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Clinical Trials/NCT04421937
NCT04421937
Completed
N/A

The Effects of Neuromuscular Electrical Stimulation on Swallowing Functions in Stroke Patients With Dysphagia: Randomized Controlled Trial

Istanbul University1 site in 1 country34 target enrollmentApril 15, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Istanbul University
Enrollment
34
Locations
1
Primary Endpoint
Change in Functional Oral Intake Scale (FOIS)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

In our study, our aim is to evaluate the effect of neuromuscular electrical stimulation added to traditional dysphagia therapy in stroke patients with dysphagia, on functional oral intake status, dysphagia-related symptoms, quality of life, and complications related to dysphagia.

Registry
clinicaltrials.gov
Start Date
April 15, 2020
End Date
February 16, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elif Tarihçi

Principal Investigator

Istanbul University

Eligibility Criteria

Inclusion Criteria

  • After the first week after a stroke, detecting dysphagia by using bedside water assessment test
  • Lesion location is shown by MRI or CT
  • Unsupported sitting balance
  • The score of Mini-mental state examination test (MMSE) 20 and above
  • Over 18 years old

Exclusion Criteria

  • Global aphasia or cognitive disorders that may affect the understanding of the instructions
  • Patients with major medical problems that may affect participation
  • Tracheostomy presence
  • Previous neck surgery
  • To have received radiotherapy in the head or neck area
  • Presence of a cardiac pacemaker or a history of epilepsy

Outcomes

Primary Outcomes

Change in Functional Oral Intake Scale (FOIS)

Time Frame: before intervention, immediately after intervention, 3 months after the intervention

Functional Oral Intake Scale (FOIS) is a scale that shows the functional oral intake of patients with dysphagia. FOIS used for evaluation is a two part scale consisting of 7 levels. It is used to show whether the individual is dependent on the feeding tube and the level of oral intake. On this scale, 7 shows the best and 1 shows the worst functional oral intake. The change in FOIS will be our primary outcome measure in our research. It has been evaluated as an appropriate tool to demonstrate the change in functional oral intake in stroke patients. It is suitable as an independent measure of functional oral intake in prospective studies of stroke-related dysphagia.

Secondary Outcomes

  • Change in Eating Assessment Tool-10 (EAT-10) Score(before intervention, immediately after intervention, 3 months after the intervention)
  • Change in Swallowing-related Quality of Life (SWAL-QOL) Score(before intervention, immediately after intervention, 3 months after the intervention)
  • Change in Voice-Related Quality of Life (V-RQOL) Score(before intervention, immediately after intervention, 3 months after the intervention)
  • Change in Visual Analog Scale (VAS)(before intervention, immediately after intervention, 3 months after the intervention)
  • Change in Laryngostroboscopy Examination(before intervention, immediately after intervention)
  • Change in Fiberoptic Endoscopic Evaluation of Swallowing (FEES)(before intervention, immediately after intervention)

Study Sites (1)

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