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

NCT03649295 | Completed DMC

• 1 other identifier: 2388931
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia, Oropharyngeal; Stroke, Ischemic

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (1)

• Clinical evaluation of swallowing through the risk assessment protocol for dysphagia - PARD

  5 days (before and immediately after intervention)

Study Arms (2)

Functional Electrical Stimulation

EXPERIMENTAL

\- 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

Other: Functional Electrical Stimulation; Other: Conventional Speech Therapy

Placebo

PLACEBO COMPARATOR

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

Other: Conventional Speech Therapy

Interventions

Functional Electrical Stimulation 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

Functional Electrical Stimulation

Conventional Speech Therapy OTHER

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

Functional Electrical Stimulation; Placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Geral de Fortaleza: lead

Study Sites (1)

Ubiversidade Federal do Ceará

Fortaleza, Ceará, 60430-160, Brazil

Location

Related Publications (1)

• 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.

  PMID: 35733098 DERIVED

MeSH Terms

Conditions

Deglutition Disorders; Ischemic Stroke

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Klayne C Matos, MD

  Hospital Geral de Fortaleza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 28, 2018
• Study Start: September 20, 2018
• Primary Completion: July 26, 2020
• Study Completion: July 26, 2020
• Last Updated: October 20, 2020

Record last verified: 2020-10

Locations

BR (1)