Smartwatch-Guided Secondary Prevention After Stroke (NCT07640360) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Smartwatch-Guided Secondary Prevention After Stroke
France50 participantsStarted 2026-09
Plain-language summary
After a first stroke or transient ischemic attack (TIA), the risk of recurrence is high in the weeks and months following the initial event. There are several modifiable risk factors that can reduce this risk, such as blood pressure, diet, physical activity, and smoking. Many stroke patients (NIHSS \< 5) have a low daily step count during the early recovery period, despite a good functional prognosis.
Active smartwatches provide real-time feedback, track progress, and set personalized walking goals, thereby boosting motivation and adherence to physical activity recommendations.
The combination of advice provided by nurses and active behavioral coaching supported by a smartwatch, compared to passive monitoring, could significantly increase daily step counts over a 12-week period. The results of this research will help guide future large-scale secondary prevention strategies integrating digital health and structured nursing support.
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is not yet recruiting — do you know when it's expected to open, and should I be doing anything now in the meantime to improve my activity levels after my stroke or TIA?
2The study compares a smartwatch that gives you active feedback versus one that just tracks steps passively, both alongside a nurse-led activity program — do you think the nurse-led program itself, separate from the smartwatch component, is something that would benefit me right now?
3Since this trial measures daily step count over 12 weeks, how realistic is that kind of walking goal given my current recovery, and are there any physical limitations from my stroke or TIA that might make participation difficult?
4Because this trial is listed as Phase NA — meaning it's more of a behavioral or device study than a drug trial — what are the main risks or downsides you'd want me to think through before I consider enrolling when it opens?
5Are there existing stroke or TIA secondary prevention programs, like supervised exercise or cardiac rehab, that I could start now rather than waiting for this trial, and how would you compare those options to what this study is testing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine whether the addition of an active smartwatch providing structured feedback to a nurse-led activity program produces a significantly greater increase in daily step count over 12 weeks compared with the same program paired with a passive smart