An interventional study of IQoro and Usual care for swallowing function in Dysphagia, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-27.
Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment
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.
710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.
This study's enrollment of 22 is below the median of 60 across 471 interventional studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The intervention group receives usual training of swallowing function along with training 3 times each day with an IQoro oral screen
Device: IQoro · Other: Usual care for swallowing function
The comparison group receives usual training of swallowing function
Other: Usual care for swallowing function
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.
Cuff deflation, speaking valve, masako exercises, shaker exercises, coughing, stimulation of the oral cavity, neuromuscular electrical stimulation, postural control
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.
Time frame: Number of days from baseline assessment until decannulation or right censoring at 365 days
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
Time frame: 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
Time frame: 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.
Time frame: Baseline and after four weeks
Milliliters of saliva above the cuff
Daily amount of saliva above the cuff of the tracheostomy tube
Time frame: Daily measures for up to four weeks
Functional oral intake (FOIS)
FOIS range is 1-7, with 7 representing better outcome
Time frame: 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
Time frame: Baseline and after four weeks
Plan to share: No
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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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University of Aarhus