NCT07793682Active, not recruiting
Early Neuropsychological Rehabilitation and Family Psychoeducation After Ischemic Stroke
Efficacy of Early Neuropsychological Rehabilitation and Family Psychoeducation After Ischemic Stroke: A Randomized 2×2 Factorial Clinical Trial With Blinded Outcome Assessment
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
Cognitive impairment and reduced quality of life are frequent consequences of ischemic stroke and can also affect family caregivers, who often assume caregiving responsibilities with limited preparation. Evidence regarding rehabilitation interventions initiated during the early poststroke period remains limited. This randomized clinical trial evaluates two independent interventions initiated after baseline assessment and randomization, approximately 20 days after the index stroke: a structured computerized neuropsychological rehabilitation program for the patient and a structured psychoeducational program for the primary family caregiver. A 2×2 factorial design allows the main effect of each intervention to be estimated within a single sample and permits an exploratory assessment of their interaction. The primary outcome is quality of life at 3 months after stroke, measured using the CAVIDACE total direct score and completed by a family informant. Secondary outcomes include cognitive performance, functional status, mood, and caregiver burden. Molecular biomarkers and acute structural neuroimaging variables are examined as exploratory outcomes.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 81 (actual)
- First submitted
- 26 Aug 2026
- Start date
- 19 Nov 2025
- Primary completion date
- 25 Nov 2026
- Lead sponsor
- Althaia Xarxa Assistencial Universitària de Manresa
- Diseases
- Stroke
- NCT number
- NCT07793682
What you commit to
- Study type: Interventional
- Participants enrolled: 81
- From 19 Nov 2025 to the primary completion date, 25 Nov 2026
- 1 site 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.
Prior treatment
- Previous neurological or psychiatric disease associated with cognitive impairment
Other illness
- Severe systemic disease
- Severe stroke, defined as a National Institutes of Health Stroke Scale score \>19 at admission
- Sensory impairment preventing valid neuropsychological assessment or use of the intervention materials, such as severe visual or hearing impairment
Other
- Life expectancy of less than 1 year
- Alcohol or other substance abuse, excluding tobacco use
- Clinically relevant aphasia preventing comprehension of neuropsychological test instructions, operationalized as a score \<5 on the fluency subscale of the Western Aphasia Battery
- Functional illiteracy, defined as inability to read and understand simple written instructions
Who the study is looking for
- First-ever ischemic stroke, excluding transient ischemic attack
- Age 18 years or older
- Inclusion within 96 hours of symptom onset
- Functional independence before the index stroke, defined as a prestroke Modified Rankin Scale score ≤1
- Diagnosis of ischemic stroke classified according to the Oxfordshire Community Stroke Project as total anterior circulation infarction, partial anterior circulation infarction, posterior circulation infarction, or lacunar infarction
- Capacity to provide written informed consent at enrollment or, in cases of temporary incapacity, availability of a legally authorized representative to provide consent on the participant's behalf, followed by participant re-consent if decision-making capacity is regained
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari Sant Joan de Déu de Manresa, Fundació Althaia Coordinator of this site? Confirm its status | Manresa | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.