Effect of Oral Neuromuscular Training on Swallowing

NCT05235282 | Completed

• 1 other identifier: 764706
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia

Keywords

Dysphagia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS)

  Baseline and after four weeks

• Penetration Aspiration Scale (PAS)

  Baseline and after four weeks

• Yale Pharyngeal Residue Scale

  Baseline and after four weeks

• Milliliters of saliva above the cuff

  Daily measures for up to four weeks

• Functional oral intake (FOIS)

  Baseline and after four weeks

Study Arms (2)

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

Device: IQoro; Other: Usual care for swallowing function

Usual care

ACTIVE COMPARATOR

The comparison group receives usual training of swallowing function

Other: Usual care for swallowing function

Interventions

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.

Usual care + IQoro

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

Usual care; Usual care + IQoro

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cuff tracheostomy tube

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead
• Hammel Neurorehabilitation Centre and University Research Clinic: collaborator

Study Sites (1)

Hammel Neurorehabilitation Centre and University Research Clinic

Hammel, Central Jutland, 8450, Denmark

Location

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Deglutition

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Jesper Fabricius, PhD

  Hammel Neurorehabilitation Centre and University Research Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: February 11, 2022
• Study Start: May 6, 2022
• Primary Completion: May 10, 2024
• Study Completion: May 10, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)