Functional Electrical Stimulation in Irradiated Nasopharyngeal Carcinoma (NPC)
|Dysphagia||Device: Functional electrical stimulation Behavioral: Exercise home program||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy of Functional Electrical Stimulation in Dysphagia of Nasopharyngeal Cancer Post Radiotherapy|
- 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 ]
|Study Start Date:||July 2008|
|Study Completion Date:||October 2013|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
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...
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00815087
|Principal Investigator:||Tyng-Guey Wang, MD||Department of Physicale Medicine and Rehabilitation, National Taiwan University Hospital|