Dysphagia
Conditions
Keywords
Dysphagia
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.
Interventions
DEVICEIQoro
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.
OTHERUsual care for swallowing function
Cuff deflation, speaking valve, masako exercises, shaker exercises, coughing, stimulation of the oral cavity, neuromuscular electrical stimulation, postural control
Sponsors
Hammel Neurorehabilitation Centre and University Research Clinic
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cuff tracheostomy tube
Exclusion criteria
* Not able to comply with IQoro exercises * 3 weeks evaluation stay at the hospital
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Milliliters of saliva above the cuff | Daily measures for up to four weeks | Daily amount of saliva above the cuff of the tracheostomy tube |
Countries
Denmark
Outcome results
None listed