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We decided to go to another direction.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Traditional therapy | Active Comparator | The other group (Group B) will be receiving 24 sessions of traditional dysphagia therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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®. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
PATIENT COHORT
Exclusion Criteria:
PATIENT COHORT
PARENT COHORT
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| Name | Affiliation | Role |
|---|---|---|
| Aviril Sepulveda | Children's Hospital Los Angeles | Principal Investigator |
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| ID | Term |
|---|---|
| D014133 | Tracheal Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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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.
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| Traditional Therapy | Other | The other group (Group B) will be receiving 24 sessions of traditional dysphagia therapy. |
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