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The purpose of this study is to determine whether functional electrical stimulation is effective in the treatment of dysphagia due to nasopharyngeal cancer post radiotherapy
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Functional Electrical Stimulation (FES) | Experimental | Functional electrical stimulation: Experimental |
|
| Home Rehabilitation Program (HRP) | Active Comparator | Exercise home program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional electrical stimulation | Device | 15 sessions of VitalStim® therapy, 60 minutes per session |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Change From Baseline and Cut Point VFSS in Velocity of Displacement of Hyoid Bone at 1 to 3 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. | Averaged 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire of Life Quality | 1 to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tyng-Guey Wang, MD | Department of Physicale Medicine and Rehabilitation, National Taiwan University Hospital | Principal Investigator |
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They were assigned into the FES group and home rehabilitation program (HRP) group by the method of sex stratified randomization, and were matched by Dysphagia Outcome and Severity Scale (DOSS) score within 1 unit in order to compare two groups under the same sex proportion and similar DOSS score pairs.
Twenty subjects were referral from department of oncology & physical Medicine and Rehabilitation, National Taiwan University Hospital, Taipei, Taiwan. The study was approved by the Ethics Committee of the National Taiwan University Hospital. All participants gave their informed consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | Functional Electrical Stimulation (FES) | Functional electrical stimulation: Experimental Functional electrical stimulation : 15 sessions of VitalStim® therapy, 60 minutes per session |
| FG001 | Home Rehabilitation Program (HRP) | Exercise home program Exercise home program : Daily exercise training |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
We decided to make the cut point when the numbers of 2 groups are equal.
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| ID | Title | Description |
|---|---|---|
| BG000 | Functional Electrical Stimulation (FES) | Functional electrical stimulation: Experimental Functional electrical stimulation : 15 sessions of VitalStim® therapy, 60 minutes per session |
| BG001 | Home Rehabilitation Program (HRP) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Change From Baseline and Cut Point VFSS in Velocity of Displacement of Hyoid Bone at 1 to 3 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. | Posted | Mean | Standard Deviation | cm/s | Averaged 2 months |
|
The data were collected from cut point VFSS to 1 year.
Not any patient reported serious adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Functional Electrical Stimulation (FES) | Functional electrical stimulation: Experimental Functional electrical stimulation : 15 sessions of VitalStim® therapy, 60 minutes per session |
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Lack of information about muscle fibrosis, no control group. and the results from the small amount of subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Wang TG | Wang tyng | +886-2-23123456 | 67587 | patty.jt@gmail.com |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| ID | Term |
|---|---|
| D016059 | Range of Motion, Articular |
| ID | Term |
|---|---|
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D009142 | Musculoskeletal Physiological Phenomena |
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| Exercise home program | Behavioral | Daily exercise training |
|
|
Exercise home program
Exercise home program : Daily exercise training
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Exercise home program Exercise home program : Daily exercise training |
|
|
| Secondary | Questionnaire of Life Quality | Not Posted | 1 to 3 months |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Home Rehabilitation Program (HRP) | Exercise home program Exercise home program : Daily exercise training | 0 | 10 | 0 | 10 |
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| D010038 | Otorhinolaryngologic Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |