An interventional study of Computerized neuropsychological rehabilitation and Family psychoeducational program in Ischemic Stroke, Cognitive Impairment and Quality of Life, sponsored by Althaia Xarxa Assistencial Universitària de Manresa. Active, not recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Althaia Xarxa Assistencial Universitària de Manresa · Not applicable, Interventional, and Treatment
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.
Background and rationale
Cognitive deficits are frequent after ischemic stroke and may adversely affect functional recovery, quality of life, emotional well-being, and participation in rehabilitation. Although recovery trajectories vary considerably between individuals, the early poststroke period represents an important phase of cognitive, functional, and psychosocial adaptation. Evidence regarding structured cognitive rehabilitation initiated during this early period remains limited.
Stroke also has important consequences for family members and informal caregivers. Caregivers may experience substantial burden associated with functional dependence, cognitive and behavioral changes, emotional difficulties, and the demands of providing ongoing support. Structured psychoeducational interventions may help caregivers understand the consequences of stroke and develop appropriate strategies for supporting recovery and adaptation.
This trial evaluates both dimensions simultaneously by examining computerized neuropsychological rehabilitation directed at the patient and structured family psychoeducation directed at the primary family caregiver.
Procedures
Participants are recruited during the acute phase of ischemic stroke, within 96 hours of symptom onset. Baseline assessment of the primary outcome is performed approximately 20 days after the index stroke, before randomization and before either intervention begins. Randomization is performed after completion of this baseline assessment.
Allocation is stratified according to receipt of acute reperfusion therapy, defined as intravenous thrombolysis and/or mechanical thrombectomy versus no reperfusion treatment. Reperfusion status is used as a prespecified prognostic stratification factor. Randomization is implemented through the REDCap electronic data capture system using randomly permuted blocks of variable size. The allocation sequence is inaccessible to personnel responsible for recruitment and eligibility assessment, and the next treatment assignment cannot be anticipated.
Both intervention factors begin after randomization, approximately 20 days after the index stroke, and continue for approximately 12 weeks. The primary outcome assessment is scheduled at 3 months after stroke, corresponding to 90 days ±14 days. An optional 12-month follow-up constitutes an observational extension and is not part of the primary randomized trial analysis.
Participants allocated to computerized neuropsychological rehabilitation receive 24 sessions of structured computerized cognitive training using the Guttmann NeuroPersonalTrainer platform. Sessions last 45 minutes and are delivered twice weekly over approximately 12 weeks. The sequence and duration of the cognitive exercises are standardized, while task difficulty is individually adjusted by the platform according to previous performance. The intervention targets attention, processing speed, memory, executive functions, language, visuospatial abilities, and functional transfer of trained strategies.
Participants not allocated to computerized neuropsychological rehabilitation receive an active digital control condition consisting of simple recreational digital activities matched in duration and frequency. These activities do not incorporate adaptive difficulty, structured therapeutic progression, or cognitive performance feedback.
Primary family caregivers allocated to structured family psychoeducation receive six individual 45-minute sessions delivered by videoconference approximately every 2 weeks over 12 weeks. The program includes 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 in order to preserve the conceptual independence of the two factorial intervention components.
Primary family caregivers not allocated to structured psychoeducation receive a brief informational leaflet at the approximately 20-day visit after randomization. The leaflet provides 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.
All participants continue to receive usual poststroke clinical care. Physiotherapy, occupational therapy, speech therapy, convalescence care, and other rehabilitation services may be prescribed according to clinical indication and are recorded as co-interventions.
Outcomes and analysis
The primary outcome is the CAVIDACE total direct score at 3 months after stroke, 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.
Secondary outcomes are organized into two independent prespecified families. The family associated with computerized neuropsychological rehabilitation includes the global neuropsychological composite score, Modified Rankin Scale, Barthel Index, and Lawton-Brody Instrumental Activities of Daily Living Scale. The family associated with structured family psychoeducation includes the Zarit Burden Interview, Hospital Anxiety and Depression Scale Anxiety subscale, Hospital Anxiety and Depression Scale Depression subscale, and Beck Depression Inventory-II.
The primary analysis follows the intention-to-treat principle and uses an analysis of covariance model including the main effects of both intervention factors, baseline CAVIDACE, and the randomization stratum. The F1×F2 interaction is examined in a separate exploratory model.
Exploratory biological outcomes include brain-derived neurotrophic factor, glial fibrillary acidic protein, interleukin-6, C-reactive protein, and S100 calcium-binding protein B. Acute structural magnetic resonance imaging variables include lesion volume, lesion location, vascular territory, Oxfordshire Community Stroke Project classification, and apparent diffusion coefficient. These analyses are considered exploratory and hypothesis-generating.
A prespecified Statistical Analysis Plan defining the estimands, analysis models, handling of missing data, multiplicity, and sensitivity analyses was finalized and signed before database lock and before any comparative analysis of study outcomes.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's enrollment of 81 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Althaia Xarxa Assistencial Universitària de Manresa is the lead sponsor of 21 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Non-specific recreational cognitive activities / active digital control · Other: Written information leaflet
Behavioral: Computerized neuropsychological rehabilitation · Other: Written information leaflet
Behavioral: Family psychoeducational program · Other: Non-specific recreational cognitive activities / active digital control
Behavioral: Computerized neuropsychological rehabilitation · Behavioral: Family psychoeducational program
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.
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.
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.
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.
Quality of life (CAVIDACE total direct score)
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.
