Effect of Oral Neuromuscular Training on Swallowing

Effect of Oral Neuromuscular Training on Swallowing Function and Time Until Decannulation

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dysphagia
• Intervention / Treatment: Device: IQoro; Other: Usual care for swallowing function

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jesper Fabricius, PhD; Phone Number: 78419051; Email: Jesper.Fabricius@rm.dk

Study Locations

• Denmark
  • Midtjylland
    • Hammel, Midtjylland, Denmark, 8450
      • Hammel Neurorehabilitation Centre and University Research Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Cuff tracheostomy tube

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Usual care + IQoro; The intervention group receives usual training of swallowing function along with training 3 times each day with an IQoro oral screen	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
Active Comparator: Usual care; The comparison group receives usual training of swallowing function	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Hammel Neurorehabilitation Centre and University Research Clinic
• Investigators: Principal Investigator: Jesper Fabricius, PhD, Hammel Neurorehabilitation Centre and University Research Clinic

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2022
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: January 18, 2022
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (Actual): February 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Dysphagia
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: 764706

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No