Oral neuromuscular training device to help swallowing after stroke
Official title: Effect of an Oral Neuromuscular Training Device on Dysphagia: an Assessor-blinded Randomized Controlled Trial
Run by University of Aarhus · NCT07451028 · Data updated 2026-11-12
This trial tests whether using an oral neuromuscular training device helps people who recently had a stroke and have swallowing difficulties.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Hammel, Jutland) |
| Status | Recruiting |
| Started | June 1, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | July 7, 2026 |
| Trial ID | NCT07451028 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with a first-ever stroke and validated dysphagia (FOTT-SAS) who can cooperate with mouth closure and do not have a tracheostomy or other contraindications.
✕Probably not a fit
Patients who cannot use the device due to cooperation issues, contraindications, or those whose dysphagia is not responsive to this type of training may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study examines an oral neuromuscular training device (IQoro) used with usual care to help dysphagia after first-ever stroke. Participants must be adults with stroke-related dysphagia confirmed by FOTT-SAS and must not have a tracheostomy or other contraindications. The device is used as a home or clinical exercise tool to strengthen lip, tongue, and pharyngeal muscles, with outcomes compared to usual care alone. The study is conducted at Hammel neurorehabilitation centre and a university research clinic in Denmark, led by the University of Aarhus.
Why it matters
Potential benefit: If successful, patients may experience improvements in swallowing function and reduced risk of aspiration.
How similar studies have gone: Prior studies in similar devices suggested potential benefits but had limitations, so results remain to be confirmed in a blinded or more rigorous design.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * First-ever stroke * Dysphagia assessed with the FOTT-SAS * Age ≥ 18 years Exclusion Criteria: * Tracheostomy tube * Admitted for short-term evaluation * Lack of ability to cooperate with mouth closure * Contraindications for using IQoro
Where it's running
-
Hammel neurorehabilitation centre and university research clinic
Hammel, Jutland, Denmark Recruiting
Study contacts
- Principal investigator: Jesper Fabricius, PhD — Hammel Neurorehabilitation Centre and University Research Clinic & Department of clinical medicine, Aarhus University
- Study coordinator: Jesper Fabricius, PhD
- Email: jesperjm@hotmail.com
- Phone: +4578419051
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.