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

NCT ID: NCT03649295

Last Updated: 2020-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-20
• Study Completion Date: 2020-07-26

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.

Conditions

Dysphagia, Oropharyngeal; Stroke, Ischemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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 therapy should be performed in conjunction with functional electrostimulation

-Conventional speech therapy with laryngeal elevation exercises, stimulation of oral reflexes, tongue movements, lips and cheeks, gustatory therapy

Group Type: EXPERIMENTAL

Functional Electrical Stimulation

Intervention Type: OTHER

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

Intervention Type: OTHER

Conventional speech therapy with laryngeal elevation exercises, stimulation of oral reflexes such as swallowing reflex, tongue movements, lips and cheeks, gustatory therapy

Placebo

Sham.The electrodes are placed at 0 Hz

-Conventional speech therapy with laryngeal elevation exercises, stimulation of oral reflexes, tongue movements, lips and cheeks, gustatory therapy

Group Type: PLACEBO_COMPARATOR

Conventional Speech Therapy

Intervention Type: OTHER

Conventional speech therapy with laryngeal elevation exercises, stimulation of oral reflexes such as swallowing reflex, tongue movements, lips and cheeks, gustatory therapy

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Geral de Fortaleza

OTHER_GOV

Sponsor Role: lead

Responsible Party

Klayne Cunha Matos

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Klayne C Matos, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Geral de Fortaleza

Locations

Ubiversidade Federal do Ceará

Fortaleza, Ceará, Brazil

Countries

Brazil

References

Matos KC, de Oliveira VF, de Oliveira PLC, Carvalho FA, de Mesquita MRM, da Silva Queiroz CG, Marques LM, Lima DLN, Carvalho FMM, Braga-Neto P. Combined conventional speech therapy and functional electrical stimulation in acute stroke patients with dyphagia: a randomized controlled trial. BMC Neurol. 2022 Jun 22;22(1):231. doi: 10.1186/s12883-022-02753-8.

Reference Type: DERIVED

PMID: 35733098 (View on PubMed)

Other Identifiers

2388931

Identifier Type: -

Identifier Source: org_study_id