NCT06306144Not yet recruiting
Early-phase Telecare Programs for Minor Stroke
Mild Cognitive Impairment After Minor Stroke: Evaluation of Early-phase Telecare Programs (Psychoeducation and Computerized Cognitive Stimulation)
Source: ClinicalTrials.gov · Last updated 18 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 28 Feb 2024
- Start date
- 1 May 2025
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- Hospices Civils de Lyon
- Diseases
- Stroke
- NCT number
- NCT06306144
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 1 May 2025 to the primary completion date, 1 Sept 2027
- 3 sites 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
- History of stroke
- Uncorrected hearing or visual impairment
- Neurological pathology other than stroke or disabling psychiatric disorder
- Unstabilized epilepsy
- Undergoing cognitive rehabilitation in another context or having integrated a post-stroke therapeutic education program
Other
- Living in a white zone that does not allow for remote rehabilitation
- Unable to connect to the Internet
- Pregnant, parturient or breast-feeding women\* (interview data)
- Persons deprived of their liberty by judicial or administrative decision
- Persons admitted to a health or social institution for purposes other than research
- Adults under legal protection (guardianship, curatorship)
- Taking part in other interventional research involving a period of exclusion still in progress at pre-inclusion
Who the study is looking for
- Man or woman, aged between 18 and 65 years old
- Hospitalization for a first stroke
- Minor stroke: NIHSS score \< 5 on discharge from neurovascular unit
- Post-stroke delay \< 8 weeks
- Living at home (not institutionalized)
- Affiliated with social security or benefiting from such a scheme
- French language
- Presence of a cognitive complaint (FACT-Cog "perceived cognitive impairments" subscale score \< 55) and absence of major cognitive impairment
- Signature of informed consent
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| CHU Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Hôpital Henry Gabrielle Coordinator of this site? Confirm its status | Saint-Genis-Laval | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.