Back to results

Outcomes of Using LNMES on Tracheostomized Children

Primary Purpose

Trachea

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

VitalStim

Traditional Therapy

About this trial

This is an interventional treatment trial for Trachea

Eligibility Criteria

30 Days - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VitalStim

Traditional therapy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03227627

First Posted

February 27, 2017

Last Updated

July 23, 2019

Sponsor

Children's Hospital Los Angeles

1. Study Identification

Unique Protocol Identification Number

NCT03227627

Brief Title

Outcomes of Using LNMES on Tracheostomized Children

Official Title

Outcomes of Using LNMES on Tracheostomized Children

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Withdrawn

Why Stopped

We decided to go to another direction.

Study Start Date

May 1, 2017 (Actual)

Primary Completion Date

May 1, 2018 (Anticipated)

Study Completion Date

May 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trachea

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VitalStim

Arm Type

Experimental

Arm Description

Arm Title

Traditional therapy

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

VitalStim

Intervention Description

Intervention Type

Other

Intervention Name(s)

Traditional Therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Assess Quality of Swallow during the MBSS (Modified Barium Swallow Study) using the Pen-Asp scale.

Description

The investigators will measure the change based on the patient's score of the Pen-Asp scale before and after the intervention provided.

Time Frame

3 months. LNMES intervention will be provided for 24 sessions during this time.

Title

Assess safety and adequate functional oral intake using the FOIS (Functional Oral Intake Scale)

Description

The investigators will measure the change based on the patient's score of the FOIS before and after the intervention provided.

Time Frame

3 months. LNMES intervention will be provided for 24 sessions during this time.

Secondary Outcome Measure Information:

Title

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

Description

Assess changes in parental stress level after treatments have been completed using the PSI-4 scale.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Days

Maximum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aviril Sepulveda

Organizational Affiliation

Children's Hospital Los Angeles

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Outcomes of Using LNMES on Tracheostomized Children

We'll reach out to this number within 24 hrs