Outcomes of Using LNMES on Tracheostomized Children

NCT03227627 | Withdrawn FDA Device

• 1 other identifier: CHLA-17-00081
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (1)

• Assess Change in Parental Stress Level using the PSI-4 (Parent Stress Index-4)

  3 months

Study Arms (2)

VitalStim

EXPERIMENTAL

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®. VitalStim® therapy involves the placement of electrodes to the muscles of the throat that is attached to a device that provides electrical stimulation. The intensity will be increased according to the subject's tolerance and when a "therapeutic" level is reached. Signs of reaching therapeutic level include changes in audible quality of swallows, triggers of swallows, and changes in quality of voice. This therapy is to be performed by a VitalStim® certified practitioner.

Device: VitalStim

Traditional therapy

ACTIVE COMPARATOR

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

Other: Traditional Therapy

Interventions

VitalStim DEVICE

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®.

VitalStim

Traditional Therapy OTHER

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

Traditional therapy

Eligibility Criteria

• Age: 30 Days - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

MeSH Terms

Conditions

Tracheal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Aviril Sepulveda

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Model Details: 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 other group (Group B) will be receiving 24 sessions of traditional dysphagia therapy. After the 24 sessions, participants will have a repeat MBSS and results will be scored using the Pen-Asp scale and FOIS scale. Both the control group and experimental group will answer the PSI-4 after the repeat MBSS.

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: July 24, 2017
• Study Start: May 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2020
• Last Updated: November 15, 2024

Record last verified: 2024-11