Early Neuropsychological Rehabilitation and Family Psychoeducation After Ischemic Stroke

Summary

Cognitive impairment and reduced quality of life are frequent consequences of ischemic stroke, and they also affect the patient's family, who often assume a caregiving role without preparation. Most rehabilitation trials begin three to four months after the acute event, and evidence about earlier intervention is scarce.

This randomized clinical trial evaluates two independent interventions initiated 20 days after hospital admission: a structured computerized neuropsychological rehabilitation program for the patient, and a psychoeducational program for the main caregiver. A 2×2 factorial design allows the main effect of each intervention to be estimated within a single sample, as well as their potential interaction.

The primary outcome is health-related quality of life at 3 months post-stroke, measured with the CAVIDACE scale and reported by the reference family member. Secondary outcomes include cognitive performance, functional status, mood and caregiver burden. Molecular biomarkers and structural neuroimaging variables are examined as exploratory prognostic factors.

Conditions

• Ischemic Stroke
• Cognitive Impairment
• Quality of Life
• Caregiver Burden

Interventions

BEHAVIORAL

Computerized neuropsychological rehabilitation

Structured computerized cognitive training program (Guttmann NeuroPersonalTrainer). 24 sessions of 45 minutes, twice weekly over 12 weeks, starting after randomization at day 20 post-admission.

BEHAVIORAL

Family psychoeducational program

Six individual 45-minute sessions delivered fortnightly by videoconference to the main caregiver, covering stroke information, the family role in recovery, emotional management, behavioral difficulties, cognitive therapy techniques and behavioral activation.

OTHER

Non-specific recreational cognitive activities

Simple recreational digital activities without adaptive difficulty, performance feedback or structured progression, matched in duration and frequency to the experimental program.

OTHER

Written information leaflet

Informational leaflet on stroke, its consequences and available community resources, provided at hospital discharge.

Sponsors & Collaborators

• University of Vic - Central University of Catalonia

  collaborator OTHER

• Jordi Sanchez Monteagudo

  lead OTHER

Principal Investigators

• Jordi Sanchez Monteagudo, Doctorate Student · Hospital Universitari Sant Joan de Déu de Manresa, Fundació Althaia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-19

Primary Completion

2026-11-25

Completion

2027-03-20

Countries

• Spain

Study Locations