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

Stroke, Ischemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03649295
• Other study ID #: 2388931
• Status: Completed
• Phase: N/A
• Start date: September 20, 2018
• Est. completion date: July 26, 2020

Study information

• Verified date: October 2020
• Source: Hospital Geral de Fortaleza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 26, 2020
• Est. primary completion date: July 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Stroke - ischemic type;
• Dysphagia following stroke;
• 40 to 70 years old;
• Exclusive enteral Feeding;
• Glasgow > 11.

Exclusion Criteria:

• Pregnants;
• Febrile Condition;
• Neoplasia;
• Pacemaker;
• Cochlear Implant;
• Anxious Patient;
• Degenerative Neurological Diseases.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia, Oropharyngeal
• Stroke
• Stroke, Ischemic

Intervention

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
• 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

Locations

Country	Name	City	State
Brazil	Ubiversidade Federal do Ceará	Fortaleza	Ceará

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Geral de Fortaleza

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of dysphagia assessed by videoendoscopy of swallowing	Anatomical Evaluation:Tongue, palate, pharynx, larynx - normal or specify changes; Functional Evaluation: Mobility (lips/tongue), tongue's sensitivity, palatine veil's closure - adequate or inadequate; Pharynx - salivary/alimentary stasis; Larynx - normal, decreased mobility, unilateral or bilateral immobility; Deglutition assessment (liquid, thick, pasty and solid foods): -Delay of swallowing, anterior/posterior escape, stasis in vallecula/pyriform sinuses, laryngeal penetration, laryngotracheal aspiration - present or absent; Functional swallowing: alteration in anatomical or functional evaluation with absence of salivary/alimentary stasis Mild dysphagia: there is also salivary or food stasis in only one consistency with efficient maneuvers such as lowered head, Masako or effortless swallowing Moderate dysphagia: there is also laryngeal penetration to one or more consistencies Severe dysphagia: there is also laryngotracheal aspiration or absence of swallowing reflex	5 days ( before and immediately after intervention)
Primary	Safe food Intake assessed by Functional Scale Oral Ingestion - FOIS	Measured by the Functional Oral Ingestion Scale (FOIS). FOIS results are rated on a scale of 1 to 7 levels. The levels will increase according to the safe amount of oral diet ingested by the patient safely.; Level1 - nothing by mouth; Level 2 - tube dependent with minimal attempts of Food or liquid; Level 3 - tube dependent with consistence oral Intake of Food or liquid; Level 4 - total oral diet of a single consistency; Level 5 - total oral diet with multiple consistencies but requiring special preparation or compensations; Level 6 - total oral diet with multiplex consistencies without special preparation, but with specific Food limitations; Level 7 - total oral diet with no restrictions.	5 days (before and immediately after intervention)
Secondary	Clinical evaluation of swallowing through the risk assessment protocol for dysphagia - PARD	Before feeding: Comprehensive language, oral reflexes(vomiting, trismus, deglutition) and sialorrhea- present or absent; Inside oral and facial sensitivity- present or reduced; During feeding (liquid, thick and pasty): Captation, anterior and posterior escape, cough reflex and gagging- present or absent; Oral transit time, number of swallowing, laryngeal elevation- adequate or inadequate; Voice normal or "wet"; Functional swallowing- there are changes that do not compromise safe feeding as reduced sensitivity (intra-oral or facial), anterior escape due to small anatomical or functional changes Mild dysphagia- multiple swallowing, inadequate laryngeal elevation, "wet" voice but cough reflex efficient Moderate dysphagia- multiple swallowing, inadequate laryngeal elevation, "wet" voice, weak cough reflex and gagging one or more consistencies Severe dysphagia- when there is no evidence of coughing, swallowing reflexes or gagging difficult to recover	5 days (before and immediately after intervention)