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Clinical Trials/NCT05102877
NCT05102877
Completed
Not Applicable

The Effect of Sensory Level Versus Motor Level Electrical Stimulation of Pharyngeal Muscles in Acute Stroke Patients With Dysphagia

Casa Colina Hospital and Centers for Healthcare1 site in 1 country31 target enrollmentSeptember 19, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke, Ischemic
Sponsor
Casa Colina Hospital and Centers for Healthcare
Enrollment
31
Locations
1
Primary Endpoint
Change in Dysphagia outcome Severity Scale
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Dysphagia is a serious cause of morbidity and mortality in stroke survivors. Electrical stimulation is often included as part of the treatment plan for dysphagia, and can be applied at a sensory or motor level intensity. However, evidence to support these different modes of stimulation is lacking. This study compared the effectiveness of sensory and motor level stimulation on post-stroke dysphagia.

Detailed Description

Objective: Dysphagia is a serious cause of morbidity and mortality in stroke survivors. Electrical stimulation is often included as part of the treatment plan for dysphagia, and can be applied at a sensory or motor level intensity. However, evidence to support sensory versus motor stimulation is lacking. This study compares the effect of sensory and motor stimulation on post-stroke dysphagia. Design: Randomized controlled trial Setting: Inpatient rehabilitation facility. Participants: Participants (50-75 years of age) who had dysphagia caused by a stroke within 6 months prior to enrollment were included. Participants were excluded if they had a contraindication for electrical stimulation, previous stroke, psychiatric disorder, contraindications for MBS, or pre-stroke swallowing disorders. Interventions: Each patient received ten, 45-minute anterior neck sensory or motor level electrical stimulation sessions in addition to standard speech therapy. Motor stimulation was administered as a stimulus intensity sufficient to produce muscle contractions. Sensory stimulation was defined as the threshold when the patient feels a tingling sensation on their skin (approximately 4-5mA). Main Outcome Measures: Swallow FIM, National Outcome Measurement System (NOMS), Dysphagia Outcome Severity Scale (DOSS), and change in modified diet.

Registry
clinicaltrials.gov
Start Date
September 19, 2018
End Date
November 30, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Emily Rosario

Director of Research

Casa Colina Hospital and Centers for Healthcare

Eligibility Criteria

Inclusion Criteria

  • acute ischemic CVA within the first month and confirmed by MRI.
  • Diagnosis of dysphagia will be obtained by bedside swallowing exam and MBS/FEES studies.

Exclusion Criteria

  • patients who have contraindications for electrical stimulation (malignancy, DVT/thrombophlebitis, hemorrhagic conditions, pregnancy, pacemaker or other electrical hardware)
  • known premorbid swallowing disorders
  • dementia or psychiatric disorder
  • bilateral cerebral involvement
  • contraindications for FEES/MBS (infectious disease such as HIV, HCV, HBV, nasal obstruction, decompensated heart disease, risk of bleeding such as active ulcers, allergy to contrast).

Outcomes

Primary Outcomes

Change in Dysphagia outcome Severity Scale

Time Frame: up to 2 months

seven-point functional outcome scale designed to assess dysphagia severity on the MBSS, lowest score = 1; highest = 7.

Change in Swallow Functional Assessment Measure

Time Frame: up to 2 months

7 point swallow scale the Functional oral intake scale (FOIS) lowest score = 1; highest = 7.

Secondary Outcomes

  • Change in Swal-Qol(up to 3 months)
  • Change in PenAsp(up to 2 months)

Study Sites (1)

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