Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorUniversity of Aarhus
Academic / other
Locations1 site (Hammel, Jutland)
StatusRecruiting
StartedJune 1, 2026
Main results expectedDecember 31, 2027
Study endsDecember 31, 2027
Registry record updatedJuly 7, 2026
Trial IDNCT07451028 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.