NCT Number: NCT06306144
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
CHU de Bordeaux, Bordeaux, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Arm 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.
Arm 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
Arm 3 : No specific care.
Time frame: At the end of the study : 36 months
Difference in the Participation score (from the Participation subscale of the stroke impact scale) between the pre-intervention evaluation and the evaluation 6 months post-stroke, between the intervention and non-intervention groups
Time frame: At the end of the study : 36 months
the effects of the proposed programs will be evaluated with quality of life measured using the WHOQOL-BREF Difference in each outcome measure score between the pre-intervention evaluation and the evaluations post-intervention and at 9 months post-stroke, between the intervention and non-intervention groups.
Time frame: At the end of the study : 36 months
the effects of the proposed programs will be evaluated with cognitive complaint measured using the FACT-Cog;
Difference in each outcome measure score between the pre-intervention evaluation and the evaluations post-intervention and at 9 months post-stroke, between the intervention and non-intervention groups.
Time frame: At the end of the study : 36 months
the effects of the proposed programs will be evaluated with cognitive function (notably attentional, executive and memory functions) measured using a custom-designed battery of neuropsychological tests;
Difference in each outcome measure score between the pre-intervention evaluation and the evaluations post-intervention and at 9 months post-stroke, between the intervention and non-intervention groups.
Time frame: At the end of the study : 36 months
the effects of the proposed programs on mood and anxiety will be measured by the HADS
Difference in each outcome measure score between the pre-intervention evaluation and the evaluations post-intervention and at 9 months post-stroke, between the intervention and non-intervention groups.
Time frame: At the end of the study : 36 months
the effects of the proposed programs on fatigue will be measured by the FACIT-Fatigue
Difference in each outcome measure score between the pre-intervention evaluation and the evaluations post-intervention and at 9 months post-stroke, between the intervention and non-intervention groups.
Time frame: At the end of the study : 36 months
the effects of the proposed programs on participation will be measured by the score on the Participation subscale of the Stroke Impact Scale
Difference in each outcome measure score between the pre-intervention evaluation and the evaluations post-intervention and at 9 months post-stroke, between the intervention and non-intervention groups.
Time frame: At the end of the study : 36 months
the effects of the proposed programs on health status will be measured by EQ-5D-5L;
Difference in each outcome measure score between the pre-intervention evaluation and the evaluations post-intervention and at 9 months post-stroke, between the intervention and non-intervention groups.
Time frame: At the end of the study : 36 months
the effects of the proposed programs on the medico-economic impact of these interventions.
Difference in each outcome measure score between the pre-intervention evaluation and the evaluations post-intervention and at 9 months post-stroke, between the intervention and non-intervention groups.
Contact information is provided by the study sponsor or research team.
CHARLOIS Anne-Laure
CONTACT
PUGNIET Virginie
CONTACT
Hospices Civils de Lyon
Other
Mild Cognitive Impairment After Minor Stroke: Evaluation of Early-phase Telecare Programs (Psychoeducation and Computerized Cognitive Stimulation)
Acronym: COGaDOM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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