DysphagiaNCT07451028
Effect of an Oral Neuromuscular Training Device on Dysphagia
A study testing IQoro in people with Dysphagia, run by University of Aarhus at 1 site in Denmark.
Trial summary
Dysphagia is a frequent complication following stroke, with an estimated prevalence of 42%. One training modality which have been implemented in both hospitals and municipalities for alleviating dysphagia are oral neuromuscular training devices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- IQoro
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First-ever stroke
- Dysphagia assessed with the FOTT-SAS
- Age ≥ 18 years
Who cannot join
- Tracheostomy tube
- Admitted for short-term evaluation
- Lack of ability to cooperate with mouth closure
- Contraindications for using IQoro
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Hammel neurorehabilitation centre and university research clinic
Hammel, Jutland, 8450
Jesper Fabricius, PhD, +4578419051, jesperjm@hotmail.com
About this study
Official title: Effect of an Oral Neuromuscular Training Device on Dysphagia: an Assessor-blinded Randomized Controlled Trial
Dysphagia is a frequent complication following stroke, with an estimated prevalence of 42%. One training modality which have been implemented in both hospitals and municipalities for alleviating dysphagia are oral neuromuscular training devices. These devices are hand-held acrylic devices which are inserted between the lips and teeth by the patient or an assistant and pulled forward against lip pressure. According to the developers of one of these devices coined IQoro, the training strengthens the orofacial and pharyngeal muscles. One of recent studies by the developer of IQoro, have demonstrated a positive effect of IQoro in improving swallowing function and reducing clinical signs of aspiration among older people in intermediate care. However, aspiration risk was based on unblinded subjective water swallowing tests, and findings may therefore be biased. Additionally, it should be considered that the study was a cluster-randomized study, in which the intervention was performed in some care units, and the usual care was performed in other care units. Since usual care is not described in detail, results in favor of IQoro may also be due to differences in the usual care practice between care units. Focusing on individuals with stroke, only observational studies have been carried out. These studies have shown functional improvements in all four quadrants of the mouth, improved lip strength, and improved swallowing capacity. However, observational studies suffer from the inherent limitation that it is not possible to establish whether training with IQoro is actually the cause of these improvements.
The present research group recently published a small Randomized Controlled Trial (RCT), investigating the effectiveness of IQoro on swallowing function and decannulation in a very selective population of patients with cuffed tracheostomies due to severe acquired brain injury . Here, 22 subjects were randomized to either usual care, or usual care plus IQoro training as an add-on. In the study, there was no effect of IQoro in either time until decannulation, or swallowing function (as the implicit mechanism of action), compared with usual care. Patients with cuffed tracheostomy tubes are a very selective patient group, and results may not be generalized to a broader group of patients with post-stroke dysphagia.
Read more
Based on this, more high-quality clinical trials with IQoro, on a broader population of patients with dysphagia admitted for neurorehabilitation is warranted, in order to clarify whether training with IQoro have an effect on swallowing.
Aim and hypothesis The aim of this study is to investigate the effectiveness of oral neuromuscular training with IQoro on swallowing function in patients with dysphagia due to stroke. The hypothesis is that patients will have improved swallowing function because of training with IQoro as an add-on to usual care, compared with patients who only receive usual care.
Study design An assessor-blinded randomized controlled trial. Study participants will be randomly assigned to either the IQoro (intervention group) or usual care (control group). The trial will be conducted in accordance with the ethical principles outlined in the Declaration of Helsinki and approved by the Danish National Medical Research Ethics Committee
- Conditions
- Dysphagia
- Being tested
- IQoro, Usual Care
- Keywords
- Dysphagia, Stroke, Oral neuromuscular training
- Medical subject headings
- Deglutition Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IQoroDevice
Training with IQoro according to instructions for use
Usual CareBehavioural
Usual care for dysphagia, diet modification, swallowing exercises, posture
| Study group | Role | What they receive |
|---|---|---|
| IQoro | Experimental | IQoro training as an add-on to usual care Receives: Device: IQoro; Behavioral: Usual Care |
| Control | Active comparator | Usual care Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
McGill Ingestive Skills Assessment
MISA is a standardized and validated assessment tool for quantifying degree of dysphagia. MISA consist of 36 items divided in four subscales: Positioning, Self-feeding skills, liquid ingestion, and solid ingestion. Total score ranges from 36 to 108, with higher score representing better swallowing function.
