Effect of Oral Neuromuscular Training on Swallowing

NCT ID: NCT05235282

Last Updated: 2024-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-06

Study Completion Date

2024-05-10

Brief Summary

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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.

Detailed Description

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Conditions

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Dysphagia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual care + IQoro

The intervention group receives usual training of swallowing function along with training 3 times each day with an IQoro oral screen

Group Type EXPERIMENTAL

IQoro

Intervention Type 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 for swallowing function

Intervention Type OTHER

Cuff deflation, speaking valve, masako exercises, shaker exercises, coughing, stimulation of the oral cavity, neuromuscular electrical stimulation, postural control

Usual care

The comparison group receives usual training of swallowing function

Group Type ACTIVE_COMPARATOR

Usual care for swallowing function

Intervention Type OTHER

Cuff deflation, speaking valve, masako exercises, shaker exercises, coughing, stimulation of the oral cavity, neuromuscular electrical stimulation, postural control

Interventions

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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.

Intervention Type DEVICE

Usual care for swallowing function

Cuff deflation, speaking valve, masako exercises, shaker exercises, coughing, stimulation of the oral cavity, neuromuscular electrical stimulation, postural control

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Cuff tracheostomy tube

Exclusion Criteria

* Not able to comply with IQoro exercises
* 3 weeks evaluation stay at the hospital
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hammel Neurorehabilitation Centre and University Research Clinic

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jesper Fabricius, PhD

Role: PRINCIPAL_INVESTIGATOR

Hammel Neurorehabilitation Centre and University Research Clinic

Locations

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Hammel Neurorehabilitation Centre and University Research Clinic

Hammel, Central Jutland, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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764706

Identifier Type: -

Identifier Source: org_study_id

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