Time frame: 3 months post-stroke (day 90 ± 14 days)
Global neuropsychological composite score
The global neuropsychological composite score is calculated as the unweighted mean of standardized z scores across five cognitive domains: attention and processing speed, memory and learning, language, executive functioning, and visuospatial functioning. Individual neuropsychological test scores are standardized using the corresponding normative data. At least three valid cognitive-domain scores are required to calculate the composite. Because the composite consists of standardized z scores, it has no fixed theoretical minimum or maximum. Higher scores indicate better global cognitive performance.
Time frame: 3 months post-stroke (90 days ±14 days)
Modified Rankin Scale
The Modified Rankin Scale assesses global disability after stroke on an ordinal scale ranging from 0 to 6. A score of 0 indicates no symptoms, whereas a score of 6 indicates death. Higher scores indicate greater disability and a worse outcome.
Time frame: 3 months post-stroke (90 days ±14 days)
Barthel Index
The Barthel Index assesses independence in basic activities of daily living. The total score ranges from 0 to 100. Higher scores indicate greater functional independence and a better outcome.
Time frame: 3 months post-stroke (90 days ±14 days)
Lawton-Brody Instrumental Activities of Daily Living Scale
The Lawton-Brody Instrumental Activities of Daily Living Scale assesses independence in instrumental activities of daily living. The 8-item version used in this study ranges from 0 to 8. Higher scores indicate greater independence and a better functional outcome.
Time frame: 3 months post-stroke (90 days ±14 days)
Zarit Burden Interview, 22-item version
The 22-item Zarit Burden Interview assesses perceived caregiver burden. Each item is rated from 0 to 4, yielding a total score ranging from 0 to 88. Higher scores indicate greater perceived caregiver burden and a worse outcome.
Time frame: 3 months post-stroke (90 days ±14 days)
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
The Hospital Anxiety and Depression Scale Anxiety subscale consists of 7 items and yields a total score ranging from 0 to 21. Higher scores indicate greater severity of anxiety symptoms and a worse outcome.
Time frame: 3 months post-stroke (90 days ±14 days)
Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)
The Hospital Anxiety and Depression Scale Depression subscale consists of 7 items and yields a total score ranging from 0 to 21. Higher scores indicate greater severity of depressive symptoms and a worse outcome.
Time frame: 3 months post-stroke (90 days ±14 days)
Beck Depression Inventory-II
The Beck Depression Inventory-II consists of 21 items and yields a total score ranging from 0 to 63. Higher scores indicate greater severity of depressive symptoms and a worse outcome.
Time frame: 3 months post-stroke (90 days ±14 days)
Biomarker concentrations (BDNF, GFAP, IL-6, CRP, and S100B)
Exploratory longitudinal biomarker outcomes including brain-derived neurotrophic factor, glial fibrillary acidic protein, interleukin-6, C-reactive protein, and S100 calcium-binding protein B. Biomarker concentrations are examined in relation to clinical and cognitive recovery.
Time frame: Acute hospitalization (≤96 hours after stroke), approximately 20 days after stroke, and 3 months after stroke (90 days ±14 days); optional observational assessment at 12 months
Acute structural MRI lesion characteristics
Exploratory variables derived from acute structural magnetic resonance imaging include lesion volume, lesion location, vascular territory, Oxfordshire Community Stroke Project classification, and apparent diffusion coefficient.
Time frame: Acute hospitalization (≤96 hours after stroke)
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment evaluates global cognitive performance. Total scores range from 0 to 30, with higher scores indicating better global cognitive performance.
Time frame: Acute hospitalization (≤96 hours), approximately 20 days after stroke, 3 months after stroke, and optional observational follow-up at 12 months.
Functional Ambulation Category (FAC)
The Functional Ambulation Category assesses functional walking ability. Scores range from 0 to 5, with higher scores indicating greater independence in ambulation.
Time frame: Acute hospitalization (≤96 hours), approximately 20 days after stroke, 3 months after stroke, and optional observational follow-up at 12 months.
Hessisch Oldendorf Risk of Falling Scale (HOSS)
The Hessisch Oldendorf Risk of Falling Scale assesses risk of falling. Total scores range from 0 to 22, with higher scores indicating greater risk of falling.
Time frame: Acute hospitalization (≤96 hours), approximately 20 days after stroke, 3 months after stroke, and optional observational follow-up at 12 months.
Depression Signs Scale (ESD)
The Depression Signs Scale (Escala de Signes de Depressió), developed by the Catalan Agency for Health Quality and Assessment, comprises 6 dichotomously scored items and yields a total score ranging from 0 to 6. Higher scores indicate a greater number of observed signs suggestive of mood disturbance.
Time frame: Acute hospitalization (≤96 hours), approximately 20 days after stroke, 3 months after stroke, and optional observational follow-up at 12 months.
Plan to share: Yes — Following publication of the primary trial results, deidentified individual participant data underlying the published analyses, together with the corresponding data dictionary where applicable, may be made available upon reasonable request. Access will be subject to approval by Fundació Althaia and compliance with applicable ethical, institutional, informed-consent, and data-protection requirements.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning after publication of the primary trial results.
Access criteria: Access may be granted following a reasonable scientific request, review and approval by Fundació Althaia, and compliance with applicable ethical, institutional, informed-consent, and data-protection requirements.
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Nov 2026, 12 months after the start.
Of 572 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 12 months is below that.
Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Althaia Xarxa Assistencial Universitària de Manresa