Effect of Oral Neuromuscular Training on Swallowing

Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05235282
• Other study ID #: 764706
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 6, 2022
• Est. completion date: May 2024

Study information

• Verified date: April 2024
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cuff tracheostomy tube

Exclusion Criteria:

• Not able to comply with IQoro exercises

• 3 weeks evaluation stay at the hospital

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

Device:
• IQoro
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.

Other:
• Usual care for swallowing function
Cuff deflation, speaking valve, masako exercises, shaker exercises, coughing, stimulation of the oral cavity, neuromuscular electrical stimulation, postural control

Locations

Country	Name	City	State
Denmark	Hammel Neurorehabilitation Centre and University Research Clinic	Hammel	Midtjylland

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Hammel Neurorehabilitation Centre and University Research Clinic

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Milliliters of saliva above the cuff	Daily amount of saliva above the cuff of the tracheostomy tube	Daily measures for up to four weeks
Secondary	Functional oral intake (FOIS)	FOIS range is 1-7, with 7 representing better outcome	Baseline and after four weeks
Secondary	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