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Can a smart breathing device boost recovery after stroke?

NCT ID NCT07276477

Symptom relief Sponsor: Uşak University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 21, 2026 · Updated 3 times

Summary

This study tests whether using a mobile breathing trainer (AiroFit PRO™) for 6 weeks can improve lung function, muscle strength, and quality of life in people with hemiplegia (paralysis on one side) after a stroke. 54 adults who are at least 3 months post-stroke will be randomly assigned to use the device or do standard breathing exercises. The goal is to see if the device offers extra benefits over traditional methods.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AiroFit PRO™ mobile respiratory trainer
What this could lead to
If it works, this could offer a simple, at-home breathing exercise device to help stroke survivors breathe better and feel stronger.
What could go wrong
This is a small, early-stage trial with only 54 people. The device may not prove better than standard breathing exercises, and results may not apply to all stroke patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

54 people

The number who actually took part.

Started

Jan 2026

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Clinical Diagnosis: A confirmed diagnosis of unilateral hemiplegia or hemiparesis (e.g., secondary to ischemic or hemorrhagic stroke), sustained at least 3 months prior to enrollment. * Age: Aged between 18 and 80 years. * Stable Medical Condition: Medically stable, as determined by the treating physician, with no changes in their primary rehabilitation regimen or medication for spasticity/neurological condition in the past 4 weeks. * Cognitive \& Communication Ability: Sufficient cognitive function and language comprehension to understand and follow simple commands and provide informed consent, as assessed by a Mini-Mental State Examination (MMSE) score of ≥ 24 (or a similar validated tool). * Respiratory Status: Able to perform forced expiratory maneuvers for spirometry and tolerate the breathing training protocols. Exclusion Criteria: * Pre-existing, significant respiratory diseases (e.g., severe COPD, asthma, pulmonary fibrosis, active lung cancer). * Unstable cardiovascular conditions (e.g., uncontrolled hypertension, unstable angina, recent myocardial infarction within the past 6 months, congestive heart failure NYHA Class III or IV). * Inability to achieve a proper seal with the breathing trainer mouthpiece due to facial muscle weakness or other anatomical reasons. * Inability to commit to the 6-week training and assessment schedule

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Conditions

The condition(s) this trial relates to.

hemiplegia lung disorder Motor Activity stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Exercise Pulmonary Stroke

Contacts and locations

Locations

  • University of Usak

    Uşak, 64200, Turkey (Türkiye)

More trials for these conditions

Other studies related to the condition(s) this trial covers.