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Can a smartwatch prevent a second stroke?

NCT ID NCT07640360

Disease control Sponsor: University Hospital, Brest 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests whether an active smartwatch that gives real-time feedback, combined with regular nurse coaching, can help people who had a minor stroke or TIA walk more each day. Fifty participants will be randomly assigned to either an active smartwatch or a passive one that just tracks steps. The goal is to see if the active group increases their daily steps by at least 1,500 over 12 weeks, which could lower the risk of another stroke.

What this could mean

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

Active substance
smartwatch with structured feedback and nurse-led coaching
What this could lead to
If successful, this approach could help stroke survivors increase physical activity and lower their risk of another stroke.
What could go wrong
This is a small pilot trial with only 50 participants, so results may not apply broadly. The intervention relies on patient motivation and technology adherence.

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

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

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

40 to 75 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: * Age ≤ 40-75 * Patients with recent minor ischemic stroke or TIA, initial NIHSS ≤5 (\< 30 days) * mRS ≤2 before stroke and on discharge * Patient with Wifi access (for data transmission) * Able to understand smartwatch instructions * Written informed consent * Ambulatory ≥10 meters without assistance and without walking aid * Expected to live at home during the study period. Exclusion Criteria: * Patients with transient neurological deficits resolving within one hour and normal brain imaging will be excluded * Not affiliated to social security * Patient under legal protection or deprived of liberty by a judicial or administrative decision * Patient whose follow-up will be impossible * Cognitive impairment interfering with participation (e.g., MoCA \<20). * Unstable cardiac conditions preventing walking goals. * Major visual or upper limb impairment preventing use of the smartwatch. * Life expectancy \<1 year. * Already highly active (\>10,000 steps/day, or about 1.5 hours of walking). * Participation in competing interventional trials.

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Conditions

The condition(s) this trial relates to.

ischemic stroke stroke disorder transient ischemic attack

As listed by the trial registrant

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

Stroke Transient ischemic attack

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Brest

    Brest, 29200, France

More trials for these conditions

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