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Outcomes of Using LNMES on Tracheostomized Children

NCT03227627 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-11-15

No results posted yet for this study

Summary

Tracheostomy tubes are known to have a negative impact on swallowing. Dysphagia treatment includes using laryngoneuromuscular electrical muscular stimulation (LNMES). Evidence exist on the efficacy of LNMES in the treatment of dysphagia in adults, and scarce in pediatrics. There is no literature available for the efficacy of LNMES in the treatment of dysphagia on patients with tracheostomy tubes. The purpose of this study to determine the outcomes on dysphagia on children with tracheostomy tubes when treated using LNMES. Furthermore, the investigators aim to determine the relationship between parental stress and a child's modified diet.

Conditions

  • Trachea

Interventions

DEVICE

VitalStim

One group of children (Group A) will receive 24 sessions of NMES for combined with traditional therapy including oral motor exercises and laryngeal exercises will be performed to the participants. The equipment to be used for NMES is VitalStim®. VitalStim is a product of Empi®.

OTHER

Traditional Therapy

The other group (Group B) will be receiving 24 sessions of traditional dysphagia therapy.

Sponsors & Collaborators

Principal Investigators

  • Aviril Sepulveda · Children's Hospital Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Days
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2018-05-01
Completion
2020-05-01
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03227627 on ClinicalTrials.gov