Effect of Oral Neuromuscular Training on Swallowing

Study Overview
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Brief Summary
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In this randomized controlled trial the investigators wish to investigate the effect of an oral neuromuscular training device (called IQoro) on swallowing function and time until decannulation from a tracheostomy tube, in patients admitted for neurorehabilitation due to a severe acquired brain injury.

Official Title
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Effect of Oral Neuromuscular Training on Swallowing Function and Time Until Decannulation

Conditions
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Dysphagia

Intervention / Treatment
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* Device: IQoro
* Other: Usual care for swallowing function


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cuff tracheostomy tube Exclusion Criteria: Not able to comply with IQoro exercises 3 weeks evaluation stay at the hospital

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Usual care + IQoro<br>The intervention group receives usual training of swallowing function along with training 3 times each day with an IQoro oral screen | Device: IQoro<br>* An acrylic mouth guard with a pulling loop. The mouth guard is placed in the mouth of the patient on the outside of the teeth. The therapist pulls the loop in different directions and the patient try to close his/her mouth on the mouth guard to keep it inside the mouth.<br>Other: Usual care for swallowing function<br>* Cuff deflation, speaking valve, masako exercises, shaker exercises, coughing, stimulation of the oral cavity, neuromuscular electrical stimulation, postural control<br>|
| Active Comparator: Usual care<br>The comparison group receives usual training of swallowing function | Other: Usual care for swallowing function<br>* Cuff deflation, speaking valve, masako exercises, shaker exercises, coughing, stimulation of the oral cavity, neuromuscular electrical stimulation, postural control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days from admission until decannulation | Time from admission until decannulation from a tracheostomy tube. For patients still admitted, decannulation is determined from the clinicians and documented i medical records. For discharged patients, decannulation is determined through medical records. | Number of days from baseline assessment until decannulation or right censoring at 365 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS) | FEDSS is a scale used for Fiberoptic Endoscopic Evaluation of Swallowing. FEDSS range is 1-6, with lower scores representing better outcome | Baseline and after four weeks | 
| Penetration Aspiration Scale (PAS) | PAS is a scale used for Fiberoptic Endoscopic Evaluation of Swallowing. PAS range is 1-8, with lower scores representing better outcome | Baseline and after four weeks | 
| Yale Pharyngeal Residue Scale | Yale Pharyngeal Residue Scale is a scale used for Fiberoptic Endoscopic Evaluation of Swallowing. The Yale Scale encompass two subscales with score 1-5 on each scale, with 1 representing better outcome. | Baseline and after four weeks | 
| Milliliters of saliva above the cuff | Daily amount of saliva above the cuff of the tracheostomy tube | Daily measures for up to four weeks | 
| Functional oral intake (FOIS) | FOIS range is 1-7, with 7 representing better outcome | Baseline and after four weeks | 
| Iowa Oral Performance Instrument (IOPI) | Lip strength measured with the IOPI. Measured in Pascal with greater values representing greater strength | Baseline and after four weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dysphagia