Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06306144 | NOT YET RECRUITING | Minor Stroke

Early-phase Telecare Programs for Minor Stroke
Sponsor:

Civil Hospices of Lyon

Brief 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.

Condition or disease

Minor Stroke

Intervention/treatment

Psychoeducation

Computerised Cognitive Stimulation

Usual Care

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 80 participants
Masking : NONE
Primary Purpose : HEALTH_SERVICES_RESEARCH
Official Title : Mild Cognitive Impairment After Minor Stroke: Evaluation of Early-phase Telecare Programs (psychoeducation and Computerized Cognitive Stimulation)
Actual Study Start Date : 2025-02-01
Estimated Primary Completion Date : 2027-07-01
Estimated Study Completion Date : 2028-04-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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
Exclusion Criteria
  • * 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
  • * 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
Early-phase Telecare Programs for Minor Stroke

Location Details

NCT06306144

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

France,

Bordeaux University Hospital

Bordeaux, France, 33000

Not yet recruiting

France,

CHU Lille

Lille, France, 59037

Not yet recruiting

France,

Henry Gabrielle Hospital

Saint-Genis-Laval, France, 69230