Early Neuropsychological Rehabilitation and Family Psychoeducation After Ischemic Stroke

NCT07793682 | Active Not Recruiting

• 1 other identifier: CER-21-39
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

stroke rehabilitation; neuropsychological rehabilitation; psychoeducation; caregiver; factorial design; acute phase

Outcome Measures

Primary Outcomes (1)

• Health-related quality of life (CAVIDACE total direct score)

  Total direct score of the CAVIDACE scale (Quality of Life in Acquired Brain Injury), completed by the reference family member. Score range 0 to 192; higher scores indicate better quality of life. Analysed by ANCOVA adjusting for the baseline value at day 20 and for the randomization stratum.

  3 months post-stroke (day 90 ± 14 days)

Secondary Outcomes (8)

• Global neuropsychological composite score

  3 months post-stroke

• Modified Rankin Scale

  3 months post-stroke

• Barthel Index

  3 months post-stroke

• Lawton IADL Scale

  3 months post-stroke

• Caregiver burden (Zarit)

  3 months post-stroke

Other Outcomes (2)

• Biomarks (BDNF, GFAP, IL-6, CRP, S100B)

  3 months post-stroke

• Neuroimaging

  3 months post-stroke

Study Arms (4)

Group 1: Control

ACTIVE COMPARATOR

Other: Non-specific recreational cognitive activities; Other: Written information leaflet

Group 2: Neuropsychological rehabilitation

EXPERIMENTAL

Behavioral: Computerized neuropsychological rehabilitation; Other: Written information leaflet

Group 3: Family psychoeducation

EXPERIMENTAL

Behavioral: Family psychoeducational program; Other: Non-specific recreational cognitive activities

Group 4: Combined intervention

EXPERIMENTAL

Behavioral: Computerized neuropsychological rehabilitation; Behavioral: Family psychoeducational program

Interventions

Computerized neuropsychological rehabilitation BEHAVIORAL

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.

Group 2: Neuropsychological rehabilitation; Group 4: Combined intervention

Family psychoeducational program BEHAVIORAL

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.

Group 3: Family psychoeducation; Group 4: Combined intervention

Non-specific recreational cognitive activities OTHER

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

Group 1: Control; Group 3: Family psychoeducation

Written information leaflet OTHER

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

Group 1: Control; Group 2: Neuropsychological rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First-ever ischemic stroke (transient ischemic attack excluded)
• Age 18 years or older
• Prior functional independence (modified Rankin Scale ≤ 1)
• Diagnostic criteria for ischemic stroke (TACI, PACI, LACI, POCI)
• Capacity to provide informed consent, or availability of a legal representative

You may not qualify if:

• Previous neurological or psychiatric disease associated with cognitive impairment
• Severe systemic disease
• Life expectancy under one year
• Severe stroke (NIHSS score above 19 at admission)
• Alcohol or substance abuse (tobacco excluded)
• Clinically relevant aphasia preventing comprehension of test instructions Sensory impairment preventing neuropsychological assessment
• Functional illiteracy

Sponsors & Collaborators

• Jordi Sanchez Monteagudo: lead
• University of Vic - Central University of Catalonia: collaborator

Study Sites (1)

Hospital Universitari Sant Joan de Déu de Manresa, Fundació Althaia

Manresa, Barcelona, 08243, Spain

Location

MeSH Terms

Conditions

Ischemic Stroke; Cognitive Dysfunction; Caregiver Burden

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Jordi Sanchez Monteagudo, Doctorate Student

  Hospital Universitari Sant Joan de Déu de Manresa, Fundació Althaia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the interventions, participants, their family members and the professionals delivering the interventions cannot be blinded. Outcome assessors, laboratory personnel, the neuroimaging reader and the statistician are blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Neuropsychologist, Principal Investigator

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 28, 2026
• Study Start: November 19, 2025
• Primary Completion (Estimated): November 25, 2026
• Study Completion (Estimated): March 20, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Locations

ES (1)