Effect of Oral Neuromuscular Training on Swallowing

Not Applicable

Completed

• Conditions: Dysphagia
• Interventions: Device: IQoro; Other: Usual care for swallowing function

• Registration Number: NCT05235282
• Lead Sponsor: University of Aarhus

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-18
• Study First Submitted QC: 2022-02-01
• Study First Posted: 2022-02-11
• Study Start: 2022-05-06
• Status Verified: 2024-04
• Primary Completion: 2024-05-10
• Study Completion: 2024-05-10
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Cuff tracheostomy tube

Exclusion Criteria

• Not able to comply with IQoro exercises
• 3 weeks evaluation stay at the hospital

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care + IQoro	IQoro	The intervention group receives usual training of swallowing function along with training 3 times each day with an IQoro oral screen
Usual care	Usual care for swallowing function	The comparison group receives usual training of swallowing function
Usual care + IQoro	Usual care for swallowing function	The intervention group receives usual training of swallowing function along with training 3 times each day with an IQoro oral screen

Primary Outcome Measures

Name	Time	Method
Number of days from admission until decannulation	Number of days from baseline assessment until decannulation or right censoring at 365 days	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hammel Neurorehabilitation Centre and University Research Clinic; 🇩🇰 Hammel, Midtjylland, Denmark