Measured: From enrollment to the end of treatment at four weeks
Secondary outcomes (2)
Iowa Oral Performance Instrument (IOPI)
Measurement of lip strength
Measured: From enrollment to the end of treatment at four weeks
Dysphagia Handicap Index (DHI
Patient reported outcome on dysphagia
Measured: From enrollment to three months follow-up after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Jun 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jesper Fabricius, PhD, Principal investigator, Hammel Neurorehabilitation Centre and University Research Clinic & Department of clinical medicine, Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451028
- Sponsor's protocol ID
- 2501204
- Status last verified
- Dec 2025
- First submitted
- 27 Feb 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Oral Neuromuscular Training Device on Dysphagia: an Assessor-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07451028
- Acronym / sponsor ID
- 2501204
- Conditions
- Dysphagia
- Keywords
- Dysphagia, Stroke, Oral neuromuscular training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dysphagia is a frequent complication following stroke, with an estimated prevalence of 42%. One training modality which have been implemented in both hospitals and municipalities for alleviating dysphagia are oral neuromuscular training devices. These devices are hand-held acrylic devices which are inserted between the lips and teeth by the patient or an assistant and pulled forward against lip pressure. According to the developers of one of these devices coined IQoro, the training strengthens the orofacial and pharyngeal muscles. One of recent studies by the developer of IQoro, have demonstrated a positive effect of IQoro in improving swallowing function and reducing clinical signs of aspiration among older people in intermediate care. However, aspiration risk was based on unblinded subjective water swallowing tests, and findings may therefore be biased. Additionally, it should be considered that the study was a cluster-randomized study, in which the intervention was performed in some care units, and the usual care was performed in other care units. Since usual care is not described in detail, results in favor of IQoro may also be due to differences in the usual care practice between care units. Focusing on individuals with stroke, only observational studies have been carried out. These studies have shown functional improvements in all four quadrants of the mouth, improved lip strength, and improved swallowing capacity. However, observational studies suffer from the inherent limitation that it is not possible to establish whether training with IQoro is actually the cause of these improvements.
The present research group recently published a small Randomized Controlled Trial (RCT), investigating the effectiveness of IQoro on swallowing function and decannulation in a very selective population of patients with cuffed tracheostomies due to severe acquired brain injury . Here, 22 subjects were randomized to either usual care, or usual care plus IQoro training as an add-on. In the study, there was no effect of IQoro in either time until decannulation, or swallowing function (as the implicit mechanism of action), compared with usual care. Patients with cuffed tracheostomy tubes are a very selective patient group, and results may not be generalized to a broader group of patients with post-stroke dysphagia.
Based on this, more high-quality clinical trials with IQoro, on a broader population of patients with dysphagia admitted for neurorehabilitation is warranted, in order to clarify whether training with IQoro have an effect on swallowing.
Aim and hypothesis The aim of this study is to investigate the effectiveness of oral neuromuscular training with IQoro on swallowing function in patients with dysphagia due to stroke. The hypothesis is that patients will have improved swallowing function because of training with IQoro as an add-on to usual care, compared with patients who only receive usual care.
Study design An assessor-blinded randomized controlled trial. Study participants will be randomly assigned to either the IQoro (intervention group) or usual care (control group). The trial will be conducted in accordance with the ethical principles outlined in the Declaration of Helsinki and approved by the Danish National Medical Research Ethics Committee
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IQoro | Experimental | Device: IQoro, Behavioral: Usual CareIQoro training as an add-on to usual care |
| Control | Active comparator | Behavioral: Usual CareUsual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- First-ever stroke
- Dysphagia assessed with the FOTT-SAS
- Age ≥ 18 years
Key exclusion criteria (4 listed)
- Tracheostomy tube
- Admitted for short-term evaluation
- Lack of ability to cooperate with mouth closure
- Contraindications for using IQoro
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IQoroTraining with IQoro according to instructions for use | Device | IQoro |
| Usual CareUsual care for dysphagia, diet modification, swallowing exercises, posture | Behavioural | Control, IQoro |
Primary outcome
McGill Ingestive Skills Assessment
Time frame: From enrollment to the end of treatment at four weeks
MISA is a standardized and validated assessment tool for quantifying degree of dysphagia. MISA consist of 36 items divided in four subscales: Positioning, Self-feeding skills, liquid ingestion, and solid ingestion. Total score ranges from 36 to 108, with higher score representing better swallowing function.
2 secondary outcomes
Iowa Oral Performance Instrument (IOPI)
Time frame: From enrollment to the end of treatment at four weeks
Dysphagia Handicap Index (DHI
Time frame: From enrollment to three months follow-up after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jesper Fabricius, PhD principal investigator
Hammel Neurorehabilitation Centre and University Research Clinic & Department of clinical medicine, Aarhus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IQoro in people with Dysphagia, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jesper Fabricius, PhD (+4578419051, jesperjm@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
McGill Ingestive Skills Assessment (time frame: From enrollment to the end of treatment at four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.