Clinical trial NCT03649295: Combined Conventional Speech Therapy and Functional Electrical Stimulation in Dysphagia Following Stroke
Official title: Randomized Study of the Influence of Functional Electrical Stimulation in Patients With Dysphagia After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia, Oropharyngeal
Stroke, Ischemic
Lead sponsor: Hospital Geral de Fortaleza
Sponsor class: OTHER_GOV
First posted: 2018-08-28
Enrollment: 33
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Level of dysphagia assessed by videoendoscopy of swallowing
timeFrame: 5 days ( before and immediately after intervention)
measure: Safe food Intake assessed by Functional Scale Oral Ingestion - FOIS
timeFrame: 5 days (before and immediately after intervention)
Secondary outcomes:
measure: Clinical evaluation of swallowing through the risk assessment protocol for dysphagia - PARD
timeFrame: 5 days (before and immediately after intervention)
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Ubiversidade Federal do Ceará
state: Ceará
Study officials:
affiliation: Hospital Geral de Fortaleza
name: Klayne C Matos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.