Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-27 @ 3:07 PM
Study NCT ID:
NCT03649295
Status:
COMPLETED
Last Update Posted:
2020-10-20
First Post:
2018-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Conventional Speech Therapy and Functional Electrical Stimulation in Dysphagia Following Stroke
Sponsor:
Hospital Geral de Fortaleza
Organization:
Study Overview
Official Title:
Randomized Study of the Influence of Functional Electrical Stimulation in Patients With Dysphagia After Stroke
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the effectiveness of conventional speech therapy associated with functional electrical stimulation in patients with dysphagia after ischemic stroke. Included patients will be divided into two groups, where in the intervention group the speech therapy is associated to functional electrical stimulation, and in the control group, the patients will receive the conventional speech therapy with electrical stimulation Placebo with intensity 0hz.
Detailed Description:
Since the 1980's, electrical stimulation has been used for therapeutic purposes in Brazil, and, since 1990's, it has been used as a relevant therapeutic tool in the cases of oropharyngeal dysphagia in addition to speech therapy. Positive results have been observed in the treatment of swallowing disorders, including in patients that carry neurological diseases. However, there is no substantial evidences for this interventions.
In this study, the electrotherapy will be used as a complement to conventional speech therapy and performed the application of electrical stimulation protocol in dysphagia, through the apparatus Neurodyn Portable TENS/FES (transcutaneous electrical neurostimulation/ functional electrical stimulation), which is a transcutaneous neuromuscular stimulator flow TENS/FES from two channels with independent intensity adjustment. It is about a non-invasive technique with no systemic effect, causing no dependence or undesirable side effects, and consists by gentle application in electrical stimulation, through electrodes placed in body areas affected by pain or to activate skeletal muscles and produce movements. A channel of electrodes will be placed in the submental region and the other channel on the thyroid cartilage., in formation of a T. The explication of the procedure in the patient treatment, is describing the sensations that he should expect that happened during the stimulation. The intensity of necessary flow to apply in the treatment, will depend in the sensation of the patient, therefore, it is applicable until the tolerance level or desirable muscular contraction. Thus, the treatment should be initiated with minimal levels of intensity, by being carefully raised if appropriate effects are achieved on the procedure and according to the patient report.
In this study, the electrotherapy will be used as a complement to conventional speech therapy and performed the application of electrical stimulation protocol in dysphagia, through the apparatus Neurodyn Portable TENS/FES (transcutaneous electrical neurostimulation/ functional electrical stimulation), which is a transcutaneous neuromuscular stimulator flow TENS/FES from two channels with independent intensity adjustment. It is about a non-invasive technique with no systemic effect, causing no dependence or undesirable side effects, and consists by gentle application in electrical stimulation, through electrodes placed in body areas affected by pain or to activate skeletal muscles and produce movements. A channel of electrodes will be placed in the submental region and the other channel on the thyroid cartilage., in formation of a T. The explication of the procedure in the patient treatment, is describing the sensations that he should expect that happened during the stimulation. The intensity of necessary flow to apply in the treatment, will depend in the sensation of the patient, therefore, it is applicable until the tolerance level or desirable muscular contraction. Thus, the treatment should be initiated with minimal levels of intensity, by being carefully raised if appropriate effects are achieved on the procedure and according to the patient report.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: