Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06306144
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-02-28
Brief Title:
Early-phase Telecare Programs for Minor Stroke
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Mild Cognitive Impairment After Minor Stroke Evaluation of Early-phase Telecare Programs psychoeducation and Computerized Cognitive Stimulation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COGaDOM
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 delayedcompromised 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
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 delayedcompromised 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None