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NCT07640360Not yet recruiting

Smartwatch-Guided Secondary Prevention After Stroke

WATCH-STEP : Pilot Trial: Smartwatch-Guided Secondary Prevention After Stroke Randomized Trial of Nurse-led Program With Active vs Passive Smartwatch in Minor Stroke. A Randomized Controlled Trial Evaluating a Nurse-led Secondary Prevention and Physical Activity Program Supported by Either an Active Smartwatch (Structured Feedback) or Passive Smartwatch in Patients With Minor Stroke.

Source: ClinicalTrials.gov · Last updated 10 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
50 (estimated)
First submitted
29 May 2026
Start date
1 Sept 2026
Primary completion date
31 Dec 2027
Lead sponsor
University Hospital, Brest
Diseases
Stroke
NCT number
NCT07640360

What you commit to

  • Study type: Interventional
  • Planned participants: 50
  • From 1 Sept 2026 to the primary completion date, 31 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Other

  • 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
  • Life expectancy \<1 year.
  • Already highly active (\>10,000 steps/day, or about 1.5 hours of walking).
  • Participation in competing interventional trials.

Who the study is looking for

  • 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.

Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chu Brest
Coordinator of this site? Confirm its status
BrestFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.