A Phase 2 interventional study of Functional electrical stimulation and Exercise home program in Dysphagia, sponsored by National Taiwan University Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-26.
Sponsored by National Taiwan University Hospital · Phase 2, Interventional, and Treatment
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.
816 studies on the registry are indexed under Nasopharyngeal Carcinoma; 282 are open to participants now.
This study's enrollment of 20 is below the median of 84 across 668 interventional studies indexed under Nasopharyngeal Carcinoma.
Browse Nasopharyngeal Carcinoma studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Exclusion Criteria:
Functional electrical stimulation: Experimental
Device: Functional electrical stimulation
Exercise home program
Behavioral: Exercise home program
15 sessions of VitalStim® therapy, 60 minutes per session
Also known as: VitalStim®
Daily exercise training
Also known as: 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
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.
Time frame: Averaged 2 months
Questionnaire of Life Quality
Time frame: 1 to 3 months
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.
| Milestone | Functional Electrical Stimulation (FES) | Home Rehabilitation Program (HRP) |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
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.
| cm/s | Functional Electrical Stimulation (FES) | Home Rehabilitation Program (HRP) |
|---|---|---|
| The Change From Baseline and Cut Point VFSS in Velocity of Displacement of Hyoid Bone at 1 to 3 Months | 0.8 ± 0.5 | -0.4 ± 0.8 |
Results for this outcome have not been posted.
Collected over The data were collected from cut point VFSS to 1 year.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Functional Electrical Stimulation (FES) | — | 0/10 (0%) | 0/10 (0%) |
| Home Rehabilitation Program (HRP) | — | 0/10 (0%) | 0/10 (0%) |
We decided to make the cut point when the numbers of 2 groups are equal.
| Age, Categorical(Participants) | Functional Electrical Stimulation (FES) | Home Rehabilitation Program (HRP) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 10 | 20 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Functional Electrical Stimulation (FES) | Home Rehabilitation Program (HRP) | Total |
|---|---|---|---|
| Mean | 52.3 ± 7.4 | 56.1 ± 11.8 | 54.2 ± 10.3 |
| Sex: Female, Male(Participants) | Functional Electrical Stimulation (FES) | Home Rehabilitation Program (HRP) | Total |
|---|---|---|---|
| Female | 4 | 4 | 8 |
| Male | 6 | 6 | 12 |
| Region of Enrollment(participants) | Functional Electrical Stimulation (FES) | Home Rehabilitation Program (HRP) | Total |
|---|---|---|---|
| Taiwan | 10 | 10 | 20 |
No study locations are listed for this record.
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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National Taiwan University Hospital