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| Name | Class |
|---|---|
| Hammel Neurorehabilitation Centre and University Research Clinic | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care + IQoro | Experimental | The intervention group receives usual training of swallowing function along with training 3 times each day with an IQoro oral screen |
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| Usual care | Active Comparator | The comparison group receives usual training of swallowing function |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IQoro | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Penetration Aspiration Scale (PAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesper Fabricius, PhD | Hammel Neurorehabilitation Centre and University Research Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammel Neurorehabilitation Centre and University Research Clinic | Hammel | Central Jutland | 8450 | Denmark |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| ID | Term |
|---|---|
| D003679 | Deglutition |
| ID | Term |
|---|---|
| D004068 | Digestive System Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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| Usual care for swallowing function | Other | Cuff deflation, speaking valve, masako exercises, shaker exercises, coughing, stimulation of the oral cavity, neuromuscular electrical stimulation, postural control |
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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 |
| 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 |
| Milliliters of saliva above the cuff | Daily amount of saliva above the cuff of the tracheostomy tube | Daily measures for up to four weeks |
| Functional oral intake (FOIS) | FOIS range is 1-7, with 7 representing better outcome | 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 | Baseline and after four weeks |
| D010038 | Otorhinolaryngologic Diseases |