Outcomes of Using LNMES on Tracheostomized Children

Trachea Clinical Trial

Official title:

Outcomes of Using LNMES on Tracheostomized Children

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03227627
• Other study ID #: APP-16-01573
• Status: Withdrawn
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: May 1, 2020

Study information

• Verified date: July 2019
• Source: Children's Hospital Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

Inclusion Criteria:

PATIENT COHORT

• Children between 0-4 years 11 months

• Currently have tracheostomy tubes

• MBSS must indicate penetrations of more than 50% of swallows or aspiration of thin, ½ nectar-thick, nectar-thick or honey-thick liquids.

• The child must be on a modified diet of honey-thick liquids, nectar-thick liquids, ½ nectar-thick liquids, or no liquids by mouth.

• Able to tolerate a voice valve PARENT COHORT

• At least one primary caregiver of a qualifying child (see Child cohort).

• Parent/caregiver must be at least 18 years of age or older, provide primary care, and have medical decision making rights for the child.

Exclusion Criteria:

PATIENT COHORT

• Children who are not on modified diets or using a g-tube as an alternate means of nutrition

• Children with suspected or diagnosed heart problems

• Children with suspected or diagnosed epilepsy

• Children with a tendency to hemorrhage following acute trauma or fracture

• Children who have undergone recent surgical procedures when muscle contraction may disrupt the healing process

• Children for whom the LNMES would be: 1) over carotid sinus, 2) over neoplasm, 3) over active infection and 4) over areas of skin which lack normal sensation

• Children with difficulty tolerating tactile stimulation and tolerate the whole duration of the LNMES sessions.

• Children with difficulty tolerating tactile sensory stimulation such as tape and electrodes on the anterior aspect of the neck.

PARENT COHORT

• The caregiver that does not provide the primary care of the child and does not have medical decision making right

• Parents under 18

Related Conditions & MeSH terms

• Trachea

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess Quality of Swallow during the MBSS (Modified Barium Swallow Study) using the Pen-Asp scale.	The investigators will measure the change based on the patient's score of the Pen-Asp scale before and after the intervention provided.	3 months. LNMES intervention will be provided for 24 sessions during this time.
Primary	Assess safety and adequate functional oral intake using the FOIS (Functional Oral Intake Scale)	The investigators will measure the change based on the patient's score of the FOIS before and after the intervention provided.	3 months. LNMES intervention will be provided for 24 sessions during this time.
Secondary	Assess Change in Parental Stress Level using the PSI-4 (Parent Stress Index-4)	Assess changes in parental stress level after treatments have been completed using the PSI-4 scale.	3 months