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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05235282
Other study ID # 764706
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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