JMIR Publications

ABSTRACT

Background:

Poststroke cognitive impairment can adversely affect functional recovery, quality of life, emotional well-being, and family functioning. Computerized cognitive rehabilitation and family-directed psychoeducational interventions may address complementary components of recovery, but their independent and combined effects during the early poststroke period remain insufficiently characterized.

Objective:

This study aims to evaluate the independent effects of early computerized neuropsychological rehabilitation and structured family psychoeducation on quality of life after ischemic stroke using a randomized 2×2 factorial design. Secondary objectives are to assess effects on cognitive and functional recovery, caregiver burden, and emotional outcomes and to explore the interaction between both intervention factors and complementary biological and neuroimaging outcomes.

Methods:

This single-center randomized controlled trial uses a 2×2 factorial design evaluating computerized neuropsychological rehabilitation (F1: present vs absent) and structured family psychoeducation (F2: present vs absent). Participants are allocated to 4 groups: active computerized control plus informational material (G1), computerized neuropsychological rehabilitation plus informational material (G2), active computerized control plus family psychoeducation (G3), or both active interventions (G4). Computerized neuropsychological rehabilitation comprises 24 sessions delivered twice weekly over approximately 12 weeks, while family psychoeducation comprises 6 individual sessions delivered approximately every 2 weeks. The primary outcome is the CAVIDACE total direct score at 3 months after stroke (90 days ±14 days), adjusted for the corresponding baseline score obtained approximately 20 days after stroke. The primary analysis follows the intention-to-treat principle using factorial analysis of covariance to estimate the main effects of F1 and F2, adjusting for baseline CAVIDACE and reperfusion stratum. The F1×F2 interaction is prespecified as exploratory. Secondary outcomes include a global neuropsychological composite score, modified Rankin Scale, Barthel Index, Lawton-Brody Instrumental Activities of Daily Living Scale, Zarit Burden Interview, Hospital Anxiety and Depression Scale, and Beck Depression Inventory-II. Missing data, intercurrent events, multiplicity, and sensitivity analyses are prespecified in a Statistical Analysis Plan finalized before database lock and comparative outcome analysis.

Results:

Recruitment was completed in July 2026. A total of 81 participants were randomized across the 4 factorial groups: 20 to G1, 20 to G2, 20 to G3, and 21 to G4. Follow-up assessments are ongoing, and completion of primary 3-month outcome collection is expected by November 25, 2026. At the time of manuscript preparation, the study database had not been locked and no comparative analyses of primary, secondary, or exploratory outcomes had been performed.

Conclusions:

This trial will provide evidence on the independent effects of early computerized neuropsychological rehabilitation and structured family psychoeducation after ischemic stroke while allowing their potential interaction to be explored. Its factorial design, active computerized control, blinded assessment of selected outcomes, and prespecified statistical analysis are intended to strengthen interpretation of the effects of patient- and family-directed rehabilitation strategies during early poststroke recovery. Clinical Trial: ClinicalTrials.gov NCT07793682; https://clinicaltrials.gov/study/NCT07793682