Combined Conventional Speech Therapy & Functional Electrical Stimulation

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03649295
Study type	Interventional
Source	Hospital Geral de Fortaleza
Contact
Status	Completed
Phase	N/A
Start date	September 20, 2018
Completion date	July 26, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Combined Conventional Speech Therapy and Functional Electrical Stimulation in Dysphagia Following Stroke

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms