Early Neuropsychological Rehabilitation and Family Psychoeducation After Ischemic Stroke

Condition(s) studied

Investigational drug(s) / intervention(s)

Computerized neuropsychological rehabilitation: Structured computerized cognitive training using the Guttmann NeuroPersonalTrainer platform. The intervention comprises 24 sessions of 45 minutes, delivered twice weekly over approximately 12 weeks, starting after randomization approximately 20 days after the index stroke. The sequence and duration of cognitive exercises are standardized, while task difficulty is individually adjusted by the platform according to previous performance.

Family psychoeducational program: Six individual 45-minute sessions delivered by videoconference to the primary family caregiver approximately every 2 weeks over 12 weeks. The program covers stroke education, the role of the family in recovery, emotional management, behavioral difficulties, cognitive restructuring, relaxation, self-compassion, mindfulness-based coping strategies, and behavioral activation. Caregivers are not trained in cognitive rehabilitation techniques.

Non-specific recreational cognitive activities / active digital control: Simple recreational digital activities matched to the computerized neuropsychological rehabilitation condition in session duration and frequency. The activities do not incorporate adaptive difficulty, structured therapeutic progression, or cognitive performance feedback.

Written information leaflet: A brief informational leaflet provided at the approximately 20-day visit after randomization. The leaflet includes general information about stroke and its physical, communicative, cognitive, emotional, and behavioral consequences, together with recommended educational resources. It does not include behavioral management strategies, structured psychoeducational techniques, or cognitive rehabilitation training.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Quality of life (CAVIDACE total direct score) — 3 months post-stroke (day 90 ± 14 days)
  The CAVIDACE scale (Quality of Life in Acquired Brain Injury) is completed by a family informant. The total direct score ranges from 0 to 192, with higher scores indicating better quality of life. The corresponding CAVIDACE score obtained approximately 20 days after stroke is used as the baseline covariate in the primary analysis.

Trial sites (1)

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