Smartwatch-Guided Secondary Prevention After Stroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorUniversity Hospital, Brest
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Smartwatch-Guided Secondary Prevention after Stroke
Other interventionSetting daily walking goals, assessing obstacles Regular phone calls (twice a week) to review progress, adjust goals, and provide support
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: "Passive" Smartwatch armNo intervention 0 interventions
Group B: "Active" Smartwatch armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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
Difference in steps/day at 12 weeks between both arms (average of the final 14 valid days) (target Δ ≥ 1500)
Time frame
Week 12Secondary outcomes
1
To evaluate feasibility to smartwatch wear
Wear-time adherence at W6 and W12
Time frame
Week 6 and Week 122
To evaluate adherence to smartwatch wear
System Usability Scale (SUS) at W6 and W12
Time frame
Week 6 and Week 123
To evaluate acceptability of digital feedback.
TAM (technology Acceptance Model) at W6 and W12
Time frame
Week 6 and Week 124
To assess the impact of active smartwatch feedback on sedentary time.
Resting time (excluding sleep) at baseline, W6 and W12
Time frame
day 1 to week 12Sponsors and contacts
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Source ClinicalTrials.gov
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