NCT03227627

Outcomes of Using LNMES on Tracheostomized Children

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Children's Hospital Los Angeles · Academic / Other
• Sex: All
• Age: 30 Days – 5 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2017-05-01
• Primary completion: 2018-05-01
• Completion: 2020-05-01
• First posted: 2017-07-24
• Last updated: 2024-11-15

Regulatory

• FDA-regulated device study