ Time Frame: 1 to 3 months ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00815087
|Principal Investigator:||Tyng-Guey Wang, MD||Department of Physicale Medicine and Rehabilitation, National Taiwan University Hospital|