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Not Yet RecruitingNCT06306144

Early-phase Telecare Programs for Minor Stroke

Mild Cognitive Impairment After Minor Stroke: Evaluation of Early-phase Telecare Programs (Psychoeducation and Computerized Cognitive Stimulation)

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
80 (estimated)
Sponsor
Hospices Civils de Lyon · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

Minor strokes (few acute neurological symptoms ; NIHSS score \<5), represent almost 65% of cerebrovascular ischemic events. The increasing incidence of stroke in people under 65, together with advances in diagnostic and revascularization techniques, mean that post-stroke life expectancy is now in the order of decades. Most patients with minor stroke are rapidly discharged from hospital, with follow-up focused on secondary prevention and they are offered little or no rehabilitation. However, up to 70% of patients with minor stroke experience difficulties resuming their social or professional activities, which can lead to social and economic disruption (delayed/compromised return to work) and an increased risk of depression. While some care recommendations exist for this population, in France there is no consensus nor identified care pathway for follow-up assessment or management of these patients. Furthermore, existing services are unevenly distributed across the country, and research into the effectiveness of rehabilitation is still scarce, leading to uncertainty as to which interventions should be prioritized to decrease difficulties related to cognitive impairment. Since there are currently no rehabilitation proposals in France for patients with mild cognitive impairment after mild stroke, in this trial the investigaror will investigate the effectiveness of two six-week telerehabilitation programs each consisting of a weekly session supervised by a therapist and a self-rehabilitation session. The aim of this multicenter randomized controlled trial is the evaluate the relevance and feasibility of early identification of patients eligible for a cognition-focused management proposal and the efficacy of two telecare programs, (a) psychoeducation and (b) computerized cognitive rehabilitation.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPsychoeducationArm 1 : Psychoeducation aims to inform patients about post-stroke cognitive impairment, teach them coping strategies to compensate for these difficulties, provide information on symptom recognition and management, and offer emotional and psychological support to help them meet the challenges associated with these potential cognitive impairments.
BEHAVIORALComputerised Cognitive StimulationArm 2 :Patients will participate in a 6-week cognitive stimulation telerehabilitation intervention, that will consist of two 45-minute sessions per week. Each week they will participate in a 45-minute on-line session with a rehabilitation clinician and later in the week will complete 45 minutes of on-line exercises set by the rehabilitation clinician
BEHAVIORALUsual CareArm 3 : No specific care.

Timeline

Start date
2025-05-01
Primary completion
2027-09-01
Completion
2028-06-01
First posted
2024-03-12
Last updated
2025-04-18

Locations

3 sites across 1 country: France

Source: ClinicalTrials.gov record NCT06306144. Inclusion in this directory is not an endorsement.