NCT03649295

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

Randomized Study of the Influence of Functional Electrical Stimulation in Patients With Dysphagia After Stroke

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Hospital Geral de Fortaleza · Other Government
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dysphagia, Oropharyngeal
• Stroke, Ischemic

Interventions

Type	Name	Description
OTHER	Functional Electrical Stimulation	Functional electrical stimulation device obeying the following steps: Muscle heating - 2 min, 10 Hz, 250 μm; Potentiation of muscle fibers type I - 8 min, 30 Hz, 250 μm; Potentiation of muscle fibers type II - 8 min, 80 Hz, 300 μm; Toning - 8 min, 30 Hz, 300 μm; Muscle Relaxation - 4 min, 5 Hz, 200 μm One channel of electrodes will be placed in the submental region and the other in the thyroid. Treatment should be started at minimum levels of intensity, increasing carefully until appropriate effects are achieved in the procedure
OTHER	Conventional Speech Therapy	Conventional speech therapy with laryngeal elevation exercises, stimulation of oral reflexes such as swallowing reflex, tongue movements, lips and cheeks, gustatory therapy

Timeline

• Start date: 2018-09-20
• Primary completion: 2020-07-26
• Completion: 2020-07-26
• First posted: 2018-08-28
• Last updated: 2020-10-20

Locations

1 site across 1 country: Brazil